Pfizer

Skin & localized to injection site symptom reports

Female, 40 - 59 years

Age Reported Symptoms Notes
40 2020-12-31 injection site pain, injection site warmth, injection site redness, injection site swelling Injection site swelling, redness, warm to touch, mildly tender that did not start until today-11 day... Read more
Injection site swelling, redness, warm to touch, mildly tender that did not start until today-11 days after injection. I had none of the above directly after or in the 48 hours after the injection. There was absolutely no tenderness to injection site.
40 2020-12-31 injection site pain Sore arm at the site x 3 days. that evening fatigue, myalgias. at 4 am the next morning awoke with a... Read more
Sore arm at the site x 3 days. that evening fatigue, myalgias. at 4 am the next morning awoke with abdominal pain, nausea, then an episode of liquid stool. These continued throughout the next day until the evening of day 2. By morning of day 3 they were gone
40 2021-01-01 rash Rash throughout scalp, face, neck, ears,torso,thighs,legs, arms, back, itchy throat and ears. Benad... Read more
Rash throughout scalp, face, neck, ears,torso,thighs,legs, arms, back, itchy throat and ears. Benadryl 50 mg Pepcid 40 mg Prednisone 60 mg The rash started after 1 hour. Took 25 mg benadryl then by 9 pm it got worse, took another 25 mg benadryl without improvement. Continue taking benadryl next day and took pepcid by 12 noon the next day. Following day 22nd December the patient went to hospital ER at 1200 noon. There got prescribed 60 mg prednisone PO with benadryl 50 mg and pepcid 20 mg. Received instructions to continue taking same dose for another 4 days.
40 2021-01-01 itchy skin itching sensation. No rash. No shortness of breath. No anaphylaxis.
40 2021-01-02 injection site numbness, injection site pain, injection site tingling Axilla lymph node swelling with tenderness and soreness 6 days post vaccine. No other symptoms. Ini... Read more
Axilla lymph node swelling with tenderness and soreness 6 days post vaccine. No other symptoms. Initial symptoms after receiving the covid vaccine was slight numbness and tingling of left arm where injection was. This resolved within the first hour. However, did have some left neck soreness and ache, as well as injection site soreness in left arm for three days
40 2021-01-03 vaccination site swelling, vaccination site redness Extreme swelling and erythema at vaccination site, mild pain, multiple episodes of diarrhea.
40 2021-01-03 hives, rash Hives/rash on both arms and chest
40 2021-01-03 injection site mass I got my left arm pit, lump on it, I have bigger than 1 cm 2 lumps, hidradenitis/Pain under my arm; ... Read more
I got my left arm pit, lump on it, I have bigger than 1 cm 2 lumps, hidradenitis/Pain under my arm; Patient received Pfizer Covid-19 Vaccine who is a nursing mom; Patient received Pfizer Covid-19 Vaccine who is a nursing mom; Mastitis; I got Myalgia all over the body, especially on my shoulders and back; I had chills but my temperature was normal; This is a spontaneous report from a contactable physician (patient herself). This physician reported information for herself (mother) and baby. This is the mother case. A 40-year-old female patient received her first dose of bnt162b2 (BNT162B2, also reported as Pfizer Covid-19 Vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on 20Dec2020 18:30 at single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient informed that she got in her left shoulder and left arm pit, lump on it. It was bigger than 1 cm 2 lumps, hidradenitis under her pits arm same size on 21Dec2020. She also reported that she was nursing mom to her self-kid which is 16 months old. She had Mastitis right now (20Dec2020) and informed that she hadn't it her life before. She got her vaccine on Sunday (20Dec2020) in night. She started to have pain under her arm on monday afternoon (21Dec2020) and then since yesterday (20Dec2020) she had mastitis. The mastitis in the right side, lump and the in the left side, which was the site of the vaccine. She never got a fever but got myalgia all over the body, especially on her shoulders and back and also she had chills but her temperature was normal. The outcome of events was unknown. Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on the close temporal relationship, the association between the event mastitis with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020520371 Fetal case
40 2021-01-03 injection site mass, injection site pain Patient immediate burning in her shoulder. Puncture site found to be too high for deltoid. Contacted... Read more
Patient immediate burning in her shoulder. Puncture site found to be too high for deltoid. Contacted Pfizer and IM/ID physician. Will re vaccinate in 5 days. Arm very painful, lump under acromion process. Feels like bursitis.
40 2021-01-03 hives local- soreness systemic/local-urticaria
40 2021-01-04 rash Angioedema; This is a spontaneous report from a contactable Other Health Professional (patient). A 4... Read more
Angioedema; This is a spontaneous report from a contactable Other Health Professional (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL1284, intramuscular in the right arm (also reported as right shoulder), first dose on 22Dec2020 00:30 at a single dose for Covid-19 immunization. The patient's relevant medical history included severe reaction to some animal dander and pollen, severe reactions to poison oak, possible drug induced reactions (unspecified) post C-section, mild rash with influenza vaccine this year (2020) (with no other hx of adverse reaction to a vaccine); had allergies to pollen, mold, some animals. The patient previously took influenza vaccine (split virion, inactivated) and experienced rash. The patient had no covid prior vaccination nor was she tested post vaccination. Adverse event reported was angioedema on 24Dec2020 with outcome of recovering. Systems started appearing on 23Dec2020 evening with slight rash and fluid collection under right eye. Developed more rash on 24Dec2020. In the evening to early morning of 25Dec2020, symptoms worsened significantly. Rapid swelling to face occurred. Swelling was concentrated around eyes and cheeks the most. Both right and left side of the face and neck were affected. However, the right side face had a more pronounced reaction. MD ordered oral prednisone and Benadryl as treatment plan. Also, ordered episode-pen for a worst case scenario. Symptoms have been improving under treatment but still persist some. The events were reported as non-serious. The adverse event start date was 24Dec2020 (as reported). The event resulted in doctor or other healthcare professional office/clinic visit.; Sender's Comments: There is a reasonable possibility that the event angioedema was related to BNT162b2 based on known drug safety profile and temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
40 2021-01-04 itchy skin, hives Hives, wheezing,SOB,itching, Tingling in tongue initially. 01/05/2021 Fever 100.8, headache and join... Read more
Hives, wheezing,SOB,itching, Tingling in tongue initially. 01/05/2021 Fever 100.8, headache and joint pain Treated with Albuterol inhaler and Benadryl 25mg x2
40 2021-01-04 hardening One week post Injection, on 12/28, I noticed a hard lump on my left clavicle (about 1.5 inches in s... Read more
One week post Injection, on 12/28, I noticed a hard lump on my left clavicle (about 1.5 inches in size)-same side as injection. It was painful and partially mobile. No other symptoms other than those of headache a few days prior mentioned below. I went to urgent care on 12/29 where CXR and soft tissue ultrasound were ordered. CXR normal. US 12/30 showed cluster of lymph nodes in that area. Lump appears to be smaller this week and not painful. Also, I developed a severe migraine on 12/26 (5d post vaccine). So severe that it was debilitating which is unusual for me. It lasted approximately 36 hours.
40 2021-01-04 rash Rash on legs and arms developed 12-24 hours after vaccine administered. Lasted one day. Treated with... Read more
Rash on legs and arms developed 12-24 hours after vaccine administered. Lasted one day. Treated with OTC medication.; This is a spontaneous report from a contactable consumer. This consumer reported for a 40-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730) on 23Dec2020 at single dose in left arm for covid-19 immunization. Medical history was not reported. Concomitant drug was Spironolactone in two weeks. It was reported that patient experienced Rash on legs and arms developed 12-24 hours after vaccine administered on 23Dec2020. Lasted one day with outcome was recovered. Treated with OTC medication. Patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient not been tested for COVID-19. No Allergies to medications, food, or other products. No follow up attempts are needed. No further information is expected.
40 2021-01-05 vaccination site pain Burning when the medication was injected; Injection was given under the shoulder bone instead of the... Read more
Burning when the medication was injected; Injection was given under the shoulder bone instead of the deltoid muscle; This is a spontaneous report from a Pfizer-sponsored program. A contactable healthcare professional (patient) reported that a 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration under the shoulder bone (arm), on 30Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history included use of multivitamin for a healthy lifestyle. The patient's concomitant medication included ongoing unspecified multivitamin. The patient received the COVID-19 vaccine this morning (30Dec2020) as she works in a COVID unit. The injector put it under her shoulder bone and not in the deltoid muscle; injection was given under the shoulder bone instead of the deltoid muscle. The patient complained of it burning - started when the medication was injected. The patient also asked if this was good enough and if it will it be effective. The patient was recovering from the event.
40 2021-01-05 injection site pain I received the vaccine at 1050hrs on 12/16/20. At around 0900hrs on 12/18/20, I began to experience... Read more
I received the vaccine at 1050hrs on 12/16/20. At around 0900hrs on 12/18/20, I began to experience severe fatigue. At ~1330 on the same day, I had a mildly elevated temperature - normal baseline for me is 97.6, with that reading at 99.4. Due to the fatigue, I slept from 1400 hrs until 0500 on the following day, 12/19/20. No other symptoms to report besides a tender injection site for the first 48 hours.
40 2021-01-05 rash, hives, redness Patient became anxious, felt her throat closing and pressure in her chest. Pulse rate increased. R... Read more
Patient became anxious, felt her throat closing and pressure in her chest. Pulse rate increased. Rash noted initially on arms, chest, and back. Palms of hand became very red. Shortly after, she became hoarse, and hives were noted on chest and neck.
40 2021-01-05 itchy skin, rash Received vaccine in left arm the morning of 12/23/2020. Developed itchy palms and rash on torso the ... Read more
Received vaccine in left arm the morning of 12/23/2020. Developed itchy palms and rash on torso the evening on 12/25/2020. Took Benadryl at onset. Did not seek medical attention. Reported incident on 01/06/2021. Rash almost gone, remaining only on left hand and very faded.
40 2021-01-05 vaccination site itchiness, vaccination site redness, vaccination site warmth, vaccination site swelling Red, raised, itchy bump at the insertion site that is warm to the touch. I am now over 48 hours sinc... Read more
Red, raised, itchy bump at the insertion site that is warm to the touch. I am now over 48 hours since getting the vaccination.; Red, raised, itchy bump at the insertion site that is warm to the touch. I am now over 48 hours since getting the vaccination.; Red, raised, itchy bump at the insertion site that is warm to the touch. I am now over 48 hours since getting the vaccination.; Red, raised, itchy bump at the insertion site that is warm to the touch. I am now over 48 hours since getting the vaccination.; This is a spontaneous report from a non-contactable nurse who reported for herself. A 40-year-old female patient received first single dose of BNT162B2 (Pfizer/BioNTech Covid-19 vaccine, Lot number: EL0140) intramuscularly at right arm at 10:00 AM on 29Dec2020 for Covid-19 immunization. The patient received the vaccine in hospital. The patient had a history of hypothyroidism and had known allergies to sulfa. Concomitant medications in two weeks included Levothyroxine, amlodipine, losartan, drospirenone, ethinylestradiol betadex clathrate (YAZ), tizanadine, montelukast sodium (SINGULAIR), terbinafine (LAMISIL), cetirizine hydrochloride (Zyrtec). At 12:00PM on 29Dec2020, the patient developed red, raised, itchy bump at the insertion site that was warm to the touch. No treatment was received. The events had not resolved at the time of reporting. The reporter considered the events were non-serious. No follow-up attempts are possible. No further information is expected.
40 2021-01-05 injection site pain, injection site reaction Top of Right shoulder has been very soar and painful. This is week 3 of symptoms. My range of motion... Read more
Top of Right shoulder has been very soar and painful. This is week 3 of symptoms. My range of motion is limited and I have swelling on the top of my shoulder as well. Can hear popping and clicking in my shoulder when I try to do range of motion as well.
40 2021-01-05 injection site pain Very fatigue the next day after vaccine. I had whole body tiredness. My arm was very sore and starte... Read more
Very fatigue the next day after vaccine. I had whole body tiredness. My arm was very sore and started about 3am . The site was fine but the deltoid and tricep muscles were very sore.
40 2021-01-05 itchy skin, injection site warmth Warmth at injection site Warm all over body Itchy tingling on my lips. Same feeling I have when I ea... Read more
Warmth at injection site Warm all over body Itchy tingling on my lips. Same feeling I have when I eat shrimp.
40 2021-01-05 hives Weak, nausea, hives, high fever 102.9 for 16 hours, chills, joint pain (arms, hips, legs and back), ... Read more
Weak, nausea, hives, high fever 102.9 for 16 hours, chills, joint pain (arms, hips, legs and back), symptoms improved after 32 hours. Loss of voice at 42 hours but has since came back.
40 2021-01-05 vaccination site swelling, injection site pain, vaccination site redness, vaccination site itchiness, vaccination site hardening a red area at the injection site /growing red spot at injection site; raised area at the injection s... Read more
a red area at the injection site /growing red spot at injection site; raised area at the injection site/It was raised; irritated area at the injection site/really irritated; sore arm/arm it would wake her up with pain; itching /painful itchy growing red spot at injection site; normal pain at the injection site; there was an induration there; This is a spontaneous report from a contactable physician reporting for herself. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. Caller was a ER Physician who received her COVID 19 vaccine last Monday 21Dec2020, and was reporting adverse event at injection site. She reported a red, raised, irritated area at the injection site, stated "thought I got bit by something" and didn't link it to the vaccination, originally. She took Benadryl, treated it like cellulitis by using a heating pad, and applied cortisone. She stated it was persistently getting worse, even seemed worse last night. She had been taking pictures of the skin reaction and wanted to know if there was a way to submit those for follow-up/monitoring. It was also reported painful itchy growing red spot at injection site was reported as worsened. Caller had the vaccine 10 days ago, which was last Monday. She didn't notice at first. She had the normal pain at the injection site. She woke up 3-4 days later, and she felt like she got bit by something. It was a little red. It was painful, itchy, and really irritated. She paid attention to it 3 days ago. She thought this wasn't right. When sleeping on that arm it would wake her up with pain. So she would switch sides. She started taking pics of it yesterday. The redness is getting bigger. She was an Emergency Medicine Physician. She didn't have a prescribing doctor. She got it at (Institution name). She noticed it was there when she first got the shot. It felt like a normal flu shot, and she was fine. She worked out the next day. She had a sore arm like usual with any type of a shot a Tetanus shot or something. She didn't notice anything out of the ordinary until later on, and there was an induration there. It was raised, red, and kind of warm. It was painful and itchy at the same time. It was almost like if a tag in the back of clothes were rubbing it, and she couldn't move all day. There would be an irritated area there. It is getting bigger. Now it was starting to go around her arm. It was not terrible debilitating. She was not allergic to anything. She has put cortisone cream on it, but it didn't change anything. Then, last night, she tried cortisone cream and Neosporin a little later. She then put a medium hot heating pad on it for a nice chunk of the night. It was growing near her lymph nodes now. She said the vial size looked to be about 10 mL. It was a small vial. The nurse did say she could get one more dose out of that vial. She did take Benadryl to sleep at night. So she didn't feel like it was an allergic reaction. Benadryl-Unysom expiration- May2022 Lot: 20E330 Cortisone: Lot: 11885 The Cortisone's lot number was imprinted, and hard to see. The outcome of the events were not resolved.
40 2021-01-05 vaccination site redness, vaccination site pain hsv-1 outbreak; sore arm redness and bruising at site; sore arm redness and bruising at site; sore a... Read more
hsv-1 outbreak; sore arm redness and bruising at site; sore arm redness and bruising at site; sore arm redness and bruising at site; This is a spontaneous report from a contactable physician. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL1204), intramuscular into the left arm on 23Dec2020 at 18:00 as single dose for COVID-19 immunization. Medical history included herpes simplex 1 (HSV1) from an unknown date. The patient's concomitant medications were not reported. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There were no allergies to medications, food, or other products. On 27Dec2020, patient experienced HSV-1 outbreak and sore arm redness and bruising at site. This was elaborated as 4- 5 days post vaccine, there was marked HSV-1 outbreak, different than typical outbreak and that was not responding to valacyclovir hydrochloride (VALTREX). There was also sore arm redness and bruising at site. The events were not serious. Therapeutic measures were taken as a result of the events as aforementioned (valacyclovir hydrochloride). The outcome of events, HSV-1 outbreak and sore arm redness and bruising at site was not recovered.
40 2021-01-06 shingles After 10 mins of shot had hot flash, nagging headache, nausea in waves. Driving home more hot flash... Read more
After 10 mins of shot had hot flash, nagging headache, nausea in waves. Driving home more hot flashes and nausea, pain in left hip. Got really sleepy. Had problems with left hip, problem getting out of car very stiff. Couldn't stand on the left leg. Had stinging with every step. Burning sensation in the hip. Right arm started having nagging pain with tingling, took Tylenol. Tried to get out of bed, left hip felt like something was poking with fire. Saw bumps on hip, left back. Upper arm was still having tinge. Took Benadryl. Next morning woke up with lesions on left hip, some ruptured that felt like acid and then form a scab. The right arm started with the lesions. Went to urgent care. Dr. diagnosed patient with shingles. Patient questions the Shingles at her age. Pt was given Valtrex for the shingles.
40 2021-01-06 hives, itchy skin Angioedema & UrticariaPruritus
40 2021-01-06 injection site pain Developed chills, fever (102), headache, body aches, back pain, sore arm at injection site. I had co... Read more
Developed chills, fever (102), headache, body aches, back pain, sore arm at injection site. I had covid March 2020.
40 2021-01-06 skin warm, redness, itchy skin Localized swelling/redness/warmth/soreness that started on the day after vaccine. I thought it was j... Read more
Localized swelling/redness/warmth/soreness that started on the day after vaccine. I thought it was just a normal vaccine reaction because I have had those in the past. It seemed to get a little smaller and less red/warm in the next few days but then started to get more red and swollen in the past 24-48 hours. It has been a week since the vaccine. It is itching some now for the past 2 days as well.
40 2021-01-06 itchy skin, hives On Monday January 4th I received my Covid-19 vaccine at work, at 410pm. That evening went uneventful... Read more
On Monday January 4th I received my Covid-19 vaccine at work, at 410pm. That evening went uneventful. The following day, Tuesday January 5th I woke up with a sore right arm and a slight headache. The headache increased in intensity throughout the day, developing also body aches and a fever of 100.4. The symptoms seemed to improve slightly after taking Tylenol. The next day, Wednesday January 6th I felt much better, the body aches were almost gone, I had no fever and no headache. When I got home from work I noticed hives all over my arms, anterior and posterior neck - going into the hairline, face, especially around my mouth, chest, abdomen, upper and lower back. The affected areas were itchy and I also felt a slight burning/stinging sensation on my neck. Even though I did not notice any hives on my legs, my right ankle was itchy, as well. I took Claritin 10 mg and I did not notice much difference. When I woke up today, Wednesday January 7th the hives were still present on my arms, chest, abdomen and back and they looked like dissipating. It is currently 6:12 pm on January 7th and my hives are almost gone
40 2021-01-06 rash with redness, rash papular, itchy skin Patient describe itching of back. Red, slightly raised rash noted across shoulders. Administered 25 ... Read more
Patient describe itching of back. Red, slightly raised rash noted across shoulders. Administered 25 mg Benadryl PO. Patient waited additional 20 minutes. Rash persists. Patient described sensation of slight itching on legs. Denies and shortness of breath or itching of throat. Patient advised not to drive if she felt any sleepiness. She verbalized understanding.
40 2021-01-06 injection site swelling Severe muscle pain, that went into back, and all the way down to fingers of left hand. Swelling at i... Read more
Severe muscle pain, that went into back, and all the way down to fingers of left hand. Swelling at injection site, and then swelling and tingling in left hand. and head ache. Symptoms didn't subside until day 3. Still have pain in left arm that radiates down to elbow. All other symptoms subsided.
40 2021-01-06 rash rash on arms and torso; shortness of breath, and body aches
40 2021-01-07 rash Acute allergic reaction Tongue swelling Facial swelling Throat swelling Rash on throat and chest Re... Read more
Acute allergic reaction Tongue swelling Facial swelling Throat swelling Rash on throat and chest Redness in throat Diaphoresis Momentary loss of consciousness
40 2021-01-07 redness, rash Around at 7AM when I arrived at work I started feeling chills, took temperature 99.5F that is alread... Read more
Around at 7AM when I arrived at work I started feeling chills, took temperature 99.5F that is already elevated for me. About 9:30 my temp was 101.8F and they sent me home. I just had the chills and fever. I got home and developed a headache and around 1PM I started feeling really dizzy. The temperature did not subside and the next day I woke up and I couldn't function, I felt really dizzy I kept laying down and drinking water, I could not keep anything down my stomach did not feel well. I felt like I had to vomit. When I sat down in the toilet then my ears started ringing pretty bad all of a sudden I could not hear anything and I passed out in the toilet. My husband found me and tried to wake me up. After that I still feel dizzy. I did not have any appetite either. I could barely hold water. The next day I was not as dizzy but my stomach was still upset but I could hold some soup down but then started with diarrhea. Employee health kept calling me everyday and I did the the telehealth appt and I also had a little bit of a rash in my chest that appeared all of a sudden red like a streak. The dizziness I had for the first 4 days, diarrhea did not come until the 3rd day and I had it for 2 days and my temperature was back to normal on the 4th day. Everything started to get better (my stomach stopped feeling queezy) around the 4th day but still felt fatigued until about 12/29/2020.
40 2021-01-07 itchy skin Employee woke with sensory disturbance on left side of face itchy sensation, left eyelid and bottom ... Read more
Employee woke with sensory disturbance on left side of face itchy sensation, left eyelid and bottom lip droop, left ear pain. She was ordered steroids by her PCP.
40 2021-01-07 sensitive skin Fever, muscle/body aches. Stiff neck Arm VERY sore. Woke up the night after receiving with cold s... Read more
Fever, muscle/body aches. Stiff neck Arm VERY sore. Woke up the night after receiving with cold sweats and arm throbbing (like someone punching repeatedly in the arm) and sensitive to tje touch. Arm painful for 3-4 days
40 2021-01-07 itchy rash, hives Hive, itchy rash 1 week after the injection which has continued despite mutiple doses of benadryl, c... Read more
Hive, itchy rash 1 week after the injection which has continued despite mutiple doses of benadryl, claritin, and loratidine; Hive, itchy rash 1 week after the injection which has continued despite mutiple doses of benadryl, claritin, and loratidine; This is a spontaneous report from a contactable nurse. A 40-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular in right arm, on 18Dec2020 at 09:00 ( at the age of 40 years-old) as a single dose for COVID-19 immunization. The patient was administered the vaccine at a hospital. Medical history was not reported. Prior to the vaccination the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. There were also no other medications taken in the last two weeks. On approximately 25Dec2020 (reported as one week after vaccination on 18Dec2020), the patient experienced hives and itchy rash. The patient was not hospitalized for the events but received treatment with diphenhydramine (BENADRYL), loratadine (CLARITIN) and generic loratadine. clinical outcome of hives and itchy rash was not recovered: the patient reported that the hives and itchy rash continued despite multiple doses of BENADRYL, CLARITIN, and loratadine. Since the vaccination, the patient has not been tested for COVID-19. Information on lot/batch number has been requested.
40 2021-01-07 rash, hives, injection site pruritus Initial itching at injection site, observed and returned to work. Came back ~30-40 minutes later wit... Read more
Initial itching at injection site, observed and returned to work. Came back ~30-40 minutes later with itchiness in throat and hives to arm. Given Benadryl PO and observed for extended period of time. Symptoms not resolving. Patient transferred to Emergency Department for further care. At that point observed to have full body rash, SOB. Given Epi while in ED. Developed tachycardia, hypotension. Treatment continued.
40 2021-01-07 itchy skin Patient received dose #2 at 2:35 pm, at 2:45 pm onset of severe pruritis, shortness of breath with r... Read more
Patient received dose #2 at 2:35 pm, at 2:45 pm onset of severe pruritis, shortness of breath with rapid onset of dyspnea. Epinephrine Injection, USP Auto-Injector 0.3 mg administered. Code blue called. This occured in hospital setting, emergency department responded to vaccination clinic. Oxygen therapy, Methlyprednisolone 125 mg IV push, Diphenhydramine 50 mg IV push.
40 2021-01-07 itchy skin, rash papular Red bumps and itching to arms, legs and belly; Red bumps and itching to arms, legs and belly; This i... Read more
Red bumps and itching to arms, legs and belly; Red bumps and itching to arms, legs and belly; This is a spontaneous report from a non-contactable Other HCP (patient). A 40-year-old female patient received the first dose of BNT162b2 (Lot number: EL1284), via an unspecified route of administration at left arm on 05Jan2021 12:00 at single dose for covid-19 immunization. Medical history included Allergies to medications, food, or other products (unspecified allergies). The patient's concomitant medications were not reported. The patient experienced red bumps and itching to arms, legs and belly at 12:30 on 05Jan2021. The patient received the Benadryl as treatment. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
40 2021-01-07 injection site pain Tingling and numb face and lips mostly on right side of face, right ear pain, right jaw pain, right ... Read more
Tingling and numb face and lips mostly on right side of face, right ear pain, right jaw pain, right side headache, sore arm at site, nausea, dizziness, lethargic
40 2021-01-07 injection site warmth, injection site bruising low-level headache (was able to go to work, but a bit miserable), tired/run down-lasted several hour... Read more
low-level headache (was able to go to work, but a bit miserable), tired/run down-lasted several hours (no more than 10) arm pain (at injection site)-it is a bit warm to the touch and a small bruise- still occuring (approximately 12 hours after it started this morning)
40 2021-01-08 sensitive skin 1/6/21: left arm soreness and decreased range of motion around 5pm. lower extremity weakness and pa... Read more
1/6/21: left arm soreness and decreased range of motion around 5pm. lower extremity weakness and pain, skin sensitivity (feeling like a sunburn when touched) chills and fever (100.4) around 8pm. 1/7/21: fever (101.1), headache, dental/jaw pain around 2am. Nausea started around 6am. Fever lasted all night till around 10am. Blood pressure 138/85 and resting HR 125 and fever started again around 12pm. Chest tightness during exhalation around 2pm. Went to the Emergency Room around 2:30pm. Fever and headache returned around 8pm and gone by 10pm.
40 2021-01-08 rash macular, redness, hives 11:30 SHOT GIVEN, BY 11:40 FELT TINGLING IN LIPS AND THROAT AND HEART RATE 125 (MY RESTING HEARTRATE... Read more
11:30 SHOT GIVEN, BY 11:40 FELT TINGLING IN LIPS AND THROAT AND HEART RATE 125 (MY RESTING HEARTRATE IS 68), BY 11:45 TIGHTNESS IN CHEST AND NECK, HEARTRATE STILL 125 RANGE, NOON: BP 154/75 (MY NORMAL IS 96/58) AND HIVES 12:10 BENADRYL (25MG) GIVEN 12:25: BP 163/78 AND ALL OTHER SYMPTOMS STILL PRESENT 1:00 SECOND BENADRYL (25MG) GIVEN 1:11: BP 158/78 1:45 HEARING TURNED MUFFLED MOVED DOWNSTAIRS TO ER SECTION AT HOSPITAL GIVEN STEROIDS, PEPCID AND WATCHED FOR ADDITIONAL TIME ON 1/9/21: STILL ON BENADRYL AND STEROIDS: WOKE UP AT 8:00 AM SORE ARM AND SLIGHT HEADACHE, 9:00 RED SPLOTCHES ON FACE, NECK AND CHEST, 11:30AM ON 1/9/21: TIGHTNESS IN CHEST AND NECK CONTINUING STEROIDS AND BENADRYL
40 2021-01-08 injection site pain Headache (4/10) and body aches (5/10) pain respectively began at about 18 hours after injection. Bod... Read more
Headache (4/10) and body aches (5/10) pain respectively began at about 18 hours after injection. Body and head aches, particularly joints and back, continue and have worsened at 30 hours out. Mild-mod soreness at injection site (4/10)
40 2021-01-08 rash I had a rash on the back of my leg and significant pain around the rash.
40 2021-01-08 injection site hardening, injection site warmth, injection site rash, injection site pruritus, injection site redness Shot was given lower in arm than it should have been. There is a hard, warm and red bump where given... Read more
Shot was given lower in arm than it should have been. There is a hard, warm and red bump where given. Its starting to get itchy as well.
40 2021-01-09 pain of skin Approx 12 hours after injection fever (t-max 101.3), chills, body ache, head ache, skin ache, and fa... Read more
Approx 12 hours after injection fever (t-max 101.3), chills, body ache, head ache, skin ache, and fatigue lasting approx 24 hours. Severe fatigue lasted 48 total hours. Fully back to normal 4 days after vaccine. These were severe symptoms, but those that were expected. I only report here because I didnt know how else to make side effects known, in case this is still being followed.
40 2021-01-09 injection site redness, injection site pain, redness, itchy skin Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice ... Read more
Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice with persistent wheezy cough after 5 min Progressed to itchy/burning/red face/chest/ears after 10 min. Wheeled to the emergency department 20-25 minutes after injection. Had to have benadryl, solumedrol, pepcid, zofran, and an epinephrine injection to stop the anaphylaxic reaction.
40 2021-01-09 rash, itchy skin Patient received Pfizer-BioNTech COVID19 Vaccine on 01/08/2021 at 1426. Given the patient's medical... Read more
Patient received Pfizer-BioNTech COVID19 Vaccine on 01/08/2021 at 1426. Given the patient's medical history, the patient was required to stay for observation for 30 minutes. Within the first 15 minutes, the patient began to experiencing itching. Initially, there was concern that she was reacting to the bandaid (history of latex allergy). The bandaid was removed and staff confirmed the bandaid was LATEX FREE. Per protocol, the patient was administered diphenhydramine 25 mg po x 1 dose. After 15 minutes, the patient's itching continued and she started to develop a skin rash on her chest. Diphenhydramine 25 mg po x 1 dose was repeated and the decision was made to take the patient to the Emergency Department in a wheelchair. Documentation from the Emergency Department Provider: 40 y/o F who comes in from the covid vaccine clinic for a possible allergic reaction. Initially thought to be to latex but then we found out she was not given a bandaid with latex so we assume it is the vaccine. pt had a rash and scratchy throat and initialy felt improved with the benadryl, pepcid and steroids but after about 2 hours had recurrence of her sx. She was then given IM epi. She has now been observed for four more hours and is still feeling well. Will d/c to home with steroids and an epi pen and epi traning. Given return precautions and f/uw ith PCP. .
40 2021-01-10 itchy skin, redness 0808- shot 0812- face got extremely red and hot- burning from inside out 0816- nausea 0829- started ... Read more
0808- shot 0812- face got extremely red and hot- burning from inside out 0816- nausea 0829- started to feel chest get tight and began wheezing 0850- went home - itchy on chest stomach, back, and chin/throat. Still very red. 0915- took Benadryl did breathing treatment- cold pack to face 1015- itchy- less- headache, no wheezing no nausea- fell asleep 1215- woke up- chest tight- did breathing treatment- headache 1515- took another 25mg Benadryl Slept most of day til next morning. Went to work 12/29/21 at 6am by 12 feeling really under the weather and tired. Went home took Motrin600mg and went to bed . 12/30 went to work back to normal
40 2021-01-10 injection site vesicles, injection site pruritus, injection site redness 2 days after receiving the 2nd dose Of vaccine, redness, itchiness, and tiny blisters were noted ab... Read more
2 days after receiving the 2nd dose Of vaccine, redness, itchiness, and tiny blisters were noted about 1inch around the injection site.
40 2021-01-10 itchy skin, vaccination site pain 24 hours later sever dizziness; Injection site soreness; Internal itching; This is a spontaneous rep... Read more
24 hours later sever dizziness; Injection site soreness; Internal itching; This is a spontaneous report from a contactable Other HCP. A 40-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), intramuscular on 04Jan2021 10:00 at single dose for COVID-19 immunisation. Medical history included diabetes mellitus from an unknown date. Anatomical location was left arm. The patient experienced internal itching on 04Jan2021 10:15, 24 hours later severe dizziness on 05Jan2021, injection site soreness on 04Jan2021 10:15. The patient underwent lab tests and procedures which included covid-19 test on 05Jan2021 (unknown result). The events outcome was unknown. Information on the Batch/Lot number has been requested.
40 2021-01-10 injection site warmth, injection site swelling, injection site rash, injection site pruritus, injection site redness, skin warm About 12 hours post vaccine I experienced headache, fatigue, muscle aches, and chills. About 48 hour... Read more
About 12 hours post vaccine I experienced headache, fatigue, muscle aches, and chills. About 48 hours post vaccine developed rash - raised red swollen area around where the vaccine was given. The area was hot to the touch and very itchy. Currently great than 72 hours post vaccine and rash is still there and still hot and itchy.
40 2021-01-10 skin burning sensation Auditory & visual hallucinations; Auditory & visual hallucinations; tachycardia; extreme panic; conf... Read more
Auditory & visual hallucinations; Auditory & visual hallucinations; tachycardia; extreme panic; confusion; felt like skin was on fire/pulsating; felt like skin was on fire/pulsating; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; uncontrollable vomiting; bad chills and fever; bad chills and fever; insomnia; felt as if she had been given drugs; This is Spontaneous report from a contactable Other Healthcare Professional reported for herself. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), via an unspecified route of administration on 04Jan2021 14:30 at single dose on right arm for COVID-19 immunization. Medical history included COVID prior vaccination and latex allergy. There were no concomitant medications. No other vaccine in four weeks. The patient previously had allergic to diazepam (VALIUM), clonazepam (KLONOPIN), ondansetron (ZOFRAN) and lorazepam (ATIVAN). The patient experienced auditory & visual hallucinations, tachycardia, extreme panic, confusion, felt like skin was on fire/pulsating, severe pain especially at knees/hips/base of head and neck, uncontrollable vomiting, bad chills and fever, insomnia. She felt as if she had been given drugs. All of the events happened on 05Jan2021 01:30 and resulted in Doctor or other healthcare Recovering professional office/clinic visit. No treatment received for the events. No COVID tested post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Auditory hallucinations and Visual hallucinations cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
40 2021-01-10 hives, redness I had large red and hot welt. I had lip node enlargement. It lasted for a week.
40 2021-01-10 vaccination site pain Palpitations, anxious, no temperature but my body feels really hot in the inside, very bad pain unde... Read more
Palpitations, anxious, no temperature but my body feels really hot in the inside, very bad pain under the arm pit close to my breast on the arm of vaccine, weak ,lightheaded, sweating, headache,
40 2021-01-10 injection site pain, hardening Patient states on 01/09/2021 had soreness to the injection site. Felt " discomfort but not pain" . ... Read more
Patient states on 01/09/2021 had soreness to the injection site. Felt " discomfort but not pain" . Described discomfort as constant. The next day on 01/10/2021 at about 8am, the discomfort started to radiate down to her left armpit area and left lateral breast area. Denied redness or fever but did state area was " swollen" . Stated affected areas felt " hard but it was probably because there was swelling". Patient states she had full range of motion to left arm, no numbness or tingling to left arm or hand. No complaints of shortness of breath , chest pain, or rash.
40 2021-01-10 injection site hardening, injection site warmth, injection site redness The person administering the vaccine did not go deep enough into the muscle and the vaccine accumula... Read more
The person administering the vaccine did not go deep enough into the muscle and the vaccine accumulated in the subcutaneous fat layer. I had a hard, red, hot spot under the skin that night and continued to spread out very slowly over the next day being hot to touch and very red. I massaged the area with my hand for the next two days and the hard spot where the vaccine was got a little softer but is still there. I haven't had any other reactions except the redness and hot to touch. I'm concerned that since the vaccine was not administered correctly that I will not get the full immunity expected by the second dose. I do have pictures I took of my arm if needed.
40 2021-01-10 redness, rash with redness This is the 2nd vaccine for the patient. She was not given another lot# for this vaccine. Patient r... Read more
This is the 2nd vaccine for the patient. She was not given another lot# for this vaccine. Patient reports nausea, feels like throat is closing, change in her voice (hoarse), patient reports a metal taste in her mouth. Flushed cheeks, facial swelling and whole body was red and flushed, reddish spotting. Also reporting headache. She is still reporting the abnormal taste and headache.
40 2021-01-10 injection site pain believed it was injected incorrectly because she didn't have pain in her deltoid but she did have al... Read more
believed it was injected incorrectly because she didn't have pain in her deltoid but she did have all the pain inside her shoulder, like in the bursa; received the first dose 17DEC2020 / received the second dose 4JAN2021; anterior medial shoulder joint/shoulder pain/pain in shoulder after second dose of COVID 19 vaccine; can't actively use shoulder / can't move her arm; weakness in her hand; bone pain; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for herself. A 40-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685, expiry date not provided) via an unspecified route of administration in the left arm on 17Dec2020 13:30, and the second dose (lot number EK9231, expiry date not provided)via an unspecified route of administration in the left arm on 04Jan2021 13:30, for COVID-19 immunization. There was no relevant medical history. The patient's concomitant medications were not reported. The patient experienced anterior medial shoulder joint/shoulder pain/pain in shoulder after second dose of the vaccine on 04Jan2021, and couldn't actively use shoulder. She believed it was injected incorrectly because she didn't have pain in her deltoid but she did have all the pain inside her shoulder, like in the bursa, and she couldn't move her arm and felt weakness in her hand. She noticed the pain and all other symptoms immediately when they were injecting it. She told the nurse who said she was tensing up. The events were considered medically significant by the patient. She also reported experiencing bone pain, unable to put in sutures at work. She was taking 600mg Ibuprofen and 1000mg paracetamol (TYLENOL) every 6-8 hours. The events were not resolved. The pain had gotten worse. The other symptoms were persisting.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
40 2021-01-10 itchy skin itchy, clammy, sweaty
40 2021-01-11 bruising, hives, cellulitis, redness Employee's arm is red/sore (big/hive) with a black/ bluish bruise, evolving cellulitis. Started on K... Read more
Employee's arm is red/sore (big/hive) with a black/ bluish bruise, evolving cellulitis. Started on Keflex 500 mg PO Q8hr x 10 days. Had a temp of 103 on 1/4/21 but resolved by 1/8/21.
40 2021-01-11 redness, skin infection at injection site, injection site bruising Employee's arm is sore 3 days after vaccine. Arm is red with a bruise that is black/bluish, with evo... Read more
Employee's arm is sore 3 days after vaccine. Arm is red with a bruise that is black/bluish, with evolving cellulitis. Provider prescribed Keflex 500 mg PO Q8hr x 10 days. Had a temperature of 103 on 1/4 but resolved on 1/8.
40 2021-01-11 injection site redness, injection site warmth, injection site pain Headache unable to improve with medication, body aches, fever up to 101, 3.5" nodule of erythema, wa... Read more
Headache unable to improve with medication, body aches, fever up to 101, 3.5" nodule of erythema, warmth, pain at injection site.
40 2021-01-11 injection site warmth, injection site swelling, injection site hardening, injection site inflammation Headache- severe x 4 days High Fever (103) (6 hours post injection begain, lasted 1. 5 days) Myalgia... Read more
Headache- severe x 4 days High Fever (103) (6 hours post injection begain, lasted 1. 5 days) Myalgia Pain - bone, and muscle Vomiting Nausea Agitation Diarrhea Inflammation, edema, heat firm induration at injection site
40 2021-01-11 hardening Patient had her second dose of the Pfizer vaccine Friday, 1/8/2021 at 10:30am. She has had the expec... Read more
Patient had her second dose of the Pfizer vaccine Friday, 1/8/2021 at 10:30am. She has had the expected fatigue, muscle aches, headache, chills. however, she had also developed significant swelling in her left armpit and the swelling has spread into her left chest wall and down into her left ribs. It has also become painful. It?s very painful to lower her arm against her body, to raise her arm above her shoulder, to lift anything, even a bottle of water. It?s also painful to take a deep breathe right in the area on the left chest where the swelling is and into her ribs under her armpit. The area doesn?t seem to be significant red or warm. It is very tender to touch and the swollen area is firm. It has not responded to ice or NSAIDS. Her shoulder and arm do not seem to have any swelling."
40 2021-01-11 itchy skin, hives Prior to 1st Covid vaccination the patient reported a history of mast cell syndrome resulting in num... Read more
Prior to 1st Covid vaccination the patient reported a history of mast cell syndrome resulting in numerous anaphylactic events. The patient had been consulted by her immunologist to proceed with vaccination and due to her history she was observed for a period of 30 minutes. Upon returning for her 2nd vaccination she reported that she experienced some skin manifestations (hives) but no anaphylactic reaction resulting in difficulty breathing. She stated that she had discussed this again with her immunologist and she wished to proceed with the 2nd dose and she was prepared to receive EpiPen if necessary if reaction develops. Within 10 minutes of the vaccination she felt flushing sensation and then itching all over and her "throat closing up". She was quickly administered 0.3 mg IM epinephrine and IM diphenyhydramine with some improvement in her symptoms. While being transported to the ED an additional 0.3 mg dose of epinephrine was administered. The emergency department also administered the following treatments: famotidine 40 IV x 1 dose, methylprednisolone 125 mg IV x 1 dose, racepinephrine nebulized x 1 dose. The patient was ultimately discharged approximately 2 hours later with return to her baseline condition.
40 2021-01-11 rash, itchy skin Pt developed itching and a rash on her arm approximately 2 hours post vaccine. colleague self medic... Read more
Pt developed itching and a rash on her arm approximately 2 hours post vaccine. colleague self medicated with Benadryl 7 hours post vaccine. symptoms resolved and colleague reported to work the following day without issue
40 2021-01-11 rash Rash appear on my arm that Sunday. The rash was all over my body. I was on heavy Benadryl for abo... Read more
Rash appear on my arm that Sunday. The rash was all over my body. I was on heavy Benadryl for about 1 week.
40 2021-01-11 injection site pain Sore injection site. Injection was given via tuberculin syringe and did not penetrate the muscle, it... Read more
Sore injection site. Injection was given via tuberculin syringe and did not penetrate the muscle, it was subcutaneous. My dose was a waste and I may not have immunity due to operator error.
40 2021-01-11 rash with redness Spots on feet
40 2021-01-11 injection site swelling swelling to left arm with lymph nodes swelling; mild headaches, body ache lasting more than 48 hours... Read more
swelling to left arm with lymph nodes swelling; mild headaches, body ache lasting more than 48 hours left arm cellulitis on steroid and antibiotic
40 2021-01-12 redness, rash macular, rash, itchy skin, injection site swelling, injection site rash, injection site redness ABOUT 40 MINUTES AFTER THE SHOT I STARTED TO ITCH THAT PROGRESSIVELY GOT WORSE. BY THE TIME I MADE ... Read more
ABOUT 40 MINUTES AFTER THE SHOT I STARTED TO ITCH THAT PROGRESSIVELY GOT WORSE. BY THE TIME I MADE IT OUT TO MY FIRE ENGINE I WAS RED AND BLOTCHY ON MY CHEST AND BACK THAT STARTED TO GO UP MY NECK. ONE OF MY FIREFIGHTERS GAVE ME BENADRYL IM IN THE RIGHT ARM. THE ITCHING STAYED THE SAME FOR ANOTHER 10 MINUTES UNTIL IT STARTED TO GET WORSE AND MOVE DOWN MY SIDE, STOMACH, LEGS AND ARMS. I THEN STARTED TO DEVELOP BUMPS AND REDNESS TO MY NECK AND BEHIND BOTH MY EARS AND BOTH MY FOREARMS. IN THE ARM WHERE I RECEIVED THE VACCINE IT TURNED RED WITH SOME SWELLING AND BUMPS. MY PARAMEDIC THEN GAVE A DOSE OF EPI 1:1,000 IM ON THE LEFT ARM. ABOUT 1 HOUR LATER THE MAJORITY OF THE BUMPS AND ITCHING WENT AWAY. ABOUT 10 HOURS LATER THE REDNESS AND SWELLING ON THE LEFT ARM WHERE I RECEIVED THE VACCINE WENT AWAY.
40 2021-01-12 injection site redness, injection site hardening Employee had first Pfizer COVID-19 vaccine on 12/16/20 at hospital. She developed an erythematous i... Read more
Employee had first Pfizer COVID-19 vaccine on 12/16/20 at hospital. She developed an erythematous indurated firm wheal at injection site post-vaccination that lasted for 2 weeks. Evaluated in EH clinic on 12/28/20 and referred to PCP for treatment. Prescribed antibiotics and resolved without complications.
40 2021-01-12 rash, skin warm, itchy skin, rash with redness I noticed a rash on both arms at the antecubital fossa on 1/10/21. The rash is red, tender to painf... Read more
I noticed a rash on both arms at the antecubital fossa on 1/10/21. The rash is red, tender to painful and warm to the touch., slightly itchy but painful when itched. I did not notice the rash anywhere else that day. I feel warm in the face and ears but temperature has stayed between 98.3-98.9 since vaccination was administered. I noticed raised red bumps from my olecranon to mid forearm on the ulnar side of both arms but moreso on the right arm.
40 2021-01-12 skin burning sensation Patient experiencing moderate-severe body aches, chills, feeling of burning all over skin, skin flus... Read more
Patient experiencing moderate-severe body aches, chills, feeling of burning all over skin, skin flushing, nausea, headache, dizziness, near syncope, and bouts of being tachycardia. acetaminophen 1gm q6 hours x 4 doses for 2 days ondansetron 4mg x 1 dose
40 2021-01-12 vaccination site pain heaviness on the one/left side of her body; left ear pain; left side of tongue is sore; pain that we... Read more
heaviness on the one/left side of her body; left ear pain; left side of tongue is sore; pain that went down from her neck to her abdomen; pain that went down from her neck to her abdomen; injection pain on left arm.; This is a spontaneous report from a contactable nurse (patient). A 40-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EJ1686, expiration date not reported), intramuscular on the left arm on 05Jan2021 at 15:00 to 05Jan2021 15:00 at SINGLE DOSE for Covid-19 vaccine. Medical history included allergies, gallbladder problems, and had a little diarrhea. Concomitant medications included famotidine (PEPCID) for any potential allergic reaction, and diphenhydramine hydrochloride (BENADRYL) for allergies, all are ongoing. On 05Jan2021, the patient experienced left ear pain, left side of tongue is sore, pain that went down from her neck to her abdomen, injection pain on left arm, and on 06Jan2021, heaviness in one/left side of the body. The patient is most concerned with the pain she is experiencing. The patient was calling about Covid vaccine and got her first shot yesterday, on 05Jan2021, around 3pm. The patient stated that they had her stay about 30 minutes to make sure no major side effects. She had gone home and noticed that her tongue on left side was swollen and persisted into the evening and had a little diarrhea. She was experiencing left ear pain and decided to lay down. She stated that when she laid down noticed that she had pain that went down from her neck to abdomen, that when she woke up this morning that she had pressure on left side of her body and everything else had gotten better. She clarified that it was not swollen but sore. She stated that the diarrhea is not related to the Covid vaccine but is because she had gallbladder problems, her gallbladder was taken out before the vaccine. She stated not pressure just heavy and that the arm was regular injection pain. She stated that the shooting pain in ears is continuous like she was getting an ear infection. She stated that the symptoms are all on her left side, she clarified pressure on left side as heaviness. Stated that the allergies were diagnosed way before Covid vaccine. The patient wanted to know if other people have experienced these side effects. She stated that left side of tongue swollen resolved overnight because she did not wake up with it. Later she clarified that her left tongue was sore. Resolved completely. She stated left ear pain started last evening, that it comes and goes. Stated that the pain that went from neck to her abdomen started yesterday evening and stopped yesterday evening. Stated her left arm is sore. Stated it is sore if she touches it and is okay if she is just sitting there. She stated that she took diphenhydramine hydrochloride 25mg in case her tongue was swollen and she was having a reaction. Stated that she took two acetaminophen (TYLENOL) before she went to bed. The outcome of the events of left ear pain and injection pain in left arm was not recovered, while pain that went down from her neck to abdomen recovered on 05Jan2021, heaviness in one side of the body recovered on 06Jan2021, the rest of the events recovered on an unspecified date. The seriousness of left arm injection pain was not provided, reporter assessed other events as non-serious. The causality for the event of injection pain to left arm was related to the suspect drug, causality for other events was unknown.
40 2021-01-12 rash, bruising, itchy skin itching (benadryl did not relive) strange dark rash/bruising or lesions on left side of body- includ... Read more
itching (benadryl did not relive) strange dark rash/bruising or lesions on left side of body- including lower extremity. Painful.
40 2021-01-12 vaccination site pain soreness at the injection site; This is a spontaneous report from a non-contactable other healthcare... Read more
soreness at the injection site; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ek5730), via an unspecified route of administration at the left arm on 06Jan2021 17:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. Concomitant medications included ascorbic acid (VIT C), ergocalciferol (VIT D), glucosamine and curcuma longa (TURMERIC). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced soreness at the injection site on an unspecified date. The patient assessed the event as non-serious. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
40 2021-01-13 vaccination site pain Body chills, extreme fatigue, arm soreness at injection site; Body chills, extreme fatigue, arm sore... Read more
Body chills, extreme fatigue, arm soreness at injection site; Body chills, extreme fatigue, arm soreness at injection site; Body chills, extreme fatigue, arm soreness at injection site; This is a spontaneous report from a contactable Nurse (patient). This 40-year-old female Nurse reported for herself received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: Elt9899/expiration date: unknown), via unknown route of administration, on 17Dec2020 at 07:45 PM (at the age of 40 years old) as a single dose in the left arm and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: Eh9899/expiration date: unknown), via unknown route of administration, on 07Jan2021at 06:30 AM (at the age of 40 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included asthma. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Albuterol inhaler. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 03:00 PM, the patient experienced body chills, extreme fatigue, arm soreness at injection site. No treatment was received for the events body chills, extreme fatigue, arm soreness at injection site. The outcome of the events body chills, extreme fatigue, arm soreness at injection site was unknown. Since the vaccination, the patient had not been tested for COVID-19.
40 2021-01-13 injection site swelling, injection site pain, injection site pruritus, injection site rash FIVE DAYS OF SINTOMES,PAIN INJECTIN SITE, SWELLING INJECTION SITE, RASH AND INCHING.
40 2021-01-13 injection site redness, injection site swelling, injection site warmth Fever, chills, body aches, headache, redness, swelling and hot to touch at injection site. Ibuprofen... Read more
Fever, chills, body aches, headache, redness, swelling and hot to touch at injection site. Ibuprofen after vaccine given. No problem until following day, late morning. Ibuprofen and tylenol alternating. Swelling and redness at injection site have increased daily.
40 2021-01-13 rash, itchy skin, hives, rash papular Hives, red swollen itchy bumps on left ankle foot and mid leg. Various hives and pumps that would po... Read more
Hives, red swollen itchy bumps on left ankle foot and mid leg. Various hives and pumps that would pop up on hands and elbows, and right foot that would itch and come and go, but the bumps on the left leg wont go away. I have taken benadryl (2 adult tablets each night), hydrocortisone cream, alcohol rub, and still hasn't gone away a week later. Headache for 7 days. A little dizziness.
40 2021-01-13 injection site pain Low grade fever (99.8-100.2), headache, fatigue, and soreness at injection site
40 2021-01-14 injection site redness, injection site pruritus, injection site swelling "after my 2nd shot i got a swollen area, with some redness which according the email was normal but ... Read more
"after my 2nd shot i got a swollen area, with some redness which according the email was normal but what concerned me was alot of itching to the site which is still there along with the redness and swelling."
40 2021-01-14 vaccination site pain Fever to 99.8; muscle aches; Headache; sore arm for days; This is a spontaneous report from a non-co... Read more
Fever to 99.8; muscle aches; Headache; sore arm for days; This is a spontaneous report from a non-contactable nurse. A 40-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 28Dec2020 12:00 to 28Dec2020 12:00 at a single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient previously took chlorhexidine and experienced allergies. The patient experienced Fever to 99.8 body, muscle aches, Headache and sore arm for days, felt like being punched repeatedly in the arm; all on 28Dec2020. The outcome of the event was recovered on unspecified dates. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
40 2021-01-14 injection site pain HA, fatigue, pain at the injection site and nausea. Treatment include: Tylenol, hydration and tums ... Read more
HA, fatigue, pain at the injection site and nausea. Treatment include: Tylenol, hydration and tums the next day. Outcome complete resolution of symptoms on day 3.
40 2021-01-14 injection site pain, injection site redness, bruising Patient had regular soreness, redness of injection site. Fever, chills, fatigue hours after vaccine.... Read more
Patient had regular soreness, redness of injection site. Fever, chills, fatigue hours after vaccine. Patient experienced syncope the morning after vaccination for about 15 minutes. Having bruised head and left eye.
40 2021-01-14 rash, itchy skin Rash on left forearm/itching/throat itching/ heart rate fast/left hand itching
40 2021-01-15 bruising My right temple started to get sore to the touch, I?m about day 3 post injection. It is fine unless ... Read more
My right temple started to get sore to the touch, I?m about day 3 post injection. It is fine unless I touch it, but if I do bump it or make contact with it, it hurt like the area was very bruised or recently injured. The pain has improved but it is still very sensitive. I didn?t think it was related to the shot, but I could not recall any injury. I can function like normal. My dr suggested I do a round of steroids, but to contact her immediately or go to ER if it worsened. I am to follow up with her in 2 weeks.
40 2021-01-16 injection site pain Dizziness, weakness, injection site pain, tiredness, headache, chills, joint pain, nausea.
40 2021-01-16 injection site bruising Migraine the day after initial injection (12/24/20). Lasted in to the morning of the 2nd day post in... Read more
Migraine the day after initial injection (12/24/20). Lasted in to the morning of the 2nd day post injection (12/25/20). Mild to minimal nausea off and on the day after injection. Extreme left arm pain from that injection day through the 4th day post injection (12/27/20). After 2nd dose - bruised arm at injection site. Left arm pain not as severe as 1st injection. Headache more mild.najsea a bit more noticeable off and on. Wheezing and nasally. Muscle aches.
40 2021-01-17 injection site pain 102 F fever through 1 gram acetaminophen (104.6 prior to medication), extreme body aches and headach... Read more
102 F fever through 1 gram acetaminophen (104.6 prior to medication), extreme body aches and headache, overwhelming fatigie, and diapohretic x 2days. Swelling of arm from elbow to axilla during same. Unable to work during symptoms. Moderate fatigue, body aches, headache, and site tenderness persist to date of reporting.
40 2021-01-18 vaccination site pain 3.5 hours after injection all of a sudden HR was at 161; Muscle pain around injection site and some ... Read more
3.5 hours after injection all of a sudden HR was at 161; Muscle pain around injection site and some fatigue, but not bad.; Muscle pain around injection site; Muscle pain around injection site and some fatigue, but not bad.; I was warmflush feeling; When HR jumped to 161 she had a weird sensation run down both of arms; This is a spontaneous report from a contactable consumer. This 40-year-old female (no pregnant) patient received first dose of BNT162B2 (lot# EL3249) on 08Jan2021 02:30 PM on arm Left for COVID-19 immunization. Medical history was Type 1 IDDM (Diabetes), Anxiety/Panic Disorder. Concomitant drug included desvenlafaxine succinate (PRISTIQ), Clonazepam, insulin lispro (HUMALOG), cetirizine hydrochloride (ZYRTEC), all received within 2 weeks of vaccination. Past drug was Allergies to levofloxacin (LEVAQUIN). It was reported that 3.5 hours after injection (08Jan2021 06:00 PM) all of a sudden HR was at 161, patient layed down and it came down a little to 115-125, for 4-5 thereafter it stayed around 110-115, and after about 6 hours it returned to normal. She was warm flush feeling but without a fever. When HR jumped to 161 she had a weird sensation run down both of arms but is subsided with kaying down and HR coming down a bit. No toher bad issues since. Muscle pain around injection site and some fatigue, but not bad. Emergency room/department or urgent care visit. Treatment: EKG, CXR, Labwork, very brief monitoring of HR/BP. Outcome of the event was recovered. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts are needed. No further information is expected.
40 2021-01-18 hives, rash During the Covid vaccine observation period the patient complained of hoarseness, itching and throat... Read more
During the Covid vaccine observation period the patient complained of hoarseness, itching and throat swelling. The patient had history of chronic urticaria and prior to receiving her vaccine had taken benadryl, ranitidine as well as an OTC antihistamine at home. She was escorted via wheelchair to the ED, BP 151/102 and pulse 101 in ED, pt noted to have blanching hive-like rash on her chest as well. Received Epinephrine 0.3mg, prednisone 60mg PO x 1. Pt was monitored for 3 hours and discharged to home.
40 2021-01-18 rash I started to get a painful rash on my left torso and at first thought it was a bug bite but then aft... Read more
I started to get a painful rash on my left torso and at first thought it was a bug bite but then after 48 hrs it got worse and more painful and I realized it was shingles. I have never had shingles and I am healthy and young and so I thought it might be related to getting the vaccine- Maybe COVID vaccine induced it or made me susceptible. I am nursing a 4 month old to give more information.
40 2021-01-18 hardening STARTED ON 1/15/2021 4PM WITH NUMBNESS, TINGLING RIGHT UPPER EXTREMITY, AXILLLARY EDEMA AND INDURATI... Read more
STARTED ON 1/15/2021 4PM WITH NUMBNESS, TINGLING RIGHT UPPER EXTREMITY, AXILLLARY EDEMA AND INDURATION WITH SEVERE PAIN AND ELEVATED TEMPERATURE IN AREA, DIFFICULTY WITH ADDUCTION OF ARM, PAIN RIGHT SHOULDER WITH SWELLEING AND RIGHT TORSO PAIN,
40 2021-01-18 vaccination site warmth, vaccination site redness, vaccination site swelling at the injection site, it is raised, warm and red; at the injection site, it is raised, warm and red... Read more
at the injection site, it is raised, warm and red; at the injection site, it is raised, warm and red; at the injection site, it is raised, warm and red; This is a spontaneous report from a contactable other health professional (HCP). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on her right arm, on 06Jan2021 at a single dose for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. Patient received the first vaccine 2 days ago (06Jan2021) and last night (07Jan2021) at the injection site, it is raised, warm and red. She has had no other symptoms and no fever. She was asking if it is normal for it to take time to occur and for how long will it last. On 08Jan2021, it was reported that she did see that it was normal but was asking if it is normal 48 hours later. Otherwise, she was completely fine. She works as a technician at the hospital. She just took a picture of it so she can keep track of it. The outcome of the events was unknown. Information on the lot/batch number has been requested.
40 2021-01-19 rash 1/1/21 sore throat lung pain in back . F/U with Dr antibiotic Amoxicillin Strep diagnosis, swollen p... Read more
1/1/21 sore throat lung pain in back . F/U with Dr antibiotic Amoxicillin Strep diagnosis, swollen pressure in lungs, antibiotic has provided some relief to lungs but pain continues, feels lungs are fatigue and worked. 20 days swollen throat has continued, and small rashes with no itch come and go on eyelid, chin, shoulder.
40 2021-01-19 vaccination site pain Fevers; chills; body aches; headache; sore arm; on 22Dec2020 12:00 at first single dose; then on 08J... Read more
Fevers; chills; body aches; headache; sore arm; on 22Dec2020 12:00 at first single dose; then on 08Jan2021 at second single dose; on 22Dec2020 12:00 at first single dose; then on 08Jan2021 at second single dose; This is a spontaneous report from a Non-contactable nurse. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685) via intramuscular into left arm on 22Dec2020 12:00 at first single dose; then on 08Jan2021 at second single dose for covid-19 immunization. No covid prior vaccination. The patient known allergies included Cytotec, peanuts, lentils, peas, chick peas and other medical history included Asthma, migraines, kidney stone. There is no other vaccine administered in four weeks. Other medications in two weeks included multi vitamins, vit B2 and magnesium. On 09Jan2021, the patient experienced Fevers, chills, body aches, headache, sore arm and no treatment involved. No covid tested post vaccination. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
40 2021-01-19 injection site redness Ongoing treatment for vertigo
40 2021-01-19 rash Rash, swelling, nausea, headache, diarrhea, muscle pain, fever, chills
40 2021-01-20 rash Broke out in a rash on neck and torso. Body aches and headache as well. Treated with Benadryl and ... Read more
Broke out in a rash on neck and torso. Body aches and headache as well. Treated with Benadryl and Prednisone
40 2021-01-20 itchy skin Employee reported flushing, itching and burning sensation noted to her cheeks, nose, chin, and chest... Read more
Employee reported flushing, itching and burning sensation noted to her cheeks, nose, chin, and chest within hours of receiving 2nd dose of vaccine. She stated that she has continued experiencing it intermittently, has taken Benadryl at night time, and is planning on trying Zyrtec.
40 2021-01-20 pain of skin Experience skin nerve pain all over my body; Experience skin nerve pain all over my body; Extreme co... Read more
Experience skin nerve pain all over my body; Experience skin nerve pain all over my body; Extreme cold sensation after bowel movements; This is spontaneous report from a contactable other HCP (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number not provided), via an unspecified route of administration on 04Jan2021 10:15 at single dose for covid-19 immunization. Patient is not pregnant. Medical history included severe post concussion syndrome (5 major concussions), anxiety, depression, raynaud's syndrome, pineal gland cyst (last MRI Oct2020 reveal cyst was 12mm). The known allergies included Cipro, sensitive to many food, high allergy to mold, grasses, trees. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), fluoxetine hydrochloride (PROZAC), rizatriptan benzoate (MAXALT), montelukast sodium (SINGULAIR), levocetirizine dihydrochloride (XYZAL) , lactulose (LACTUL), ongoing medications included mometasone furoate (FLONASE), budesonide (BUDESONIDE), olopatadine (OLOPATADINE), ipratropium (IPRATROPIUM) , fremanezumab (AJOVY), allergy shots. 48 hours after injection on 06Jan2021 13:00, patient began to experience skin nerve pain all over body accompanied with extreme cold sensation after bowel movements, has been 6 days and getting worse. She will be going to urgent care tomorrow. She was between primary care physicians until 13Jan2021. Patient didn't receive treatment for the adverse events. The outcome of events was not recovered. Information about lot/batch number has been requested.
40 2021-01-20 injection site pain I woke up at 2:45am with chills, a bad headache, sore arm at test site and nausea. I took extra stre... Read more
I woke up at 2:45am with chills, a bad headache, sore arm at test site and nausea. I took extra strength Tylenol and went back to sleep. The following day, I continued to have the headache and fatigue. I took Tylenol and/or Advil all day to keep the headache at bay and also needed a nap. Today, I feel much better.
40 2021-01-20 skin warm, rash It looked like a spider bite that was about about 8 inches in Diameter.. The area was really hot a... Read more
It looked like a spider bite that was about about 8 inches in Diameter.. The area was really hot and swollen Rash on chest . that was similar to chicken Pox
40 2021-01-20 shingles, rash, itchy skin Shingles: Redness and tenderness in right eye area at 7:00 PM on 1/14/21, later that nigh (approxima... Read more
Shingles: Redness and tenderness in right eye area at 7:00 PM on 1/14/21, later that nigh (approximately 11:00 PM) experienced sharp pain behind right eye. On 1/15/21 bumps in right eyebrow and itchiness on right side of scalp. on 1/16/21 developed redness in right eye. Pain behind right eye and itchiness persisted for >5 days. Went to Urgent Care on 1/20/21 and shingles suspected. Referred to confirm diagnosis. Antiviral pills and drops prescribed, as well as steroid drops.
40 2021-01-20 injection site pain, injection site redness temperature elevated (99.8, 101.8, 101); at the injection site (upper left deltoid) she was experien... Read more
temperature elevated (99.8, 101.8, 101); at the injection site (upper left deltoid) she was experiencing very small redness and a sharp shooting pain; at the injection site (upper left deltoid) she was experiencing very small redness and a sharp shooting pain; She is very achy; shooting pain all the way down from her left upper deltoid to her middle and ring finger on left hand; This is a spontaneous report from a contactable nurse (patient). This 40-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EJ1686) intramuscular, in left deltoid, on 11Jan2021 at 10 AM, COVID-19 immunization. Prior vaccinations (within 4 weeks) or on the same day: none. Medical history included ongoing asthma diagnosed at childhood, ongoing diabetes diagnosed in her twenties, she was overweight, about 7 or 8 years ago she ended up having cellulitis due to the nurse not using aseptic technique but not due to a vaccine, she was diagnosed with COVID on 18Dec2020 (she was off quarantine as of 28Dec2020, going back to work on 31Dec2020). When she was diagnosed with COVID, it caused an asthma exacerbation and she needed a 5-day oral burst of 40 mg prednisone. Concomitant medications were none. On 11Jan2021 the patient experienced temperature elevated, at the injection site (upper left deltoid) she was experiencing very small redness and a sharp shooting pain and she was very achy. Her temperature started last night (11Jan2021), temperature was 99.8. She tried to hydrate. She also had a temperature at 6 AM on 12Jan2021 morning. On 12Jan2021 she had temperature of 101.8 and this was after taking antipyretics 6 hours before. Then, on 12Jan2021, her temperature was 101. She was on the phone with her primary care provider and she was told to take more antipyretics. She just took more antipyretics. She stated it felt almost like they hit a nerve when administering the vaccine since she was experiencing shooting pain all the way down from her left upper deltoid to her middle and ring finger on left hand. She believed, based on anatomy, that there were nerves going right there. She knew she was overweight but her upper arms were not that bad. She tried to take a shower to cool herself down. She received the vaccine through pharmacy since she was working at a long term care facility around COVID. Pharmacist came to the long term care facility where she works to administer the vaccine. The events did not require ER visit. Relevant tests: none. Fever outcome was unknown. The other events had not yet resolved. Sharp shooting pain came and went. The reporter considered all the events serious as medically significant and related to BNT162B2 vaccine.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
40 2021-01-21 injection site redness 1/22 @ 15:00-low grade fever, chills, body aches, headache 1/23 @ 17:30-noticed swelling in left ar... Read more
1/22 @ 15:00-low grade fever, chills, body aches, headache 1/23 @ 17:30-noticed swelling in left armpit and Red circle around injection site
40 2021-01-21 redness, rash with redness, rash I begin to lose consciousness; I felt lightheaded; My face and ears got red and I begin to feel warm... Read more
I begin to lose consciousness; I felt lightheaded; My face and ears got red and I begin to feel warm; My face and ears got red and I begin to feel warm; Then My whole body felt really weird; my lips went numb; Afterwards for approximately 4 hours I could barely talk or open my eyes; Afterwards for approximately 4 hours I could barely talk or open my eyes; I got red rash on my neck and chest; I felt so weak, I could not move my body!; This is a spontaneous report from a contactable Other HCP reporting for herself. A 40-years-old female patient received the second dose bnt162b2 (BNT162B2) vaccine , intramuscular in the left arm on 18Dec2020 12:15 at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. On an unknown date the patient received the first dose of the vaccine. The patient experienced got red rash on my neck and chest on 18Dec2020 12:15 with outcome of recovering , felt lightheaded on 18Dec2020 12:15 with outcome of recovering , face and ears got red and begin to feel warm on 18Dec2020 12:15 with outcome of recovering , then whole body felt really weird on 18Dec2020 12:15 with outcome of recovering , lips went numb on 18Dec2020 12:15 with outcome of recovering , begin to lose consciousness on 18Dec2020 12:15 with outcome of recovering , afterwards for approximately 4 hours could barely talk or open my eyes on 18Dec2020 12:15 with outcome of recovering , felt so weak, could not move my body on 18Dec2020 12:15 with outcome of recovering. The patient was hospitalized for one day for all the reported events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 18Dec2020 . The patient received Epipen injection, steroids, saline & Benadryl as treatment for the reported events. Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on the compatible time association, the reported events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
40 2021-01-21 injection site pain No symptoms or reactions immediately. Injection site was very sore the following day. Followed by b... Read more
No symptoms or reactions immediately. Injection site was very sore the following day. Followed by body aches, chills, headache, muscle and joint pain. Tired.
40 2021-01-21 itchy skin, rash with redness Twelve minutes after receiving the vaccine injection, patient reported tingling in both arms and acr... Read more
Twelve minutes after receiving the vaccine injection, patient reported tingling in both arms and across her upper back. She had taken a dose of Benadryl, 50 mg p.o. prior to coming to the clinic, due to her prior history of allergies. Her blood pressure was checked in left arm, 134/94. She denied chest pain, SOB or feeling of swelling in tongue or face. After the tingling sensation, she began to experience pruritus of her arms, back and scalp. Visual inspection revealed no visible rash or hives. When she began rubbing on her left arm to relieve the itchy sensation, the area of rubbing became erythematous. She was observed for 45 minutes after the injection. Symptoms did not progress and she was discharged from the clinic. Phone follow-up 24 hours later: pruritus has resolved. She took 2 more doses of Benadryl 50 mg p.o. yesterday, at 2 p.m. and 11 p.m. Only symptom reported today is sleepiness.
40 2021-01-21 rash vesicular, dry skin, rash with redness, skin peeling, itchy rash right abdominal vesicular rash with erythema, pruritits for 8 days turning into dry scaly skin (not ... Read more
right abdominal vesicular rash with erythema, pruritits for 8 days turning into dry scaly skin (not painful)
40 2021-01-22 skin swelling, skin warm, pain of skin Tear through swelling, pain, wamth at site of previous hialuronic acid injection 4 months prior
40 2021-01-23 injection site pain Joint pain, pain at injection site, chills and muscle aches
40 2021-01-23 injection site pain Joint pain, pain at injection site, muscle aches
40 2021-01-24 itchy skin, hives Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nyst... Read more
Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nystagmus in her eyes; passing out; vomiting/puke when vertical; Dizziness; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; heart rate 125; BP of 170/100; throat tightness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=El1283) via an unspecified route of administration at left arm on 08Jan2021 11:30 at single dose for covid-19 immunization. Vaccine was administered at hospital. Medical history included ongoing autoimmune disorder. The patient had known allergies to Amoxicillin and wasps. No family medical history relevant to events. Ongoing concomitant medication included hydroxychloroquine sulfate (HYDROXYCHLOROQUINE) for autoimmune disorder, celecoxib (CELEBREX) for autoimmune disorder, oral dimenhydrinate (DRAMAMINE), oral fexofenadine hydrochloride (ALLEGRA) and oral famotidine (PEPCID). No other vaccine in four weeks. The patient previously took flu vaccine (Expiry Date: Nov2020), tetanus vaccines for immunization. At 11:40 on 08Jan2021, the patient had tingling and numbness in throat and lips, heart rate was 125. By noon had hives and blood pressure (BP) of 170/100 (normal BP was 96/58 and heart rate was 65), chest tightness and throat tightness, the patient was given Benadryl (50mg) and monitored. No change so walked to emergency room. Given intravenous Benadryl and steroids then released the same day on 08Jan2021. The patient woke up on Saturday and shortly after hives came back, itching, chest tightness, headache and body aches. Saturday night on 09Jan2021 she went back to hospital due to continued reaction from 09Jan2021 06:00 pm until 10Jan2021 04:30 PM. The patient was admitted for heart testing then released on Sunday afternoon simply due because each doctor said they didn't know what to do. The patient slept from late Saturday night to Monday (except testing and eating at hospital), on 11Jan2021 around noon the patient took a shower and hives, itching and tingling all came back. Completely started over with reaction and started dizziness. On Tuesday 12Jan2021, primary care physician (PCP) for tests. Chest tightness started subsiding but very dizzy, puke when vertical. Wednesday: rheumatoid doctor. The patient had extreme vertigo. Other reported events: passing out, vomiting. Nystagmus in her eyes was very strong so that she got very dizzy. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care or Hospitalization. Adverse event start time also reported as 11:45 am. The patient underwent lab tests and procedures which included blood pressure 170/100 on 08Jan2021, blood test and electrocardiogram (EKG) with unknown results, heart rate: 125 on 08Jan2021. Normal BP was 96/58 and heart rate was 65. Heart and lungs examination with clear result. The patient had no Covid prior vaccination. Nasal Swab of Covid tested post vaccination on 05Jan2021 with a result of negative. Heart rate 125 recovered on 12Jan2021. BP of 170/100 recovered on 12Jan2021. Chest tightness sometimes she has episodes. She cannot walk without assistance. She stated she currently was 100% dependent on someone else. Throat tightness recovered on 11Jan2021. Outcome of other events was not recovered. She was treated at hospital with Oral and IV Benadryl and IV Steroids on 08Jan2021. On 09Jan2021 she was administered Oral Prednisone, Oral Diphenhydramine HCl (BENADRYL) and Oral Acetaminophen(Tylenol). Steroids switched from prednisone Oral to dexamethasone Oral twice daily. On 13Jan2021 she started on ondansetron (ZOFRAN) 4mg 3xday Promethazine (Fenagrin) 25 mg once at night. Information on Lot/Batch has been requested.
40 2021-01-24 injection site warmth, injection site redness, injection site irritation Localized injection site irritation. Skin is red and hot at injection location. Symptoms increased o... Read more
Localized injection site irritation. Skin is red and hot at injection location. Symptoms increased on Sunday -- injection was Friday.
40 2021-01-24 rash Rash and Swelling on left side with Headache and fatigue
40 2021-01-24 injection site pain, injection site redness, injection site swelling Right arm injection site pain/swelling/red circle. Right Axillary lymph node swelling in arm injecte... Read more
Right arm injection site pain/swelling/red circle. Right Axillary lymph node swelling in arm injected. Headache, tiredness, muscle pain, chills, fever- T max. 101.8, feeling unwell.
40 2021-01-24 vaccination site swelling beginning around 8pm on 1/20/21 (day of vaccine), chills. woke up around 2am on 1/21/21 with nausea,... Read more
beginning around 8pm on 1/20/21 (day of vaccine), chills. woke up around 2am on 1/21/21 with nausea, feeling warm -- temp of 100.7; chills, fever, and nausea all morning of 1/21/21; fever and chills continued through 1/22/21 around 11am. Treated with Tylenol and Zofran. On 1/22/21 noticed lymph node swelling on arm where vaccine given. Neuropathy 1/22/21. Treated wtih ibuprofen 600mg TID. Lymph node remains swollen as of 1/25/21. Lymph node is hard.
40 2021-01-25 rash 1. ALL started around 4:00pm on 1/24/21-Severe muscle aches, fever (100.8), severe headache, chills,... Read more
1. ALL started around 4:00pm on 1/24/21-Severe muscle aches, fever (100.8), severe headache, chills, sore throat, nausea 2. Noticed rash on 1/15/21-Rash on right side on stomach, side, and around back
40 2021-01-25 injection site pain I received the 2nd dose of the vaccine on Monday 1/4/2021 at 1600. Over the afternoon and evening I ... Read more
I received the 2nd dose of the vaccine on Monday 1/4/2021 at 1600. Over the afternoon and evening I developed arm pain at the injection site. Since there were no other side effects in the morning, I returned to work for my regularly scheduled shift on 01/05/2021 at 0545. At approximately 0615 I began to get body aches and restlessness. At approximately 0725 in addition to the body aches and restlessness, I began to get severe nausea, weakness, light-headedness, headache, profuse sweating, and severe chest pain and shortness of breath. Because of the severity of my symptoms my manager immediately told me to go to the ED and a fellow co-worked brought me down via wheelchair. In the emergency department I was assessed and worked up and after several tests and xrays I was given a diagnosis of adverse reaction to drug/vaccine. I was discharged to home at approximately 1130 on 01/05/2021. Upon arriving home I continued to have body aches, and then developed chills, shaking and fever of 101.00. All of this combined became unbearable and I had to take 500mg of Tylenol at 2230 on 01/05/2021. On 01/06/2021 I still felt horrible with body aches, fever, nausea and fatigue. My weakness, fatigue are still present today 01/07/2021 at 0945.
40 2021-01-25 itchy skin Itching to face and chest around 3 hours after administration. Facial swelling noted overnight.
40 2021-01-25 injection site hives, rash with redness, itchy skin, rash macular, hives On 1/20/2021, approximately 2.5 hours after my second dose, I had nausea with dry heaving and starte... Read more
On 1/20/2021, approximately 2.5 hours after my second dose, I had nausea with dry heaving and started having intense, crushing pain in my CTL back (with the worst of it being in my thoracic and lumbar areas). *The nausea and subsequent dry heaving subsided within 6-8 hours with prescribed anti nausea. *The back pain only intensified, with me finally calling my doctor who recommended contacting ONE Parkview. This back pain continues today (1/26/2021). On 1/21/2021, in the early hours of the morning, I woke to hives over my entire trunk, left arm (injection site), and left thigh. *This subsided in maybe 10 or so hours with antihistamines. On 1/23/2021, at approximately 1100, I felt heat in my left arm. This coincided with a heavy feeling in my left arm. When examined, I noted that my upper arm was slightly swollen, blotchy, and had a reddened rash approximately 4x4 inches. Minor itching. *The swelling subsided by 1/25/2021, but the heat and reddened rash continues today (1/26/2021).
40 2021-01-25 rash Rashes to upper body anterior and posterior; Generalized body pain; chest pain; This is a spontaneou... Read more
Rashes to upper body anterior and posterior; Generalized body pain; chest pain; This is a spontaneous report from a contactable Nurse (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), intramuscularly in left arm on 01Jan2021 06:15 at single dose for COVID-19 immunization. Medical history was none. Known allergies: No. Other medical history: No. The patient was not pregnant. Concomitant medication in two weeks included colecalciferol (VITAMIN D). If other vaccine in four weeks: No. The patient experienced rashes to upper body anterior and posterior, generalized body pain, chest pain, all on 12Jan2021 17:00 with outcome of not recovered. No treatment received for the events. If covid prior vaccination: No. If covid tested post vaccination: No. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
40 2021-01-25 skin peeling, injection site pain, skin discolouration pain in injection site. I noticed today that my skin had peeled away at the injection site after my... Read more
pain in injection site. I noticed today that my skin had peeled away at the injection site after my son pointed it out. There is a large square and of skin peeled away. The skin is also discolored.
40 2021-01-25 redness, skin warm pain, redness, and warm to touch, progressively has gotten worse
40 2021-01-26 injection site warmth, injection site pain, injection site redness 36 hours after the injection I developed large red, warm and painful area at the injection site. 24 ... Read more
36 hours after the injection I developed large red, warm and painful area at the injection site. 24 hours after that I was experiencing fever and chills again. I also started to vomit
40 2021-01-26 skin warm, itchy skin About 20 minutes after receiving her 2nd dose of vaccine, the patient developed tingling lips (no ap... Read more
About 20 minutes after receiving her 2nd dose of vaccine, the patient developed tingling lips (no apparent angioedema), itching and warmth of the face and chest. Her face and upper chest did appear flushed. She was administered Benadryl, and her symptoms resolved after half an hour.
40 2021-01-26 injection site pain Fatigue Pain at injection site
40 2021-01-26 injection site pain, shingles Later on the day of vaccination I started feeling fatigue & pain on the site of the injection. I had... Read more
Later on the day of vaccination I started feeling fatigue & pain on the site of the injection. I had continues fatigue & muscle pain this lasted about 5-6 days. On 12/28/2020 I started noticing that I developed shingles on my right side of forehead also experiencing pain till current. I saw my doctor on 12/28/2020 & prescribed medication.
40 2021-01-26 hives Patient developed urticaria migratory about one week after shot
40 2021-01-26 redness Swelling with redness and low grade fever (topped at 100.4 degrees)
40 2021-01-26 injection site pain woke up during the night after her second dose (dose given on Friday) with joint pain (around midnig... Read more
woke up during the night after her second dose (dose given on Friday) with joint pain (around midnight or shortly after); joint pain; intense fatigue; muscle aches; arm was sore at the injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration (left arm) on 08Jan2021 (11:00) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EH9899) on 18Dec2020 (02:45 PM) via an unspecified route (right arm) for Covid-19 immunization. The patient's medical history included drug allergy (reported as known allergies: Cephalosporin (mild reaction of hives one time after having taken it with no issues for years-pending clarification)). There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. The patient reported that she woke up during the night after her second dose (dose given on Friday) with joint pain (around midnight or shortly after [09Jan2021, 12:15AM]). The entire day after her 2nd dose (during the day Saturday) every joint in her body ached and she experienced intense fatigue. There were also some muscle aches in her shoulders and her arm was sore at the injection site as it usually is after a tetanus shot (she stated she had soreness in her arm the day after the first injection but no other adverse events after the first injection). She did not seek medical treatment and did not take any over the counter medications to alleviate the symptoms as she does not typically take medications unless absolutely necessary. By the next day (Sunday), she was much better and had only slight joint pain remaining in her neck. By the following day (Monday;11Jan2021), all symptoms had resolved. She further stated that the symptoms experienced for one day did not make her regret getting the vaccine and she continue to strongly recommend the vaccine. The outcome of events was recovered on 11Jan2021. The patient has not been tested for COVID-19 since the vaccination.
40 2021-01-27 blister, itchy skin, redness On 1/22, I noticed a painful red itchy bump on my left foot. Another bump appeared on my right inde... Read more
On 1/22, I noticed a painful red itchy bump on my left foot. Another bump appeared on my right index finger the day after, and then another bump appeared today 1/28 under my right arm. They are getting larger, more painful and swollen, itchier, and seem to be filled with white pus. The one on my left foot has burst.
40 2021-01-27 injection site pain Patient is a healthcare worker who received the first dose of the COVID-19 vaccine. Later that day,... Read more
Patient is a healthcare worker who received the first dose of the COVID-19 vaccine. Later that day, patient had excessive fatigue and some site injection pain. The next morning patient has loss of consciousness witnessed by husband. At the same time patient was drooling, not speaking clearly, and then eyes rolled back in her head, and passed out for a few minutes.
40 2021-01-27 rash Went to hospital in middle of night when resting heart rate was 136/ woke up in middle of night with... Read more
Went to hospital in middle of night when resting heart rate was 136/ woke up in middle of night with racing heart/was 133; chills; fever; body aches; swollen axillary lymph nodes; rash on shoulder, armpit and back close to the vaccine site; bad headache; This is a spontaneous report from a contactable nurse. A 40-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (left arm) from 13Jan2021 10:45 to 13Jan2021 10:45 at a single dose for covid-19 immunization. Medical history included asthma and hypothyroidism. Concomitant medication included beclometasone dipropionate (QVAR) and levothyroxine. The patient also has allergies to Codeine and Azithromycin. The patient took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Dec2020. Information on the lot/batch number has been requested. It was reported that the patient went to the hospital (Emergency Room/Urgent Care) in the middle of the night when her resting heart rate was 136 on 13Jan2021. She had fever, chills, body aches. She woke up in the middle of the night with racing heart. Was 133 in the hospital, they gave her 2 liters of fluids which eventually brought it down to 105. They ran a lot of test and ruled out anything else. On Jan2021, they also found swollen axillary lymph nodes. It's now 48 hours later, still have a fever, HR finally is below 100, she now has a rash on her shoulder, armpit and back close to the vaccine site and she have a bad headache. The outcome of the event fever was not recovered while recovered with sequel on unspecified dates for the other events.
40 2021-01-28 rash Approximately 15 minutes after vaccine patient began feeling flushed, but denied any rash or respira... Read more
Approximately 15 minutes after vaccine patient began feeling flushed, but denied any rash or respiratory issues. Patient chose to leave facility and went to a store where she purchased Benadryl and took 25mg orally. Patient returned to site where vaccine was given (which is also her place of employment). Nurse evaluated patient and rash noted on chest. Blood pressure elevated to 220/115 and heart rate 120. Physician evaluated patient. EKG performed and patient found to have sinus tachycardia. Benadryl 25mg and Kenalog 40mg administered intramuscularly. Blood pressure came down to 150/104 which patient reported was close to her recent baseline as she recently had a medication adjustment. After approximately 15 minutes patient no longer felt flushed. Patient was instructed to take and additional dose of Benadryl 50mg orally that evening and a Prednisone dose pack was prescribed.
40 2021-01-28 injection site pain, skin tightness Day 2 after injection just injection site pain and tired. Severe hips/knees/ankles/wrists/back pain ... Read more
Day 2 after injection just injection site pain and tired. Severe hips/knees/ankles/wrists/back pain on day 5 and 6 after injection and calves pain and tightness.
40 2021-01-28 redness, itchy skin Delayed onset of mild pain, swelling, erythema, paroxysmal moderate to intense pruritus.
40 2021-01-28 injection site pain I received 2 dose on 1/26 at 8:40 a.m. About 4:30 p.m. I start feeling a throbbing pain at injectio... Read more
I received 2 dose on 1/26 at 8:40 a.m. About 4:30 p.m. I start feeling a throbbing pain at injection site. I around home about 6:00 p.m. immediately I start having chills, fever, muscle ache , nausea , and headaches. I could not sleep all night I was back and forth with chills and fever up to 102 for two days. On third day I felt better but headache and nausea linger still.
40 2021-01-28 hives Large painful red welts on abdomen and back
40 2021-01-28 shingles Shingles involving R. flank, with first lesion presenting 15JAN. Treated with valacyclovir, amitript... Read more
Shingles involving R. flank, with first lesion presenting 15JAN. Treated with valacyclovir, amitriptyline, prednisone. Treatment still ongoing on 29JAN
40 2021-01-28 injection site pain The muscle at the injection site was sore. It progressively got worse over about 12 hours and the ne... Read more
The muscle at the injection site was sore. It progressively got worse over about 12 hours and the next morning I could barely lift it equal to my shoulder. The soreness was manageable and it was gone by the next morning.
40 2021-01-28 itchy skin approximately 10 minutes after vaccine patient had shortness of breath and felt wheezy. She also ha... Read more
approximately 10 minutes after vaccine patient had shortness of breath and felt wheezy. She also had intermittent itching and chills. Rapid Response team notified and she was observed for an additional 30 minutes with improvement in symptoms. She was dismissed at 1000 to home
40 2021-01-28 rash, itchy skin patient developed itching and rash on chest and neck with some throat tightness. RRT called and she... Read more
patient developed itching and rash on chest and neck with some throat tightness. RRT called and she was transferred to the ER
40 2021-01-29 injection site numbness, redness Patient c/o slight numbenss at the injection site and to the back side of the arm along with feeling... Read more
Patient c/o slight numbenss at the injection site and to the back side of the arm along with feelings of queasiness. Ears were flush, no redness noted at the injection site or arm after fifteen minutes. Pt was able to lift her arm and hold it without any difficulty. Pt reported not eating anything this morning before recieving the vaccine. Pt allowed to lie down and monitored for 15 more minutes. Pt verbalized that she felt better after the additional 15 minutes, ears were with in normal color.
40 2021-01-29 itchy skin Pt received her first pfizer vaccination and after approximately 10 minutes, pt started itching thro... Read more
Pt received her first pfizer vaccination and after approximately 10 minutes, pt started itching throughout her entire body and burning to her perineal area. SQ Epi given on scene and IV benadryl given in route by EMS.
40 2021-01-30 injection site pain PT presented to ED complaining of fever (TMAX 102), frontal headache, chills, high heart rate (MAX 1... Read more
PT presented to ED complaining of fever (TMAX 102), frontal headache, chills, high heart rate (MAX 153), injection site pain PT took Tylenol at home, presented to ED r/t high heart rate
40 2021-01-30 injection site pain Severe site pain, chills, and joint pains, muscle aches and fatigue. Mild diarrhea
40 2021-01-30 skin warm Throat itchy, felt like right side of throat swelling, dizzy, skin hot. Seen by doctor in vaccine c... Read more
Throat itchy, felt like right side of throat swelling, dizzy, skin hot. Seen by doctor in vaccine clinic who held me for one hour. Took Benadryl which helped reduce throat itching and feeling of swelling in throat.
40 2021-01-31 blister I experienced red, irritated eyes following the vaccine. Also experienced a blister likely chemosis ... Read more
I experienced red, irritated eyes following the vaccine. Also experienced a blister likely chemosis which lasted approx 1 day.
40 2021-01-31 injection site pain Injection site soreness. Muscle aches in both thighs. Menstrual spotting on 1/28 & 1/29.
40 2021-01-31 injection site redness, injection site warmth, injection site pruritus Localized allergic reaction. Itchy, red, hot to touch over injection site. Mild pain. No ROM restric... Read more
Localized allergic reaction. Itchy, red, hot to touch over injection site. Mild pain. No ROM restrictions. Growing in size on 2/1/21.
40 2021-01-31 hives Patient administered 2nd dose of Pfizer COVID vaccine on 1/25/2020. Six days later the patient de... Read more
Patient administered 2nd dose of Pfizer COVID vaccine on 1/25/2020. Six days later the patient developed generalized hives treated with over the counter antihistamine (benadryl). The next day patient again had hives, trouble swallowing, and difficulty breathing. She presented to an Emergency Department and was treated with epi IM and oral antihistamines (H1 and H2). Discharged to home on prednisone 40 mg PO QD x 3 days and then 20 mg PO QD x 2 days. Patient again had trouble breathing 2/1/2020 and returned to the ED. Patient 10 weeks pregnant.
40 2021-01-31 rash Systemic: Rash (other than injection site)-Medium; Systemic: Other- half face swollen several hours ... Read more
Systemic: Rash (other than injection site)-Medium; Systemic: Other- half face swollen several hours later; symptoms lasted 1 day.
40 2021-01-31 hives severe chills, body aches, joint pain, small patch of hives by left shoulder. Took Tylenol and Advi... Read more
severe chills, body aches, joint pain, small patch of hives by left shoulder. Took Tylenol and Advil
40 2021-02-01 injection site pain Have had a lot of swelling or inflammation in both of my knees since a week after first dose injecte... Read more
Have had a lot of swelling or inflammation in both of my knees since a week after first dose injected and have pain with it - unable to stand too long because of the swelling and pain ongoing for 3 weeks now without improvement Came on out of the blue because Endo not normally have this issue.
40 2021-02-01 rash with redness, rash, itchy rash Two days post-injection patient developed a red rash across the neck that has not subsided. Patient ... Read more
Two days post-injection patient developed a red rash across the neck that has not subsided. Patient States that rash is flush red and itchy since time of the injection.
40 2021-02-01 rash myself the patient i had the first covid Pfizer vaccine on 01/04/21, symptoms started on monday nite... Read more
myself the patient i had the first covid Pfizer vaccine on 01/04/21, symptoms started on monday nite 1-04-21 feeling very fatigue and tired, on 01-05-21 felt just a little tired and fatigued had no rash mark, on 01-06-21. i threw up and just a bit tired. After a few days i fully recovered from the first dose of the covid 19 Pfizer, When i received the Second dose of the Pfizer on 01-29-21 that nite i started with a massive headache n chills, on 01-30-31 the entire day had diahrea severe chills massive headache and sweats.On 01-30-21 thru today 02-02-21 i have a round circle rash with heat and bump underneath it each day the rash is bigger were the right arm had the covid Pfizer vaccine injected on 01-29-21.
40 2021-02-02 rash EE states she received Covid vaccine on Wednesday 1/27/21. She had to call off work on Thursday (1/2... Read more
EE states she received Covid vaccine on Wednesday 1/27/21. She had to call off work on Thursday (1/28/21) due to headache, general body aches and nausea. Came back to work today (1/29/21) and came to EH with c/o uppder body aches, intermittent headaches and a rash to back, chest and bilateral underarms. EE afebrile at this time. EE medicated with Benadryl PO, as per standing order.
40 2021-02-02 redness Pfizer-BioNTech was administered at 4:19 pm, she was advised she would need to wait 30 for any adver... Read more
Pfizer-BioNTech was administered at 4:19 pm, she was advised she would need to wait 30 for any adverse reaction. At 4:25pm patient started to fee palpations, braking out with redness on her chest and her left arm where the vaccine was administrated. Epinephrine 0.3 mg auto injector was given in her right thigh by the doctor. We then called 911 to transport her to the emergency room.
40 2021-02-02 hives The employee received both Pfizer covid vaccines (12/17/20 - R deltoid and 1/7/21 -L deltoid per re... Read more
The employee received both Pfizer covid vaccines (12/17/20 - R deltoid and 1/7/21 -L deltoid per report). The employee reports taking only OTC Claritin the day of vaccination for both covid vaccines per employee report. The employee offers no other recent illness, no new medication regimen, nor change in overall health. The employee reports two small "hive" spots noticed on her R buttock on 1/12/21, 5 days after the second covid vaccine. Since 1/12/21, the employee has a described flat, red, non-itching rash extending from her R buttock to her R groin and flank, extending to the R breast. The redness has extended across her abdomen and now includes involvement on the left, from the L axillae to the L groin. Newest spots per employee include now her left wrist and two spots on her left upper arm.
40 2021-02-02 rash macular tip of nose still funny feeling; Slight dry cough; clearing throat; hoarse voice; pins and needles o... Read more
tip of nose still funny feeling; Slight dry cough; clearing throat; hoarse voice; pins and needles on face; numb face; Red spots on nose and legs; mottled leg color but looked like a flat rash; mottled leg color but looked like a flat rash; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL1283 and Expiration Date unknown) via an unspecified route of administration on 19Jan2021 07:15 PM (vaccine location: Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EJ1685 and Expiration Date unknown) via an unspecified route of administration on 31Dec2020 11:30 AM (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history included asthma, chronic migraines from neck injury, increased weight, known allergies to Reglan. No covid prior vaccination. The concomitant medications was reported as pregabalin (LYRICA), cefixime (FLEXERIL), sertraline hydrochloride (ZOLOFT), omeprazole (PROTONIX), sumatriptan succinate (IMITREX).On 19Jan2021 08:00 PM, patient experienced pins and needles on face. Then numb face. Red spots on nose and legs. Then mottled leg color but looked like a flat rash. Next day (20Jan2021) tip of nose still funny feeling. Spots remain. Slight dry cough, clearing throat, hoarse voice. Events resulted in Emergency room/department or urgent care. Treatment information included IV fluid, Benadryl, pepcid, steroids.The outcome of events was recovering after treatment given. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
40 2021-02-03 injection site pain, injection site tingling, injection site numbness 12/30/2020: COVID Vaccine Pfizer-BioNTech dose 1 of 2 left arm. Acute onset left shoulder/arm pain 1... Read more
12/30/2020: COVID Vaccine Pfizer-BioNTech dose 1 of 2 left arm. Acute onset left shoulder/arm pain 1-2 days later without inciting event (no trauma, no sports/weights), progressively worsening to severe next 2 days with onset of numbness and paresthesias in left upper arm and hand by 1/5/2021 seen at urgent care with dx: Cervical Neuropathy. Follow-up cervical MRI 1/22/21 without significant canal or foraminal impingement. Seen by Neurologist 2/3/2021, at that time pain improved and localized to left shoulder joint area radiating under scapula and paresthesia resolved to numbness. Physical exam findings: Absent triceps reflex, Left FDI atrophy, left hand finger extensor weakness, left abduction limited to 90 degrees. Dx: Neurologic Amyotrophy (Parsonage Turner Syndrome); Complication of COVID vaccination. Plan: EMG, NCS, Left shoulder MRI, labs pending. PT OT ordered. Rx: Nortriptyline, Medrol Dosepak. F/U 2-3 months with neurology.
40 2021-02-03 injection site pain, injection site numbness Swollen face, eyes lids, nose and lips. Received the vaccine on 1-11-21. Experienced left arm numbne... Read more
Swollen face, eyes lids, nose and lips. Received the vaccine on 1-11-21. Experienced left arm numbness and pain on site. Numbness subsided and pain was minimal. Went to bed and work up around 6am to face, eyes, nose and lips swollen. Barely unable to open eyes. Immediately contacted employer employee health and contacted PCP. Appointment scheduled with PCP. PCP assessment completed. Recommended prednisone for swelling. Unable to take because of previous reaction. Recommended for Benadryl to be taken every 4-6 hrs and also Ibuprophen
40 2021-02-04 injection site warmth 45 minutes after administration pt became nauseated, tachycardic, numbness and tingling hands and fe... Read more
45 minutes after administration pt became nauseated, tachycardic, numbness and tingling hands and feet, progressing to the knees. Injection site warm, BP 132/96. On exam, oropharynx mild erythema - no edema and no stridor. Lungs CTA. Cor - S1 S2 slightly rapid. Abd soft, non-tender, positive BS. No rashes. Gave Benadryl 50 mg and prednisone 20 mg. BP 110/72. HR 72. O2 Sat 98%. Temp 98.3F.
40 2021-02-04 hives Hives, backache, fatigue, and body aches
40 2021-02-04 shingles Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under ey... Read more
Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye.; Tenderness under eyebrow of right eye/pain behind right eye that did not go away for more than 5 days; Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye.; This is a spontaneous report from a contactable healthcare professional (HCP). A 40-year-old female patient received first single dose of BNT162B2 (Pfizer- BioNTech, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 14Jan2021 16:00 for COVID-19 immunization. Vaccination facility: Hospital. The patient had no relevant history. The patient was not pregnant at time of vaccination and at the time of reporting. The patient had no known allergies. The patient did not have Covid prior vaccination. Concomitant medication (other medications in two weeks) included multivitamin (unspecified). There was no other vaccine in four weeks. On 14Jan2021 19:00, the patient experienced shingles: approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye. Experienced pain behind right eye that did not go away for more than 5 days. Sought medical attention and ophthalmologist diagnosed shingles on 20Jan2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. Treatment for the adverse events included antiviral medication and steroid drops. Patient was not Covid tested post vaccination. The patient had not recovered from the events at the time of reporting. Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events herpes zoster, eyelid pain and erythema of eyelid cannot be excluded. The information available in this report is limited; information on previous occurrences of shingles, if any, would aid in case assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
40 2021-02-04 injection site pain With the 1st dose I had myalgia, arthralgia and pain at the injection site which began the next morn... Read more
With the 1st dose I had myalgia, arthralgia and pain at the injection site which began the next morning when I woke up at around 10:00 am and lasted 48 hours. For the 2nd dose, the reaction was more profound. I had pain at the injection site within 6 hours of the injection and by the next day around 11:00 am I woke up with myalgia, arthralgia, fever of 101.2 F, fatigue, headache, and sore throat. Symptoms lasted for 4 days and I missed 2 days of work.
40 2021-02-06 injection site warmth 15 minutes after injection, I saw white spots and felt dizzy. The white spots in vision occurred o... Read more
15 minutes after injection, I saw white spots and felt dizzy. The white spots in vision occurred on and off for the following 24 hours. Injection site warm to touch (compared to other arm) but without redness.
40 2021-02-06 hives, redness Pfizer-BioNTech Covid-19 vaccine EUA. 3 x 3 inch red welt, hot to touch at injection site. Fever of ... Read more
Pfizer-BioNTech Covid-19 vaccine EUA. 3 x 3 inch red welt, hot to touch at injection site. Fever of 101.5 beginning 19 hours after injection. Fever ongoing 48 hours after injection (has not ceased as of yet). Body aches, especially lower back, swollen lymph nodes throughout entire body, chills, lethargy, lack of appetite, dizziness, mild headache. There is a large swollen lump under collarbone about 4 inches and is raised from skin. Also pain under left armpit. Since this occurred over the weekend, I plan to follow up with primary care doctor Monday.
40 2021-02-07 hives 25 minutes after her vaccine, patient's tongue and lips started tingling. She said they were not swo... Read more
25 minutes after her vaccine, patient's tongue and lips started tingling. She said they were not swollen but she definitely had a tingling feeling. She felt as if she had difficulty swallowing and had some hives on her back. These symptoms all resolved after 3 hours. She never had trouble breathing and was able to eat her dinner.
40 2021-02-07 hives Nausea, vomiting, dizziness, chills, body aches, hives on right leg
40 2021-02-08 hives Hives, on right shoulder and right hand, given 50 mg Benadryl. Client went back to work after Benad... Read more
Hives, on right shoulder and right hand, given 50 mg Benadryl. Client went back to work after Benadryl was given and vitals remained stable, hives did not continue to spread.
40 2021-02-08 itchy skin Patient experienced tachycardia, chills, and itch within 15 minutes of observation. No treatment w... Read more
Patient experienced tachycardia, chills, and itch within 15 minutes of observation. No treatment was given. Patient was observed and later discharged
40 2021-02-08 injection site swelling, injection site redness, injection site nodule, injection site pruritus, injection site warmth The day after vaccine administration, pt experienced an injection site that was raised, red, itchy a... Read more
The day after vaccine administration, pt experienced an injection site that was raised, red, itchy and warm. She contacted per PCP and he said the rxn was secondary to the vaccine administration. He recommended she receive the 2nd dose of the vaccine in the opposite arm. 1 week later she still had a knot at her injection site but it was getting smaller daily.
40 2021-02-08 injection site numbness hard time catching her breath; throat felt a little tight; her throat felt a little tight, and she f... Read more
hard time catching her breath; throat felt a little tight; her throat felt a little tight, and she found it hard to swallow; little nervous; very lightheaded; her husband told her she looked very pale; her heart rate jumped to over 150, according to her (company name) watch; she had pins and needles up and down her entire left arm; her left arm initially felt almost totally numb from her shoulder to her finger tips, and then she felt pins and needles down the entire length of her arm.; maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of bnt162b2 (Lot Number: EK4176), via an unspecified route of administration in left arm on 25Jan2021 12:50 at single dose for covid-19 immunization. Medical history included coeliac disease from Mar2013 and ongoing. There were no concomitant medications. She said initially she was OK after she received the COVID-19 Vaccine. She said after about 5 minutes in from receiving the COVID-19 Vaccine, she had a hard time catching her breath, and her throat felt a little tight, and she found it hard to swallow. She said she thought she was nuts at first, and was a little nervous for a minute. She said the staff at the vaccination center made people wait 15 minutes after receiving the COVID-19 Vaccine before being allowed to leave. She said she actually spoke to the vaccination center staff while she was waiting for the 15 minutes to go by. She said she didn't say anything to the staff because she thought she might be crazy. She said she scheduled her second COVID-19 Vaccine dose, and after the 15 minutes went by, she left. She said her husband had drove her to and from the COVID-19 Vaccine facility location. She said 5 minutes into her car trip after leaving the facility, she became very lightheaded. She said her throat began to feel tight again (saying the throat tightness was worse than what she first experienced at the convention center), and she kept trying to clear her throat. She said her husband told her she looked very pale. She said her heart rate jumped to over 150, according to her Apple watch. She said she had pins and needles up and down her entire left arm. She clarified her left arm initially felt almost completely numb from her shoulder to her finger tips. She said she thought that maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm. She clarified the numbness improved in her left arm, but she still has a pins and needle sensation down the length of her left arm. Patient asked if it is OK for her to received the second COVID-19 Vaccine based on what she experienced after the first COVID-19 Vaccine dose. Reported if she would have been driving the car after she received her first COVID-19 Vaccine dose, she would have had to pull over on the side of the road because of the side effects she was experiencing. Reported the side effects she experienced in the car after leaving the vaccination facility, resolved after a couple minutes, with the exception of the pins and needles and numbness in her left arm. She said the pins and needles, and numbness in her left arm improved, but was still present. Reported she had a well visit not too long ago, and her blood work was perfectly fine. The outcome of the events Peripheral nerve injury, Pins and needles, Numbness of upper extremities was recovering, other events was recovered on 25Jan2021.
40 2021-02-09 vaccination site pain Headache Extreme; fatigue; Pain at injection site; armpit and breast (all L) Ncek pain; armpit and b... Read more
Headache Extreme; fatigue; Pain at injection site; armpit and breast (all L) Ncek pain; armpit and breast (all L) Neck pain; armpit and breast (all L) Neck pain; This is a spontaneous report from a non-contactable Other HCP (patient). A 40-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 19Jan2021 15:00 for an unspecified indication Covid-19 immunisation. Medical history included irritable bowel syndrome (IBS), asthma, allergies to sulfa. Patient was not pregnant. The patient had not experienced Covid-19 prior vaccination. The patient's concomitant medications were not reported. No other vaccine was received in four weeks. On 20Jan2021 the patient experienced headache extreme, fatigue, pain at injection site, armpit and breast (all l) neck pain. No treatment received. COVID was not tested post vaccination. The outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
40 2021-02-09 injection site pain I had Chills, low grade fever, site sorness, arm stiffness, worsened joint and muscle pain and fatig... Read more
I had Chills, low grade fever, site sorness, arm stiffness, worsened joint and muscle pain and fatigue for 3 days
40 2021-02-09 vaccination site rash, rash papular Raised rash on face; Raised rash on face and injection site; flushed feeling face; chills; Body ache... Read more
Raised rash on face; Raised rash on face and injection site; flushed feeling face; chills; Body aches; brain fog/ overall not up to feeling like myself; This is a spontaneous report from a contactable nurse reported for herself. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the right arm on 22Jan2021 15:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing and cerebrovascular accident from an unknown date and unknown if ongoing. The patient previously took morphine and experienced drug hypersensitivity. On 23Jan2021 10:30, the patient experienced raised rash on face and injection site, flushed feeling face, chills, overall not up to feeling like myself, body aches and brain fog. No treatment was received for the events. The outcome of the events was recovering. Information on the lot/batch number has been requested.
40 2021-02-09 vaccination site pain, rash Rash on my upper back; sore/tender armpit on injection arm.; This is a spontaneous report from a con... Read more
Rash on my upper back; sore/tender armpit on injection arm.; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received bnt162b2 (Lot: EL0142), via an unspecified route of administration on 07Jan2021 (dose: 1) at 04:00 PM single dose (Left arm) and then on 28Jan2021 (dose: 2, Lot: EL3246) at 03:45 PM single dose for COVID-19 immunization. Medical history included allergies: Sulfa. Concomitant medications included omeprazole, fexofenadine hydrochloride, hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ), iron, fish oil, vitamin D and probiotic. The patient previously took azithromycin (ZITHROMAX) and experienced drug allergy. On 19Jan2021, the patient experienced rash on upper back and sore/tender armpit on injection arm. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Treatment was not received for the adverse events. The outcome of the events was not recovered.
40 2021-02-09 injection site pain blurry vision, kaleidoscope vision accompanied by a headache - entire body soreness, soreness at inj... Read more
blurry vision, kaleidoscope vision accompanied by a headache - entire body soreness, soreness at injection site
40 2021-02-10 injection site pain Pain at injection side for a week. Fevers for 2 days up to 103.9. Fever stayed around 102.5 despite ... Read more
Pain at injection side for a week. Fevers for 2 days up to 103.9. Fever stayed around 102.5 despite taking IBU every 5 hours. Severe fatigue. Then on day 3 had severe nausea.
40 2021-02-10 injection site pain Pain at site of injection upon waking the next morning and in shoulder area. About 15 hours after ... Read more
Pain at site of injection upon waking the next morning and in shoulder area. About 15 hours after vaccine. Began to feel moderate body aches all over body with a headache. Began using restroom repeatedly with significant back pain and spasms. Muscle aches and pain continue. This reaction is after the 1st dose and I have had Covid July 2020.
40 2021-02-10 rash with redness Swelling of hands, fingers; rash and redness on forearms/red rash; Face swollen; Very hot.; This is ... Read more
Swelling of hands, fingers; rash and redness on forearms/red rash; Face swollen; Very hot.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 02Feb2021 at 03:15 (at the age of 40-years-old) as a single dose for COVID-19 immunization. Medical history included obesity from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications included pantoprazole sodium sesquihydrate (PROTONIX) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took amoxicillin/clavulanic acid (AUGMENTIN) and dextropropoxyphene napsilate/paracetamol (DARVOCET); both from unknown dates to unknown dates for unknown indications and experienced allergy. On 02Feb2021 at 15:45, the patient experienced swelling of hands/fingers, rash and redness on forearms/red rash, face swollen, and very hot; all reported as serious of being life-threatening. The events required a visit to the urgent care (physician's office). The patient was treated with epinephrine (EPIPEN) and unspecified medications at the urgent care after emergency medical services were called. The clinical outcomes of swelling of hands/fingers, rash and redness on forearms/red rash, face swollen, and very hot were recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
40 2021-02-11 rash with redness, rash About 12 hours after the vaccine I developed headache, fever 100.5, nausea and vomiting, and red ra... Read more
About 12 hours after the vaccine I developed headache, fever 100.5, nausea and vomiting, and red rash across my chest up to my neck and under both breasts. All symptoms but the rash improved the following day. I went to have my 8 week pregnancy US 6 days after this second vaccine dose and there was no fetal heart rate. The baby measured 8.7mm and there should be a heart rate when the baby measures >7mm. I had all of my pregnancy symptoms up through the day of the vaccine and then they disappeared the day my vaccine symptoms improved. I do not have a history of miscarriage.
40 2021-02-14 vaccination site redness, itchy skin Dose number 1 start of drug 08Jan2021/Dose number 2 start of drug 25Jan2021; Rash at injection site,... Read more
Dose number 1 start of drug 08Jan2021/Dose number 2 start of drug 25Jan2021; Rash at injection site, upper back, back of knee on right leg; generalized itching all over; This is a spontaneous report from a contactable 40-year-old female other healthcare professional reporting for herself A 40 years old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medicao history included allergies to Latex, peniccillin, Tomatoes, and Pineapple, diabetes mellitus and hypertension. The patient received first dose of BNT162B2 (Lot number:EJ1685) on 08Jan2021 intramuscular on left arm. Concomitant medications were not reported. On 26Jan2021 the patient experienced rash at injection site, upper back, back of knee on right leg and generalized itching all over. The patient did not received treatment for the events. The patient also experienced inappropriate schedule of vaccine administered as second dose was administered 17 days after first dose with outcome unknown. The patient had not yet recovered from other reported events.
40 2021-02-14 skin laceration Fainted twice! Causing massive head trauma & wounds. It happened 35 hours after the vaccination & I ... Read more
Fainted twice! Causing massive head trauma & wounds. It happened 35 hours after the vaccination & I was given no warning that this could happen.
40 2021-02-14 redness Red face, high blood pressure
40 2021-02-14 itchy skin, hives, rash with redness red rash came up on her chest; upper chest muscles just below her collar bone. the pressure of the w... Read more
red rash came up on her chest; upper chest muscles just below her collar bone. the pressure of the water hitting her was painful; Diarrhea; pain and stiffness in her chest that extended across her shoulders; can't seem to regulate her body temperature; laboring to breathe; joint pain; pulse and it had dropped down to 40; She has a history of tachycardia, but her pulse kept reading normal; muscle pain; inflammation; she woke up and she was itchy around her left forearm. She was really itching; couldn't really taste, things didn't really taste right to her; immediate soreness in arm; she has pain that extends up into her neck; Nausea; hasn't had much of an appetite; sweating; left hand swelling; hives on forearm; gastrointestinal issues; Fever; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982), intramuscular at left arm on 21Jan2021 15:38 at a single dose for COVID-19 immunization. Medical history included Tachycardia (started about 4 years ago), Hypertension (started about 4 years ago) and Essential tremor from 2020 (she has been having symptoms for a while; finally, during the summer of 2020, she was diagnosed through a neurologist) and anxiety, all ongoing; pain, back problems and sleep disorder.Concomitant medications included ongoing Tizanidine as muscle relaxant for back problems, ongoing Metoprolol tartrate for hypertension and tachycardia, Primidone for Essential tremor and ongoing Clonazepam for essential tremors, to help her sleep, and also for anxiety. No prior vaccinations (within 4 weeks). The patient got the first COVID vaccine dose. Afterwards, she went to school and it "was downhill from there". 5 days of persistent symptoms including sweating, muscle pain, joint pain and left hand swelling. It was further reported that she had to wait 15 minutes and then she drove home which is about a 35-minute drive. So about 45 mins after receiving the vaccine, she noticed her tongue, it was more on the right side of her tongue, she can't explain the sensation. She couldn't really taste. Things didn't taste right to her. This lasted 24 hours. She woke up the next day, 22Jan2021, feeling not quite right. She took some Tylenol that morning and went on into school. She took some ibuprofen in the middle of day, it wasn't a big deal. She has a history of tachycardia, but her pulse kept reading normal. She had a drink she was drinking from lunch and she ended up having the remainder of it the last few hours of that day. At about the end of her workday, around 15:30 she was finishing the Cdrink off and she said to herself "oh that taste like a regular drink again". This tongue sensation/lack of taste resolved. At that point, she got really excited because she thought this was all that she would experience with the vaccine. She was grateful she had the chance to have the vaccine. She mentions her arm was very sore right off the bat. She experienced immediate soreness in her arm right after receiving the COVID-19. She thought when they were injecting her, it hit her bone. In fact, she joked about this with the person administering the vaccine. The person at the facility told her to rub it, it actually helps with that. This kind of soreness didn't seem like a major problem. She was still experiencing this soreness. If she is sitting on the couch sideways, with her side of her arm against the couch, she has pain that extends up into her neck. It was pretty painful. Friday, 22Jan2021 (24 hours later after receiving the vaccine), by the time she got home from work, she was really sore. She had some real muscle pain around her hips and upper thighs, both of them. The soreness extended across. It was like she had inflammation that started flaring up. She felt pretty sore that evening. It wasn't like a normal muscle soreness. She went to bed because she was pretty tired. The next morning (Saturday, 23 Jan 2021), she couldn't get off the couch. She had such bad muscle and joint pain. She slept off and on, the pain was pretty bad. Her whole body had so much stiffness and inflammation. Every muscle and every joint just hurt. She confirmed that she hasn't been able to regulate her body temperature. This has been going on since Saturday evening (23Jan2021). She stated that this wasn't normal for her. She does take medications to lower heart rate but she hadn't taken it. She was talking to her best friend about how she had been sore and slept all evening. She checked her pulse and it had dropped down to 40. Her O2 level was at 92. She didn't think it was that big of a deal. Her best friend was kind of freaking out about it. She had such pain and stiffness in her chest that extended across her shoulders, it made it difficult to breathe. She was laboring to breathe. She checked her pulse thinking maybe she was feeling anxious about it and her HR was up, but it wasn't. She states happened so bad yesterday, yesterday was worse than before. She got up on Sunday morning, 24Jan2021, and took a hot shower. When the water from the shower head hit her chest, clarified as her upper chest muscles just below her collar bone, the pressure of the water hitting her was painful. However, she was able to get up, she was moving around. Still the whole time. she had this fever-ish feeling. Her kids were telling her that they were sweating because she had the house at 76 degrees. Monday morning, 25Jan2021, she woke up and she was itchy around her left forearm. She was really itching on Friday night, but she didn't think anything about it. When she took a hot shower yesterday (25Jan2021), a red rash came up on her chest and it looked like she had hives on her forearm. She didn't know if the hot water flared that up, but she doesn't have any allergies. She also had gastrointestinal issues. She has had some nausea that has lasted the entire time since she received the vaccine. She clarifies the nausea has came and gone. She hasn't had much of an appetite. They thought she had a fever yesterday at school. It was 99. something but she had already taken Tylenol a couple hours before and she was sweating so much. She states she has also had diarrhea the last few days, clarified as the last 2 days (24Jan2021). She has already spoken to someone to report her symptoms but wasn't sure about and had question about getting the second vaccine dose. She reported having gone to Urgent care where she was told she had Post covid vaccine syndrome and that she shouldn't have a problem with the second dose. She explained she went to the urgent care yesterday, 25Jan2021. She called her doctor that morning and was told to continue to treat her symptoms and take ibuprofen and Tylenol but if she got worse, to go to urgent care. So, she went to the urgent care (Product information for the Tylenol and Ibuprofen she has been taking (Ibuprofen: UPC/NDC: not provided when probed. Lot: P142385 Expiry date: Apr2023 and Tylenol: UPC/NDC: not provided when probed. Lot: P121664 Expiry date: Sep2023). The nurse just explained (Name Withheld) was having the same exact symptoms as the patient, except it was (Name Withheld) second dose. Her symptoms were identical to the patient. The patient wasn't initially sure if it was from the vaccine or if it was her anxiety. The patient didn't feel anxious and her heart rate wasn't up. The patient told she didn't think anxiety caused her to feel like she had a fever. The school nurse looked it up and found out more symptoms kind of wax and wane. Her symptoms got much worse. On 25Jan2021, Test: Rapid COVID-19 test Result: Negative. The event immediate soreness in arm was not recovered; event couldn't really taste, things didn't really taste right to her recovered on 22Jan2021 and nausea recovered in Jan2021; and unknown outcome for the other events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021101606 same reporter/drug, similar events, different patient
40 2021-02-16 rash, skin swelling Days 1-2 after injection: tightness and ache in chest, collar bones, and ribs. Day 3: rash in lef... Read more
Days 1-2 after injection: tightness and ache in chest, collar bones, and ribs. Day 3: rash in left armpit Day 4: rash grew, swollen lymph node in left armpit noticeable Day 5: swelling and rash receding, still notable
40 2021-02-18 itchy skin 24 hours post vaccine, developed bilateral eye swelling, itchy ness full body and right orbital pain... Read more
24 hours post vaccine, developed bilateral eye swelling, itchy ness full body and right orbital pain along with the feeling of my heart racing. Swelling lasted 9 hrs, self medicated with Zyrtec (Benadryl makes my heart race) . Tylenol 1000mg every 4 hrs for headache pain. Headache is still present daily. Switched to 800 Motrin every 6 hrs. Headache and lower extremity muscle pain, as well as nerve twitches and cramping still occurring 8 days post vaccine.
40 2021-02-18 itchy skin, hives Sever joint pain, headache Hives on the backside of not of my legs with itching that turned into lar... Read more
Sever joint pain, headache Hives on the backside of not of my legs with itching that turned into large welts a few hours later that then turned into 2 large welts on the side/back of my upper thighs. 2 days later and ever since I have severe nerve pain that is constant and is affecting my ADLs.
40 2021-02-21 vaccination site redness, vaccination site warmth, vaccination site swelling Lymphoid under left day swollen and bruised. 2 inches under vaccine site was swollen, red and hot to... Read more
Lymphoid under left day swollen and bruised. 2 inches under vaccine site was swollen, red and hot to touch. Now bruising down the arm to her elbow. Last Lymphoid behind her left knee was swollen and enlarged.
40 2021-02-22 injection site pain, injection site swelling Evening of vaccine starting around 3 pm I had Diarrhea, Nausea, Headache, & Fatigue. Over night I ha... Read more
Evening of vaccine starting around 3 pm I had Diarrhea, Nausea, Headache, & Fatigue. Over night I had chills so possible fever but I did not check it. Next morning woke up with Full Body Aches, Very Fatigued, Headache, Injection Site Pain and Swelling.
40 2021-02-22 injection site redness, injection site rash Large red rash similar to COVID arm side effect appeared at the injection site. This was almost a we... Read more
Large red rash similar to COVID arm side effect appeared at the injection site. This was almost a week later.
40 2021-02-22 injection site discomfort Started with discomfort on arm where the vaccine was administered. When I got up to take acetaminoph... Read more
Started with discomfort on arm where the vaccine was administered. When I got up to take acetaminophen, I felt very dizzy, nauseous, stay up, couldn't talk, after I drank cold water, I started with profuse sweating followed by chills, also had lower abdominal pain and pain on the left side of the chest. I went to the bathroom and did not have diarrhea. I was finally able to get up with help from my wife. Slow walking. The event lasted about 15 minutes. Since then I've take acetaminophen every 4 hrs.
40 2021-02-22 injection site redness, injection site pain, injection site swelling generalized muscle ache fatigue injection site swelling, errythema and pain Headache
40 2021-02-23 injection site pain ?Burning? sensation at injection site continuing after administering vaccination.
40 2021-02-23 injection site discomfort Following the injection, after approximately four hours later I began to feel some slight disorienta... Read more
Following the injection, after approximately four hours later I began to feel some slight disorientation and tiredness. Later the same evening I experienced brain fog and confusion for the next several days as well as a terrible headache. Additionally my tongue felt tingly. All of these symptoms passed within several 3- 4 days following the vaccination. injection site discomfort was also a symptom.
40 2021-02-23 vaccination site pain Pain at the site of injection; This is a spontaneous report from a contactable other healthcare prof... Read more
Pain at the site of injection; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL 3247), via an unspecified route of administration in left arm on 26Jan2021 12:45 PM at single dose for COVID-19 immunization. The patient's medical history included seasonal allergies. The patient had no allergies to medications, food, or other products. Concomitant medications included azelastine hydrochloride/fluticasone propionate (DYMISTA) and cetirizine hydrochloride. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 26Jan2021 16:00, the patient experienced pain at the site of injection. The event was considered as non-serious by the other healthcare professional. The patient did not receive any treatment for the adverse event. The outcome of the event was recovered on an unspecified date in 2021.
40 2021-02-24 injection site pain, hair loss The day of the vaccine my left arm was in pain. The pain continued to get worse the next day. I was ... Read more
The day of the vaccine my left arm was in pain. The pain continued to get worse the next day. I was unable to touch or move my arm without intense pain. It felt as though my arm had been stabbed. A week later I noticed a patch of hair loss on my scalp. I went to a dermatologist and was diagnosed with alopecia. There is no family history of alopecia and the only thing I can think of that could have triggered my immune system to start attacking itself is from my bodies response to the vaccine.
40 2021-02-24 hives light headed; woke up with hives on my neck; This is a spontaneous report from a contactable Other H... Read more
light headed; woke up with hives on my neck; This is a spontaneous report from a contactable Other Health Professional (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number PAA15 6651), via an unspecified route of administration in left arm on 03Feb2021 09:00 at single dose for Covid-19 immunization. Medical history included allergies to medications, food, or other products: Penicillin. Pregnant at the time of vaccination: No. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. Prior to vaccination, was the patient diagnosed with COVID-19: No. There were no concomitant medications. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: None. The patient previously took erythromycin and experienced Allergies: erythromycin. The patient experienced light headed and woke up with hives on her neck on 04Feb2021 06:00 with outcome of recovered in Feb2021. Since the vaccination, has the patient been tested for COVID-19: Yes. The patient underwent lab tests and procedures which included BinaxNOW Covid-19 Ag Nasal Swab: negative on 05Feb2021 and negative on 08Feb2021. No treatment received for the adverse event. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
40 2021-02-25 shingles Developed Shingles after 2nd Vaccine
40 2021-02-25 itchy skin, rash I received the first dose on 12/30/20 and the 2nd dose on 1/20/21. I started have an allergic react... Read more
I received the first dose on 12/30/20 and the 2nd dose on 1/20/21. I started have an allergic reaction after eating walnuts on 1/30/21. I have never had reactions to nuts before. I had swelling, itching and rash on my face. I took Benadryl and after 32 hours, my symptoms improved. I have since avoided tree nuts. I have also been having wrist and finger "tightness" in both hands since 2/10. and it seems to wax and wane. Both hands feel stiff. Prior to the vaccinations, I have had no health conditions. I have an appointment w/ my PCP later in the month.
40 2021-02-26 skin warm During the observation period after the vaccine, at the 5-6 minutes time frame, my heart was poundi... Read more
During the observation period after the vaccine, at the 5-6 minutes time frame, my heart was pounding like palpitations. My arm was warm up to my chest. EMS was called. They took my vitals signs. All of my vitals were normal accept my pulse was elevated 113 and then it finally came back down to 108.
40 2021-02-26 itchy skin My face began to itch around 9 pm last night. I woke this morning with a slightly swollen face and e... Read more
My face began to itch around 9 pm last night. I woke this morning with a slightly swollen face and extremely itchy face even my ears. I took a antihistamine which has helped but it still itchy. It?s currently 1 pm the following day after the first dose
40 2021-02-27 injection site inflammation Inflammation at site initially
40 2021-02-28 vaccination site pain Headache; pain at injection site; This is a spontaneous report from a contactable consumer (Patient)... Read more
Headache; pain at injection site; This is a spontaneous report from a contactable consumer (Patient). A 40-year-old female non-pregnant patient received first dose of bnt162b2 (formulation: Solution for injection, Brand: Pfizer, Lot number: unknown) via unspecified route of administration at 12:15 on 27Jan2021, on left arm at single dose for COVID-19 immunization. The patient medical history was not reported. The concomitant medication included CELEXA (celecoxib), NEXIUM (esomeprazole sodium) and ZYRTEC (cetirizine hydrochloride). It was reported that on an unknown date in Jan2021 at 07:00, the patient experienced headache and pain at injection site. The events were reported as non-serious by the reporter. The patient had not diagnosed with COVID-19 prior to vaccination and since the vaccination. It was reported that patient had no allergies to medications, food, or other products. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
40 2021-02-28 redness, skin discolouration Her hand is a purple color; Her skin feels like a BP cuff is on it; entire left arm is swollen and r... Read more
Her hand is a purple color; Her skin feels like a BP cuff is on it; entire left arm is swollen and red; entire left arm is swollen and red; Her entire left arm, which is the arm that received the vaccine is swollen and red. It feels like the circulation is being cut off; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL8982 and Expiration date: 31May2021), via an unspecified route of administration at the left arm on 21Jan2021 at a single dose for covid-19 immunization. The patient's has no medical history. There were no concomitant medications. On 22Jan2021, her entire left arm, which is the arm that received the vaccine is swollen and red. It feels like the circulation is being cut off. It hasn't been seeming to get better. The first time she noticed it was the morning after the vaccine. Her entire arm was swollen. She thought it would dissipate. At times it has kind of gotten better, but then the swelling keeps coming right back. Like right now her arm was uncomfortable in her coat. On an unspecified date, her hand was purple color. Her skin feels like a BP cuff was on it. She has not had treatment for it. The outcome of the events was not recovered.
40 2021-02-28 rash, hives Patient describes hives over anterior neck and chest approximately 1-2 hours after receiving the inj... Read more
Patient describes hives over anterior neck and chest approximately 1-2 hours after receiving the injection. The rash lasted about 3-4 days and then resolved.
40 2021-02-28 injection site pain pain at injection site, myalgia, severe headache, joint pain x 3 weeks, psoriasis flare, carpal tunn... Read more
pain at injection site, myalgia, severe headache, joint pain x 3 weeks, psoriasis flare, carpal tunnel syndrome flare, chills, menstrual spotting, ovarian cyst
40 2021-02-28 itchy skin patient experience swollen neck, itching, and elevated heart rate. she was administered 1/2 iv dose ... Read more
patient experience swollen neck, itching, and elevated heart rate. she was administered 1/2 iv dose of benadryl by local emt. Symptoms resolved.
40 2021-02-28 rash rash appeared in both upper arms/the rash had extended to the rest of the arms/ both legs also displ... Read more
rash appeared in both upper arms/the rash had extended to the rest of the arms/ both legs also displayed the rash; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262), via an unspecified route of administration in left arm on 25Jan2021 14:30 at a single dose for COVID-19 immunisation. The patient has no medical history. No allergies to medications, food, or other products. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. On 25Jan2021 21:00, a few hours after receiving the vaccine, a rash appeared in both upper arms. By the end of the day, the rash had extended to the rest of the arms. After 36 hours of receiving the vaccine, both legs also displayed the rash. The event was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of the event was not recovered.
40 2021-03-01 hair loss Excessive hair loss
40 2021-03-01 injection site swelling, injection site rash, rash with redness, injection site warmth Near injection site is raised, red rash near injection site. Red marks above and below injection. Ve... Read more
Near injection site is raised, red rash near injection site. Red marks above and below injection. Very hot to the touch.
40 2021-03-02 rash Dizzy Friday when given shot, Chills and fever Friday night, upset stomach, headache, low grade feve... Read more
Dizzy Friday when given shot, Chills and fever Friday night, upset stomach, headache, low grade fever on Saturday, upset stomach, headache, lowgrade fever on Sunday, Swollen lymph nodes, rash on chest/shoulders/upper back and chills Monday, Rash spread to torso, arms, legs and neck, eyes burned and left ear hurt, chills, fever was 104, resting hear rate was 120 bpm
40 2021-03-02 itchy skin Once injected, I felt a Swooshing in my brain, immediate numbness in my arm and fever in fifteen...n... Read more
Once injected, I felt a Swooshing in my brain, immediate numbness in my arm and fever in fifteen...nurse had me lay down for ten mins. Still felt weird and numb in arm, she said it was normal and sent me to leave. Tem mins into my car ride home my left cheek starting tingling and going numb. The nerves in my left leg began tingling all over. By the time I got to the hospital, I had similar symptoms of Temporary paralysis on left side yet my limbs were still functioning. When I left the hospital a few hours later, I was like 50 percent numb on my left side, all test results showed everything was good, blood, EKG and cat scan. I felt like I'd been injected with novacaine all over the left side of my body and I was in the stage where it is starting to wear down with tingling and itching on my hand leg and cheek on my left side. My back on left side and neck locked up. The numbing in my face took two weeks to decipate. While exercising never agitation occurred and felt like nerves were firing for two weeks. Severe ear nerve pain occured within first week. Followed up with personal doctor had mri of brain w/ and without contrast and that looked good. I am pretty healthy, maybe a few extra covid lbs. EKG good, CT scan good, blood work good. I am waiting to see neurologist for more testing. There is still random tingling in and out, very faint on left side of my body only. Use of my left hand feels
40 2021-03-02 itchy skin Patient had 2 minutes left on her 20 minute post-vaccination observation and began to complain of me... Read more
Patient had 2 minutes left on her 20 minute post-vaccination observation and began to complain of metallic taste, tongue feeling wierd and facial itching; no SOB, no rash or redness noted; Vitals were WNL, given Benedryl 50 mg chewable and drink of water; at no time did client c/o or appear SOB, pO2 remained at 99% and vitals remained WNL; continued observation for an additional half hour and c/o subsided; client released to home.
40 2021-03-03 itchy skin Diziness and vertigo transiently Itchiness of feet and then Lower Extremities with no rash, hives
40 2021-03-03 redness, rash macular, itchy skin Histamine reaction: red, hot sweaty cheeks that became a little puffy; slightly itchy lips; red splo... Read more
Histamine reaction: red, hot sweaty cheeks that became a little puffy; slightly itchy lips; red splotchy patches on parts of my legs, chest, feet (mostly toes), and hands (mostly fingers). Started with my cheeks within minutes of the shot, got worse over the next hour. It took about 4-5 hours to dissipate. But even the next day, I have been a little itchy.
40 2021-03-03 injection site pain I developed a very bad migraine about 4 hours after getting the vaccine that lasted all night and th... Read more
I developed a very bad migraine about 4 hours after getting the vaccine that lasted all night and the next day my arm was very tender where I got the shot. The adverse side effect I'm most concerned about developed 2 days later. I noticed it hurt to turn my head and realized I had a lump on the right side of my neck sort of under my chin but a little to the right of that. It's making my throat hurt even though my throat itself is fine and the pain from this knot is radiating up to my right ear. I'm sure it's a swollen lymph node. I've had swollen lymph nodes before with strep throat but never have they hurt as much as this is and I've never had just one lymph node swell until now. I got the shot on a Saturday and this symptom began on Monday. I've been dealing with it for 3 days now, so if it's now gone in 2 more days I'll be going to my doctor for evaluation. I just wanted to report this and I was also wondering if this reaction has anything to do with the brain tumor surgery I had for an acoustic neuroma brain tumor and they put a metal plate in my head that my body had a bad reaction to causing hives, itching, and a lot of extra pain and irritation.
40 2021-03-03 rash with redness, itchy skin I woke up on 2/27/2021 with a red rash on my neck, chest, stomach, back, arms, legs, bottom and pelv... Read more
I woke up on 2/27/2021 with a red rash on my neck, chest, stomach, back, arms, legs, bottom and pelvic area. I called the on call physician. Took over the counter Benadryl. The rash cleared up on Monday, 3/1/2021. Still feel itchy on 3/1/21, 3/2/21, 3/3/21, 3/4/21. Used over the counter hydrocortisone cream.
40 2021-03-03 itchy skin, rash Pruritus followed by a full body viral looking rash
40 2021-03-03 rash, redness Rash from latex: Rx steroid ointment for earlier unrelated rash, Benadryl Wine flush/congestion: no... Read more
Rash from latex: Rx steroid ointment for earlier unrelated rash, Benadryl Wine flush/congestion: nothing Face swelling/redness/shortness of breath: Benadryl
40 2021-03-03 injection site swelling, injection site pain Sore, painful and swelling aroubd injection site. Painful lump in right armpit.
40 2021-03-05 rash Fevers ranging from 99-103 daily for 3 weeks now, headache x 3 weeks, body aches, nauseous x 3 weeks... Read more
Fevers ranging from 99-103 daily for 3 weeks now, headache x 3 weeks, body aches, nauseous x 3 weeks, facial rash/flushing daily the past week 2 weeks from last dose. Severe fatigue unable to do my daily activities, missed work and sought care by pcp. Trying to see immunology at where vaccine was administered and Getting the run around by everyone.
40 2021-03-05 itchy skin Pt. c/o itching of eyes, abdomen, behind ears and sore throat. Denied SOB or chest pain. Hx of ana... Read more
Pt. c/o itching of eyes, abdomen, behind ears and sore throat. Denied SOB or chest pain. Hx of anaphylaxis to TDap and NSAIDs. Pt stated felt similar to other reactions in past. 0917 BP 175/112 and 0927 170/105. Pt. states forgot to take BP meds. 0921 Benedryl 50 mg IM given per Dr. orders. Pt. observed for 20 min and reported all symptoms subsided. Pt. released to home driven by spouse.
40 2021-03-07 hives Hives on face, chest, arms Congestion Used Benadryl, atarax, albuterol inhaler
40 2021-03-07 hives Within 5 min I had hives and facial swelling. I was given Benadryl and 20 min later I had body shak... Read more
Within 5 min I had hives and facial swelling. I was given Benadryl and 20 min later I had body shaking/tremors
40 2021-03-08 injection site pain Fast onset of Tiredness occurred at 11:00pm until 11:00am.. Sore arm at injection site lasted for 4... Read more
Fast onset of Tiredness occurred at 11:00pm until 11:00am.. Sore arm at injection site lasted for 4 days. Trouble breathing, felt like a weight on my chest and it was difficult to speak lasted for 90 minutes.
40 2021-03-08 injection site pain, injection site swelling, injection site redness Headache since about 15 minutes after injection. Injection site pain started about 10 minutes after ... Read more
Headache since about 15 minutes after injection. Injection site pain started about 10 minutes after injection and stopped after day 2. Tiredness started a few hours after injection and got better after day 4. Muscle pain and chills started the same day and stopped on day 4. Injection site swelling started on day 2 and went down on day 4. Injection site redness started as pink but is now purple. Nausea started within 10 minutes of injection but went away the same day. Feeling unwell started the same day of the injection and has been ongoing off and on since. My whole arm felt swollen on Saturday. The same day, I started noticing blood blisters on my fingertips on my left hand. More and more have shown up since then.
40 2021-03-08 rash, itchy skin, hives I started to itch all on my legs at first and when I would scratch the itch, I would get hives and b... Read more
I started to itch all on my legs at first and when I would scratch the itch, I would get hives and bumps in that area. Itching spread to arms, head and back. I would itch at random times and random spots on my body. Itching became worse after my second vaccine on 3/2/2021.
40 2021-03-08 rash, itchy rash Itchy rash located on left upper chest
40 2021-03-09 rash, itchy skin 1. Joint pain start 02112021 end 02222021 2. Skin rash and itchy start 02182021 and faded overtime. ... Read more
1. Joint pain start 02112021 end 02222021 2. Skin rash and itchy start 02182021 and faded overtime. 3. Pregnant 02172021?miscarriage 03072021
40 2021-03-09 injection site pain A few hours after receiving my 2nd dose vaccine I got sores on my tongue. The following day I felt v... Read more
A few hours after receiving my 2nd dose vaccine I got sores on my tongue. The following day I felt very fatigued, had a low fever for a couple hours, sore neck and shoulder to the injection site, sore throat, headache, light sensitivity and hazy/foggy feeling. I also had a finger feel sore and inflamed for about 5 days. It has been 1 week now and I still have major fatigue, headaches, brain fog, morning sore throat and just a feeling of ?not well?. I try to workout, but after I get so fatigued I can?t perform regular daily tasks. I have been so foggy, I can?t help my kids with their school work.
40 2021-03-09 hives hives all over my body including my eyelids
40 2021-03-10 rash About 10 minutes after receiving the vaccine, the back of my neck started tightening badly and start... Read more
About 10 minutes after receiving the vaccine, the back of my neck started tightening badly and started getting uncomfortable. My throat then started to get dry and began breaking out with a rash on my neck and chest. This lasted about 30 minutes before the symptoms started to cease (in total 45 minutes after receiving the vaccine). Within 2 hours after receiving the vaccine, all symptoms had subsided. Treatment - at the vaccine clinic, EMTs observed me and took my vital signs. My blood pressure was slightly elevated, but did not require medical treatment. They continued to monitor me with the recommendation that I use my EPI-pen if symptoms got worse and instructed me to seek emergency medical treatment if symptoms got worse. No further treatment was sought out as symptoms all started to improve.
40 2021-03-10 injection site pain Received COVID Vaccine Dose #1 Friday morning around 8am. Pain at injection site was manageable. Fri... Read more
Received COVID Vaccine Dose #1 Friday morning around 8am. Pain at injection site was manageable. Friday evening I began to feel achy. Went to bed and woke up around 1am Saturday with a fever (101.5), muscle aches and chills. I also had a headache but headaches are more common for me so may or may not have been related to the vaccine. Fever subsided with ibuprofen. Continued to take ibuprofen every 6 hrs throughout the day on Saturday. By Sunday, I felt fine. FYI I did have COVID back in December.
40 2021-03-12 rash Left arm pain between elbow and wrist, extreme nausea, pounding headache, dizziness, blurry vision, ... Read more
Left arm pain between elbow and wrist, extreme nausea, pounding headache, dizziness, blurry vision, rash on face, extreme fatigue
40 2021-03-14 injection site pain Mild shoulder muscle soreness at site injection day of 2nd dose; next day, lymph node (underarm) was... Read more
Mild shoulder muscle soreness at site injection day of 2nd dose; next day, lymph node (underarm) was noticeably swollen to the size of a small orange - symptom began to subside by morning of 3/15/21.
40 2021-03-14 itchy skin Patient reported "my throat is closing up", then devoped generalized pruritis, more tightening and d... Read more
Patient reported "my throat is closing up", then devoped generalized pruritis, more tightening and dyspnea. Epinephrine 0.3IM and EMS called. She refused transport. She called her primary care office who also urged her to go to ER 15 minutes later symptoms recurred along with anxiety EMS administered Epi IM, benedryl and solumedrol IV. She then refused transport again and departed. 10:22 - 114/81 P-111 02 98% 10:31 137/70, 102, 99% 10:40 130/80, 106. 98%
40 2021-03-14 vaccination site mass, vaccination site itchiness, vaccination site redness, vaccination site warmth, vaccination site swelling injection site that was raised, red, itchy and warm; injection site that was raised, red, itchy and ... Read more
injection site that was raised, red, itchy and warm; injection site that was raised, red, itchy and warm; injection site that was raised, red, itchy and warm; injection site that was raised, red, itchy and warm; knot at her injection site; This is a spontaneous report from a non-contactable pharmacist. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot EL9262, first dose (at the age of 40 years), intramuscular on 28Jan2021 at single dose for covid-19 immunisation. COVID-19 vaccine was administered at hospital. The patient medical history and concomitant medications were not reported. It was unknown if the patient was pregnant at the time of vaccination. On 29Jan2021 the patient experienced injection site that was raised, red, itchy and warm. One week later she still had a knot at her injection site but it was getting smaller daily. It was unknown if treatment was received for the events. The patient contacted per PCP and it was explained that it was secondary to the vaccine administration. It was recommended to receive the 2nd dose of the vaccine in the opposite arm. The events were non serious with outcome of recovering. No follow-up attempts are possible. No further information is expected.
40 2021-03-15 itchy skin, skin warm, hives Full body hives. Started on my right arm, then spread throughout the day. Still have some hives on ... Read more
Full body hives. Started on my right arm, then spread throughout the day. Still have some hives on my head, face and legs. Very itchy, warm to the touch.
40 2021-03-15 rash maculo-papular fine maculopapular rash on right side of face, onset ~4-6 hours after vaccination, not painful or pr... Read more
fine maculopapular rash on right side of face, onset ~4-6 hours after vaccination, not painful or pruritic
40 2021-03-16 injection site hardening, injection site pruritus, injection site warmth, rash macular Large red spot, that is warm to the touch, very itchy, and hard.
40 2021-03-16 rash, rash with redness Red rash on chest. Got the same rash when I got Covid back in January. I feel very light headed and ... Read more
Red rash on chest. Got the same rash when I got Covid back in January. I feel very light headed and tired. Sore arm. Took 2 Tylenol. Nothing has helped .
40 2021-03-16 shingles, skin burning sensation, rash Saturday, March 13 I started experiencing burning on my stomach and back. Sunday morning, March 14 I... Read more
Saturday, March 13 I started experiencing burning on my stomach and back. Sunday morning, March 14 I noticed a rash on the right side of my stomach and side body. I went to the nurse practitioner at CVS minute clinic on Monday, March 15 who diagnosed me with shingles. I was given an anti-viral medication to take 3 times a day for 7 days. I continue to experience burning on my stomach and back. Although I have had chicken pox as a child, this is the first time I have had shingles.
40 2021-03-17 injection site pain I received my second dose of the COVID vaccine on 3/5/21. The symptoms began on 3/7/21 with pain in ... Read more
I received my second dose of the COVID vaccine on 3/5/21. The symptoms began on 3/7/21 with pain in my upper left arm. The next following night, I was awakened by sharp pains from the top of my left arm to my fingers. Even the back of my left arm is swollen. It even traveled down my back. I went to urgent care on Sunday 3/9/21 to see what had happened. A CNP said it seems musculoskeletal and the pain radiated from the injection site. I've taken Tylenol, Ibuprofen, been prescribed muscle relaxers and steroids to numb the pain but it doesn't work. This is still occurring to this day.
40 2021-03-18 itchy skin, hives, injection site pain, skin burning sensation I began to feel very itchy all over my body within 30-60 minutes, I felt swollen in my hand, feet, t... Read more
I began to feel very itchy all over my body within 30-60 minutes, I felt swollen in my hand, feet, tongue, my mouth and throat felt itchy, the itching got so bad that i had hives in some places such as my forearm and legs and skin just felt like it was on fire, I had issues breathing and felt as though someone was sitting on my chest, i have been shortness of breath since and have trouble catching my breath.. This was all that same night. The next day I had the same issues adding the sore arm of the injection site and feeling very tired all day. the next day from there am I am feeling better but am still experiencing shortness of breath, I am using my inhaler, I am still itchy but not as severe as the first night or next day. The arm tenderness has gone unless you touch the injection site and am no longer feeling over tired.
40 2021-03-18 hives, itchy skin, injection site swelling I received the 2nd shot out of the Covid 19 series on Wednesday March 10th. I had severe left arm pa... Read more
I received the 2nd shot out of the Covid 19 series on Wednesday March 10th. I had severe left arm pain where I received the shot, could not even sleep on it and/or lift it. The following morning I woke up to go to work and throughout the day the symptoms progressed.it began with slight dizziness, headache, fatigue, nausea, chills and fever for the 24hrs following -- I ended up taking Tylenol Extra Strength for relief of the headache/fever. Exactly 6 days later I felt an itching on my wrist that later progressed to "Covid Arm" swelling at the site of injection, onto an upper body allergic reaction with hives then later to lower body as well. it has been relieved with Benadryl nightly.
40 2021-03-18 hives Welt at injection site 1 inch appeared this morning
40 2021-03-18 rash, itchy skin Within 2 to 3 minutes after the shot, I experienced swelling in my throat. My glands were sore. I wa... Read more
Within 2 to 3 minutes after the shot, I experienced swelling in my throat. My glands were sore. I was monitored for 30 minutes by the nurse and as the symptoms were not getting worse she suggested I drive home and take Benadryl. It was a 45 minute drive. Halfway home (about one hour after my shot) I started experiencing itching, swollen tongue, swollen lips. I took 62.5 mg of Children?s Benadryl and met up with my husband and he drove me to the ER, arriving at about 10;15. After being there about 15 minutes some of my symptoms started going away. At about 11 a rash appeared on my chest. The ER doctors gave me Pepcid 10 mg around 1130 or so. They just charge me and recommended I follow up with my allergy doctor.
40 2021-03-18 itchy skin developed dizziness, "throat was closing" and pruritus Given Benadryl 25 mg/ IM Sent home improved.
40 2021-03-18 hives, rash diffuse rash on body with hives on chest, back and bilateral arms - Benadryl for three days and rash... Read more
diffuse rash on body with hives on chest, back and bilateral arms - Benadryl for three days and rash resolved - rash has recurred three weeks later with rash on chest, back and bilateral arms - second rash has not resolved
40 2021-03-18 vaccination site pain severe body aches; slight fever; chills; severe diarrhea; dizziness almost fainted; fast heart beat;... Read more
severe body aches; slight fever; chills; severe diarrhea; dizziness almost fainted; fast heart beat; headache; pain in the injection site; This is a spontaneous report from a contactable consumer (patient). This 40-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration in the right arm on 26Feb2021 09:30 at a single dose for COVID-19 immunisation. Medical history included allergies: dairy. Concomitant medications included ergocalciferol, retinol palmitate (VITAMINS A & D), apple cider vinegar (APPLE CIDER VINEGAR), cranberry, and allium sativum (GARLIC (DEODORIZED). Patient is not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Feb2021 14:30, on the first day, patient experienced moderate headache and pain in the injection site. On 28Feb2021, the second day, patient experienced severe headache, severe body aches, slight fever, chills, severe diarrhea, dizziness almost fainted, fast heart beat. Patient is recovering from the events. No treatment was received. Information on about lot/batch number has been requested.
40 2021-03-19 itchy skin, rash Received vaccine around 11:40am. Around 7pm same night on 3/19/21 noticed rash to tops of both feet,... Read more
Received vaccine around 11:40am. Around 7pm same night on 3/19/21 noticed rash to tops of both feet, with mild swelling and itching to feet and lower legs. Took 2 benadryl and went to sleep. Woke up this morning with facial swelling, eyes swollen shut. Took Claritin and states improved greatly. Reports itchiness in throat but denies difficulty breathing, throat swelling, chest pain or shortness of breath. Rash on feet/legs was gone when she woke up, still has itchy sensation to body but no rash. Patient reports improving symptoms at time of evaluation in Urgent Care, but would like to report side effect/reaction.
40 2021-03-20 dry skin, rash, redness About 30 minutes after getting the vaccine I was driving home and suddenly felt like I was losing co... Read more
About 30 minutes after getting the vaccine I was driving home and suddenly felt like I was losing consciousness. It lasted for a few seconds and then the feeling went away. I called 911 because I didn't know what was happening and other than a bit of an elevated heartrate I was ok so I deferred the option to go to the hospital. At the time that the paramedics were checking on me, one of them noticed a red area on the inside of my right elbow. I hadn't noticed it until then, but it could have been there and I just missed it. After about 2 days the rash appeared on my left inner elbow. It didn't really itch but it was painful and felt very dry and irritated. I was told it looked like eczema so I began using eczema cream. It has seemed to help a little. I have never had eczema prior to this. I contacted my doctor and he said he had no way of really knowing if it was an allergic reaction.
40 2021-03-20 injection site swelling, injection site redness, injection site warmth Fatigue Swollen, red, hot at the injection site
40 2021-03-20 vaccination site pain body aches; prickly skin; Intense pain at injection site and in right shoulder traveling down to elb... Read more
body aches; prickly skin; Intense pain at injection site and in right shoulder traveling down to elbow. Unable to raise arm overhead.; Intense pain at injection site and in right shoulder traveling down to elbow. Unable to raise arm overhead.; Intense pain at injection site and in right shoulder traveling down to elbow. Unable to raise arm overhead.; Chills; fatigue; general malaise; This is a spontaneous report from a contactable Other HCP, the patient. A 40-year-old non-pregnant female patient first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Lot Number: UNKNOWN), via an unspecified route of administration, in the right arm on 03Feb2021 at 12:00 PM (at the age of 40-years-old) as a single dose for COVID-19 vaccination. Medical history included patient was diagnosed with COVID-19 (prior to vaccination). Since the vaccination, the patient had not been tested for COVID-19.The patient had no Known allergies. Concomitant medications included multivitamin and magnesium supplement. On 03Feb2021 at 16:00 the patient expereinced Intense pain at injection site and traveling down to elbow. Unable to raise arm overhead. Chills, body aches, fatigue, prickly skin, general malaise. No treatment was received for the events. Outcome of the events were recovered on an unspecified date. Information on the lot/batch number has been requested.
40 2021-03-21 injection site pain, injection site pruritus, injection site redness Approximately one week after receiving my first dose of the COVID19 Pfizer vaccine, I experienced so... Read more
Approximately one week after receiving my first dose of the COVID19 Pfizer vaccine, I experienced soreness, redness and itchiness at and around the injection site. All three symptoms lasted 3 days and then cleared. The itchiness was treated with a topical cortizone cream which did provide relief.
40 2021-03-21 hives, itchy skin Had localized itch on back prior to vaccine. Within days or at most a couple weeks of receiving the ... Read more
Had localized itch on back prior to vaccine. Within days or at most a couple weeks of receiving the second dose of my vaccine I started to have symptomatic dermatographia with scratching that manifested as follicular urticaria. This became more widespread where ever I was itchy and scratched. Im being treated with antihistamines and it is improving but not resolved.
40 2021-03-21 itchy skin The Chief Complaint is: 40 y/o F with history of allergic rhinitis including systemic reaction to sk... Read more
The Chief Complaint is: 40 y/o F with history of allergic rhinitis including systemic reaction to skin testing years ago presents for COVID vaccination. She and I discussed getting vaccinated with her history a few weeks ago and I recommended vaccination. She reports that today she is in previous good health but 15 minutes after vaccination she started to feel itching all over her body which was rapidly followed by throat itching and difficulty swallowing. She was taken to the treatment area of the vaccination center and evaluated. - Pruritis, flushing, sclerae injection after COVID vaccination with PFizer vaccine. May be allergic or due to complement release. Treatment course - took patient back to the treatment area and administered 0.3mg epinephrine with rapid improvement in symptoms and signs and minimal side effects. Follow up BP lower, flushing improved, sclerae improved and throat symptoms improved. Called 911 for EMS response to observe her in the ED will complete VAERS and contact patient by phone for follow up
40 2021-03-22 injection site swelling, injection site bleeding, injection site pain, injection site bruising Nurse injected but needle may have not been at 90 degree angle and more toward 45 degrees. there w... Read more
Nurse injected but needle may have not been at 90 degree angle and more toward 45 degrees. there was some bleeding from site immediately upon removal of needle and some palpable swelling in sub dermal tissue thereafter. The question is whether this was fully injected into sub cutaneous tissue, partially into sub q and partially into muscle, or into muscle tissue. The patient was informed of possibilities and was to call if any further swelling, bruising or pain. I will follow up by phone on 24 march 21.
40 2021-03-22 rash, rash macular, rash with redness Pt presented to the medical tent with complaints of tingling in her tongue. States has long history ... Read more
Pt presented to the medical tent with complaints of tingling in her tongue. States has long history of allergies, has 2 epi pens with her and premedicated herself prior to coming to the vaccination site with 50 mg of PO benadryl at 1100. As pt was monitored she developed a rash on neck that was splotchy, flat, red. Tongue tingling stopped and moved to her fingers. BP was 152/90, other VS were WNL. Seen by MD on site. 1252 pt was feeling better, rash gone, all tingling gone. Pt left on own from vaccine site.
40 2021-03-23 injection site swelling, injection site redness After 12 days, I am still experiencing a lot of tenderness in my arm. It is slightly red and swollen... Read more
After 12 days, I am still experiencing a lot of tenderness in my arm. It is slightly red and swollen at the injection site and I have overall felt rundown for 12 days now.
40 2021-03-23 hives Patient presented with tightness in chest after 1st dose of COVID vaccine. Patient has history of se... Read more
Patient presented with tightness in chest after 1st dose of COVID vaccine. Patient has history of severe allergic reactions to vaccinations. Administered 50mg of Benadryl PO. Patient condition worsened rapidly with hives and anxiety. 911 contacted for transport. 0.3mg Epi administered in right deltoid. Epi began working quickly. Care transferred to EMS and transferred to Hospital.
40 2021-03-23 rash Rash started on stomach near belly button, over 24 hrs spread to my neck, face, ears, now starting u... Read more
Rash started on stomach near belly button, over 24 hrs spread to my neck, face, ears, now starting up my arms.
40 2021-03-24 itchy skin 03.15.2021 1:40 vaccinated 1:55 left site, returned home ~3:00 began itch around waistband. Aleve fo... Read more
03.15.2021 1:40 vaccinated 1:55 left site, returned home ~3:00 began itch around waistband. Aleve for back. 3:30-4:00 symptoms undeniable: itch on neck, face, trunk, lips tingle/swell, lump in throat. Hoarse. No hives. 4:00 Claritin 4:30 talk to Dr take vitals (Sp02 100%, heartbeat normal, BP 131/79, pulse 67, temp normal) 5:15 Benadryl 5:30 itch spreads to whole body, including legs 6:30 talk to Dr Symptoms steady now. 7:30 fall asleep from Benadryl 8:30 wake up for dinner 9:30 laying in bed, breathing becomes shallow. O2 and bpm still normal. 10:00 Talk to Dr. Advises ER if vitals outside of norm. Report to PCP in am. 11:00 breathing normalizes. Sp02 and bpm normal, BP 122/82, pulse 70. Aleve before bed. midnight-1:00 fall asleep 03.16.2021 7:20 Wake up. Water, Wellbutrin, Aleve. Read in bed about an hour until fall back asleep. 11:15 Wake up. Headache. Sp02, bpm, temp, normal. Stay in bed. 12:25 Send report to Dr. 12:30 Get out of bed for first time; coffee, bathroom. Back to bed. 1:10 Spoke with triage nurse. Concern is that lips are still swollen at almost 24 hours. Recommends urgent care for steroids if increased lip/face or respiratory symptoms. Can take Claritin an hour early. 2:30 Get out of bed and shower. Warm to wash, cool to rinse. Got dressed, moved around. Increased itching, skin mottled; still no hives. Aleve. 3:00 Claritin, call from Dr nurse. 3:30 Heat up late lunch, continue to move around the house, answer work questions. 4:30 Upticked symptoms not abating, still mottled skin, lips more swollen. Harder to swallow and dry cough starts, worse when talking. Take vitals: Sp02 and bpm normal, BP 107/83, pulse 73 5:00 Leave for urgent care; BP there 159/71, pulse 79, temp normal. No steroids. Referral to allergy/immunology. Prescription H2 inhibitor, switch to Zyrtec in am. 6:40 Pepcid. Back in bed. 11:30 Benadryl, Aleve. 12:40 Sp02, bpm normal 1:15 Fall asleep 03.17.2021 8:55 Wake up. Water, Wellbutrin, Aleve. 9:30 Sp02, bpm normal. Get up for Pepcid, Zyrtec, bathroom then back in bed. 11:20-11:40 Dozed off, woken up by heart symptoms. Palpitations, panic feeling. Sp02, bpm normal 12:45 Dr called. Allowed to switch back to Claritin tomorrow. Recommends Benadryl more often. Allergy: 504.842.6742 Dr 3:00 Aleve. BP 117/80 pulse 75 4:15 Benadryl 8:20 Hoarse again 9:20 Pepcid. Itching increasing as Benadryl wears off. 10:20 Benadryl 10:30 BP 103/77, pulse 73. Sp02, bpm normal, PI 2.5% 11:45 Aleve 12:00 itching increasing as move around/get ready for bed 1:15 Fall asleep 12.18.2021 6:30 Benadryl. Tired, itch still present (improving), headache. Fell back asleep 7:30. 8:55 Water, Wellbutrin, Aleve, Claritin, Pepcid. Fell back asleep until 11:30 11:45 Sp02, bpm normal, PI 8.0 2:00 Finished shower, didn't worsen itch. 2:45 Aleve 6:00 Been "on" for work about 4 hours. Exhausted. Nauseated. Verge of collapse. Most itching is face/scalp and clothing seams. Lips almost normal though. 8:00 Meds definitely wearing off; face/lips symptoms increasing again. 8:30 Benadryl. Throat symptoms. Swollen lymph nodes. 9:15 Pepcid. Slight cough returned. 10:30 BP 120/85, pulse 80 (was just moving around quickly), Aleve. Itching better, throat/lymph nodes painful 12:45 Benadryl. Ibuprofen. Neck muscles hurt too. 1:15-1:30 fall asleep 03.19.2021 9:00 Water, Wellbutrin, Aleve. Throat still swollen. Itch primarily face/head, back of thighs. 9:15 Pepcid, Claritin. Sp02 normal, bpm low (51-53 back in bed), PI 4.1 3:15 Aleve. Lump in throat still impacts swallowing. Eating makes me hoarse. Neck muscles hurt. 11:00 Pepcid 12:15:Benadryl, Aleve. BP 109/76, pulse 69 2:30 fall asleep 03.20.2021 10:00 Water, Wellbutrin, Aleve. Lips swollen again. 10:15 Pepcid, Claritin 11:25 Symptoms: itching better, mostly gone from body (remains on head). Headache. Throat/neck improved. Lips still swollen. Sp02, bpm normal. PI 10.2% 6:00 Aleve. Itching only head/face. Throat/neck still symptomatic. 11:30 Aleve, Pepcid. Sp02 normal, bpm 70s. 12:15 Benadryl 1:20 Throat sore but no lump. Lymph nodes returning to normal. Still some itch head/face/neck. 1:45-2:00 fall asleep 03.21.2021 7:00 Claritin, back to sleep 11:00 Aleve, Pepcid, Wellbutrin. 5:00 Aleve 11:10 Pepcid, Benadryl. Mild itching. No lump. Throat still slightly sore. BP 113/77, pulse 69 12:20 Aleve 1:15-1:30 fall asleep 03.22.2021 9:45 Water, Wellbutrin, Aleve, Claritin, Pepcid 5:50 Aleve 10:00 Pepcid 12:15 Aleve. Minimal, occasional itching. Lips almost normal. Sp02 normal, bpm 70s 03.23.2021 9:45 Water, Wellbutrin, Aleve, Claritin, last Pepcid
40 2021-03-24 injection site swelling, injection site pruritus One week after my first dose, my arm got swollen and itchy at the injection site. It lasted several ... Read more
One week after my first dose, my arm got swollen and itchy at the injection site. It lasted several days.
40 2021-03-24 injection site swelling, injection site pain Swelling/soreness at injection site. Diarrhea beginning the morning after injection and lasting into... Read more
Swelling/soreness at injection site. Diarrhea beginning the morning after injection and lasting into the evening. Treated with over-the-counter medications (Ibuprofen and Imodium)
40 2021-03-24 injection site redness, injection site pain, injection site swelling Worse asthma than usual for several hours, but not so bad that I had to use my rescue inhaler. At no... Read more
Worse asthma than usual for several hours, but not so bad that I had to use my rescue inhaler. At noon I had severe pain the entire length of my right arm, and I felt drowsy so I fell asleep for several hours and the pain in my arm was moderate and restricted to injection sight when I woke up. I went to bed at 10 pm and woke up at 1 am with diarrhea. I spent the the next hour having a few diarrhea bowel movements. On 3/20 my right arm was still in moderate pain and injection site was swollen and red. At 8 am I woke up with a headache and so I went back to bed. By afternoon I had the chills and went to bed for another nap and when I woke up the chills were gone. On 3/21 my right arm still had moderate pain. On 3/22 I had another bout of diarrhea for one bowel movement, and my arm pain was still moderate. On 3/23 the swelling and redness at the injection site went away but the area is still slightly tender to the touch on 3/25. On 3/25 at 1 am I was in bed trying to sleep, but I kept having intense dizzy spells that lasted 3-4 hours.
40 2021-03-24 itchy skin itching to left arm Benadryl 25mg given 129/80 BP Pulse 88 O2 99% went home
40 2021-03-25 redness B/P high, redness to face, Left arm numbness
40 2021-03-25 injection site redness, injection site swelling Felt slight swelling in left armpit exactly one week after the vaccine (3/25). On 3/26 swelling was ... Read more
Felt slight swelling in left armpit exactly one week after the vaccine (3/25). On 3/26 swelling was mildly painful and the place of original shot was red and slightly raised.
40 2021-03-26 itchy skin 4 hours after the shot, I noticed that my left eyelid was a bit swollen. No pain or itchiness. Not s... Read more
4 hours after the shot, I noticed that my left eyelid was a bit swollen. No pain or itchiness. Not sure when it began to swell. I didn't think much of it, until about 2 hours as I could feel that it was more swollen. I was with friends, they recommended benedryl. So, went and talked to a pharmacist. On the way there, back began to feel itchy (similar to when I have broken out in hives in the past when an allergic reaction starts). Pharmacist recommended 25 ml of liquid benedryl every 4-6 hours and increase to 30 ml if swelling remains. After 1-2 days, if still present to go to doctor. I already have a doc office visit early Monday morning.
40 2021-03-26 injection site pruritus, injection site redness, injection site warmth, injection site rash First 24 hours: Large red raised hot-to-touch bump at injection site (applied ice pack) Severe pain ... Read more
First 24 hours: Large red raised hot-to-touch bump at injection site (applied ice pack) Severe pain from site up back of neck and down to fingers Low grade temperature 99.9° Next 24 hours: Still have large raised red hot-to-touch bump at injection site but now site is very itchy (applied ice pack) Pain has dulled but still present Fever gone Sore throat and slightly swollen tonsils
40 2021-03-27 hives Anaphylactic reaction including throat swelling, face, hand and feet swelling. Hives Tongue Swellin... Read more
Anaphylactic reaction including throat swelling, face, hand and feet swelling. Hives Tongue Swelling Syncope Lethargy Brain Fog ongoing Livedo reticularis on upper and lower arms and buttocks first started on 1/15/2021. I still have purple mottling over these areas that do not go away when warmed. The livedo reticularis is present at all times. Dyspnea and Tachycardia first started on approximately 1/20/2021 and has become progressively worse.
40 2021-03-28 itchy skin, rash Mild rash on chin and itchiness on face, neck, and throughout body
40 2021-03-28 rash On 3/10/2021 Migraine headache started at 6:15pm Ear ringing (tinnitus) started at 7:00 pm 3/11/202... Read more
On 3/10/2021 Migraine headache started at 6:15pm Ear ringing (tinnitus) started at 7:00 pm 3/11/2021 Additional hearing muffled was was noticeable 3/16/2021: severe migraine, throwing up, nauseous 3/17/2021: facial rash prominent **hearing loss deemed permanent, ringing continuous
40 2021-03-29 itchy skin Left Eye swelling; Severe Itching all over; Severe Headache; Stiff neck; This is a spontaneous repor... Read more
Left Eye swelling; Severe Itching all over; Severe Headache; Stiff neck; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient she received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6198) via an unspecified route of administration in the left arm on 26Feb2021 at 16:30 (at the age of 40-years-old) as a single dose for COVID-19 immunization. Medical history included variable immune deficiency, asthma, and eosinophilic esophagitis (EOE). Allergies to medications included amoxicillin, erythromycin, clindamycin, ciprofloxacin (CIPRO), sulfamethoxazole/ trimethoprim (BACTRIM), and oxycodone/ paracetamol (PERCOCET). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 26Feb2021 at 17:15, the patient experienced left eye swelling, severe itching all over, severe headache, and stiff neck. The patient was not treated for left eye swelling, severe itching all over, severe headache, and stiff neck. The clinical outcome of left eye swelling, severe itching all over, severe headache, and stiff neck was not recovered.
40 2021-03-30 vaccination site redness Redness at the injection site 9 days after dose 1; This is a spontaneous report from a contactable o... Read more
Redness at the injection site 9 days after dose 1; This is a spontaneous report from a contactable other health care professional (patient herself). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Ek4176), via an unspecified route of administration in right arm at the age of 40-years (non-pregnant at the time of vaccination), on 03Feb2021 at 02:30 PM at a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient had no known allergies. Concomitant medications included desogestrel, ethinylestradiol (VELIVET), loratadine, pseudoephedrine sulfate (CLARITIN-D), and cyanocobalamin (VITAMIN B 12 [CYANOCOBALAMIN]). The patient received other vaccine in four weeks was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID. On 13Feb2021 at 08:45 AM (9 days after dose 1), the patient experienced redness at the injection site. The patient did not receive any treatment for the event. The outcome of the event was not recovered. It was also reported that post vaccination, the patient had not been tested for COVID.
40 2021-03-30 vaccination site pain sore arm where shot was given; nauseous; shortness of breath; tongue tingly; right Eye bothersome; m... Read more
sore arm where shot was given; nauseous; shortness of breath; tongue tingly; right Eye bothersome; metallic taste; elevated heart rate; headache; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: EL 3257, Expiration date: unknown) via unspecified route on 30Jan2021 01:30 PM, in the left arm, deltoid at a single dose for COVID-19 immunization. The patient's relevant medical history included asthma and seasonal allergies. Concomitant medications included Nortriptyline, oxcarbazepin, montelukost. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient did not have COVID-19 prior to vaccination or tested since the vaccination. On 30Jan2021 at 02:00 PM the patient experienced very sore arm where shot was given, nauseous, shortness of breath, tongue tingly, right eye bothersome, metallic taste, elevated heart rate and headache. It was unknown if the patient had received any treatment for the events. Outcome of events was not resolved.
40 2021-04-03 hair loss she felt like she had been in a car accident. My entire body was sore; I was very hungry - ate three... Read more
she felt like she had been in a car accident. My entire body was sore; I was very hungry - ate three breakfasts and a big lunch and was still starving; I had a 101 temp; chills; extreme joint pain; muscle aches; dizziness; exhaustion; she felt off; unusual hair loss; This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 05Mar2021 17:15 (Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation, 40 years old at doctor's office/urgent care. Medical history included coeliac disease, sjogren's syndrome, hypersensitivity (known allergies), all from an unknown date, and Covid-19 from Nov2020 (First, I had a mild case of COVID in Nov2020 and recovered fully). No other vaccine in four weeks and not other medications in two weeks. Patient is not pregnant. The patient's concomitant medications were not reported. On 06Mar2021 09:00, the day after first vaccine, patient had a 101 temp, chills, extreme joint pain, muscle aches, dizziness, exhaustion. The following morning on 07Mar2021, she felt like she had been in a car accident. My entire body was sore, she was exhausted, and she was very hungry - ate three breakfasts and a big lunch and was still starving. The following week (Mar2021) she felt off and experienced some unusual hair loss. She does not feel comfortable taking the second shot. Patient was asking some guidance on whether to take the second shot. Treatment was not given for the events. Outcome of the events was recovering.
40 2021-04-08 hives, redness Patient received Pfizer COVID-19 vaccine on 4/6/2021. Patient reports the following adverse reactio... Read more
Patient received Pfizer COVID-19 vaccine on 4/6/2021. Patient reports the following adverse reactions: facial swelling, lips swelling, reddness, small hives. Patient was given 25mg Benadryl PO per protocol. Dr was made aware. Monitored patient. Patient started to experience some throat tightness but no shortness of breath or difficulty breathing. Spoke with Dr again and gave patient 0.3mg Epinephrine in right deltoid. Dr came down to clinic as patient was going to ED per car with her sister driving. In the ED , patient was treated for anaphylaxis at hospital and stayed overnight (epinephrine, solumedrol, pepcid x2). After discharge on prednisone 40mg daily x5 days, patient came back with hives and was readmitted and treated overnight with pepcid/benadryl expect to be discharged again today.
40 2021-04-11 shingles I received my first Pfizer COVID vaccination on 3-1-2021. Seven days later I had a Shingles outbrea... Read more
I received my first Pfizer COVID vaccination on 3-1-2021. Seven days later I had a Shingles outbreak, which I've never had before. My doctor advised that I should continue to get the second vaccination as it's a two step process, which I did on 3-25-2021. I'm now experiencing numbness and loss of sensation that started in my foot and hand which has now progressed up my leg to my hip and from my hand up my arm. My doctor ordered a MRI scan which showed lesions on my spinal cord. Based on the results of the first MRI scan my doctor has ordered a second scan (showing more of the spinal cord) and a brain scan. She has also scheduled me an appointment to speak with a Neurologist to try to determine the cause of this. I can't help but feel that this vaccine was the cause of this as it all started shortly after I was given my first dose.
40 2021-04-14 shingles Dose 1 on March1, Dose 2 on March 25. Shingles rash on March 8th. Numbness and tingling starting Mar... Read more
Dose 1 on March1, Dose 2 on March 25. Shingles rash on March 8th. Numbness and tingling starting March 28th. MRI showing multiple foci of enhancement suggesting demyelination vs transverse myelitis.
40 2021-04-15 injection site pain, vaccination site swelling, injection site pruritus Body aches, chills, fatigue, headache, and eye pain for 24 hours. Arm soreness at the site for 3 day... Read more
Body aches, chills, fatigue, headache, and eye pain for 24 hours. Arm soreness at the site for 3 days, followed by swelling and itch on entire upper arm where vaccinated. Swelling and itch lasted for 10 days.
40 2021-04-16 skin spots, bruising March 24 - normal bloodwork April 5-7 heavy menses. First menses postpartum while exclusively breast... Read more
March 24 - normal bloodwork April 5-7 heavy menses. First menses postpartum while exclusively breastfeeding. Delivery date 12/28/2020 April 10 noticed petechia and abnormal bruising but with high energy April 13 - second COVID shot. April 13 - nose bleed with continued petechia and abnormal bruising. No other symptoms
40 2021-04-21 itchy skin throat constriction, dryness, scratcy/itchy. facial itiching, head, arm, back itching, eye swelling,... Read more
throat constriction, dryness, scratcy/itchy. facial itiching, head, arm, back itching, eye swelling, overheating, tachycardic. epinephrine administered, 911 called, ambulance taken across the street to ER for observation. steroids given. further benadryl taken at home. symptoms started 10-15 minutes post injection. I am allergic to PEG, my allergist put me on a pre dose of anthystamines & steroids to lessen or prevent reaction so overall reaction was fairly mild but epi was the only thing left to give as I had already had 400mg hydroxyzine, 40 mg pepcid x3, 28mg medrol x5 during the 24 hours prior to my vaccination.
40 2021-04-24 hives, rash anaphylaxis; rash/hives on face; rash/hives on face; progressed to swollen lips, tongue; progressed ... Read more
anaphylaxis; rash/hives on face; rash/hives on face; progressed to swollen lips, tongue; progressed to swollen lips, tongue; cough; throat irritation; wheezing; This is a spontaneous report from a contactable consumer (patient). The 40-year-old non pregnant female patient received first dose of BNT162B2 (Pfizer Covid-19 vaccine, lot number: EW0150 expiry date unknown) via an unspecified route of administration on Left arm as a single dose on 06Apr2021 09:30 AM. Medical history included asthma, known allergies: Biaxin, albuterol, xopenex, apples, pears, stone fruit (peaches, plums, apricot, etc), almond, hazel-nut. Concomitant medications included Zyrtec, Nasonex, Flovent, Singulair and Zoloft. On 06Apr2021 10:00 AM, started with rash/hives on face, then progressed to swollen lips, tongue, cough, throat irritation/swelling and wheezing. Initially treated in emergency room (ER) for anaphylaxis then released. Within 30 minutes, symptoms returned and was treated ER for anaphylaxis and was admitted for observation. She was discharged in the morning of 07Apr2021, but had to return to ER that evening, and was discharged in the morning of 09Apr2021. She was treated with Epinephrine, Benadryl, steroids and Pepcid. She did not receive any other vaccine in four weeks prior to the suspect. The patient was not suffering from covid prior vaccination. On 06Apr2021, she was tested through Nasal Swab for Covid and results were found to be negative. The outcome of events was recovering. No further information was available.
40 2021-04-24 vaccination site pain lost my consciousness; My upper front teeth was broken; fell down to the front on floor; injuries wi... Read more
lost my consciousness; My upper front teeth was broken; fell down to the front on floor; injuries with my lip and teeth; injuries with my lip and teeth; chills; headache; nausea; injection site pain; muscle pain; unwell; This is a spontaneous report from a contactable consumer. A non-pregnant 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 06Apr2021 17:30 (Batch/Lot Number: EW0151) as single dose (at the age of 40 years old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2, dose 1, (lot number=EN6204), on 13Mar2021 04:00 PM, administered on left arm for COVID-19 immunisation. The patient stated, "I got various symptoms such as chills, headache, nausea, injection site pain, muscle pain, unwell, and one day after getting the shot (on 06Apr2021 20:00) and on 07Apr2021, I lost my consciousness and fell down to the front on floor and it caused injuries with my lip and teeth. My upper front teeth was broken". The patient received no treatment. The patient was rushed to the emergency room and physician was visited. The outcome of the events was not recovered.
40 2021-04-25 injection site pain Vaccine was improperly administered into shoulder joint rather than deltoid muscle below the joint. ... Read more
Vaccine was improperly administered into shoulder joint rather than deltoid muscle below the joint. Sharp shooting pains at the time of vaccine continuing to this hour. Severe pain and inflammation. Unable to move arm in shoulder joint. Radiating pain across left back and neck, arm, and hands.
40 2021-04-26 shingles Shingles outbreak; This is a spontaneous report from a contactable consumer. A 40-year-old non-pregn... Read more
Shingles outbreak; This is a spontaneous report from a contactable consumer. A 40-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 40 years, via an unspecified route of administration, administered in Arm Left on 01Mar2021 09:00 (Batch/Lot Number: EN6200) as a single dose for covid-19 immunization. The patient's medical history included known allergies to Penicillin. Concomitant medication included doxycycline monohydrate (DOXYCYCLINE MONOHYDRATE) taken for an unspecified indication, start and stop date were not reported. The patient experienced shingles outbreak on 07Mar2021 06:00 which she never had before. It was unknown if patient was treated for the event. She was advised by her doctor to still proceed with the second shot which she got on 25Mar2021. Patient would be speaking with a neurologist week and doing additional test/scans. The patient was tested negative for Covid-19 on 07Apr2021. The outcome of the event was not recovered
40 2021-04-27 rash macular, bruising, itchy skin, rash, rash with redness Radiating very red painful rash. Began at the hips, went down legs, then arms, torso and face. Hands... Read more
Radiating very red painful rash. Began at the hips, went down legs, then arms, torso and face. Hands and feet. Left large bruises. Rash diminished to small spots with prednisone/benadryl. Have photos.
40 2021-04-30 itchy skin general itchiness; throat tightening; dizziness; This is a spontaneous report from a contactable Phy... Read more
general itchiness; throat tightening; dizziness; This is a spontaneous report from a contactable Physician reported for a consumer (patient). A 40-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198, Expiry date was not reported) intramuscular at left arm on 25Feb2021 at 09:30 am (age at vaccination was 40 years) at a single dose for COVID-19 immunization. Medical history included HTN. The patient had known allergies to Penicillin and vancomycin. Concomitant medication patient received within 2 weeks of vaccination included duloxetine (DULOXETINE), gabapentin (NEURONTIN), verapamil (VERAPAMIL) and naproxen (NAPROXEN). The patient received shot and shortly after on 25Feb2021 at 09:45 am, the patient felt general itchiness and throat tightening and dizziness. The facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received Epinephrine x2 steroids, Benadryl, famotidine now sxs improved. The reporter evaluated the patient in the emergency room. The outcome of all the events was recovering.
40 2021-05-04 rash, blister, vaccination site pain, hives shingles type blistering, weeping, oozing and kind of on fire type of feeling; shingles type blister... Read more
shingles type blistering, weeping, oozing and kind of on fire type of feeling; shingles type blistering, weeping, oozing and kind of on fire type of feeling; shingles type blistering, weeping, oozing and kind of on fire type of feeling; hives and a rash that continues to get worse; hives and a rash that continues to get worse; When clothes touching it hurts, it is very uncomfortable; injection site soreness; This is a spontaneous report from a contactable registered nurse, the patient. This 40-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151; Expiration Date: 01Jul2021) via an intramuscular route of administration in the left arm on 14Apr2021 09:00 (at the age of 40-year-old) as single dose for COVID-19 immunization. Medical history included anxiety depression. Concomitant medication included bupropion hydrochloride (WELLBUTRIN XL) taken for 15 years (2006) and ongoing for anxiety depression. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021, the patient experienced some expected injection site soreness. On Friday evening 16Apr2021, the patient broke out in hives and rash that continued to get worse. The patient described the hives started on right side of neck and now is on her face on the right side and neck, on left breast and right lower abdomen which spread around the back down on the leg and on the left bikini line on the groin. She stated now it is like shingles type blistering, weeping, oozing and kind of on fire type of feeling. It is mostly on the right side and there are some spots on the left. When clothes touching it hurts, it is very uncomfortable. She had a friend/physician to call in for her for oral steroids but don't seem to be doing much. The patient clarified the oral steroids as a MEDROL Dose pack, methylprednisolone 4mg tablets, and she only one full-day worth so far, she took all 6 tablets for yesterday (19Apr2021) and has taken one tablet so far today with doses being titrate down daily. It is not any worse than yesterday, but it has not started getting any better either. The patient stated that she has nothing on the left arm where she got the injection, no rash on left arm. Her second dose is scheduled 05May2021 and she does not know if she should get it. The clinical outcome of the event injection site soreness was resolved on 16Apr2021 while the events "hives and a rash that continues to get worse", "shingles type blistering, weeping, oozing and kind of on fire type of feeling" and "When clothes touching it hurts, it is very uncomfortable" were not resolved.; Sender's Comments: Based on temporal association, a contributory role of BNT162b2 to the events of broke out in hives and rash, blistering, weeping, oozing and kind of on fire type of feeling cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
40 2021-05-07 shingles diagnosed in-clinic with shingles; This is a spontaneous report from a contactable other hcp (patien... Read more
diagnosed in-clinic with shingles; This is a spontaneous report from a contactable other hcp (patient herself). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982, expiration date not reported), via an unspecified route of administration, administered on the right arm on 14Jan2021 15:00 (at the age of 40-years-old) at a single dose for COVID-19 immunisation. Medical history included asthma (allergy-related asthma), drug hypersensitivity (Penicillin allergy), allergy to animal (pet dander), seasonal allergy (hay-fever), and seasonal allergy (pollen). The patient was reported to be taking other medications (unspecified) in the last two weeks prior vaccination. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. On 26Jan2021 09:30, two weeks following the first dose vaccination, the patient was diagnosed in-clinic with shingles. The event resulted to a physician office visit. Patient received anti-viral medication as a result of the event. The outcome of the event was recovered on an unspecified date. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Considering a plausible temporal relationship , a possible contributory role of suspect vaccine BNT162B2 to the reported event shingles cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
41 2020-12-31 itchy skin Migraine x 4 days, nausea off and on x 3 days, itching arms and stomach x 2 hours, fatigue x 2days
41 2021-01-02 injection site pain Injection Site pain, Tiredness, And Headache using Tylenol.
41 2021-01-03 injection site swelling, injection site pain 12/24/20- tenderness, swelling at injection site for 1 week; 12/30- flu like symptoms, dizzy, weak, ... Read more
12/24/20- tenderness, swelling at injection site for 1 week; 12/30- flu like symptoms, dizzy, weak, headache, muscle pain, nausea, vomiting. Seen in ED on 1/3/21 with reports of all over body numbness, shortness of breath, cough, sore throat, unable to eat/drink. EMS reports patient went unresponsive at home, but was doing purposeful movements. Respiratory panel which included COVID, Flu, was resulted as not detected. CXR, CBC, Comprehensive metabolic panel, Urinalysis. Patient diagnosed with COVID-19; Cough; Shortness of Breath; Nausea and Vomiting; generalized body aches. Discharged home with prescription for Tessalon 10mg capsule - Take one every 8 hours and Zofran 4mg PRN every 8 hours and follow-up with primary And follow up with primary care MD.
41 2021-01-03 injection site pain, itchy skin Taste buds went numb, metallic taste, slight swelling of throat, itchiness all to upper body, joint ... Read more
Taste buds went numb, metallic taste, slight swelling of throat, itchiness all to upper body, joint pain, and pain at injection site. Lasting about 12 to 24hours. Antihistamines treated at home.
41 2021-01-03 rash The next day on 12/19 I was super sore. On 12/20 really bad joint pain and I had rash located on ... Read more
The next day on 12/19 I was super sore. On 12/20 really bad joint pain and I had rash located on my face and chest. I went to PCP on 12/21 seen PCP given EpiPen.
41 2021-01-04 rash "Pfizer-Bio-Tech COVID-19 Vaccine EUA" Provider contacted an individual in regards to an individual ... Read more
"Pfizer-Bio-Tech COVID-19 Vaccine EUA" Provider contacted an individual in regards to an individual who received the Covid-19 Vaccine on 12/19/2020. The individual reported sand paper face rash and full swollen face that started 3 days after receiving the vaccine (1/1/2021). Individual reported that she had Botox and facial fillers on 12/15/2020. This event was an unwitnessed by the staff at Health Department. The event was reported to Epidemiologist.
41 2021-01-04 redness, itchy skin 20 Minuets after injection hot air, red , moved across face, neck. 1 hour after injection. high BP ... Read more
20 Minuets after injection hot air, red , moved across face, neck. 1 hour after injection. high BP chest heavy face and nose itchy @ 3:15 pm Benadryl 25 mg IM + difficulty swallowing.
41 2021-01-04 injection site swelling, injection site bruising, injection site warmth, injection site redness, injection site pain 41-year-old female HCW who received Pfizer BioNTech vaccine (Lot # EK5730) on 21 Dec 2020 in her lef... Read more
41-year-old female HCW who received Pfizer BioNTech vaccine (Lot # EK5730) on 21 Dec 2020 in her left upper arm. No other vaccines were received that day. She reports a sensation of warmth and tenderness locally right after vaccination. On the evening of vaccination, she noted a small area of redness and swelling at the vaccination site. She denied anything out of the ordinary with regard to vaccine administration, except the vaccine might have been given "a little lower" than usual. She did not experience any respiratory, CV, dermatologic, or gastrointestinal signs/symptoms during observation post-vaccination or during the next several days. Post-vaccination day (PVD) one, patient noted some tenderness, warmth, redness, and some bruising surrounding the vaccination site. (SEE PVD 1 Photo); local reaction gradually resolved (SEE PVD 7 Photo) and currently, all that remains is a big bruise. On the evening of 26 Dec, patient reported having some "congestion" and took some Nyquil. She reports a good night's sleep, but upon awakening, she noted mild shortness of breath and she "couldn't open" her eyes due to swelling. She also noted her bottom lip and tongue were swollen and she experienced a tight feeling in her throat and chest. She also reports mild swelling of her hands. She denies hives/urticaria, wheezing, stridor, dysphagia, loss of consciousness, or gastrointestinal-related symptoms. Patient self-treated with oral Benadryl, Pepcid, and Zyrtec, as well as using her Albuterol inhaler. After 2 hours, her symptoms had not improved, so her spouse took her to the Emergency Room. In the ER, she was placed on a cardiac monitor, and shortly after arrival, she received IM Epinephrine (x2), followed by IV Solumedrol. She was observed for 8-10 hours and discharged home with a 5-day course of oral steroids. She was diagnosed with "anaphylaxis" and instructed to follow-up with her Primary Care Provider. Since discharge, she has continued to note some facial swelling, and on 29 Dec, she was having problems breathing for which she used her inhalers, and symptoms resolved. On the day of vaccine receipt, patient reports feeling well prior to vaccination. She denies previous vaccine reactions. She denies any exposures that might have been potential triggers to her reaction on 27 Dec – "the only thing different was the vaccine"
41 2021-01-04 shingles Developed shingles on 12/23/20- went to urgent care on 12/24/20, was given Prednisone and Acyclovir ... Read more
Developed shingles on 12/23/20- went to urgent care on 12/24/20, was given Prednisone and Acyclovir prescriptions. Rash sites dried on 12/28/20.
41 2021-01-04 vaccination site pain Fatigue; Myalgia; Injection site pain; Headache (frontal)/Worsening headache; Joint pain; Chills; Na... Read more
Fatigue; Myalgia; Injection site pain; Headache (frontal)/Worsening headache; Joint pain; Chills; Nausea; Vomiting; Worsening headache w/ photophobia; Subjective fever; This is a spontaneous report from a contactable physician (patient). A 41-year-old female non-pregnant patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=59267-1000-1 /EH9899), via intramuscular on 28Dec2020 09:45 at single dose on her right arm for Covid-19 immunization. Medical history included psoriasis. The patient had no known allergies. Allergies to medications, food, or other products was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. It was reported that 6h after administration on 28Dec2020 16:00, the patient experienced fatigue, myalgia, injection site pain; 10h after (in addition to above) on 28Dec2020, the patient experienced headache (frontal), joint pain, chills and 12-28h after (in addition to above) in Dec2020, the patient experienced nausea, vomiting, worsening headache w/ photophobia, subjective fever, joint pain. The patient was not received any treatment for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.
41 2021-01-04 skin warm, rash Immediately post-vaccine, face felt hot and tingling, lasted 45 minutes. Nausea 12/26-12/27. Rash ... Read more
Immediately post-vaccine, face felt hot and tingling, lasted 45 minutes. Nausea 12/26-12/27. Rash on flexural of both arms, started with just left then progressed to both arms 12/27; achy feeling still; "gross feeling;" swollen lip with blister, started 1/3; left supraclavicular lymph node swollen
41 2021-01-04 vaccination site itchiness, itchy skin Itching that began localized to the injection site then spread all over the body. Feels like a burni... Read more
Itching that began localized to the injection site then spread all over the body. Feels like a burning sensation as well and an itch you can't scratch; Itching that began localized to the injection site then spread all over the body. Feels like a burning sensation as well and an itch you can't scratch; Itching that began localized to the injection site then spread all over the body. Feels like a burning sensation as well and an itch you can't scratch; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. The patient medical history and concomitant medications were not reported. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated itching that began localized to the injection site then spread all over the body. Felt like a burning sensation as well and an itch you can't scratch on 29Dec2020. Patient received Benadryl as treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was not recovered. The events were reported as non-serious. No follow-up attempts are possible; Information about batch/lot number cannot be obtained.
41 2021-01-04 itchy skin, injection site hives PT experienced itchiness and a sore arm on 12/23/2020. Developed hives on 1/5/2021 at injection site
41 2021-01-05 rash, rash with redness Broke out in red rash on neck, chest and arms. Lips itchy and tinging.
41 2021-01-05 hives, itchy skin Hives and itching 1 hour after receiving vaccine
41 2021-01-05 redness, skin warm, hardening I received the vaccine on 12/23/20, and the reaction popped up around new years. On 1/1/21 an area o... Read more
I received the vaccine on 12/23/20, and the reaction popped up around new years. On 1/1/21 an area on the skin became bright pink, medium hard to the touch and very warm compared to the skin around it. The area got larger and continued to spread over about two more days. Today is 1/6/21 and the skin is back to normal. I did not get a fever, chills, or any other symptom of note.
41 2021-01-05 injection site pain Injection site pain 1.5 days, extreme fatigue days 2&3
41 2021-01-05 shingles Shingles-diagnosed at Urgent Care
41 2021-01-05 vaccination site itchiness, vaccination site redness, vaccination site swelling, hives, itchy skin hives; intense itching; headache; injection site is red and raised and itches intensely.; injection ... Read more
hives; intense itching; headache; injection site is red and raised and itches intensely.; injection site is red and raised and itches intensely.; injection site is red and raised and itches intensely.; This is a spontaneous report from a contactable nurse. A 41-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular in the right arm, on 28Dec2020 at 08:45 (at the age of 41 years-old) as a single dose for COVID-19 immunization. The vaccine wad administered at a hospital. There were no other vaccinations given within 4 weeks and no other medications were taken within 2 weeks. Medical history included allergies to penicillin and shrimp. There were no concomitant medications. The patient previously took codeine and experienced an allergy. On 28Dec2020, the patient experienced hives, intense itching coupled with a headache, injection site is red, raised and itched intensely. The clinical course was as follows: Within 3 hours of receiving the vaccine she developed hives and intense itching coupled with a headache. She reported that the hives come and go and have covered pretty much her entire body in waves of occurrences. The injection site was red and raised and itched intensely. It has been 48 hours since and still there are hives. The patient was not hospitalized for the events. Treatment included diphenhydramine (BENADRYL) however she stated that it does not seem to affect the hives or address the itching. The clinical outcome of the events: hives, intense itching coupled with a headache, injection site is red, raised and itched intensely, was not recovered. The patient was not tested for COVID-19 after receiving the vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
41 2021-01-05 vaccination site hardening, vaccination site redness, vaccination site itchiness, vaccination site rash, vaccination site warmth vaccine site was pink, warm, indurated (size of tennis ball); vaccine site was pink, warm, indurated... Read more
vaccine site was pink, warm, indurated (size of tennis ball); vaccine site was pink, warm, indurated (size of tennis ball); vaccine site was pink, warm, indurated (size of tennis ball); vaccine site rt deltoid began to itch and had red blotches; vaccine site rt deltoid began to itch and had red blotches; Headache; low grade fever; sore throat; This is a spontaneous report from contactable healthcare professional . A 41-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at a right deltoid on 16Dec2020 11:00 at a single dose for COVID-19 immunization, at a hospital. Medical history included seasonal allergy. No known allergies to medication, food or other products. The patient's concomitant medications were not reported. On 19Dec2020 16:00, day 3 post vaccine, the patient experienced headache, low grade fever, and sore throat. On 27Dec2020, day 11, patient experienced vaccine site right (rt) deltoid began to itch and had red blotches. On 28Dec2020, day 12, the patient experienced vaccine site was pink, warm, indurated (size of tennis ball). Treated with paracetamol (TYLENOL), topical/oral diphenhydramine (BENADRYL) and topical 1% hydrocortisone. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any medications within 2 weeks of vaccination. The patient was tested for COVID-19 with via rapid test and PCR with nasal swab, both negative on 22Dec2020. The patient recovered from the events, headache, low grade fever, and sore throat on 24Dec2020, day 8 post vaccine and the rest of the events on 30Dec2020, day 14. Information about lot/batch number has been requested.
41 2021-01-06 injection site hives, injection site redness, injection site pain, injection site swelling, hives 24-48 hrs site red, swelling, pain, sore arm, severe fatigue, hive to arm and neck of injection site... Read more
24-48 hrs site red, swelling, pain, sore arm, severe fatigue, hive to arm and neck of injection site, 48-96 nausea and diarrhea X24hrs, severe migraine, improving fatigue and hives. treated with rest, advil , and Benadryl
41 2021-01-06 itchy skin, skin warm, redness Dizziness light headed, itchiness on head, ears felt hot and red, elevated BP and elevated HR Narra... Read more
Dizziness light headed, itchiness on head, ears felt hot and red, elevated BP and elevated HR Narrative: Tool Prednisone, Hydroxazine, and Zyrtec- all previously prescribed medications for general allergies.
41 2021-01-06 injection site pain Fever, chills, body aches, ( muscle and joint pain), pain at injection site, nausea, 1 episode of vo... Read more
Fever, chills, body aches, ( muscle and joint pain), pain at injection site, nausea, 1 episode of vomiting, abdominal pain
41 2021-01-06 hives Hives, fatigue, and fever
41 2021-01-06 hives Hives, sneezing, anaphylaxis, wheezing, itchy throat, stuffy, started in evening, hives first then i... Read more
Hives, sneezing, anaphylaxis, wheezing, itchy throat, stuffy, started in evening, hives first then itchy throat, probably about an hour, as that got worse throat started swelling. Took 50mg prednisone 2 benadryl and albuterol inhaler. Breathing got better and hives went away but still had swollen throat and took pepcid. Headache afterwards but that's typical of an allergic reaction. I can't be sure it was from the vaccine or not but nothing I did yesterday would normally trigger that reaction
41 2021-01-06 itchy skin, rash STARTING ON 12/24/2020 I developed burning and itching in both feet and along both deltoids. This ... Read more
STARTING ON 12/24/2020 I developed burning and itching in both feet and along both deltoids. This resulted in raised red pruritic wheals. I dosed Benadrly and used hydrocortisone cream to the area. Throughout the night, the rash appeared on both thighs, knees, back of the arms and along the back of the lower legs. Again raised pruritic wheals. It would improve with anti-histamine use. this continued until 12/29/2020. No persistent symptoms. There are no other changes in medicine, OTC medication use, no changes in foods/soaps etc.
41 2021-01-06 hives after receiving vaccine patient has hives on arm & body aches
41 2021-01-06 injection site pain fatigue - onset about 1230, I usually don't take naps but I took a 4 hour nap that day headache - on... Read more
fatigue - onset about 1230, I usually don't take naps but I took a 4 hour nap that day headache - onset about 1230, lasted the rest of the day and intermittently the next few days injection site pain x 3 days - moderate, pain would wake me in my sleep if I rolled onto affected side
41 2021-01-06 injection site swelling, injection site hives, hives, injection site redness, injection site pain site red, swelling, pain, hives, nausea, diarrhea, severe fatigue, severe migraine, hives to arm and... Read more
site red, swelling, pain, hives, nausea, diarrhea, severe fatigue, severe migraine, hives to arm and neck side of injection 24-96hrs. Treated with rest, advil, Benadryl
41 2021-01-06 injection site pain woke up 1/6/21 @ 4am with chills and nausea. Took a Zofran. Awoke again at 5am with fever of 100.6 F... Read more
woke up 1/6/21 @ 4am with chills and nausea. Took a Zofran. Awoke again at 5am with fever of 100.6 F. Fever did not respond to 600 mg ibuprofen. Later that day developed headache and body aches. Pain at injection site present as well.
41 2021-01-07 injection site redness, rash with redness 0930 vaccine, and at 1030am (1 hour after vaccine injection) pt experienced red, hot rash from left ... Read more
0930 vaccine, and at 1030am (1 hour after vaccine injection) pt experienced red, hot rash from left deltoid injection site up to her neck. Pt states that she took Benadryl at 1230 and this rash and redness is now resolved.
41 2021-01-07 vaccination site pain Abdominal cramping; Diarrhea on 30Dec pm over night; Injection site soreness; Arm pain; General ache... Read more
Abdominal cramping; Diarrhea on 30Dec pm over night; Injection site soreness; Arm pain; General aches; fatigue; This is a spontaneous report from a contactable healthcare profess. A 41-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899), intramuscular on 29Dec2020 14:45 at a single dose for Covid-19 immunization. Medical history included colitis ulcerative. Concomitant medications included infliximab (REMICADE), calcium D, sertraline hydrochloride (ZOLOFT), and probiotics. The patient previously took ampicillin sodium (OMNIPEN) and BACTRIM DS and experienced allergies. On 30Dec2020, at 04:45 PM, the patient experienced abdominal cramping and diarrhea on pm overnight, injection site soreness/arm pain, general aches and fatigue. The patient did not receive any treatment for the events. The patient has no Covid prior to vaccination and did not take Covid test post vaccination. The outcome of the events was recovering.
41 2021-01-07 itchy skin Employee received Pfizer COVID-19 vaccine and subsequently developed full body itching and reported ... Read more
Employee received Pfizer COVID-19 vaccine and subsequently developed full body itching and reported feeling like tongue was swelling. Patient was given 50 mg PO Benadryl. No improvement patient was escorted to ED by RN for evaluation
41 2021-01-07 rash, rash with redness Got vaccine at 1:15. At 1:27. Became very hot, red rash all over, tachycardia . I alerted the nur... Read more
Got vaccine at 1:15. At 1:27. Became very hot, red rash all over, tachycardia . I alerted the nurse and at that time my watch was beeping afib.
41 2021-01-07 hives Hives,
41 2021-01-07 skin burning sensation, dry skin, rash papular I initially developed 3 small red raised bumped on my R arm around Day 9 after the injection . One o... Read more
I initially developed 3 small red raised bumped on my R arm around Day 9 after the injection . One on forearm, one near antecubital, and one at inner upper arm. The bumps did not itch or have any drainage. The area increased in size, remained red, and had a central clearing, as if the skin came off the surface. The skin is now dry and cracked. I applied hydrocortisone 1% OTC on Day 7 and it caused a burning sensation to the area. The lesions are still, red, dry, no scabbing noted.
41 2021-01-07 injection site pain Lethargy onset approximately 4 hours after dose. SOB while supine. 1 day later continued lethargy ... Read more
Lethargy onset approximately 4 hours after dose. SOB while supine. 1 day later continued lethargy and orthopnea, plus imms site soreness.
41 2021-01-07 itchy skin, hives PT had aa mild reaction with hives and itchy skin on her upper chest and face. No airway or breathin... Read more
PT had aa mild reaction with hives and itchy skin on her upper chest and face. No airway or breathing involvement. Pt given 25mg Benadryl, symptoms began to resolve after 30-40 min.
41 2021-01-07 injection site mass, injection site pain Symptoms - ? EE reports pain at injection immediately after injection. EE reports ?nickel size? kno... Read more
Symptoms - ? EE reports pain at injection immediately after injection. EE reports ?nickel size? knot on her arm almost immediately after, worsening to 2x2 size this morning (1/8). 1/7 morning: body aches, chills, feelings of unwell. Unsure of fever as she has been rotating Tylenol and motrin. EE reports she saw RN at campus this morning for inspection of injection site. Home remedies? - ice pack to injection site and rotating Tylenol (last dose 20:30 1/7) and motrin (last dose 23:00 1/8) Any improvement? ? mild improvement Recommendation? EE encouraged to continue to ice injection site and to rotate Tylenol and motrin. EE encouraged to continue to monitor symptoms and to call vaccine support with further questions and/or concerns. EE denied history of COVID-19 exposure without proper PPE and denied recent travel. EE educated to manange per Illness in the Workplace Policy. EE encouraged to fill out V-safe. EE verbalized back understanding and denied further questions at this time.
41 2021-01-07 vaccination site pain chills & shivering; high fevers (peaked 102.7); tachycardia (noted to be 148 standing, 120's at rest... Read more
chills & shivering; high fevers (peaked 102.7); tachycardia (noted to be 148 standing, 120's at rest in supine); headaches; nasal/sinus congestion; fatigue; dehydration; dizziness; sore throat; GI issues; Sore arm; This is a spontaneous report from a contactable other hcp (patient). A 41-year-old female patient received first dose of BNT162B2 (COVID-19 vaccine, lot number EK5730), via an unspecified route of administration on 28Dec2020 11:00 at single dose on left arm for COVID-19 immunization. Medical history included COVID-19, hyperthyroidism, Grave's Disease, benign PVCs (Premature ventricular contractions), PACs (Premature atrial contraction) from an unknown date and unknown if ongoing, allergies, Penicillin allergy, allergy to pineapple, kiwi and pomegranate, and NUMEROUS environmental allergies (dust, weed, pollen, trees, animals. it's a long list) from an unknown date and ongoing. Concomitant medication included cetirizine, fluticasone, propylthiouracil. The patient previously took clindamycin and methimazole and experienced drug allergy. On 28Dec2020 the patient experienced sore arm (like flu vaccine) the day of the vaccination. Early the following morning (on 29Dec2020 04:00) developed chills & shivering. Progressed to high fevers (peaked 102.7), tachycardia (noted to be 148 standing, 120's at rest in supine), headaches, nasal/sinus congestion, fatigue, associated dehydration & dizziness. Subsequent sore throat & GI issues. Symptoms lasted 4-5 days. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient underwent lab tests and procedures which included covid test type post vaccination (nasal swab): negative on 02Jan2021, body temperature: high fevers (peaked 102.7) on 29Dec2020, tachycardia: noted to be 148 standing, 120's at rest in supine on 29Dec2020. No treatment received for the adverse events. The outcome of the events was resolved on an unspecified date.
41 2021-01-07 vaccination site pain on day 3 after injection severe pain in left arm and weakness unable to raise arm at shoulder; on da... Read more
on day 3 after injection severe pain in left arm and weakness unable to raise arm at shoulder; on day 3 after injection severe pain in left arm and weakness unable to raise arm at shoulder; on day 3 after injection severe pain in left arm and weakness unable to raise arm at shoulder; numbness in extremities; numbness and tingling in extremities, tingling in extremities more so in left upper extremity then left foot, then right hand; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration (Left arm) on 27Dec2020 14:30 at single dose for Covid-19 immunization. The patient's medical history included connective tissue undifferentiated (disorder), cervical radiculopathy, and Covid-19. No known allergies. Concomitant medications were unspecified; the patient received other medications within 2 weeks of vaccination. The patient was diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported numbness and tingling in extremities more so in left upper extremity then left foot, then right hand on 27Dec2020 (16:00). The patient also noticed slightly on day of injection then on day 3 (30Dec2020) after injection the patient had severe pain in left arm, weakness, and unable to raise arm at shoulder. The adverse events resulted in Emergency room/department or urgent care. The patient was treated with prednisone. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.
41 2021-01-07 rash sand paper face rash and full swollen face; sand paper face rash and full swollen face; This is a sp... Read more
sand paper face rash and full swollen face; sand paper face rash and full swollen face; This is a spontaneous report from a contactable other healthcare professional (HCP). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EH9899) via intramuscular on arm left as the first dose on 19Dec2020 at single dose for COVID-19 immunization. The patient had Botox and facial fillers on 15Dec2020. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. And it was unknown whether the patient had been tested for COVID-19 since the vaccination. The patient had sand paper face rash and full swollen face that started on 01Jan2021 (also reported as 3 days after receiving the vaccine). The events were reported as non-serious. It was unknown whether treatment was received for the events. The outcome of the events was unknown.
41 2021-01-07 itchy skin, injection site swelling site swelling, itching along upper extremities, shoulders, and upper back. Itching treated with Bena... Read more
site swelling, itching along upper extremities, shoulders, and upper back. Itching treated with Benadryl x 2 doses with positive results
41 2021-01-08 itchy skin Had chill soon after the injection and about 5 minutes later had slight nausea, I was told to stay ... Read more
Had chill soon after the injection and about 5 minutes later had slight nausea, I was told to stay 15 more minutes for observation . About 30 minutes or so after the injection, I had sever nausea. The person at the observation sent me to ER for close monitoring . After couple hours of sever nausea My body started itchy for few hours without hives. In ER, prescribed zofran but didn?t take it. Stayed ER for few hours and I was released
41 2021-01-08 hives Hives all over body
41 2021-01-08 itchy skin Itching palms ears head and eyes itching then escalated to itching all over and swelling
41 2021-01-08 itchy rash, itchy skin, rash, hives Rash & UrticariaPruritus Narrative: Developed urticaria (welt) over the vaccine site hours after re... Read more
Rash & UrticariaPruritus Narrative: Developed urticaria (welt) over the vaccine site hours after receiving vaccine. mild tenderness, then rash after several hours and became itchy. Employee is concerned about the level of protection (antibody titer produced)because allegedly given subcutaneous rather than intramuscular
41 2021-01-08 rash macular, rash c/o feeling flushed within 15 minutes of being vaccinated. Blotchy rash noted to chest and neck. No ... Read more
c/o feeling flushed within 15 minutes of being vaccinated. Blotchy rash noted to chest and neck. No SOB, no hives, no airway involvement. Transported to ED and al symptoms resolved upon arrival without intervention.
41 2021-01-09 itchy skin, redness COVID-19 Vaccine (Pfizer) EL3302 Exo 05/21. Itching and redness (flushing) on chest, stomach, leg... Read more
COVID-19 Vaccine (Pfizer) EL3302 Exo 05/21. Itching and redness (flushing) on chest, stomach, legs occurring 10 minutes after receiving vaccine. Face was flushed red no itching. Initial BP 152/99 HR 84. Benadryl 50 mg PO and famotidine 20 mg PO administered. Patient reports similar reaction following the first dose of the vaccine - COVID-19 Vaccine (Pfizer) EL0140 Exp 03/21; itching resolved without medication the first time. Patient reports that this reaction is slightly worse than previous reaction to the first dose. At 3:48pm, BP 151/87 HR 82 O2=96%. Patient itching and redness on chest and flushing of face dissipating by 3:45pm. Patient clinically stable. Patient dismissed from clinic at 3:54pm.
41 2021-01-10 rash, itchy skin, hives 41 Y female who presents to the Emergency Department for evaluation of her rash. The onset of rash ... Read more
41 Y female who presents to the Emergency Department for evaluation of her rash. The onset of rash was gradual beginning 2 days ago with progression since that time. The rash began on the abdomen 2 days ago and 1 day after her second immunization with Pfizer COVID-19 vaccine. The rash over the next 24 to 48 hours spread to the back, the chest, the arms, and inguinal folds, and popliteal areas. This morning she woke up with itching and hives on her scalp. She has used Benadryl with some relief. Patient denies shortness of breath, chest pain, nausea, or vomiting.   There is no lip swelling or itching, tongue swelling or itching, sense of throat closing, or shortness of breath. There is been no nausea vomiting, no palpitations.   She has no hx of similar previous allergic reactions. She denies exposure to new medications, shampoos, detergents, soaps, lotions, sprays or allergens.
41 2021-01-10 itchy skin Approximately 5 minutes after receiving vaccine, tongue began to swell with itching to lips and chee... Read more
Approximately 5 minutes after receiving vaccine, tongue began to swell with itching to lips and cheeks and stiffness to jaw. Notified vaccine team. Received Benadryl IM with return to baseline and transported to the ER for monitoring. Received 4 days of Prednisone and Pepcid PO.
41 2021-01-10 injection site redness Arm Soreness, redness around injection site
41 2021-01-10 shingles, blister, rash, skin burning sensation I received my first vaccine 12/22/2020 at 3:45pm. My right arm was sore like I would have expected a... Read more
I received my first vaccine 12/22/2020 at 3:45pm. My right arm was sore like I would have expected and everything else was fine, until 12/31/2020. My left upper thigh had a burning feeling around the outer part and in the goin on that thigh a painful lymph node. That afternoon I had a burning sensation on my left butt cheek. When I looked I noticed a very small rash with blisters. I waited through the weekend because I knew the OBGYN was not open. I called first thing Monday morning and made an appointment as soon as they could see me which was the next day (1/5/2021)at 3:30pm. The doctor took samples and sent them to the lab for testing. The test was positive for shingles. I am now taking valtrex for shingles.
41 2021-01-10 injection site pain Mild soreness around injection site. Did not affect my daily activities.
41 2021-01-10 rash, itchy skin Patient developed an itchy rash on her arms and stomach the day after receiving this vaccine. She to... Read more
Patient developed an itchy rash on her arms and stomach the day after receiving this vaccine. She took Benadryl for two days, and it was gone. She had no other symptoms.
41 2021-01-10 injection site pain Pfizer BioNTech Covid 19 vaccine EUA- Symptoms started at 2100 on 1/5/21 and ended 0800 01/07/2021-... Read more
Pfizer BioNTech Covid 19 vaccine EUA- Symptoms started at 2100 on 1/5/21 and ended 0800 01/07/2021-- fever 101.3, body aches, chills, extreme fatigue, sore throat, dizziness, sinus congestion , abdominal pain, tender lymph nodes in neck HA and pain at injection site.
41 2021-01-10 injection site pain Severe headache with photosensitivity, soreness at injection site, malaise
41 2021-01-10 hives, itchy skin itchy and generalized hives
41 2021-01-10 itchy skin palms of hands started to swell and itch. diaphoretic, then neck started to itch. extended to thro... Read more
palms of hands started to swell and itch. diaphoretic, then neck started to itch. extended to throat leading to difficulty swallowing
41 2021-01-11 vaccination site pain Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot fla... Read more
Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; This is a spontaneous report from a contactable Nurse (patient). This 41-Year-old female Nurse (no pregnant) received first dose of BNT162B2 (Lot number: EJ1685) on 04Jan2021 09:00 AM on Left arm for COVID-19 immunization. Medical history was migraines. Concomitant drug was not reported. Known allergies: amoxicillin, cefaclor (CECLOR), ciprofloxacin hydrochloride (CIPRO), erythromycin, Zithromax. Patient experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days following injection on 05Jan2021 00:30 (reported as 04Jan2021 12:30 PM) with outcome was recovering. Treatment: Medication for nausea (zofran). Covid test post vaccination on 06Jan2021, result unknown. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Not any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Follow-up attempt are not possible. No expected further information.
41 2021-01-11 rash macular, rash with redness, rash Made felt dizzy, disoriented :15 minutes :50 minutes face, chest and neck became blochey with rednes... Read more
Made felt dizzy, disoriented :15 minutes :50 minutes face, chest and neck became blochey with redness and heart beat was racing or elavated heart rate nd took benydrol after became back of hands and face became flushed red again and took more benydrol and next day face and cheeks was still blouchey and red. Hot flashes and chills .
41 2021-01-11 injection site pain Upon resting in waiting area after administration of vaccine, I began to notice left-sided facial nu... Read more
Upon resting in waiting area after administration of vaccine, I began to notice left-sided facial numbness, extending to left shoulder / pectoris area. The symptom was mild throughout, did not get any worse. However, the symptoms have not subsided and I have continued to experience mild facial numbness (left). Yesterday, 01/07/21, I had an intermittent episode of tingling and left sided weakness which lasted a several hours in the afternoon. In addition to facial numbness, I also experienced left upper arm soreness, especially at site of injection. I also had a mild headache which lasted a three days.
41 2021-01-11 rash worsening of the rash developed tender/swollen supraclavicular lymph nodes
41 2021-01-12 injection site pain, shingles, cellulitis 24 hours after the injection I had a sore arm, developed slight body aches and headache. Since the ... Read more
24 hours after the injection I had a sore arm, developed slight body aches and headache. Since the injection I had been getting headaches almost daily, mostly on my right side of my head. On Dec. 5, 2021 I noticed I was getting a sore eyebrow. Later that evening ok noticed swollen lymph nodes throughout my scalp, face, ear, jaw, neck and chest. My eyebrow also started to swell and was slightly pink. When the swelling was worse the next day - I went to urgent care and saw A doctor that diagnosed me with facial cellulitis. After a couple days my eye was not getting any better and started to itch severely. Called to urgent care over the weekend and takes to one of the providers who said to use cold compresses and elevate my head as much as I could. On Dec. 11, 2021 I called back to the provider I had seen on Dec. 6 - he told me he believed I had developed shingles and to go to the eye doctor that day. I saw a doctor on Dec. 11 & was diagnosed with shingles. They started me on antivirals along with the antibiotics they had prescribed on Dec. 6.
41 2021-01-12 hives Employee received first vaccine 12/22/21. Developed hives on neck and face later that day. Took Bena... Read more
Employee received first vaccine 12/22/21. Developed hives on neck and face later that day. Took Benadryl routinely and Prednisone 10mg daily for three days with resolution of symptoms. Patient has a history of hives after flu vaccine, antibiotics, and childhood vaccines. Had second COVID vaccine 1/12/21. Developed hives on neck, arms, chest, and back. Also had a mild headache and nausea on 1/12/21 which have resolved. Is again taking Prednisone and Benadryl. Patient did not seek medical help. She has Prednisone on hand for these reactions since they are common for her.
41 2021-01-12 injection site pain Injection site pain, fatigue. Resolved.
41 2021-01-12 itchy skin, injection site rash, rash Itchy skin rash in elbow crease, torso, groin area and legs that started exactly after 48 hours of r... Read more
Itchy skin rash in elbow crease, torso, groin area and legs that started exactly after 48 hours of receiving the vaccine from the left elbow area (where the vaccine was administered) and gradually spread to other body parts over the next couple of hours. Has not resolved with over the counter oral anti-histamine and topical over the counter steroid cream as of 1/13/21.
41 2021-01-12 rash, hives Started having itching after vaccine. Taken to ER. Broke out in full hives. Was given IV Benadry... Read more
Started having itching after vaccine. Taken to ER. Broke out in full hives. Was given IV Benadryl and steroids.
41 2021-01-12 skin burning sensation The vaccination was given at 1802. At approximately 1804 the patient stated she did not feel quite ... Read more
The vaccination was given at 1802. At approximately 1804 the patient stated she did not feel quite right and something may be wrong. She stated she was feeling all warm. She was complaining of mild heat or burning traveling from the vaccination arm, across her chest to the other arm and down her torso. Did not complain of any breathing difficulties or other symptoms. Her heart rate and respirations were normal. Upper extremities were examined for redness or hives - none found. The heat flash lasted about 2 minutes then she stated she felt normal. She was observed for another 20 minutes. She was examined again before leaving and no signs or symptoms were noted at that time. She felt normal before leaving the clinic.
41 2021-01-12 injection site bruising bruising at injection site
41 2021-01-12 rash fever loss of appetite headache/migraine body aches muscle cramps, rash
41 2021-01-12 injection site pruritus, injection site warmth, injection site redness injection site red, hot to touch and itchy since 1/12/21
41 2021-01-12 itchy skin positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; After the shot i have he... Read more
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; A 48-years-old non-pregnant female patient, receivedBNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in left arm, on 18Dec2020 (at the age of 41 years-old) as a single dose for COVID-19 immunization. The vaccination was administered at a pharmacy/drug store. Medical history was not reported. Concomitant medication included sertraline hydrochloride (SERTRALINE HYDROCHLORIDE). The patient had not received any other vaccines within four weeks prior to the vaccination nor received any other medications withing 2 weeks prior. It was reported that the patient had been tested for COVID-19 prior to vaccination and was negative. On 18Dec2020, the patient experienced itchy sore eyes one hour after vaccination, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after. The patient was not hospitalized nor received treatment for the events. The clinical outcome of the events of Itchy, sore eyes 1 hour after, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after, was not recovered., the outcome of the COVID-19 positive was unknown. It was reported that the patient tested positive for COVID-19 via nasal swab, post vaccination on 31Dec2020. No follow-up attempts possible. No further information expected. Lot/batch number was not provided and unable to obtain
41 2021-01-13 injection site redness 01/08/21 reported around 3:30pm sick to stomach, 01/09/21 04:00am noted redness to right arm at inje... Read more
01/08/21 reported around 3:30pm sick to stomach, 01/09/21 04:00am noted redness to right arm at injection site.
41 2021-01-13 rash with redness, injection site pain Pt Complained of numbness/tingling around the mouth . Red rash . Tenderness on the injection site/l... Read more
Pt Complained of numbness/tingling around the mouth . Red rash . Tenderness on the injection site/lower arm for 5 days.
41 2021-01-13 sensitive skin Severe aches, chills, headache, stomach cramps, nausea, vomiting, diarrhea, sweats, eye pain, fatigu... Read more
Severe aches, chills, headache, stomach cramps, nausea, vomiting, diarrhea, sweats, eye pain, fatigue, skin sensitivity. Treated with Tylenol and CBD lotion. Mostly resolved within 36 hours of onset.
41 2021-01-13 injection site redness, rash, injection site pruritus Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Rash (other th... Read more
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Rash (other than injection site)-Mild; symptoms lasted 0 days
41 2021-01-13 rash, itchy skin Systemic: Rash (other than injection site)-Medium, Systemic: Fever-Medium, Systemic: Felt itchy all ... Read more
Systemic: Rash (other than injection site)-Medium, Systemic: Fever-Medium, Systemic: Felt itchy all over body, no visible hives, flushed-Medium; symptoms lasted for 1 day
41 2021-01-13 hives, itchy skin severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of brea... Read more
severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath; This is a spontaneous report from a contactable nurse (reporting for herself). A 41-year-old non-pregnant female patient received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), both via an unspecified route of administration in the left arm, the first dose on 16Dec2020 09:00 (lot number: EH9899) and the second dose on 08Jan2021 07:15 (lot number: EL0140), both at a single dose for COVID-19 immunization. Medical history included ongoing anxiety, from an unspecified date. The patient had no known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO), acetaminophen (MANUFACTURER UNKNOWN), naproxen sodium (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. On 09Jan2021 at 01:30 AM, the patient experienced severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath, all of which were reported as being life-threatening. The patient went to the Emergency room due to the events. Therapeutic measures were taken as a result of the events and included: methylprednisolone sodium succinate (SOLUMEDROL) 125 mg, famotidine (MANUFACTURER UNKNOWN) 20 mg and diphenhydramine hydrochloride (BENADRYL) 50 mg. The clinical outcome of severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
41 2021-01-13 injection site pain sore arm on the same day , fatigue, next day woke up with swollen lymph nodes on my right arm same p... Read more
sore arm on the same day , fatigue, next day woke up with swollen lymph nodes on my right arm same place where injection was given , still sore and pain full to touch and headaches .
41 2021-01-14 itchy skin, hives, rash *Rash ,whelps and swelling on bilateral arms from the shoulder area to hands. *Rash ,whelps and s... Read more
*Rash ,whelps and swelling on bilateral arms from the shoulder area to hands. *Rash ,whelps and swelling on bilateral legs from upper thighs down to feet *Severe Itching Received the vaccination on Wednesday, January 6, 2021. Symptoms started on Saturday, January 9, 2021 around 1pm. Symptoms intensified as the days went by. Went to Urgent Care on Monday, January 11, 2021.
41 2021-01-14 skin spots, injection site pain, injection site swelling, hives Day of vaccine, patient started feeling fatigue, malaise, site pain & swelling, joint pain all over,... Read more
Day of vaccine, patient started feeling fatigue, malaise, site pain & swelling, joint pain all over, profuse sweating w/no fever, chills, all over inflammation & swelling, hives upper extremity, petechial rash, and the next day after the vaccine, the patient started experiencing swelling in R-axilla (lemon size). 3 days after vaccine all symptoms have resolved except swelling in right axilla.
41 2021-01-14 skin burning sensation Dizzy at work around 4pm. Tightness in chest worked its way down to stomach - felling queasy and sic... Read more
Dizzy at work around 4pm. Tightness in chest worked its way down to stomach - felling queasy and sick to the stomach. When driving home from work, she instantly felt really hot and had a lot of flushing that felt like a hot flash. Hot all over. Had to pull over and take off layers of clothes. Sat with the air on in the car. Burning sensation when she got home felt like brillo pad was used on face. Burning sensation on cheek all the way down to chin. Face was really on fire. Today, the burning sensation have gotten better, but her cheeks still have prickly, tight sensation. Headache at 8pm yesterday when she was trying to go to bed at the back of the head. Felt like a lot of pressure.
41 2021-01-14 vaccination site pain, vaccination site rash, vaccination site itchiness Fatigue; Dry mouth; Low grade fever; Chills; Headache; Itchy rash at injection site; Itchy rash at i... Read more
Fatigue; Dry mouth; Low grade fever; Chills; Headache; Itchy rash at injection site; Itchy rash at injection site; Soreness at injection site; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 31Dec2020 12:45 at left arm, at single dose for covid-19 immunization. Medical history known allergies: penicillin, chocolate from an unknown date. Concomitant medication included acetylsalicylic acid (ASPIRIN) and Birth control pills. The patient previously took erythromycin and known allergies: Erythromycin. The patient was not pregnant at the time of vaccination. The patient experienced fatigue, dry mouth, low grade fever, chills, headache, itchy rash at injection site, soreness at injection site on 31Dec2020 15:00. No treatment was received for all events. The outcome of the events was recovered on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. No follow up attempts are possible. No further information is expected.
41 2021-01-14 vaccination site pain Inject site pain; muscle/joint pain; muscle/joint pain; fever with temperature of 99-100.6 [units un... Read more
Inject site pain; muscle/joint pain; muscle/joint pain; fever with temperature of 99-100.6 [units unspecified]; under arm lymph node pain; headache; This is a spontaneous report from a contactable healthcare professional. A 41-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EL1284; expiration date: unknown), intramuscular left arm on 08Jan2021 08:45 AM at a single dose for covid-19 vaccination. Medical history included asthma, allergies, high blood pressure and gastric sleeve. Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), beclometasone dipropionate (QVAR), mometasone furoate (FLONASE), aminobenzoic acid, calcium pantothenate, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (B-COMPLEX), cyanocobalamin (B-12), colecalciferol (D) and macrogol 3350 (MIRALAX). The patient previously took vancomycin but had allergies. The patient received the first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EK5730; expiration date: unknown) intramuscular left arm on 18Dec2020 07:45 AM at a single dose for covid-19 vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received the most recent COVID-19 vaccine in a hospital. The patient experienced inject site pain, muscle/joint pain, fever with temperature of 99-100.6 [units unspecified], under arm lymph node pain and headache on 09Jan2021 23:30. The events were considered as non-serious. The treatment the patient received for the adverse event were acetaminophen (TYLENOL), fluids, ice packs and magnesium. The patient has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included temperature was 99-100.6 [units unspecified] on 09Jan2021. The outcome of the events was recovering.
41 2021-01-14 injection site swelling, injection site pain Received second Pfizer vaccine on 1/13 at 7pm. Woke with headache and injection site pain on 1/14. A... Read more
Received second Pfizer vaccine on 1/13 at 7pm. Woke with headache and injection site pain on 1/14. As day progressed, fatigue, joint pain, mm aches increased. Fatigue, headache, injection site pain and swelling, new or worsened joint and muscle pain
41 2021-01-14 injection site pain Symptoms - ? Patient reports she woke up on 1/14 with pain to injection site and sore L arm. At app... Read more
Symptoms - ? Patient reports she woke up on 1/14 with pain to injection site and sore L arm. At approximately 0400 + chills, HA, body aches, and nausea without emesis. + fever (Tmax 100.3), Patient reports yesterday took motrin/tylenol around the clock. Today (1/15), Patient reports no fever today but ?brain fog? and feelings of fatigue. Patient reports last dose of motrin 600 mg at 08:00. Patient reports she called off work yesterday due to not feeling well. Last day of work and shift - ?Tuesday, January 12th Home remedies? - Tylenol, motrin, rest Any improvement? ? mild improvement Recommendation? Patient encouraged to take ibuprofen and acetaminophen as outlined in the TCH Medical Directive. Patient encouraged to continue to monitor her symptoms and to contact the Vaccine support line with additional questions and concerns. Patient reports she called out of work yesterday, next scheduled shift Monday (1/18). Patient educated to manage her RTW according to the TCH Illness in the Workplace policy. Patient verbalized back understanding and denied further questions at this time.
41 2021-01-14 bruising, skin discolouration Within ten minutes, I had a massive headache and the roof of my mouth went numb. Within one hour, I ... Read more
Within ten minutes, I had a massive headache and the roof of my mouth went numb. Within one hour, I had severe bruising, dark purple, the size of a half dollar, that JUST went away and I am due on 1/17/2021 for my next vaccine. I had no pain, only dark purple bruising and swelling. The headache and mouth issue went away after three days.
41 2021-01-15 itchy skin I started itching while being monitored post vaccine administration within the 5 minutes of the vacc... Read more
I started itching while being monitored post vaccine administration within the 5 minutes of the vaccine being administered. The itching was everywhere including my tongue and throat, since this is my workplace and I was working I had to go home and was given Benadryl to take upon arrival, the Benadryl did not help so I did a virtual visit with a physician who recommended that I increase the dose of benadryl at the same time I called my PCP to inform them of the issue they ordered, Atarax 25 mg every 6 hours plus taking an over the counter antihistamine.
41 2021-01-16 itchy skin 1/17/2021 2:42 pm gave vaccine 1/17/21 2:54 pm itchy throat on outside was upset and we opted fo... Read more
1/17/2021 2:42 pm gave vaccine 1/17/21 2:54 pm itchy throat on outside was upset and we opted for 25mg Benadryl as a precaution. BP 112/72. Reported itchy back. Checked back, unremarkable. 3:30, no issue ? she went home. F/u 4:30 - no issues
41 2021-01-16 itchy skin, skin warm, redness, cellulitis I received my second dose of Pfizer's Covid vaccine on 1/9/21. The person who gave the vaccine admi... Read more
I received my second dose of Pfizer's Covid vaccine on 1/9/21. The person who gave the vaccine administered it SQ, not IM. I did develop a cellulitis like reaction to the area. The redness began almost immediately following the vaccine, however, the following 2 days the area grew larger and hot to touch. The area currently is red and itchy, however, swelling and warmth is gone. My concern is the efficacy of the vaccine since it was not given IM.
41 2021-01-16 itchy skin Within 25 minutes of receiving the vaccine, my left arm became very heavy and there was a tingling/n... Read more
Within 25 minutes of receiving the vaccine, my left arm became very heavy and there was a tingling/neuro sensation in left wrist/hand. A pressure began in the anterior of my throat which increased gradually. I sought treatment in our Urgent Care just after noon that same day. The Provider monitored my vitals which were good and administered liquid Pepcid. Said Provider chose not to give Benadryl as I had taken Zyrec that morning for my allergies. I was discharged from the Urgent Care and went back to work at 1245. At 1730 hours, I had a slight headache above my right eye and extreme right-sided jaw pain with tooth sensitivity. These lasted for only 10 minutes. At 1830, the anterior and bilateral portions of my throat began to feel "prickly" and I developed a wheeze. I used an albuterol inhaler to relieve the wheeze successfully. At this time I also developed an itchiness throughout my whole body, worse on left side than right side. I took 100mg of Benadryl with no relief. At 0300, I took another dose of 100mg of Benadryl with no relief. I also took an itch pill/antihistamine of my husband's which provided no relief. At 0800, I took 20 mg of Zyrtec. At 1030, I took 100mg of Benadryl. I continued to use Benadryl throughout the day, every 4-5 hours. At 1800, I had a fullness in my throat, a tightness in my chest and my left shoulder blade felt almost numb. I also had a hoarse voice which passed by the next morning. The chest tightness was intermittent over the next day or two. On Friday, the itchiness had improved some but was still prominent. I continued to use Zyrtec and Benadryl throughout the day. My Primary Doctor called in Prednisone if needed. By Saturday morning, I felt MUCH better. Today is Sunday and I am no longer itching and I feel so much better today.
41 2021-01-17 rash 10 minutes after vaccine administered was lightheaded, heart rate increased. This lasted no more th... Read more
10 minutes after vaccine administered was lightheaded, heart rate increased. This lasted no more than 2 minutes and resolved on its own with no further recurrence. A few hours later developed rash to upper body (chest & back areas). Treated rash with antihistamines (Benadryl, Pepcid), Zyrtec. Rash resolved after 7 days, then flared after allergy medications stopped. Rash completely resolved at 16 days post vaccine.
41 2021-01-17 itchy skin, rash 5 minutes after vaccine- hot/dizzy, lasted less than 1 minute. Right side neck pain/ache, left arm p... Read more
5 minutes after vaccine- hot/dizzy, lasted less than 1 minute. Right side neck pain/ache, left arm pain/ache- lasted less than 5 minutes. 30 minutes after vaccine rash, itching- lasted 2 days. 1 hour after vaccine- severe headache lasted 4 days. 4 hours after vaccine- ears/throat itching. Took Benadryl 50mg, Tylenol 1000mg, Albuterol Inhaler 2 puffs, and Famotidine 20 mg 4 hrs after vaccine.
41 2021-01-17 injection site pain COVID positive 11/27/20. Oxygen saturation dropped to 90% with exertion and 94% resting. Also had ch... Read more
COVID positive 11/27/20. Oxygen saturation dropped to 90% with exertion and 94% resting. Also had chest pain and sinus tachycardia. Received first COVID vaccine 12/18/20.Developed continuous vomiting 1.5 hours later then muscle aches and cramps as the day went on. Symptoms were gone later the next day except site soreness. Developed SOB and wheezing on 12/24/20. Went to ER - no treatment. Called her pulmonologist and increased diltiazem for the weekend. Called cardiologist 12/28/20 and was put on Corlanor. Took care of acute issues, but still had some SOB and palpitations.
41 2021-01-17 injection site swelling, injection site pain, redness Fatigued; Sore in her throat; Lost her voice (hoarse); Reddish nose; Intermittent coughs; she went t... Read more
Fatigued; Sore in her throat; Lost her voice (hoarse); Reddish nose; Intermittent coughs; she went to work to a COVID unit which she usually didn't do; described her symptoms as a chest cold; Feeling strange like coming down; swelling and soreness in the injection site for a day or two; swelling and soreness in the injection site for a day or two; This is a spontaneous report from a contactable nurse reported for self. This 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 07Jan2021 13:30 PM at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) for COVID-19 immunization on an unspecified date. On 07Jan2021 after second dose vaccination, the patient started experiencing swelling and soreness in the injection site for a day or two. On 08Jan2021 the next day, she went to work to a COVID unit which she usually didn't do. On 08Jan2021 the next day after her shift at 15:00 PM, she started feeling strange like coming down. On 09Jan2021, she felt totally fatigued. The symptom that bothered her the most is the sore in her throat which has gone 10Jan2021, she said she lost her voice (hoarse). She was also experiencing a reddish nose and intermittent coughs. She described her symptoms as a chest cold. The patient also stated she didn't have fever or chills. She's afraid she might be sick. The outcome of event the sore in her throat was resolved on 10Jan2021. The outcome of other events was unknown. Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported chest cold cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
41 2021-01-17 hives, injection site redness I felt off/not myself for about 30 hours after the second dose. A migraine for 48 hrs. a red welt o... Read more
I felt off/not myself for about 30 hours after the second dose. A migraine for 48 hrs. a red welt on my arm at the injection site, I found it 1/13 it was small and got bigger overnight. I took Benadryl on 1/17 and it got smaller. the morning of 1/18 it was back just as big as before the benadryl. It is about 5 inches accross and 3 inches up and down
41 2021-01-17 rash PATIENT PRESENT THROAT ITCH AND SKIN RASH
41 2021-01-17 injection site pain Soreness/pain in the injection site starting 3pm on January 8, 2021 until January 10 at 11am. I cann... Read more
Soreness/pain in the injection site starting 3pm on January 8, 2021 until January 10 at 11am. I cannot lift the affected arm but still can do light activities like eating, writing, typing, etc. Chills and fatigue starts saturday January 9 at 7pm until January 10 at 11pm. I took tylenol starting January 8 for the pain until pain is gone and took Theraflu starting January 9 until sunday bedtime at 11pm. Bedrest and increase fluid intake one of the interventions, besides medicines.
41 2021-01-17 injection site warmth, injection site redness, redness Started with aches, pain and headache on 1/14 pm. By 1/15 am temperature had spiked to 106 but was ... Read more
Started with aches, pain and headache on 1/14 pm. By 1/15 am temperature had spiked to 106 but was responsive to acetaminophen and remained high until 1/17 am. patient is continuing to experience aches and pain still 1/18. Face was swollen and red until 1-17 pm. Lymph nodes in neck, collar bone and armpit on right side were swollen and sore. About 3 inches below actual injection site an area 1x2 inches is red and hot to touch still on 1/18
41 2021-01-18 hives 22 hours after the second dose started to have an allergic reaction, hives all over back and chest a... Read more
22 hours after the second dose started to have an allergic reaction, hives all over back and chest and neck. Took benedryl and pepcid at home OTC. The next morning woke up with hives, flushed feeling, and chest/throat tightening. Went to the ER was administered iv medications. Went home. 4 Hours later started again with chest and throat tightening and swelling of the eyes. Kept having break through reactions when medications were wearing off. The ER md that I saw called in some home medications that I started taking. Pepcid and Prednisone. 7 days later still having to take benedryl and pepcid due to eye itchiness and swelling.
41 2021-01-18 injection site pruritus, injection site swelling, injection site redness 5 days after my injection, I noticed a raised, bumpy area on my L upper arm. At this time, I did no... Read more
5 days after my injection, I noticed a raised, bumpy area on my L upper arm. At this time, I did not equate this with my injection since it was 5 days later. But on day 6 in the AM, the area on my L deltoid was visible and red in the mirror. It took my husband and I a few minutes to put together that this was the site of my injection. Throughout the day, the area was raised, red, and itchy- but not intolerable and I did not take any medication. I did put some hydrocortizone ointment on the area this PM (still day 6 post-injection).
41 2021-01-18 hives, itchy skin A few hours after administration, itchy hives on neck and jawline
41 2021-01-18 hives At about 4:30am on 12/24/20 she woke up with an itchy throat and hives all over body. Took 50mg Bena... Read more
At about 4:30am on 12/24/20 she woke up with an itchy throat and hives all over body. Took 50mg Benadryl and symptoms cleared up in 3 hours. Developed hives again that evening. Took Benadryl 25mg and resolved. This has continued to occur approximately once daily with relief of Benadryl 25mg. Was advised by Dr. that this could be from an allergy to the filler.
41 2021-01-18 hives Decided to get second vaccine 1/11/21 even though she was still getting hives from 1st dose. Develop... Read more
Decided to get second vaccine 1/11/21 even though she was still getting hives from 1st dose. Developed swelling on inner canthus L eye. Saw Dr. 1/14/21 and famotidine was ordered. This reduced hives. In 1/16/21 developed swelling of R inner canthus. Took Benadryl and famotidine hs on 1/17/21. Took famotidine 1/18/21 before work, but developed hives under arms and tongue began to swell that evening. Took another dose of famotidine. Tongue improved within 40 minutes but L side of face began to swell. Took Benadryl 50mg. Facial swelling improved but did not go away. Called Dr. this am and was ordered a Medrol dose pack. If this is not effective then she will be referred to Dr., allergist.
41 2021-01-18 injection site pain Got vaccine on 1/16/2021 at 8:03 am only had left arm pain site of vaccine given later in the day st... Read more
Got vaccine on 1/16/2021 at 8:03 am only had left arm pain site of vaccine given later in the day started having Headache, Body aches, Fever, Fatigue. Sunday 1/17/2021 left arm pain where vaccine given, headache, fatigue, minor body aches. Monday 1/18/2021 only headache, fatigue, minor left arm pain where vaccine given.
41 2021-01-18 itchy skin Itching all over began night of and continued for almost two days after vaccine. Mild symptoms, didn... Read more
Itching all over began night of and continued for almost two days after vaccine. Mild symptoms, didn't need Benadryl or anything.
41 2021-01-18 hives, rash Mild skin rash/welts on face. 1cm sized itchy swelling on bottom lip. puffy eyes (mild) mildly scrat... Read more
Mild skin rash/welts on face. 1cm sized itchy swelling on bottom lip. puffy eyes (mild) mildly scratchy thoat. Mildly scratchy eyes. Was better by morning and gone by the next evening. Did not take Benadryl.
41 2021-01-18 injection site pain, skin warm Roughly 2-3 minutes post injection as I was sitting in the designated waiting area, (as instructed ... Read more
Roughly 2-3 minutes post injection as I was sitting in the designated waiting area, (as instructed by the nurse to sit there for 15 minutes post injection to assure no adverse effects) I began to get very short of breath, I felt that I had to take my mask off to breath properly. ( I did not remove my mask) My heart then started to race and I felt a warming, tingling feeling throughout my body. I felt a little hot and light headed. I stayed sitting in my chair, tried to take some deep breath, and everything went away. This lasted about 30 to 60 seconds. I did NOT report this to anyone there, as I was unsure if I was actually having a reaction or not. Since it went away on it's own, I did NOT report it to anyone. I stayed for about 15-20 minutes post injection and then I left and drove home. I did feel tired and my arm is sore at injection site, but other than that, no other effects.
41 2021-01-19 rash "Pfizer-Bio-Tech COVID-19 Vaccine EUA" Physician contacted staff in regards to an individual who rec... Read more
"Pfizer-Bio-Tech COVID-19 Vaccine EUA" Physician contacted staff in regards to an individual who received the Covid-19 Vaccine on 12/19/2020. The individual reported sand paper face rash and full swollen face that started 3 days after receiving the vaccine (1/1/2021). Individual reported that she had Botox and facial fillers on 12/15/2020. This event was an unwitnessed by the staff at County Health Department. The event was reported to Epidemiologist.
41 2021-01-19 redness 5 minutes after vaccination, recipient became flushed, red in face, felt hot. Reported to observati... Read more
5 minutes after vaccination, recipient became flushed, red in face, felt hot. Reported to observation RN that she began feeling short of breath. RN administered Epinephrine in left thigh. Patient escorted to Emergency Department for further evaluation approximately 10 minutes later due to recurrence of symptoms.
41 2021-01-19 injection site pain Fever day after vaccine was given along with reaction site pain
41 2021-01-19 injection site pain Fever of 102.8, body aches, chills, fatigue, headache, injection site soreness
41 2021-01-19 hair loss On Jan 12, the patient developed positional vertigo and nausea as well as sore arm. Vertigo resolve... Read more
On Jan 12, the patient developed positional vertigo and nausea as well as sore arm. Vertigo resolved when she fell asleep. Vertigo returned on Jan 16 and17. Diarrhea occurred 6 times on Jan 17. The patient noticed significant diffuse loss of hair from January 16 to 19. She continues to have some nausea.
41 2021-01-19 rash Patient got her 2nd dose of Pfizer covid vaccine on 1/8. On 1/11 she had intermittent chest pain th... Read more
Patient got her 2nd dose of Pfizer covid vaccine on 1/8. On 1/11 she had intermittent chest pain that lasted a few days and started to notice small purpura rash on left breast. She didn't think much of it but noticed the same type of rash on her pant line and then right thigh. On 1/15 she called Occupational Health who advised her to go straight to the ED.
41 2021-01-19 rash Rashes on right hand.
41 2021-01-19 injection site pain at 6:00 pm I had diarrhea and the pain in my left arm started and I tooke tylenos 350mlg. I had a he... Read more
at 6:00 pm I had diarrhea and the pain in my left arm started and I tooke tylenos 350mlg. I had a headache in the middle of the night. today i woke up with a lot of pain non my left arm and shoulder and iI put Cbd pain cream all over my arm and tooke paracetamol 650 mlg for pain.
41 2021-01-19 vaccination site pain sore left deltoid; mild muscle aches; mild neck/joint pain; mild neck/joint pain; tired; This is a s... Read more
sore left deltoid; mild muscle aches; mild neck/joint pain; mild neck/joint pain; tired; This is a spontaneous report from a contactable nurse. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL1283), via an unspecified route of administration in the left deltoid, on 09Jan2021 (at the age of 41-years-old) at a single dose for COVID-19 immunization. Medical history included hypertension (HTN) and COVID-19. The patient was not pregnant at the time of vaccination. The patient had no known allergies. Concomitant medications, taken within two weeks of vaccination, included amlodipine besilate (NORVASC), ascorbic acid (vitamin C; MANUFACTURER UNKNOWN), ergocalciferol (reported as: vitamin D; MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), and magnesium (MANUFACTURER UNKNOWN). Other concomitant medications included unspecified daily multivitamins (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK5730), intramuscularly in left arm, on 19Dec2020 at 07:00 (at the age of 41-years-old) for COVID-19 immunization and experienced sore left deltoid (Day 1), body aches (Day 1), headache (HA) (Day 1, 2, & 3), all over body aches (Day 2), fatigue (Day 2, 3, & 4), chills (Day 2), myalgia/muscle ache (Day 3), all over joint pain (Day 3), lower/upper extremity (LUE) pain (Day 4), and muscle and bone pain (Day 4). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced sore left deltoid, mild muscle aches, mild neck/joint pain, and tired on 09Jan2021. The events were reported as non-serious. The events occurred on day 1 after vaccination and by day 2, the patient felt great with no side effects. Therapeutic measures were taken as a result of all of the events, which included paracetamol (TYLENOL) and ibuprofen (MOTRIN). The clinical outcome of sore left deltoid, mild muscle aches, mild neck/joint pain, and tired was recovered on 10Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
41 2021-01-20 itchy skin About 20 minutes after the dose of covid vaccine severe itching started covering body.
41 2021-01-20 vaccination site pain Chills; Headache; Site pain; Body ache; This is a Spontaneous report from a contactable Nurse (patie... Read more
Chills; Headache; Site pain; Body ache; This is a Spontaneous report from a contactable Nurse (patient). A 41-years-old female patient (no pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , intramuscular on 09Jan2021 08:45 (lot number EL0142) at the second single dose, intramuscular on 21Dec2020 11:15 (lot number EH9899) at the first single dose for covid-19 immunisation. Anatomical location was left arm. Medical history reported as none. The patient's concomitant medications were not reported. The patient experienced chills, headache, site pain, body ache on 09Jan2021 21:00. The patient underwent lab tests and procedures which included Covid testing viral RNA: negative on 04Jun2020 via Nasal Swab. The outcome of events was unknown.No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination
41 2021-01-20 rash Diffuse rash and left supraclavicular lymphadenopathy; Diffuse rash and left supraclavicular lymphad... Read more
Diffuse rash and left supraclavicular lymphadenopathy; Diffuse rash and left supraclavicular lymphadenopathy; This is a spontaneous report from a contactable other health professional (patient). A 41-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot:EL0142) via an unspecified route of administration into the left arm on 09Jan2021 08:45 at a single dose for covid-19 immunisation. Medical history was reported as non. The patient's concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot:ES1685) via an unspecified route of administration into the left arm on 19Dec2020 08:45 at a single dose for covid-19 immunization. On 09Jan2021 20:00, it was reported that the patient experienced diffuse rash and left supraclavicular lymphadenopathy. It was also reported that the events reported was treated with loratadine (CLARITIN). Patient was not pregnant. Outcome of events was not recovered.
41 2021-01-20 vaccination site pain LUE pain; bone pain; mialgia/muscle aches; all over joint pain; fatigue; chills; sore Left deltoid; ... Read more
LUE pain; bone pain; mialgia/muscle aches; all over joint pain; fatigue; chills; sore Left deltoid; body aches/all over body aches; Headache; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EK5730), intramuscular on 19Dec2020 07:00 am at single dose at left arm for covid-19 immunization. Medical history included hypertension, covid-19 (prior vaccination). No known allergies. Concomitant medications in two weeks included amlodipine besilate (NORVASC), ascorbic acid (VIT C), ergocalciferol (VIT D), magnesium chloride (MAG), zinc and daily multivitamins. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient had not been tested for COVID-19. The patient experienced sore left deltoid, body aches, headache all on 19Dec2020 16:00, all over body aches, headache, fatigue and chills all on 20Dec2020, mialgia/muscle aches, fatigue, headache and all over joint pain all on 21Dec2020, headache, LUE pain, muscle and bone pain, fatigue all on 22Dec2020, patient finally felt better with decreased symptoms on 23Dec2020. Outcome of all events was recovered on unspecified date. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Patient received paracetamol (TYLENOL), motrin for events.
41 2021-01-20 itchy skin, rash Really bad headache; Really itchy/itching in her upper body and in legs, like a rash; Rash/itching ... Read more
Really bad headache; Really itchy/itching in her upper body and in legs, like a rash; Rash/itching in her upper body and in legs, like a rash; Mottled skin; This is a spontaneous report from a contactable nurse reporting for herself A 41-years-old female patient received bnt162b2 (BNT162B2; Lot #EL3249) vaccine , in the left arm on 11Jan2021 13:00 at single dose for Covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. The patient experienced really bad headache on 12Jan2021 with outcome of unknown , really itchy/itching in her upper body and in legs, like a rash on 12Jan2021 with outcome of unknown , mottled skin on 12Jan2021 with outcome of unknown. Unknown treatment was given for really bad headache The reported events were considered Important Medical Events.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events headache, pruritus, rash and livedo reticularis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
41 2021-01-20 skin discolouration Several toes on my right foot and one toe on my left became purple in color and looked like "COVID t... Read more
Several toes on my right foot and one toe on my left became purple in color and looked like "COVID toes."; Stiff Neck noted in correlation with discoloration; This is a spontaneous report from a contactable Nurse reported for herself. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular at right arm on 28Dec2020 15:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included Factor V, Behcet's disease, Hypertension, and allergy to PCN. Prior to vaccination, the patient was not diagnosed with COVID-19 The patient's concomitant medication was not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's past drug history included steriod Injection to left shoulder 23Dec2020. On 09Jan2021 11:30, Approximately 12 days after receiving vaccine, several toes on my right foot and one toe on my left became purple in color and looked like "COVID toes." I was seen in the ED, unsure of what is causing this, will be seen by MD next week. Lighter purple on second day, seems to be resolving. Stiff Neck noted in correlation with discoloration. Adverse event resulted in: Emergency room/department or urgent care. No treatment received for the events. The patient underwent lab tests and procedures which included Nasal Swab 2019 Novel Coronavirus SARSCOV-2 by PCR was negative on 09Jan2021. The outcome of the events was recovering.
41 2021-01-20 skin infection at injection site, redness, skin warm hand was hurting so bad/feeling more pain in her hands; hurting down into her breast; feeling weakne... Read more
hand was hurting so bad/feeling more pain in her hands; hurting down into her breast; feeling weakness; joint hurting; fever; chills; whole body aches; restless; joints and muscles were hurting; She saw really bad redness and it was increasing in size; It was swollen and warm to touch; It was swollen and warm to touch; she has had horrible feelings; inappropriate schedule of vaccine administered (first dose on 21Dec2020, second dose on 09Jan2021); inappropriate schedule of vaccine administered (first dose on 21Dec2020, second dose on 09Jan2021); Cellulitis; This is a spontaneous report from a contactable Nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 09Jan2021 at 10:30 a.m. at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medication were not reported. The patient received first dose on 21Dec2020 (lot number: EJ1685) on left Arm. Patient received second dose of the Pfizer COVID19 Vaccine on 09Jan2021 at 10:30 a.m. and until 11 that night she had no symptoms. She started feeling weakness and joint hurting. After midnight she had fever, chills, and whole body aches. She was restless. All her joints and muscles were hurting. The chills were really bad. She was taking Motrin 200mg and she took three pills at the time, so she took high dose kind of. It didn't get better until Monday, 11Jan2021, at around 1:00PM. It was She stayed home. She has heard from so many people that the second dose gives this kind of symptoms. She was already prepared with the medication. She knew the symptoms would get better. She didn't just right away go to the doctor. For two days she was running all the symptoms. Patient commented also that the last two days she has had horrible feelings. She didn't pay attention to the arm. With any shot, pain is normal. She was getting better with the other symptoms, but was feeling more pain in her hands. She saw really bad redness and it was increasing in size. It was spreading. When moving her arm, it was radiating under the arm and to the side of her breast. Then she felt really bad and came to work. She showed it to her friend and it was spreading and hurting. It was swollen and warm to touch. She went to Urgent Care downstairs. On 12Jan2021 at 10:50AM she went to Urgent Care and was diagnosed with cellulitis in left upper arm. Antibiotics were prescribed as treatment. She informed took vitamins. At the time of the reporting event outcome was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162BB2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
41 2021-01-20 rash, itchy skin, hives itching; palpitations; back ache; had an allergic reaction; full blown hives; rash on her face, ears... Read more
itching; palpitations; back ache; had an allergic reaction; full blown hives; rash on her face, ears, legs and arms; fever; tired; sore throat; swollen lymph nodes; chills; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program. A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EJ1685, expiry: Mar2021) intramuscularly on 19Dec2020 at a single dose for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. On 20Dec2020, the patient experienced fever, tired, sore throat, swollen lymph nodes and chills. On 08Jan2021, the patient experienced rash on her face, ears, legs and arms. On 09Jan2021, the patient had an allergic reaction and had full blown hives. It was also reported that the patient experienced itching and back ache on an unspecified date. The patient also experienced palpitation on an unspecified date and she went to the emergency room in which she was prescribed with lorazepam (ATIVAN). The patient was also treated with naproxen (ALEVE) for fever and back ache, steroid (unspecified) for allergic reaction and hives, TRIAMCINOLONE cream for the rash and HYDROXYZINE for the itching. Outcome of the events fever, tired, sore throat, swollen lymph nodes and chills recovered on 21Dec2020 while for the events full blown hives, itching, had an allergic reaction, rash on her face, ears, legs and arms, palpitations and back ache was unknown.
41 2021-01-21 injection site pain, injection site reaction Employee developed severe left upper extremity pain immediately after she received the COVID Pfizer ... Read more
Employee developed severe left upper extremity pain immediately after she received the COVID Pfizer vaccinedose #2 on left arm on 1/6/2021 at 11:15 am. The pain persisted and increased in intensity despite the use of topical and oral anti inflammatory medications. She was evaluated by an orthopedist on 1/18/2021 who performed various imaging studies and diagnosed the acute condition as left subacromial bursitis and tendinitis secondary to vaccine infiltration in the left shoulder bursa. The employee informed employee health director on 1/20/2021 and evaluated on same day. On physical exam, she had marked tenderness on the left arm at site of injection and moderate decrease range of motion of the left shoulder. She has been prescribed physical therapy sessions of left shoulder for eight weeks and is continued on daily analgesics. SARSCov-2 Ab IgG test done on 1/20/2021 is negative She will follow up with her orthopedist for further diagnostic tests and treatment.
41 2021-01-21 skin infection at injection site, redness Fever, body aches, fatigue - all lasting 12 hours, then resolved. Also having cellulitis to injectio... Read more
Fever, body aches, fatigue - all lasting 12 hours, then resolved. Also having cellulitis to injection site, started with adverse symptoms, still having & redness is getting larger now (55 hours after injection)
41 2021-01-21 hives Hives started on my chest, they were very sensitive, first noticed when my chest felt raw from my sh... Read more
Hives started on my chest, they were very sensitive, first noticed when my chest felt raw from my shirt. Hives went up from my chest to my neck and eventually to my face. About 30 mins after hives started, my breathing became labored. I took 3 Benadryl and was preparing to give my self an EpiPen injection. Benadryl was enough to slowly bring everything back to normal. This began around 6:00 pm, Benadryl was taken around 6:45, by 9:00pm I was completely normal for bed.
41 2021-01-21 hives, itchy skin Hives, itchy, red skin
41 2021-01-21 injection site pain I got my 2nd vaccine on 1-14-20 at 9am. About 6 hours later I had severe headaches, fatigue, muscle ... Read more
I got my 2nd vaccine on 1-14-20 at 9am. About 6 hours later I had severe headaches, fatigue, muscle pain, also pain at the injection site. i felt very tired. The next day I had severe headaches, muscle pain and fatigue and took Ibuprofen as pain medication. My headache went from a severe to moderate. All the rest of days continued with headaches.
41 2021-01-21 itchy skin, hives Patient reported to having generalized Itchiness in back, and breast with hives after receiving firs... Read more
Patient reported to having generalized Itchiness in back, and breast with hives after receiving first shot of vaccine.. After 21 days the patient came to the clinic for the second shot, but she still presented symptoms of the adverse reaction. Dr recommended to do not received the second shot. The patient went to the ER to get a second opinion. After having Talked with Dr, he agree with Dr for to not give her the second shot. Dr. from emergency department proceed to give her Medrol dose pack, Allegra and Zyrtec to relieve the symptoms.
41 2021-01-21 rash Pfizer COVID-19 Vaccine EUA. At 1317 (18 minutes after vaccine administered) Patient observed to hav... Read more
Pfizer COVID-19 Vaccine EUA. At 1317 (18 minutes after vaccine administered) Patient observed to have rash to chest and neck. Patient stated she felt "warm in her neck and inner thighs". Rash progressed to ears and face. Patient stated she was having "tingling in the mouth w/progression to her face and eyes. Patient taken to triage area for observation, VS Q 5 mins. Patient noted to have tachycardia PR 103 and elevated BP 178/100 on initial VS. Pulse rate decrease after 5 minutes to 95. BP remained elevated. Patient placed on gurney in recumbent position and water given. Patient given a mirror to view face and patient stated " my face is swollen slightly". Absent selling to lips or tongue. EPI pen 0.3mg/0.3ml auto injector administered at 1339.patient transported to site ED for further evaluation. O2 applied enroute to ED at 4L/min via NC when patient stated she felt a little lightheaded. Patient care transferred to ED and report given.
41 2021-01-21 itchy skin Severe bilateral upper and lower extremity itching, ear and facial itching. no rash. Treatment: Con... Read more
Severe bilateral upper and lower extremity itching, ear and facial itching. no rash. Treatment: Continued taking Benadryl 25 mg every 6 hours until 9PM on 1/12/21. One dose of Prednisolone 15 mg @ 330 AM on 1/12/21 and Decadron 16 mg @ 300 PM on 1/12/21. Symptoms resolved at 1/12/21 around 8 PM. Outcome: no other reactions
41 2021-01-21 injection site swelling, injection site pain Soreness at injection site with slight swelling. Fatigue on day 1 following administration.
41 2021-01-22 itchy skin Felt dizzy and light headed immediately following injection Had flu like symptoms from 1pm through 9... Read more
Felt dizzy and light headed immediately following injection Had flu like symptoms from 1pm through 9pm I took 1,000 mg Tylenol at 5pm Developed generalized, all over body severe itchiness at 9pm Took Benadryl at 11:45pm Woke at 6:00am on 1/23/21 with continued all over body itchiness, although more mild/moderate Reporting at 6:55am on 1/23/21
41 2021-01-22 injection site pain For informational purposes, to hopefully add to current research:. Dose 1: administered in the am-li... Read more
For informational purposes, to hopefully add to current research:. Dose 1: administered in the am-lightheaded, tired, sleepy began after an hr or so after administration and continued throughout the day, blood pressure increased significantly after a few hrs (151/94); was much better the following day, only feeling tired and having pain at site of vaccine/upper arm. Dose 2: administered in the pm- lightheaded slightly for the first hr, more dizzy after 2.5 hrs, blood pressure ok, but severe headache; woke up with chills 2-3x that night, woke up with headache still, no fever, joints aching more than usual in spite of taking lots of ibuprofen; slight upper arm pain. Headaches have continued and my typical joint/back pains seem to be a lot worst and not really responding to ibuprofen. May be coincidence, maybe not. Thank you.
41 2021-01-22 skin infection at injection site, injection site swelling, cellulitis, injection site pain Nausea, vomiting, and body aches within 3 hrs of injection. Swelling and pain at injection site. Cel... Read more
Nausea, vomiting, and body aches within 3 hrs of injection. Swelling and pain at injection site. Cellulitis at injection site, L armpit, L breast, lymph nodes, L shoulder. Prescribed antibiotics and instructed to take OTC NSAIDS and Anti-hystamimes. If symptoms don't abade seek further treatment, possibly IV antibiotics.
41 2021-01-22 rash, injection site swelling Rash on lower legs and feet. No pain No itching No swelling on feet Some swelling on right Starte... Read more
Rash on lower legs and feet. No pain No itching No swelling on feet Some swelling on right Started in last 24 hrs. Seeking treatment.
41 2021-01-23 injection site swelling L arm pain and swelling at injection site. Upper body aches unable to sleep. Lasted about 12-15 hour... Read more
L arm pain and swelling at injection site. Upper body aches unable to sleep. Lasted about 12-15 hours was gone about 27 hours after injection. Fatigue and feeling flush then chilled very mild. No fever
41 2021-01-23 injection site pain Reaction site pain, Temp 100.1, fatigue
41 2021-01-23 skin tightness Sharp pain at bridge of nose that became a tightening across entire face and forehead, rapid heartbe... Read more
Sharp pain at bridge of nose that became a tightening across entire face and forehead, rapid heartbeat, nausea, numbness in lips, sinuses pushing on roof of mouth, difficulty swallowing for about 15 minutes about a half hour after taking vaccine. Then about 6 hours same symptoms but without rapid heartbeat, swallowing issues were worse, took Benadryl, after about an hour symptoms lessened and I fell asleep. Next morning roughly 13 hours later would randomly have tightness in face and under chin. Lasted off and on all day.
41 2021-01-24 itchy skin Approx 15 minutes after receiving the vaccine she started c/o lip abd facial itching. She was given ... Read more
Approx 15 minutes after receiving the vaccine she started c/o lip abd facial itching. She was given Benadryl 50mg Im to L Deltoid. She said within 5 minutes she was feeling better already. She called a friend that is a nurse practicioner to come and pick her up. no other problems noted
41 2021-01-24 injection site swelling, injection site pain Day 1: Moderate Headache, chills, low fever, moderate joint pain and body ache, and injection site p... Read more
Day 1: Moderate Headache, chills, low fever, moderate joint pain and body ache, and injection site pain and swelling Day 2: chills, low fever, moderate to severe joint pain and injection site pain, severe fatigue Day 3: mild to moderate joint pain, mild to moderate body ache, moderate to severe fatigue, malaise Day 4: moderate to severe fatigue, malaise, mild body ache Day 5: moderate fatigue, malaise, mild body ache Day 6: moderate fatigue, malaise, mild body ache
41 2021-01-24 hives, rash, itchy skin Following the 1st dose- arm soreness and pain at injection side. 2nd dose- axilla pain on the right,... Read more
Following the 1st dose- arm soreness and pain at injection side. 2nd dose- axilla pain on the right, flu like symptoms, headache, joint pain followed by migraine headache on day 3 post second dose. On Saturday day 4 hives, itching all over the body. Treated with oTC Benadryl 50mg q 6hrs. On day 5 the rash was more severe. Contacted PCP and was prescribed prednisone 20mg daily. Day 6- today, rash slightly improved but still present and itchy. Feeling weak and dizzy.
41 2021-01-24 hardening, injection site redness, injection site swelling, injection site pain I began feeling a sore, scratchy throat, a headache and localized redness and swelling at the inject... Read more
I began feeling a sore, scratchy throat, a headache and localized redness and swelling at the injection site about 6 hours after receiving my vaccine. The next morning, about 18 hours after receiving the vaccine the injection site redness had extended to about 2" and had become painful. At about 22 hours after injection I began having a significant headache, chills, elevated temperature of 100 degrees, body aches, exhaustion and overall unwell feeling. This feeling persisted through the remainder of the day. By 46 hours post vaccination the redness and swelling had grown to about 3" and now had a strong red center, was hot and hard to the touch. I was still having chills, temperature stayed around 99 degrees, still felt tired and had headache. At about 66 hours post injection I have sinus congestion and the swelling and redness at the injection site is about 3 1/2" and swelling without redness now extends about 2" past the redness down my arm.
41 2021-01-24 itchy skin Status post vaccine #2 Pfizer covid vaccine. R arm r preast started itching approx 7:45 . 8:16 T... Read more
Status post vaccine #2 Pfizer covid vaccine. R arm r preast started itching approx 7:45 . 8:16 Took own allegra, increased pruritis 8:40 called 9111 employee taken to clinic treated with benadryl and zyrtec, MD next day told to take allegra and Pepcid. 1/14 employee returned to work. Started Diarrhea on 1/15. Had intermittent diarrhea since then, still has pruritis. all over. Taking allegra and pepcid. benadryl at night. Employee Advised to contact allergist for appointment. Advised to contact MD again because of the persistent itching.
41 2021-01-24 itchy skin Throat, ears and nose itching; Nose running; Throat tightening; This is a spontaneous report from a ... Read more
Throat, ears and nose itching; Nose running; Throat tightening; This is a spontaneous report from a contactable consumer. A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730/expiration date) dose number 1 via an unspecified route of administration on 22Dec2020 17:00 at a single dose on the right arm for COVID-19 immunization. Medical history included allergy to NSAIDs. The patient previously took buproprion and experienced allergies. No other vaccine was received within 4 weeks. Concomitant medications included sertraline hydrochloride (ZOLOFT), lisdexamfetamine mesilate (VYVANSE), and clarithromycin (CLARITIN). The patient experienced throat, ears and nose itching, nose running, and throat tightening on 23Dec2020 01:00. The patient received Benedryl and Prevacid taken at home for the events. The outcome of the events was recovered.
41 2021-01-24 injection site pain, injection site swelling, hives, itchy skin following the 1st dose on 12/29/2020- soreness and swelling at injection site followinf the 2nd dose... Read more
following the 1st dose on 12/29/2020- soreness and swelling at injection site followinf the 2nd dose on 1/19/2021- swelling and pain at injection side, right axilla severe pain, flu like symptoms, nausea, headache. migrane developed on day 3, on day 4 hives and pruritus all over the body, swelling of hands and feet, on day 5 the symptoms worsened despite medicating with OTC benadryl 50mg every 6hrs. Contacted PCP and was prescribed prednisone 20mg daily with some improvement. day 6- today rash still present, pruritus present, weakness, dizziness, shaky. unable to work or drive.
41 2021-01-25 injection site swelling 20 min after injection left arm/hand swelling. Hand swelling/difficult to bend fingers. Waited 30 mi... Read more
20 min after injection left arm/hand swelling. Hand swelling/difficult to bend fingers. Waited 30 min, offered benedryl, went home and rested. Arm hand still swollen on 1/25/21 but not as severe
41 2021-01-25 itchy skin, redness, skin tightness, skin warm, hives About 45 minutes to an hour after the administration of the vaccine m, my cheeks became red, hot, an... Read more
About 45 minutes to an hour after the administration of the vaccine m, my cheeks became red, hot, and swollen. There were also hives. I took Benadryl which stopped the spreading but it did not go away. I had shortness of breath, and by about 6:00 it was hard to breath when lying down. I did an albuterol treatment with my nebulizer. It helped but it took much longer than usual. There were was about 30 minutes that I found my epipen and was going to the ED if it got worse. My breathing improved. The red changed to pink but was still swollen and tight 7 hours later. The second one of Benadryl helped get rid of most of the pinkness. When I woke up this morning, I had a little bit of a wheezy cough that I didn?t have yesterday. My daily Zyrtec and singular helped that a little. I have new hives along my jawline this morning that are very minor but they do itch. The redness and swelling was similar to reactions I?ve gotten when I drink a beer or have eaten soft shell crab, but typically Benadryl will clear that up and it doesn?t linger for so long. This was more aggressive. My side effects at this point are minor, but I have a call in to my allergist to see if I should be doing anything different and questions about the second dose.
41 2021-01-25 itchy skin, rash, rash with redness Approximately 10 mins post injection I had intermittent abdominal cramping which I didn't initially ... Read more
Approximately 10 mins post injection I had intermittent abdominal cramping which I didn't initially associate with the injection, 30 mins post injection after obs period I felt dizziness. Chills within an hour, accompanied by sweating. Continued to work through it because otherwise felt okay. Dizziness subsided shortly after additional antihistamine and Pepcid. Approximatley around 7 pm my face start burning and itching, I had a diffuse red rash all over my face and my torso. I took 50 mg of Benadryl and rash resolved. It was not hives, almost appeared as flushing, Over the weekend I had fevers, chills but nothing that prevented me from my daily life. I however, have felt since my 2nd vaccine throat irritation, and itching, sweating. I am just continue my Zyrtec and regimen I took several years ago when I had this type of immune response. I didn't bother with MD, I left a message with nurse.
41 2021-01-25 itchy skin Flushing, generalized itching, conjunctival injection, nasal congestion, dry cough
41 2021-01-25 itchy skin, hives Hives, itching, tongue swelling
41 2021-01-25 hives Two days after my second COVID vaccine I felt pretty bloated although my fatigue/chills/aches from t... Read more
Two days after my second COVID vaccine I felt pretty bloated although my fatigue/chills/aches from the previous day had subsided. That night I got hives on my neck, shoulders, chest, breasts and upper abdomen. They were not itchy and went away without treatment that night but I got up in the night to go to bathroom and had small amount of blood from rectum. The blood from rectum and bloating has continued. It is only a small amount of bright red blood but has occurred about 5 times since that second dose of vaccine.
41 2021-01-25 injection site rash, skin spots petechial rash above injection site
41 2021-01-27 vaccination site pain 15hrs post injection, muscle aches, joint pain; 15hrs post injection, muscle aches, joint pain; inje... Read more
15hrs post injection, muscle aches, joint pain; 15hrs post injection, muscle aches, joint pain; injection site pain 12hrs post injection; intense chills/shivering 12hrs post injection #2; This is a spontaneous report from a contactable nurse. A 41-year-old non-pregnant female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3248 and Expiration Date: Apr2021), via an unspecified route of administration in the left arm on 15Jan2021 at 12:00 at 41-years-old at a single dose for COVID-19 immunization in a hospital. Medical history included asthma from an unknown date and unknown if ongoing, gastrooesophageal reflux disease (GERD) from an unknown date and unknown if ongoing, thoracic outlet syndrome (arterial/neurogenic) from an unknown date and unknown if ongoing, Allergies to Iodine based contrast from an unknown date and unknown if ongoing, sulfonamide allergy from an unknown date and unknown if ongoing. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization on 28Dec2020 at 12:00 at 41-years-old and experienced no symptoms (first dose; Lot number: EJ1685, EXP: Mar2021, vaccine location: left arm). Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), levocetirizine dihydrochloride (XYZAL), omeprazole (PROTONIX); all taken for an unspecified indication from an unspecified date to an unspecified date; within two weeks of vaccination. On 16Jan2021 at 00:00, the patient experienced: injection site pain 12hrs post injection, intense chills/shivering 12hrs post injection #2. On 16Jan2021 at 03:00, the patient experienced: 15hrs post injection, muscle aches, joint pain. Therapeutic measures were taken as a result of intense chills/shivering 12hrs post injection #2: relieved by 500 mg of paracetamol (TYLENOL) upon onset of chills (as reported). The clinical outcome of the events was recovering (as reported). The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
41 2021-01-27 hives 40 min after vaccine, noticed that her throat red, hives, flushed, elevated heart rate to 120s-130s.... Read more
40 min after vaccine, noticed that her throat red, hives, flushed, elevated heart rate to 120s-130s. Took Tylenol and Benadryl which improved. Mild lip tingling. Symptoms now resolved. She believes the heart rate was due to "anxiety" After the first dose, only felt flushed.
41 2021-01-27 redness, itchy skin Patient reports that within 1 hour of receiving the first dose of vaccine, she developed redness on ... Read more
Patient reports that within 1 hour of receiving the first dose of vaccine, she developed redness on bilateral arms that extended from her shoulders down to her hands. Her arms also itched towards the top, near her shoulders. Also reports feeling an odd sensation on her back, had coworkers lift her shirt and they saw a "spiderweb-like" pattern of redness on her back. Patient also reports she had to take Zyrtec and Benadryl. No other rashes or reactions reported.
41 2021-01-27 injection site rash, injection site redness, injection site pruritus, injection site pain symptoms: exhausted/run-down, headache, some nausea, rash (red, itchy, sore) at injection site, not ... Read more
symptoms: exhausted/run-down, headache, some nausea, rash (red, itchy, sore) at injection site, not sleeping well treatment: resting, sleeping, acetaminophen, drinking fluids all symptoms started approximately 24 hours after the shot was administered. symptoms have not resolved as of typing this at 2117 28January 2021
41 2021-01-28 redness, skin tightness "Pfizer-BioTech COVID-19 Vaccine EUA" Received 1st dose of vaccine in left arm at 10:28 a.m. Drove h... Read more
"Pfizer-BioTech COVID-19 Vaccine EUA" Received 1st dose of vaccine in left arm at 10:28 a.m. Drove home and at 4:00 p.m. face, forehead, and neck turned bright red, facial tightness, feeling like face was on fire. Heart rate recorded between 112bpm and 115 bpm and began having shortness of breath. Then began feeling nauseous, eyes were itchy and had a headache. Took 10 ml Benedryl @ 4:40 p.m. and drank some water. 7:00 p.m. still have slight facial and neck redness and headache.
41 2021-01-28 rash 245 pm Rash on lower arm 600 chills 700 leg cramps significant to make muscle fasciculations 900 bow... Read more
245 pm Rash on lower arm 600 chills 700 leg cramps significant to make muscle fasciculations 900 bowel dysfunction Following day, flu like symptoms, chills, aches, etc Rash still has not gone away I have had abdominal cramping and significant pain. It has worsened to resemble the pain I had prior to my hysterectomy and endometriosis ablation/scar tissue removal.
41 2021-01-28 rash Full body rash; trouble clearing throat; felt like there was something stuck in throat; This is a sp... Read more
Full body rash; trouble clearing throat; felt like there was something stuck in throat; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3249), intramuscular (right arm), on 13Jan2021 09:45, at single dose, for covid-19 immunization. Medical history included allergies: sea salt, hypothyroidism, anemia, asthma, and seizures (when younger). Concomitant medications were not reported. The patient previously took tramadol and hydrocodone and experienced allergies to both drugs. The patient experienced full body rash on 13Jan2021 10:15 (also reported as about 30 mins after vaccination). On 13Jan2021 10:15 (also reported as about an hour after receiving vaccination), the patient had trouble clearing throat and felt like there was something stuck in throat. The patient has been taking Benadryl and Motrin for these adverse events. The patient had no other vaccine in four weeks, had no other medications in two weeks, had no Covid prior vaccination and, had not been Covid-tested post vaccination. The outcome of the events was recovering.
41 2021-01-28 vaccination site pain weird taste (bitter) in her mouth; Lymphadenopathy; significant myalgias; injection site soreness; T... Read more
weird taste (bitter) in her mouth; Lymphadenopathy; significant myalgias; injection site soreness; This is a spontaneous report from a contactable physician (patient). A 41-year-old female patient received the second dose of BNT162B2 via an unspecified route of administration on 11Jan2021 at a single dose as Covid vaccine. Medical history and concomitant medications were not reported. The patient previously had her first dose of BNT162B2 on an unspecified date as Covid vaccine. The patient experienced significant myalgias and injection site soreness, both on 11Jan2021; weird taste (bitter) in her mouth and lymphadenopathy, both on 13Jan2021. The patient received her second Covid vaccine on Monday and was having a weird taste in her mouth (weird taste as bitterness). She has significant myalgia that resolved and injection site pain (injection site pain as soreness) that was resolving. She looked it up and could not find anything. She wanted to know if this was something that they were getting a lot of. The outcome of the event significant myalgias was recovered with sequelae on 13Jan2021 while of the rest of events was recovering. Information on the lot/batch number has been requested.
41 2021-01-29 redness, injection site pain, hives, injection site swelling, skin warm 8 hours post injection: fever (101 tmax), chills, headache, injection site soreness. Fever, chills,... Read more
8 hours post injection: fever (101 tmax), chills, headache, injection site soreness. Fever, chills, headache resolved 36 hours post injection. Approx 90 hours post injection wheal lesions on R arm appear (not on injection site) ,red/warm to touch, swelling to injection site, decreased ROM to RUE.
41 2021-01-29 injection site pruritus Elevated blood pressure, fever, malaise, headache, dizziness, loss of appetite, abdominal pain. all ... Read more
Elevated blood pressure, fever, malaise, headache, dizziness, loss of appetite, abdominal pain. all of these symptoms came on gradually and worsened 20 hrs after vaccination. symptoms lasted a full 48hrs for me and slowly dissipated over the following days. Itching at injection site started 72hrs after and has now ceased
41 2021-01-30 itchy skin At the 8 to 10 minute mark: Could not stop coughing Lips burning and itching At about 20 minute ma... Read more
At the 8 to 10 minute mark: Could not stop coughing Lips burning and itching At about 20 minute mark: Still coughing Swollen mouth Lips burning and itchy - took Flovent inhaler and drank water About 45 minutes Same and worse , nurse gave me 25 mg of Benadryl After about 20 minutes coughing reduces, Swelling reduces but still itchy in moisture Still swollen at about 30 minutes of the Benadryl and the nurse gave me another dose of Benadryl. Symptoms started to get somewhat better I was very tired from the Benadryl Next day my mouth was still swollen Next day chest was very very tight and took inhaler constantly Third day after vaccine had an asthma attack, hadn?t had an asthma attack since I was in middle school. Dr prescribed prednisone and to take Zyrtec along with my inhaler I cannot return to exercise until 10 days after the start of prednisone
41 2021-01-30 injection site pain Fever and chills, fatigue, body aches, headache, weakness, vomiting, pain at injection site and back... Read more
Fever and chills, fatigue, body aches, headache, weakness, vomiting, pain at injection site and back pain, joint pain, that started approximately 10 hours post injection and lasted for approximately 36 hours.
41 2021-01-30 itchy skin, hives Itching on arms and chest began Jan 30 approximately 4pm. Got progressively worse throughout the n... Read more
Itching on arms and chest began Jan 30 approximately 4pm. Got progressively worse throughout the night. Hives covered 95% of body, including eyes which began to swell shut. Took 50mg Benadryl with little relief. Went to Urgent Care and was given: 01/31/2021 0836 famotidine (PEPCID) injection 40 mg 40 mg Intravenous 01/31/2021 0836 diphenhydrAMINE (BENADRYL) injection 25 mg 25 mg Intravenous 01/31/2021 0836 methylPREDNISolone sodium succinate (Solu-MEDROL) injection 125 mg 125 mg Intravenous 01/31/2021 0840 EPINEPHrine (EPIPEN) injection 0.3 mg 0.3 mg Intramuscular Raised lesions started to flatten 1.5 hours after medications were administered Dx to home with prescription for Epi Pen, prednisone PO 60mg 1dose/day and instructed to continue taking 50 mg Benadryl q4-6 hours and Pepcid OTC 1 dose per day. Instructed to follow up with PCP in 1 week.
41 2021-01-31 rash Two hours post injection, developed numbness, tingling, extreme cold in hands and feet with fatigue.... Read more
Two hours post injection, developed numbness, tingling, extreme cold in hands and feet with fatigue. Slept for 3 hours, awoke feeling better. 14 hours post injection developed severe body aches, chills, fever, numbness in hands and feet, severe abdominal pain and cramping, and a rash on arms and abdomen.
41 2021-01-31 rash Visible rash on left arm forearm, appeared approx. 1 week after second injection. Not relieved wit... Read more
Visible rash on left arm forearm, appeared approx. 1 week after second injection. Not relieved with OTC Zyrtec or Benadryl cream
41 2021-01-31 vaccination site warmth, vaccination site redness, hives red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site; red and hot area appro... Read more
red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site; red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site; Severe pain from neck to hand, shoulder blade to chest (right side); Severe pain from neck to hand; severe pain from neck to hand, shoulder blade to chest (right side); unable to lift arm above shoulder; second dose received on 12Jan2021; first dose received on 18Dec2020; Chills; fatigue; hive; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), intramuscular (right arm) on 12Jan2021 (14:00) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: unknown) intramuscular (right arm) on 18Dec2020 for Covid-19 immunization. Medical history included "known allergies". The patient's concomitant medications were unspecified (received in 2 weeks). The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Jan2021 (pending clarification), the patient experienced chills, fatigue, and hive. On 13Jan2021 (07:00), the patient experienced severe pain from neck to hand, shoulder blade to chest (right side) and unable to lift arm above shoulder, and hive. On 14Jan2021 (pending clarification), the patient experienced red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site. There was no treatment received for the adverse event. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. Information on the Batch/Lot number has been requested.
41 2021-02-01 vaccination site pain Injection site pain; headache; muscle pain; chills; fever; This is a spontaneous report from a conta... Read more
Injection site pain; headache; muscle pain; chills; fever; This is a spontaneous report from a contactable Other HCP reporting for self. A 41-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), via an unspecified route of administration on 18Jan2021 09:30 at single dose for COVID-19 immunization. Patient received first dose of bnt162b2 on 31Dec2020. Medical history included Fatty liver and vertigo. The patient's concomitant medications were not reported. Patient had allergies medications. The patient experienced Injection site pain, headaches, muscle pain, chills, fever on 18Jan2021 16:00. Outcome of events was recovering.
41 2021-02-01 itchy skin Patient reported to vaccine clinic to receive second dose of Pfizer Covid vaccine. First dose recei... Read more
Patient reported to vaccine clinic to receive second dose of Pfizer Covid vaccine. First dose received on 1/12/2021 without any problems or reaction. Patient reported history of anaphylaxis to shellfish so she was asked to wait 30 minutes post vaccination for observation. Around 15-20 minutes after receiving vaccination, it was noted patient was rubbing her throat. RN at vaccine clinic asked patient if she was ok and she reported she was fine, she thinks it is in her head. RN noted she continued to rub her throat and asked her to describe what it felt like. Patient felt sensation of tickle in her throat and asked for water. Patient also noticed began to itch all over. Patient provided water and 25 mg PO Benadryl. Patient noted it felt like her throat was starting to close and her tongue felt it might be swelling. Epinephrine 0.3 mg IM was administered at 12:07 and patient arrived in ER at 12:08. Patient received another dose of IV benadryl and famotidine and kept for observation. She was discharged home after a couple of hours.
41 2021-02-01 itchy rash Pt. C/O Throat tightening soon after receiving the vaccine, denied difficulty breathing, no impairm... Read more
Pt. C/O Throat tightening soon after receiving the vaccine, denied difficulty breathing, no impairment of her airway, complaint improved with swallowing water. She also developed an itchy rash (very faint) on left arm. which resolved over about 10 minutes.
41 2021-02-01 itchy rash Pt. developed faint itchy rash of upper chest and upper arms, no respiratory symptoms, no C/O throat... Read more
Pt. developed faint itchy rash of upper chest and upper arms, no respiratory symptoms, no C/O throat closing, etc.
41 2021-02-01 bruising high platelets; fatigue; sharp muscle pains in hands and elbows; Headaches; nausea; Canker sore on m... Read more
high platelets; fatigue; sharp muscle pains in hands and elbows; Headaches; nausea; Canker sore on my tongue; had a sizable bruise; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm on 09Jan2021 11:45 AM at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient is not pregnant. Patient previously took the first dose of BNT162B2 at single dose for COVID-19 immunization. Patient have had a lot of fatigue, sharp muscle pains in hands and elbows at day 9 post injection (17Jan2021). Patient was now developing a Canker sore on her tongue as a fellow coworker had the same reaction (Jan2021). Patient have high platelets and have had a sizable bruise for 9 days. Headaches and nausea were present at three hours post injection (09Jan2021). AE resulted in doctor or other healthcare professional office/clinic visit. No COVID prior vaccination. No COVID tested post vaccination. covid test type post vaccination included Nasal Swab on 12Jan2021 with test result of Negative. No treatment received for the events. Outcome of the events was unknown. Information on the Lot/batch number has been requested.
41 2021-02-01 rash rash all over body. physician treated and resolved. Patient discharged for full duty 01/22/2021.
41 2021-02-02 injection site pain 1st adverse event - Pain at injection site that started approx. 8hrs after first vaccine injection 2... Read more
1st adverse event - Pain at injection site that started approx. 8hrs after first vaccine injection 2nd adverse event (main concern) - Pain at the left fibular head. This pain was noticed as soon as I woke up on Sat. 1/9/21 @ 7:30am. The pain was intense & constant. It felt as if the fibular head was bruised, but there was no bruising & no possible injury to that site. The pain subsided by the time I woke up on Thursday, 1/14/21. No pain in this area since 1/14/21.
41 2021-02-02 hardening, injection site pain Approx 7 days post vaccine, I developed a small jelly bean sized lump near my left clavicle. Im not... Read more
Approx 7 days post vaccine, I developed a small jelly bean sized lump near my left clavicle. Im not sure when it appeared, but I noticed it on 1/20/22 in the evening due to pain in that location and on the front on my shoulder near injection site. My seatbelt was rubbing on it.
41 2021-02-02 injection site redness, injection site swelling, injection site pain, injection site discomfort Around 7:00pm, approx. 7hrs after receiving my second vaccine my left arm (the arm I received my inj... Read more
Around 7:00pm, approx. 7hrs after receiving my second vaccine my left arm (the arm I received my injection in) was extremely sore. As the evening progressed so did my discomfort & pain. By the time I went to bed I wasn't able to raise my left arm above my waist. When I woke up @ 5am my joints were achy & I had a headache. Both of my feet were freezing. Throughout the day on Tuesday, 2/2/21 my arm around the injection site continued to hurt & was fevered. I kept a headache all day. Today, Wed. 2/3/21 my left arm remains extremely painful in my upper arm. My left arm is swollen, red & fevered. There is a large 4.5in x 4.5in red, swollen, fevered area around the injection site. This is extremely painful & uncomfortable. I am worried the injection may have been administered subcutaneously instead of intramuscularly & may not be as effective as it should be. I spoke with the coordinator of ocupation health (who performs the vaccinations at my workplace). She advised me to submit this form.
41 2021-02-02 redness, skin warm Large swelling (about the size of a half baseball) Large Red area Hot to the touch Pain
41 2021-02-02 injection site pain MIGRAINE, NAUSEA, VOMITING, LIGHTHEADED, DIZZY, SORENESS AT INJECTION SITE
41 2021-02-03 hives, injection site pain, itchy skin, rash Sore arm x 48 hour, I applied ice and it resolved. Starting at about 30 hours after the shot I start... Read more
Sore arm x 48 hour, I applied ice and it resolved. Starting at about 30 hours after the shot I started feeling itchy in my upper arms, shoulders and scalp. I started getting small rashes on my upper arms, and large hard welts all over my scalp. I took 50 mg of Benadryl orally and the symptoms resolved by 6 am the following day.
41 2021-02-03 vaccination site pain Soreness in arm at injection, 24 hrs; Day after debilitating lower back pain; Day after debilitating... Read more
Soreness in arm at injection, 24 hrs; Day after debilitating lower back pain; Day after debilitating lower back pain which moved down towards buttocks & legs by 3rd day.; Day after debilitating lower back pain which moved down towards buttocks & legs by 3rd day.; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3302), via an unspecified route of administration on 18Jan2021 09:30 AM at single dose on the right arm for COVID-19 immunization. Patient is not pregnant. Medical history included psoriasis, hypothyroidism and insomnia. Patient has no known allergies. No COVID prior vaccination. Concomitant medications (Other medications in two weeks) included levothyroxine, trazodone (reported as "Trazadone"), phentermine and ergocalciferol (VIT D). No other vaccines in four weeks. Facility type vaccine was Workplace clinic. The patient experienced "soreness in arm at injection, 24 hrs. Day after debilitating lower back pain which moved down towards buttocks & legs by 3rd day. Pain in walking, sitting & movement", all on 19Jan2021 11:00 AM which resulted in Doctor or other healthcare professional office/clinic visit. Treatment was received for the events, also reported a s "Call into pcp but was not helpful". Outcome of the events was not recovered. Patient was not tested for COVID since the vaccination.
41 2021-02-03 hives, itchy skin fatigue itching both arms hands and hives
41 2021-02-03 vaccination site redness, vaccination site pain, vaccination site warmth, vaccination site swelling typical site reaction at the time of injection/The spot was raised and turned bright red; typical si... Read more
typical site reaction at the time of injection/The spot was raised and turned bright red; typical site reaction at the time of injection/The spot was raised and turned bright red; typical site reaction at the time of injection/my arm was sore; I felt lethargic; hot to the touch; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231) intramuscular on 08Jan2021 10:30 AM at single dose on the left arm for COVID-19 immunization. Patient is not pregnant. Medical history included unknown allergies(reported as "Known allergies: yes"). There were no other medical history. No COVID prior vaccination. Concomitant medications (Other medications in two weeks) included ibuprofen (ADVIL [IBUPROFEN]), fexofenadine hydrochloride (ALLEGRA 24 HOUR), diphenhydramine hydrochloride (BENADRYL) and montelukast sodium (SINGULAIR). No other vaccine in four weeks. Facility type vaccine is Hospital. The patient had a typical site reaction at the time of injection on 16Jan2021 09:00 AM. The spot was raised and turned bright red, and her arm was sore. The patient felt lethargic. After a few days those symptoms went away. The spot on her arm disappeared. Eight days later, the spot on her arm reappeared. It was bigger, bright red, and hot to the touch. Patient's arm felt sore again and she had lethargy again. A doctor confirmed it was not cellulitis. No treatment was given for the events. The events resulted in Doctor or other healthcare professional office/clinic visit. Patient was not tested for COVID-19 since the vaccination. Outcome of the events was recovering (as reported).
41 2021-02-04 hives Hives all over body that lasted almost two weeks.
41 2021-02-04 injection site pain, injection site swelling, injection site redness Temporary nausea, significant fatigue, Muscle pain, Joint pain Redness, pain and swelling still rem... Read more
Temporary nausea, significant fatigue, Muscle pain, Joint pain Redness, pain and swelling still remains at site of injection Pain on top of head, but not necessarily a fullbown headache
41 2021-02-04 vaccination site pain experienced a bad headache; had arm pain in the vaccinated arm (left), only when lifting my arm; Thi... Read more
experienced a bad headache; had arm pain in the vaccinated arm (left), only when lifting my arm; This is a spontaneous report received from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiry date: unknown), via an unspecified route of administration in the left arm, on 19Jan2021 13:00, at single dose, for COVID-19 immunization, at workplace clinic. There were no medical history and no allergies to medication, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included vitamin c, colecalciferol (VITAMIN D), vitamin b and ibuprofen (ADVIL). The patient did not receive other vaccines within 4 weeks prior to BNT162B2 vaccine. On 20Jan2021 at 08:00, the patient had a bad headache and had arm pain in the vaccinated arm (left), only when lifting her arm. The headache went away during the evening without treatment. The patient did not take any pain relief medication. No treatment was given for the events. The patient recovered from headache on the evening of 20Jan2021 and recovered from "had arm pain in the vaccinated arm (left), only when lifting my arm" on an unspecified date. The events were assessed as non-serious. No follow-up attempts are possible. No further information is expected.
41 2021-02-05 itchy rash 0945 pulled into medical site @ clinic . States she received vaccine @ 9:25 an waited 15 minutes a... Read more
0945 pulled into medical site @ clinic . States she received vaccine @ 9:25 an waited 15 minutes after receiving the vaccine & was cleared to leave. After she left the site she started feeling hot, c/o itchy rash on left side of neck, and feeling hot and shaky. EMS on site to evaluate patient. 9:47 gave Benadryl 25 mgm PO 10:10 symptoms resolved. Doctor notified. Patient instructed to take Benadryl 25 mgm when she gets home and to notify her PCP regarding additional f/u. Patient left site @ 1020.
41 2021-02-05 itchy skin Generalized itch while being observed after vaccination. No hives or rashes seen. Resolved with do... Read more
Generalized itch while being observed after vaccination. No hives or rashes seen. Resolved with dose of benadryl.
41 2021-02-05 itchy skin, rash RASH NOTED IN BILAERAL AXILLARY REGIONS. NOTICED THIS MORNING. CONCERNED BECAUSE JUST RECEIVED 1ST C... Read more
RASH NOTED IN BILAERAL AXILLARY REGIONS. NOTICED THIS MORNING. CONCERNED BECAUSE JUST RECEIVED 1ST COVID INJECTION 5 DAYS AGO. RASH DOES ITCH AT TIMES. DENIES ANY OTHER AREAS OF BODY INVOLVEMENT. RASH COMES AND GOES. DENIES NIEW SOPAS OR ALLERGENS. NO SHORTNESS OF BREATH, SENSATION OF TONGUE OR THROAT SWELLING.
41 2021-02-06 injection site pain Pain at injection site (intense pain/soreness in left deltoid for over 24 hours after shot)
41 2021-02-07 itchy skin, hives 15 hours later developed fever up to 101, chills, muscle pain throughout body, headache, sweating, ... Read more
15 hours later developed fever up to 101, chills, muscle pain throughout body, headache, sweating, and joint pain. All gradually subsided by 72 hrs except fatigue did not subside. At 96 hours after vaccine i developed hives in several different areas on my body. Some itched, some did not.
41 2021-02-07 skin burning sensation It burned incredibly bad going in and burned for a couple of days afterwards. It was different than ... Read more
It burned incredibly bad going in and burned for a couple of days afterwards. It was different than the soreness from the shot. I?m reporting it bc no one else I know who got it, said anything about burning.
41 2021-02-07 itchy skin, hives Started feeling itchy the evening I got the shot, woke up the next morning to hives up and down my l... Read more
Started feeling itchy the evening I got the shot, woke up the next morning to hives up and down my legs and arms. Granted it isn't uncommon for me to get hives, but wanted to report so that data can be collected and investigated to see maybe what else might be in the vaccine that could cause folks to have these effects.
41 2021-02-07 injection site nodule, injection site warmth Two days after injection, I had a large (baseball size) knot form at the injection site. The knot wa... Read more
Two days after injection, I had a large (baseball size) knot form at the injection site. The knot was hot to the touch and very sore. Lasted about 3 days.
41 2021-02-08 injection site pain 24 hours after injection: pain at injection site; full body aches; extreme lethargy
41 2021-02-08 hives, itchy skin The recipient developed itching ~ 2 hours after receiving the vaccine. She was at home when it occur... Read more
The recipient developed itching ~ 2 hours after receiving the vaccine. She was at home when it occurred. She called her PCP about 6 hours after the dose due to severe itching and hives. She "received treatment" unknown what type and the hives went away overnight.
41 2021-02-09 vaccination site redness, vaccination site mass Light headedness; scratchy voice; itchy eyes and throat; itchy eyes and throat; pink and hot swollen... Read more
Light headedness; scratchy voice; itchy eyes and throat; itchy eyes and throat; pink and hot swollen circular hive/welt underneath injection site on left arm; pink and hot swollen circular hive/welt underneath injection site on left arm; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021 at 07:30 (at the age of 41 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included seasonal allergies from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination, but did receive the first dose of BNT162B2, on 31Dec2020 in the left arm. On 21Jan2021 at 09:30, the patient experienced light headedness, scratchy voice, itchy eyes and throat, pink and hot swollen circular hive/welt underneath injection site on left arm. The patient did not receive treatment for the events. The clinical outcome of light headedness, scratchy voice, itchy eyes and throat, pink and hot swollen circular hive/welt underneath injection site on left arm was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
41 2021-02-10 rash, itchy rash First dose the needle broke.... seemed like none went in. Second try successful administration. Head... Read more
First dose the needle broke.... seemed like none went in. Second try successful administration. Headache, minor, immediate. Three days later a rash began on upper body and progressed to entire body. Thick, very itchy. No respiratory response. Treated with Claritin, Benadryl, hydrocortisone and oat baths. Lasted 9 days.
41 2021-02-10 injection site pain, injection site redness, injection site pruritus, injection site warmth Injection site was painful (more than with my typical flu shot) after 2nd COVID injfection on 2/4 (T... Read more
Injection site was painful (more than with my typical flu shot) after 2nd COVID injfection on 2/4 (Thursday). The arm continued to be sore. On Saturday 2/6 after removing Bandaid I noticed a large red/warm area that was painful to the touch but not indurated. I outlined the area. Took NSAID and antihistamine PO daily, ice PRN. Today 2/9 the redness continues to increased in size. It is sore, red and feels itchy. Today the area measures 6 inches x 4 inches. I have communicated with my PCP via medical message. If the area continues to increase in size I will make an appointmen in the next 1-2 days due to concerns about developing cellulitis.
41 2021-02-10 itchy skin Itchy mouth, swollen face, itchy scalp, itchy ears
41 2021-02-14 itchy skin, rash 1330- report received from RN. Patient continues to report itching on face, entire back and upper ri... Read more
1330- report received from RN. Patient continues to report itching on face, entire back and upper right arm, which has spread from initial mid back. Rash noted on chest, right arm, on face (specifically cheeks), and lower back. Patient states after receiving first Bendryl 25 mg dose given by RN, no changes or improvement noticed. Patient given Benadryl 25 mg PO. Doctor aware. 1345- BP 141/82 HR 90 RR 18 98% SpO2 on RA 1355- patient has new c/o dull headache. Doctor notified. Per Doctor, continue to monitor at this time. 1405- patient states feeling improvement with itching. "it's not as itchy as before". Will continue to monitor. 1430- patient states "just slight itching now". BP 127/76 HR 89 98% SPO2 on RA RR 18. Per Doctor, to educated patient before she can leave back to work. Patient educated on returning for care in ED or Urgent care if symptoms worsen. Patient agree to this. Patient discharged from the observation area at this time.
41 2021-02-14 rash, injection site pruritus, injection site redness, itchy skin Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Systemic: Allergic: ... Read more
Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe
41 2021-02-14 injection site pain chills, fever, sweating., body aches - muscle and join pain, sore throat, mild headache, tiredness, ... Read more
chills, fever, sweating., body aches - muscle and join pain, sore throat, mild headache, tiredness, R arm (injection site) pain including shoulder, shoulder blade and right breast Lasted about 12 hours and resolved without sequaele. No treatment given or medication taken.
41 2021-02-15 itchy skin, blister, skin reaction, hives Delayed hives reaction 9 days following injection; hives cover entire body with itchy blitches
41 2021-02-16 vaccination site pain, vaccination site swelling Fatigue; fever; vomiting; pain and swelling at injection site; pain and swelling at injection site; ... Read more
Fatigue; fever; vomiting; pain and swelling at injection site; pain and swelling at injection site; bone and muscle aches throughout body; bone and muscle aches throughout body; headaches; nausea; painful lump on under arm of the arm that the shot was given; trouble breathing; chest heaviness; This is a spontaneous report from a contactable other health professional (patient). A 41-year-old female patient (pregnant: unknown) received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, , Formulation: Solution for injection, Lot number: unknown, expiration date unknown), via intramuscular on the left arm on 04Feb2021 at 11:30 at a single dose for COVID-19 immunization in the hospital. Medical history included diverticulosis and COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19). The patient concomitant medications were not reported. The patient experienced fatigue, fever, vomiting, pain and swelling at injection site, bone and muscle aches throughout body, headaches, nausea, painful lump on under arm of the arm that the shot was given, trouble breathing, chest heaviness all on 04Feb2021 at 19:00 PM. Patient visited emergency room/department or urgent care in response to the events. Patient received Zofran, dexamethasone and espi. The reporter assessed the events as non-serious. The patient was recovering from the events. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
41 2021-02-16 injection site bruising, redness Noticed swelling in my left hand around Feb 6th, but by Feb 13th entire left arm was swollen and war... Read more
Noticed swelling in my left hand around Feb 6th, but by Feb 13th entire left arm was swollen and warm and observed blue/purple skin coloring on upper arm and lower arm was red. Went to ER on Feb 15th, and ultrasound revealed a blood clot near the junction of the subclavian vein and cephalic veins. Diagnosis was idiopathic subclavian deep vein thrombosis (DVT). Started on enoxaparin and warfarin on Feb 15th. Referred to hematology and coumadin clinic to monitor INR.
41 2021-02-21 hives During the 15 minute observation period, pt reported upper lip swelling and hives on face.
41 2021-02-21 itchy skin itchiness along left side, pain in neck on left side, itchiness of the lips, minor swelling in tongu... Read more
itchiness along left side, pain in neck on left side, itchiness of the lips, minor swelling in tongue and throat
41 2021-02-22 skin warm, rash with redness, rash papular, itchy rash Anaphylactic shock? Shortly after receiving the vaccine my arm was sore and I had a severe headache.... Read more
Anaphylactic shock? Shortly after receiving the vaccine my arm was sore and I had a severe headache. Approximately 24-48 hours after I received the vaccine I started developing a red, hot, itchy raised rash on my ears and buttocks which became more prevalent and peaked around 80-90 hours later. Approximately 82 hours after I received the vaccine, I began to feeI nauseous, dizzy, and fatigued so I stood up to get ready for bed early. While brushing my teeth, I went pale white and felt like I was going to vomit. I put the toothbrush down and got on floor. My pulse felt like it had stopped. I tried to check my pulse and I could only detect one beat every other second. I called for my spouse and by the time he got to bathroom I was passed out. I came back to after about 30 seconds and was convulsing from chills. He put a blanket on me and grabbed my Apple Watch to try to get my pulse which read in the 50s (so I assume it was much lower when I passed out). My hands and feet were tingly and I stayed on the floor until my pulse got back up. I then had diarrhea. At this point in time the rash was most prevalent and was present mostly on my buttocks but also on my ears, scalp, pointer finger on right hand, thighs, and hips. I went to doctor the following morning an my vitals, blood sugar, EKG, urine screen were stable and indicated no issues. 106 hours later I still have the rash on all areas mentioned and am dizzy, nauseous, and fatigued.
41 2021-02-22 itchy skin Patient became itchy. Given 25 mg diphenhydramine suspension. EMS took vital signs and checked BS.... Read more
Patient became itchy. Given 25 mg diphenhydramine suspension. EMS took vital signs and checked BS. Patient monitored from 10:030-11:05.
41 2021-02-22 rash Patient has a rash all over her body. Though, it appears in clusters. They are itchy. Has lasted 3 d... Read more
Patient has a rash all over her body. Though, it appears in clusters. They are itchy. Has lasted 3 days without improvement
41 2021-02-22 redness, itchy skin Pfizer shot #1: She received the 1st COVID vaccine Pfizer on January 24th at 7:00 p.m.. The followi... Read more
Pfizer shot #1: She received the 1st COVID vaccine Pfizer on January 24th at 7:00 p.m.. The following day she noted a low-grade fever. On January 26 she noted edema of her eyes and lips associated with facial redness and itching that she treated with Benadryl intermittently for the past 2.5 weeks. She was seen in follow-up by her dermatologist who suspected an inflammatory reaction and prescribed anti-itch facial cream. She was also seen by her primary care who suspected angioedema and prescribed her an EpiPen which she has not needed to use. Pfizer shot #2: 2nd shot delayed due to snow. Above sx resolved before shot #2. She had her 2nd COVID injection February 20 at 3:50 p.m. About 1.5-2 hours later she noted onset of itching to her eyes and nipples along with itching of the skin in the locations of her usual eczema. She noted that her lips and eyes were a little puffy but less severe swelling to the eyes and lips than the 1st injection. She took 2 Benadryl shortly after onset of these symptoms. This seemed to lessen symptoms about 50%. Later she noticed that her voice sounded raspy and hoarse and she had a sensation of swelling to her tongue and throat but she was able to swallow. Her throat felt scratchy. She denies having lightheadedness, urticaria or GI symptoms. She went to the ED and was treated with benadryl, solumedrol and pepcid, monitored for a few hours and then discharged on 60 mg prednisone X 3 days and advised to continue benadryl 50 mg Q6h. She takes zyrtec 10 mg BID for seasonal/perennial allergies. Allergy history: She has a history of both idiopathic urticaria in early childhood and idiopathic angioedema in her early 20's. States she had extensive testing but the cause was never exposed. Took high dose prednisone for 4-5 months, angioedema resolved spontaneously and then flared again a few months later. Finally resolved with n additional 3 months of prednisone. She has both seasonal (feb-may) and perennial allergies to cat and dust, asthma and allergy to ampicillin--rash in childhood, and humira--fevers.
41 2021-02-22 injection site redness, injection site swelling, injection site pain Woke at 3am with severe body aches, headache, fever of 101.3 and nausea. Symptoms persisted througho... Read more
Woke at 3am with severe body aches, headache, fever of 101.3 and nausea. Symptoms persisted throughout the day with max temp of 103. Also had swelling at injection site with redness the size of a baseball and extreme tenderness to upper arm.
41 2021-02-23 rash, itchy rash Chills, rigors & low-grade fever, lasted about 24 hrs. Took Tylenol & Ibuprofen for symptom relief.... Read more
Chills, rigors & low-grade fever, lasted about 24 hrs. Took Tylenol & Ibuprofen for symptom relief. Developed irregular shaped red spots on hands & feet. They come & go, sometimes they itch or hurt. These spots come & go most days since receiving the vaccination. When they itch, rub Benadryl cream which stop the itching.
41 2021-02-23 injection site pain I had some injection site soreness. I had a lot of other health symptoms going on too but don't thin... Read more
I had some injection site soreness. I had a lot of other health symptoms going on too but don't think any other the other symptoms related to the vaccine. That injection site soreness lasted a day. persisted for about a day.
41 2021-02-23 vaccination site warmth, itchy skin Itching that is spreading across my body; warm sensation at injection site; This is a spontaneous re... Read more
Itching that is spreading across my body; warm sensation at injection site; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration (at the age of 41-years-old) on 28Jan2021 15:00 at a single dose in left arm for COVID-19 immunization. Medical history included high blood pressure. The patient's concomitant medications were not reported. The patient previously took Keflex [cefalexin] and experienced allergy. The patient experienced itching that is spreading across my body and warm sensation at injection site on 28Jan2021 16:00 with outcome of not recovered. Treatment was not received for adverse event. The patient was not pregnant at the time of vaccination. The events were considered as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
41 2021-02-23 injection site pain That evening you had sore arm injection site; muscle aches. I took Tylenol and that helped. Late Thu... Read more
That evening you had sore arm injection site; muscle aches. I took Tylenol and that helped. Late Thursday is when I started feeling better. The symptoms went away completely after 36 hours.
41 2021-02-24 itchy skin, injection site pruritus, blister Took the shot on 2/18 and on 2/21 that night about 10:30 my arm started itching below where I got th... Read more
Took the shot on 2/18 and on 2/21 that night about 10:30 my arm started itching below where I got the shot on left arm. Wen to bed and woke up next morning it was broken out with blisters all over body, itching everywhere. I went to see my doctor and she hadn?t seen anything like this. I went to the dermatologist they took 3 biopsy?s and came back with a diagnosis of Sweets Syndrome which is an auto immune disorder, paperwork from dermatologist states that it would be favored more likely due to the vaccine. Now I have no job because I cannot work like this, it breaks out or flares up any my allergies flare up or anything that causes my white blood cells to go up.
41 2021-02-26 injection site pain Day of vaccine 2/20 to following day experienced injection site pain but no other symptoms. The nig... Read more
Day of vaccine 2/20 to following day experienced injection site pain but no other symptoms. The night of 2/25 (almost 6 days later) experienced flu like symptoms - chills, shaking due to cold, fever, thirst, joint and body aches, light headedness, fatigue. Morning of 2/26 chills and fever had subsided, had 8/10 severity headache that gradually decreased throughout the day. Body aches gradually subsided throughout the day and all symptoms were resolved by 6pm on 2/26. I had very similar symptoms after my first dose as well - initial injection 1/29 at 12:30pm, flu like symptoms began early morning of 2/1 that lasted about 15 hours.
41 2021-02-26 itchy skin W/in 5 min I began experiencing itchiness of the face and nose, half fever style. Because of poor ti... Read more
W/in 5 min I began experiencing itchiness of the face and nose, half fever style. Because of poor time planning on the county's part, I wasn't able to stay fir observation. By the time I drove 20 min home, the itch had spread to the most sensitive (eczema prone) regions and was all over my body within an hour. I took 4 benadryl, 1 every 2 hrs, for the rest of the evening. Slept 13 hrs through night, didn't need another benadryl until after showering. Itch continues but at a much lower level.
41 2021-02-28 injection site pain, pain of skin Friday at 4pm I experience severe unquenchable thirst and mild injection site soreness. Saturday mor... Read more
Friday at 4pm I experience severe unquenchable thirst and mild injection site soreness. Saturday morning was restless sleep and headache with severe joint pain and thirst. All Saturday same. Skin hurt to touch and knees and finger knuckles hurt to touch. Vomiting. Throbbing injection arm pain and the urge to constantly stretch all limbs. Sunday all subsided except the throbbing arm pain. Sunday evening at 8 pm throbbing arm worse and headache. Monday 3am restless sleep and miserable comfortableness. Throbbing arm and restless painful shockwaves through entire body. Skin severely hurt to touch. Went to the ER. Treated with Atavan and prescription Motrin.
41 2021-02-28 itchy skin Immediate reaction, took over care, flushed and itchy progressed to facial swelling and difficult ... Read more
Immediate reaction, took over care, flushed and itchy progressed to facial swelling and difficult of breathing and was given EPI IM and Benadryl IV, transported Hospital.
41 2021-03-01 hives, itchy skin, rash Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vac... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vaccine on 2/19/21. Unknown where the patient got their vaccine administered. Immediately afterwards, the patient developed hives, cough, and lightheadedness and was sent to Hospital. They were treated with steroids and diphenhydramine. Their symptoms resolved and they were discharged. On 2/20/21 patient came to emergency room in the morning with allergic reaction. They woke up in the morning with hives, swelling in face, and feeling of thickness in throat and shortness of breath. They were given dexamethasone, diphenhydramine, and famotidine. Their symptoms resolved and they were discharged. While at home the patient developed hives and took diphenhydramine. They had tingling and a rash over their face. On 2/20/21 the patient returned to the emergency room in the evening with a rash. The symptoms were pain and burning. They also complained of abdominal cramping, mild nausea, and left sided chest pain. Their symptoms improved and they were discharged. On 2/22/1 the patient returned to the emergency and was subsequently hospitalized. They presented with face swelling, general pruritus, and hives. She reported chest tightness and paresthesia involving her lips. Admitted on 2/22/21 to 2/25/21. She was given diphenhydramine, famotidine, and hydrocortisone.
41 2021-03-01 injection site redness, redness S: 41 yo female c/o B/L arm redness from upper arm to finger tips, dizziness, mild throat tightness ... Read more
S: 41 yo female c/o B/L arm redness from upper arm to finger tips, dizziness, mild throat tightness and facial flushing after 16:10 after Pfizer vaccine that was given at 16:10. First dose of vaccine. No SOB. O: Pt flushed, arms reddened and feeling uneasy. B/P 130/100, Pulse 98. RA STATS 99%. RR 16. Lungs CTA. Benadryl 25 mg PO at 16:29, water and reassurance. B/P at 16:41 126/82, Pulse 94, SATS 100%, Lungs clear, B/L arms normal color. Hands remained chapped and reddened (too much hand washing per patient). A: Mild allergic reaction to Pfizer vaccine, first dose. P: 16:56, patient improved, refused further care, refusal form signed and instructions given for post care and worsening symptoms. Pt discharged to home via W/C to care. Instructed to F/U as noted.
41 2021-03-01 sensitive skin Sore arm Jaw pain Skin sensitive on face Headache
41 2021-03-01 hives, itchy skin pt stated that soon after she received the covid vax she felt like the back of her neck was on fire.... Read more
pt stated that soon after she received the covid vax she felt like the back of her neck was on fire. She was flushed and itching. When she scratched her skin it would turn into a hive. Her eyes were swollen and looked bruised. She tried to eat a cracker but was not able to swallow. She became nauseous and winded. She went to the ER. Her entire back was red and inflamed. They administered Benadryl. Pt was released and to FU w/ PCP. That night she had some chills and fatigue. When she got up today 3/2/2021 she was super itchy, not able to swallow food and had diarrhea for two hours . She had a virtual appt w/ doctor and was referred to see her PCP. She made an appt w/ PCP. Her Dr. wrote her a RX for prednisone. Told her to take Benadryl as well and to stay off work for a couple of days.
41 2021-03-02 rash, itchy skin I have a rash on my face. Itchy face and top of the head.
41 2021-03-02 injection site mass, injection site pain STARTED HAVING SHOULDER PAIN IN RIGHT ARM RIGHT AFTER VACCINE BUT PAIN DID NOT IMPROVE AND STARTED H... Read more
STARTED HAVING SHOULDER PAIN IN RIGHT ARM RIGHT AFTER VACCINE BUT PAIN DID NOT IMPROVE AND STARTED HAVING LIMITED MOBILITY WHICH KEPT GETTING WORSE. BY 3RD WEEK I WENT TO MY PCP AND SHE SAID I NOW NEED PHYSICAL THERAPY AND IS NOT SURE HOW LONG I WILL NEED TREATMENT. SHE COULD FEEL A LARGE LUMP ON MY RIGHT DELTOID WHERE THE VACCINE WAS GIVEN AND RECOMMENDED HEAT AND IBUPROFEN/TYLENOL, ALSO. I AM NOT ABLE TO WASH MY HAIR WITHOUT ARM PAIN, REACH BEHIND ME, LIFT OBJECTS LIKE MY PURSE OR A MILK UG, PICK UP MY WATER BOTTLE WHILE SITTING AT MY DESK, SLEEP WITH MY ARM STRETCHED OUT, AMONG OTHER DAILY THINGS.
41 2021-03-02 redness, vaccination site warmth face started to feel "hot and on fire"; face and neck turned bright red; face started to feel really... Read more
face started to feel "hot and on fire"; face and neck turned bright red; face started to feel really tight; Heart Rate then was elevated to 115 bpm; shortness of breath; itchy eyes; headache; nausea; Arm still felt sore; fatigued; At site of injection there was a warm sensation; metallic taste in my mouth; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) solution for injection, intramuscular at left arm on 29Jan2021 at 10:30 AM at single dose for COVID-19 immunization. Medical history included asthma. The patient has no known allergies. The patient's concomitant medications were not reported. The patient was not pregnant and has no other vaccines in four weeks. She will have a birth control in two weeks. It was unknown if the patient has COVID prior to vaccination. She was not tested with COVID post vaccination. The patient was given COVID-19 vaccine at a hospital. When she initially received the vaccine on 29Jan2021, the site of injection had a warm sensation which resolved within a minute. Then on the ride home, she had a metallic taste in her mouth. While at home around 4:00 PM, her face started to feel hot and on fire and then her face and neck turned bright red. Her face started to feel really tight and hot. Heart rate was then elevated to 115 bpm. She then started having shortness of breath, itchy eyes, headache and nausea. The patient sat down and took 10 mL of BENEDRYL (as reported) at 4:30 PM or 4:40 PM. Between 5:00 PM and 7:00 PM, her face and neck were still slightly red. Her arm felt sore and she was fatigued. She again took 10 mL of BENEDRYL at 7:30 PM. She woke up on 30Jan2021 and still felt fatigued and the back of arm (tricep area) was very sore. The patient also took paracetamol (TYLENOL) 600 mg. The outcome of the event vaccination site warmth was recovered with sequel on 29Jan2021 and recovered with sequel on Jan2021 for all other events.
41 2021-03-03 redness After 10 minutes, patient reported metal taste in mouth and feeling faint. She also felt tingling in... Read more
After 10 minutes, patient reported metal taste in mouth and feeling faint. She also felt tingling in her arms and lips. She struggled to get up. Her breathing seemed fine but neck was red. She laid on floor with legs elevated until her dizziness subsided. She originally said she felt better but then dizziness returned. Called 911 and had Epi-pen ready. She was breathing fine when paramedics arrived. Her husband later called at 7:45pm and reported she was feeling fine. He said the emergency room gave her a steroid, anti-histamine, and pepcid. She is not going to receive the second covid shot. Her husband later stated she got a full body rash when she had covid. I also advised them to register on the v-safe site.
41 2021-03-03 hives Pt developed a few hive-like lesions on her legs on 1/28/2021, 2 days following first COVID vaccinat... Read more
Pt developed a few hive-like lesions on her legs on 1/28/2021, 2 days following first COVID vaccination. Over the next 2 days developed more. Each lasted less than 24 hrs, but some lesions were always present. No other symptoms. Allegra resolved hives. On 1/17/2021 after second COVID vaccination, she developed headache, body aches, and low grade fever lasting 1 day. Three days later, hives returned, worse than with first vaccination. Allegra resumed up to qid. On 2/23/2021 developed severe chest pain, waxed and waned through night, resolved by next morning. Was hive-free between 2/24 and 2/28 when the hives recurred. Has had two bouts of lip swelling. Hives persist, despite antihistamine use, to the present.
41 2021-03-03 itchy skin Skin had an almost immediate reaction of itching of the face, sneezing and runny nose.
41 2021-03-03 injection site pain With having MS, I have severe anxiety and I was anxious before going in- numbness and tingling in m... Read more
With having MS, I have severe anxiety and I was anxious before going in- numbness and tingling in my legs and tingling on my tongue. Took Benadryl - tongue tingling went away and the legs tingling and numbness was the same and started getting worse - they monitored my vitals and everything looked good and numbness remained. I had a driver and they allowed me to leave due to the Benadryl _ just took that one dose of Benadryl (didn't take anymore after that) and then the numbness in my legs remained for about two and a half weeks. I used a cane for two days. I had a fever and chills that first night, body aches and injection site pain and severe fatigue and those symptoms lasted one day except fatigue was for three days. The day after the shot was the worse of the symptoms. They followed up with me that evening and they followed up with me at work. I had the next dose - February 4, 2021 and experienced everything except the numbness in the tongue. Informal doctor visit because I work there.
41 2021-03-04 itchy rash, hives, rash with redness, rash One day following vaccine admin I broke out into a rash of itchy, red bumps on my arms and legs and ... Read more
One day following vaccine admin I broke out into a rash of itchy, red bumps on my arms and legs and back. My upper buttocks on both sides broke out into a flat, solid, red itchy rash that started spreading downward. I also developed clusters of large hives on my left hip
41 2021-03-04 hives, rash with redness, rash patient received first dose of covid vaccine, patient started having hives and red rash on left arm ... Read more
patient received first dose of covid vaccine, patient started having hives and red rash on left arm on cheeks. Started about 15 minutes after dose. patient received 50mg dose of benadryl which subsided reaction.
41 2021-03-05 injection site swelling Large swelling of injection site Fever, sore throat, runny nose - treated with tylenol but no resolu... Read more
Large swelling of injection site Fever, sore throat, runny nose - treated with tylenol but no resolution as of today.
41 2021-03-05 injection site pain My left arm (site of injection on a Wednesday) began to ache within 4 hours of receiving the vaccine... Read more
My left arm (site of injection on a Wednesday) began to ache within 4 hours of receiving the vaccine. I took Tylenol to treat the pain and drank a lot of water. I woke up the next morning at 630am in extremely bad pain. My left lymph node under my arm was extremely swollen and tight, agony to touch. My entire left side from head to fingertips to toes ached at a level of 9 out of 10. My neck aches across both shoulders and my lower back aches across to my right side; the rest of my right side was unaffected. I took Tylenol every 6 hours which dimmed the pain to about a 6, but it would wear off 4.5 hours later, jumping back up to a 9. I eventually started taking Aleve later that evening to help at around 6 pm. I would become warm off and on, running a very low fever. I didn?t have any other symptoms other than the extreme pain, aches, and feeling drained. The next day (Friday) my pain had decreased to a 7.5-8, but my lymph node was still extremely painful and swollen. The pain continued to decrease the next day to a 5; Sunday was the last day of the left side body aches and lymph node swelling. However, the next morning (Monday) I woke to extreme lower back spasms/seizing. I went to the clinic at 1pm and was given a shot of Toridol and prescribed Voltaire?s and Flexiril. The doctor had me stay at home until Thursday, but the pain is only now starting to ease today, Saturday, March 6. I still have fleeting aches at the injection shot in my left arm.
41 2021-03-06 hives, rash, itchy skin A few hours after the vaccine the pt became short of breath and wheezy, shortly after became itchy. ... Read more
A few hours after the vaccine the pt became short of breath and wheezy, shortly after became itchy. She used her albuterol inhaler, took Benadryl and went to sleep. Today her itching returned today and she devolved a rash and hives. She came to the ER, was treated with Benadryl, Pepcid, methylprednisolone, and IM epinephrine, and IV fluids. Her symptoms resolved in the ER and she was observed x2 hours, and discharged with a prescription for oral steroids.
41 2021-03-07 hives, injection site redness, itchy skin, skin tightness, skin warm Approximately 7 days after the injection the upper arm around the injection site became red and welt... Read more
Approximately 7 days after the injection the upper arm around the injection site became red and welted. It is about 3 in in diameter and has also affected the underarm area. Both places feel hot, tight, and itch.
41 2021-03-07 injection site pain At approximately 10 hours after receiving my second injection of the Covid19 vaccine, I started noti... Read more
At approximately 10 hours after receiving my second injection of the Covid19 vaccine, I started noticing nausea, headache and a neck ache. Within 5 minutes of these symptoms, my tongue felt swollen and my speech was slowed and slurred. Within ten minutes of these symptoms occurring, my nausea went away as well as my swollen tongue and speech problems. The neck ache and headache progressed into a migraine. I took Tylenol and went to sleep. I woke four hours later with abdominal pain, nausea, head ache and neck ache as well as pain at the injection site. Again I took Tylenol. I experienced fatigue, migraine, neck and back ache, night sweats and axillary adenopathy over the next 5 days. Today is day 6 and I haven't gone a day without neck pain and headache yet. It usually occurs in the afternoon. I continue to take Tylenol and it feels better.
41 2021-03-07 itchy skin Pt called to inform our office that she received the covid-19 vaccine on 3/1 around 0950 and she dev... Read more
Pt called to inform our office that she received the covid-19 vaccine on 3/1 around 0950 and she developed itchiness, nausea and difficulty swallowing 1 hr after the administration on the Pfizer vaccine. Pt stated that she still has some difficulty swallowing but all other symptoms have resolved. Pt denies having chest pain, sob, throat itching, throat tightness or feeling of suffocation. Pt stated that she begin having hoarseness begin this morning which new onset. Patient sought care in ED room 3/1 and 3/4, follow-up visits with PCP and allergists. Unable to work.
41 2021-03-07 itchy skin, injection site hardening, injection site pruritus, hives Several bug bites that I had started to itch incredibly and swelled into welts. The injection site i... Read more
Several bug bites that I had started to itch incredibly and swelled into welts. The injection site itched too and was hard. My scalp psoriasis also itched a lot. All of this was Saturday, with night being the worst. The bug bites still itch but less than before. I believe this histamine reaction is related to six wasp stings I got in August 2020. I had a bad reaction to the stings. I have been using a prescription topical steroid ointment on the bites since Saturday, which I got for the wasp stings.
41 2021-03-07 skin warm, skin burning sensation Skin became hot, burning, difficulty swallowing, difficulty breathing, anxiety, dizziness, light hea... Read more
Skin became hot, burning, difficulty swallowing, difficulty breathing, anxiety, dizziness, light headed. Took benadryl po 50 mg. Was seen at ER. Received albuterol neb, steroids IV, and prevacid PO. Sent home with po steroids and benadryl. S/S improved after treatment.
41 2021-03-07 itchy skin, rash o Complaint The patient is a 41 year(s) old Female complaining of allergic reaction, nausea. o Chief... Read more
o Complaint The patient is a 41 year(s) old Female complaining of allergic reaction, nausea. o Chief Complaint Quote Patient complained of allergic reaction that started about 45 mins ago. She got her 1st dose of Pfizer Covid vaccine yesterday morning. She complained of rash all over the body, swelling on the hands and face including eyes and lips. She denied chest pain, abdominal pain, fever, cough, vomiting and difficulty breathing. She complained of nausea that started 5 mins ago. She has not taken any meds yet for her symptoms. o Time Seen 02-18-2021 01:20 o Historian patient ADDITIONAL HPI: o Additional HPI Pt here with concerns of allergic reaction. Pt fell asleep on the couch approx 2200. She awoke 2 hours later with itching of her hands. Over the next hour she developed a full body rash, itching, and swelling of face. No wheezing, no difficulty swallowing. Upon arrival to ED pt started to feel nauseated. Pt had first dose of COVID vaccine approx 16 hours prior to onset of sxs. No h/o allergic reactions, no h/o asthma. Emergency Department Course and Clinical Decision Making: Patient presents with urticaria and swelling to her face eyes and lips. Shortly upon being roomed she started to feel very nauseated and started vomiting. No stridor or wheezing, no immediate airway compromise but given both cutaneous and GI symptoms, significant concern for anaphylaxis. Patient was immediately given epinephrine intramuscularly, 0.3 mg. An IV was placed and she was given Solu-Medrol, Benadryl, Pepcid, and Zofran. Patient's urticaria and swelling started to nearly immediately improved after the epinephrine. She is feeling much better though slightly anxious. To be reaction from the Pfizer vaccine, no other obvious triggers, patient has no history of allergic reactions or other sensitivities. We will observe in the emergency department in a monitored setting for several hours to assure no rebound symptoms, patient updated on plan. 0500 Pt has been resting. Urticaria resolved, swelling to face resolved. Discussed with pt reporting reaction to CDC, info provided. Also discussed the second dose of vaccine, recommended reaching out to Epi response team or PCP to get recommendations. Will give short course of prednisone, 4 days, Benadryl as needed, ED return precautions discussed, will dc home.
41 2021-03-07 rash, itchy skin o Complaint The patient is a 41 year(s) old Female complaining of o Chief Complaint Quote Patient st... Read more
o Complaint The patient is a 41 year(s) old Female complaining of o Chief Complaint Quote Patient states she got her COVID vaccine today and rapidly started feeling SOB, dizzy and feeling tired. Per EMS, patient did receive one IM of Epi. o Time Seen 02-17-2021 11:49 o Historian patient o Objective Statement 41-year-old female brought to the emergency room by EMS for allergic reaction. Patient says just prior to arrival she received first dose of her Covid vaccination. She said she was waiting after she received her vaccination when she began to have difficulty breathing, lightheadedness and nausea. She was given a IM dose of epinephrine and sent to the emergency department for further evaluation. In the emergency department, she says difficulty breathing has improved. She said she is now having some chest pain. She says pain is across the anterior chest, pressure-like. She said she also feels nauseous. Headache, throat tightening, rash, pruritus, abdominal pain, vomiting, diarrhea, dysuria, paresthesias or focal weakness. She has never had an allergic reaction before. Review of Systems Constitutional: Negative for chills, diaphoresis and fever. HENT: Negative for congestion, facial swelling and rhinorrhea. Eyes: Negative for discharge and visual disturbance. Respiratory: Negative for cough. Positive for chest tightness and shortness of breath. Cardiovascular: Positive for chest pain. Negative for leg swelling. Gastrointestinal: Negative for abdominal pain, diarrhea, blood in stool and vomiting. Endocrine: Negative for cold intolerance and polydipsia. Genitourinary: Negative for difficulty urinating, dysuria and hematuria. Musculoskeletal: Negative for arthralgias, joint swelling and myalgias. Skin: Negative for rash. Neurological: Negative for speech difficulty, numbness and headaches. Physical Exam Nursing notes and vital signs reviewed. GENERAL: No distress HEAD: normocephalic, atraumatic EENT: PERRL, EOMI. Conjunctivae normal color, sclerae non-icteric; moist mucous membranes. There is no pharyngeal erythema or edema, uvula midline no stridor, patient handling secretions with no difficulty NECK: Supple, non-tender; no meningismus LUNGS: Patient in mild respiratory distress, tachypneic, lungs CTA. Normal air movement. HEART: Tachycardic with regular rhythm, no murmur CHEST: No deformity; non-tender ABDOMEN: The abdomen is soft, and non-tender, no masses or bruits. EXTREM: Normal ROM; no deformity, no calf tenderness. Normal pulses palpable in all extremities. There is no pedal edema. SKIN: No rash; no diaphoresis NEURO: Alert; normal speech and cognition; CN's grossly intact; strength grossly intact without focal deficit. BACK: No CVA TTP. o ED Course 1250: On reevaluation, patient resting comfortably in the room. She said she is feeling much better. She is no longer having any difficulty breathing. Chest pain has resolved. Her vital signs have normalized. She is no longer tachycardic. CBC shows a mild leukocytosis. CMP does show hypokalemia. On her EKG she does appear to have some U waves. EKG shows sinus tachycardia, no ischemic changes. Chest x-ray unremarkable. Potassium was repleted. On arrival, patient was given Benadryl, Solu-Medrol, Pepcid. She was given epinephrine at the vaccination site so no additional epinephrine was given here and at this point I do not feel she needs an additional dose. We will continue to monitor the patient in the ED. 1520: On reevaluation, patient is resting comfortably in the room. Her vital signs remained stable. She is not having any symptoms. No chest pain or shortness of breath. We will discharge the patient home. We will give her prescription for an EpiPen. Discussed warnings indications to return to ED. Told patient she should contact her primary care provider to discuss whether or not she should receive the second dose. Patient understands and agrees with the plan.
41 2021-03-08 pain of skin Fever, lethargy, joint pain, headache, nausea, vomiting, diarrhea for 3 days. The worst was the joi... Read more
Fever, lethargy, joint pain, headache, nausea, vomiting, diarrhea for 3 days. The worst was the joint and skin pain.
41 2021-03-08 rash, itchy skin Flushing - entire body; like when you receive an injection of contrast for a CT Scan Burning - Eyes,... Read more
Flushing - entire body; like when you receive an injection of contrast for a CT Scan Burning - Eyes, face, abdomen Nauseous Pressure in head/face/ears Throat discomfort Headache Overall sick feeling Over the next couple days, my lips have broken out. I have some small mouth/tongue sores. Feeling of a cold coming on. Sinus pressure. Throat discomfort, congestion. Sneezing. Eyes burning. Face burning. Itchy patches on scalp. Face breaking out.
41 2021-03-08 hives Hives on legs, arms, stomach 7 hours after shot.
41 2021-03-08 shingles I ended up getting shingles. My symptoms started on 3-5-2021.
41 2021-03-08 shingles Unsure if directly caused by vaccine, but wanted to report it just in case: Left arm pain, numbness... Read more
Unsure if directly caused by vaccine, but wanted to report it just in case: Left arm pain, numbness, tingling and weaknesses started on Monday March 1, Rash on left hand and upper body began on Wed March 5, diagnosed with Shingles on Thursday March 6.
41 2021-03-09 injection site pain, injection site rash Day of: fatigue, sob, weakness, coughing tasting blood, runny nose, watery eyes, pain at injection s... Read more
Day of: fatigue, sob, weakness, coughing tasting blood, runny nose, watery eyes, pain at injection site, fever, chills, rash around injection site, down arm ans up shoulder and neck Day after and progression: muscle weakness to the point of falling down and inability to hold onto items, SOB, fatigue, blurred vision, ringing in ears, dizziness. Pain, numbness, tingling throughout body. Cough tasting blood, flank pain, intermittent urinary incontinence and increase urination at night, nightmares, anxiety, depression. Today: SOB, cough tasing blood, extreme fatigue, dizziness, tinnitus, nightmares, anxiety, depression. 03/02/21 New onset diagnosis: Severe Asthma I have not been able to work since 01/08/2021
41 2021-03-09 itchy rash, rash papular, rash with redness, injection site rash Itchy, red, raised circular rash around injection site that occurred 3 days after injection. The ras... Read more
Itchy, red, raised circular rash around injection site that occurred 3 days after injection. The rash was approximately 3-4 inches around. One dose of benadryl was taken. Rash disappeared within 24 hrs.
41 2021-03-10 rash Allergic skin rash on trunk and arms. Treating with Benedryl and cortisone creme
41 2021-03-10 itchy skin, hives ITCHING ALL OVER, SCRATCHY THROAT, ANAPHYLAXIS PT PREMEDICATED WITH BENADRYL 50MG PO AT HOME PRIOR T... Read more
ITCHING ALL OVER, SCRATCHY THROAT, ANAPHYLAXIS PT PREMEDICATED WITH BENADRYL 50MG PO AT HOME PRIOR TO COMMING FOR SECOND VACCINATION AT 1125 12:57 PT STATES S/S OF ANAPHYLACTIC REACTION, SCRATCHY THROAT, TONGUE SWELLING, HIVES, ITCHING VS TAKEN: HR 120,RR 20,BP 150/78, SPO2 100% RA 1258: EPI PEN GIVEN X 1 IM TO LEFT VASTUS LATERALIS, PT TOLERATED WELL. 1259: SQUAD AND ER NOTIFIED FOR NEED OF TRANSPORT TO CPH. 1301:DEXAMETHASONE10 MG IM IN RT LETOID GIVEN X 1, PT TOLERATED WELL. 1305: 20 GUAGE SL PLACED TO RT WRIST. PT TOLERATED WELL. 1315: REPEAT VS TAKEN AND STABLE HR 95, RR 20, BP 140/74, SPO2 100% RA. 1315 RESCUE ARRIVED AND TRANSFERED TO CPH
41 2021-03-10 itchy rash On the 6th day after vaccine, woke up with itchy skin rash. Have some raised bumps, other areas are... Read more
On the 6th day after vaccine, woke up with itchy skin rash. Have some raised bumps, other areas are just red. Antihistamines (Zyrtec) help, but still going on now 3 days later. Not localized to one location - both arms, stomach, neck, knees, elbows, underwear line. Wrist, stomach, knee are the itchiest locations.
41 2021-03-10 hives, itchy skin She received the vaccine at 0930 and had itching her lips became numb shortly after starting around ... Read more
She received the vaccine at 0930 and had itching her lips became numb shortly after starting around 1200. She developed hives around her entire body on her left jaw, face, arms, and rack. Rash resolved within 24 hours with a lot of Benadryl.
41 2021-03-11 hives 6 days after second vaccine hives over body. Prednisone five day course given beginning February. Hi... Read more
6 days after second vaccine hives over body. Prednisone five day course given beginning February. Hives resolved for one week, returned one week later inclusive of abd pain. Hives and or abd pain continue almost daily. Rheum labs negative basic panel normal. Allergist appt scheduled
41 2021-03-11 hives Anaphylaxis, swollen throat, itchy lips, hives.
41 2021-03-11 injection site redness, injection site swelling, injection site pruritus, injection site pain Fever, chills, aches, cough, fatigue for 2 days Pain, swelling, itching, large red patch (3"x5")at i... Read more
Fever, chills, aches, cough, fatigue for 2 days Pain, swelling, itching, large red patch (3"x5")at injection site
41 2021-03-11 rash with redness Swelling and pain in left armpit on injected side (but can?t feel a lymph node), red rash and severe... Read more
Swelling and pain in left armpit on injected side (but can?t feel a lymph node), red rash and severe pain on injected arm, headache, muscle ache, joint pain, chills, stiff neck and shoulders with possibly inflamed lymph nodes.
41 2021-03-12 rash 2 minutes after injection, right arm went numb, heart racing at 120 bpm. High blood pressure. Then ... Read more
2 minutes after injection, right arm went numb, heart racing at 120 bpm. High blood pressure. Then irregular heart beat, rash on neck and chest. Nurses administered 50 mg Benadryl. 10 minutes later, heart racing again and inability to catch my breath. Dizzy and light headed. Irregular heart beat. Pulse ox was ok throughout. Total time of nurses observing these symptoms was 45 minutes. Two days later, still light headed and dizzy.
41 2021-03-12 itchy skin, redness After receiving dose, about 15 minutes after, at 1215, patient was getting ready to leave and she as... Read more
After receiving dose, about 15 minutes after, at 1215, patient was getting ready to leave and she asked if she was red and the lead clincian stated that she was red in her chest, patient face red and flushed. Patient then was escorted to the observation area she was experiencing itching, no tingling, and she was very warm. Patient was placed on the litter, and her blood pressure obtained in her right arm, 201/ 113, HR 98 and oxygen 100% She was observed for a total of 60 minutes. Her redness resolved, and she was feeling more comfortable after the 60 minute observation.
41 2021-03-12 injection site pain Pain at injection site
41 2021-03-13 rash, itchy skin, hives Patient developed generalized puritis, nausea, hives to left triceps. Patient stated she is prone to... Read more
Patient developed generalized puritis, nausea, hives to left triceps. Patient stated she is prone to allergic reactions to other medication therapies.
41 2021-03-13 injection site redness, injection site nodule Redness and knot at injection site. Continued redness at site 2 days later.
41 2021-03-14 hives Five days after the vaccine I began breaking out in hives, having extreme and intense histamine rele... Read more
Five days after the vaccine I began breaking out in hives, having extreme and intense histamine releases that would move very quickly throughout my body. Starting at the base of my neck/upper back/chest, and then spreading down stomach, arms, and legs. Each time I spiked a temperature of around 101.5 for about 5 minutes, before returning to normal. This is the 7th day in a row of symptoms. I have never had an allergic reaction to anything before. I am not absolutely certain that the vaccine is the cause, but the timing is strange. I have not changed my diet, shampoo, lotion, or detergent, The vaccine is the only isolated event I can say that is new.
41 2021-03-14 redness, rash macular I received dose 1 of Pfizer COVID-19 vaccine on Feb 24. The initial symptoms starting Feb 25 were s... Read more
I received dose 1 of Pfizer COVID-19 vaccine on Feb 24. The initial symptoms starting Feb 25 were somnolence, mild muscle stiffness and dizziness that lasted approx 5-6 days but gradually resolved. Approx 3 days after the shot I developed chills, which took approx 2 weeks to resolve. As for neurologic symptoms, approx 6 days after the shot, I experienced a worsening of my peripheral neuropathy that is still ongoing >2 weeks since dose 1 (normally very mild at baseline and mostly limited to the feet). This exacerbation manifested primarily as stockings/gloves sensation to the mid-calves and elbows/mid-upper arms. I have also experienced some tingling in hand/feet and a notable cold sensation in the feet (worst in the toes- when I step into hot water in the shower, the feet/toes become quite painful and a transient blotchy redness appears on the feet). The stockings/gloves sensation and foot coldness persist though approx 50% better than when it started. No muscle weakness or myalgias accompany these symptoms. I am concerned about receiving my 2nd dose on March 26 given the ongoing presence of symptoms from the first. I have scheduled an appt to discuss with my Rheumatologist. My Neurologist is unsure I should receive 2nd dose.
41 2021-03-14 injection site pain, itchy skin In the arm where I received the shot and my body: Pain from shoulder to fingertip Swelling Tiredness... Read more
In the arm where I received the shot and my body: Pain from shoulder to fingertip Swelling Tiredness/fatigue Headache Muscle pain Chills Fever Nausea Armpit pain Lymph nodes swelling (size of an egg) discomfort with arm movements Itchiness Lack of appetite Pain in shoulder blade
41 2021-03-14 rash with redness Patient received Pfizer COVID19 vaccine and went to the observation area. Others in the observation... Read more
Patient received Pfizer COVID19 vaccine and went to the observation area. Others in the observation area noted that she had a red rash on her chest. Patient noted that she felt warmth in area but no itching. She denied chest pain, shortness of breath, itching, oral mucosal swelling. She was given diphenhydramine 50m g by mouth one time. She was observed for 40 minutes in treatment area with improvement of redness and rash. Patient was stable when left the treatment area. She was instructed to go to ED if rash worsened or if she developed oral mucosal swelling, difficulty breathing/SOB. Recommended that patient consult her primary care physician and see an allergy specialist before getting her second dose.
41 2021-03-15 injection site numbness numbness on extremity vaccines administered (resolved)
41 2021-03-16 itchy skin 45 minutes after the vaccine I started with all over body itching, had not eaten, drank or taken any... Read more
45 minutes after the vaccine I started with all over body itching, had not eaten, drank or taken anything between the shot and time of the itching. I did about 20 minutes after the shot have a headache, severe arm pain, and then later that evening I had body aches, and the lymph node under my arm swelled up. I am still having the arm pain, swollen lymph node and itching and its 5 days later. I have been taking my already prescribed allergy medications as well as Benadryl and Claritin as advised by my doctor.
41 2021-03-16 injection site pain Sore arm, tiredness, foggy, fever, nausea, racing heart, pulpultations, diarrhea
41 2021-03-16 itchy skin Swollen airway, head, and neck, intense itching and burning that lasted for 2-3 days
41 2021-03-17 injection site warmth, injection site pain, injection site bruising The injector could not get the shot in, and kept trying and finally after i heard a pop the shot go... Read more
The injector could not get the shot in, and kept trying and finally after i heard a pop the shot got in. Injection site is more towards side arm and shoulder. 3 hours after the second shot, I started to experience flu like symptoms, dizzy, achy, arm pain from awful injections, soar arm etc etc. The last 3 days I have experienced all symptoms that they say are normal, plus nerve pain running down my arm and across my chest to my other arm pit. Back pain, neck stiffness and just an overall feeling not good. I am concerned that there is damage from the injector not knowing what she was doing and now I am having a reaction to how she did the shot. Injection site is hot to the touch and bruised. My first vaccine I did experience dizziness and injection site looked like I was stung by a bee, very swollen but not hot to the touch like now. I have been on tylenol, which is doing anything so i switched to ibuprofen for pain, achinesss and overall just not feeling well. I cannot move my arm much, but can use my fingers. Today is day 4 of the same issues and at this point if my arm is not better by next week I will go see the doctor. My doctor has advised to report this, and ice areas and ibuprofen/tylenol. I am concerned I have nerve damage done at this point from whoever was the injector. I am hoping there is a way to find out who did mine. At the end of the appt, the injector did say sorry that was awful and I was so traumatized that I didn't even know what to do or say at the time. It was so bad my husband was getting his phone out to video but as soon as he did, she got it in deep where it was suppose to go????
41 2021-03-18 rash, hives Chills the night of the 17th, Fever, chills, body aches, headache on the 18th day. Hives began afte... Read more
Chills the night of the 17th, Fever, chills, body aches, headache on the 18th day. Hives began afternoon of the 18th on chest. Hives/rash all over the body on the 19th.
41 2021-03-18 rash with redness, skin burning sensation, rash I had dizziness and a headache that jumped around my head within 20 minutes of the shot. About two h... Read more
I had dizziness and a headache that jumped around my head within 20 minutes of the shot. About two hours in it felt like my tongue was increasingly getting heavier and heavier for around a 10 minutes timeframe. It then stopped but for two days it felt like I had burnt my tastebuds. Starting two days ago I have developed a red rash on my arms that burns at times and seems to come and go.
41 2021-03-18 hives, itchy skin Patient scheduled an appointment with her PCP, on 3/17/21. She presented with 2.5 weeks of flushing,... Read more
Patient scheduled an appointment with her PCP, on 3/17/21. She presented with 2.5 weeks of flushing, sweats, and intermittent pruritic hives since receiving her first COVID-19 vaccine on 2/27/21. She reports that the pruritis and flushing is worse with exercise. For one week, she has had a pink ovoid lesion 2-3 cm in length on right chin and left neck that are now scabbed without drainage. Neck and chin lesions treated with bactroban, patient is already on antihistamines, and instructed her to follow up if worse.
41 2021-03-20 injection site rash, skin spots, redness Petechiae (red dots that didn't blanche) all over arms, legs, chest. Racing heart rate, flush face... Read more
Petechiae (red dots that didn't blanche) all over arms, legs, chest. Racing heart rate, flush face, red eyes, red web like moving up and down the arms and legs, injection site rash.
41 2021-03-20 itchy skin Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generali... Read more
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Flushed / Sweating-Mild
41 2021-03-21 skin burning sensation Swollen eyes burning skin jittery feeling
41 2021-03-21 injection site pain, injection site numbness, injection site bruising, injection site tingling a 41 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 m... Read more
a 41 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot ER2613 on 3/22/2021. The patient experienced the following reaction(s) during the immediate of observation: 2:26pm Patient vaccinated. Patient was treated/managed as follows: 2:28pm Bruising noted at vaccinated site, left deltoid. Patient denies taking blood thinner. Patient c/o soreness to site, and numbness/tingling to left arm. Ice pack provided and applied. 2:45pm Patient reports numbness and tingling improving. Patient given educational material regarding vaccine and advised to continue to self-monitor per guidance. Patient returned to observation area with family.
41 2021-03-21 injection site pain woke up Sunday morning [2 days after] with a swollen left arm pit ;same side as vaccine was given. A... Read more
woke up Sunday morning [2 days after] with a swollen left arm pit ;same side as vaccine was given. Area was tender, not discolored or warm to touch. Irritation the more I moved around. swelling was soft and pliable, no hardness. Monday morning swelling had decreased significantly. Email my care team on Sunday, Monday response was that swelling may have been attributed to the vaccine and I should file a report with CDC. No other symptoms other than soreness at injection site and body aches that lasted 24 hours.
41 2021-03-22 skin discolouration 1/9/21 - Discoloration (purple in color) in toes bilaterally, worse on outside toes. Inititally pur... Read more
1/9/21 - Discoloration (purple in color) in toes bilaterally, worse on outside toes. Inititally purple color was worse on 3 toes on right foot and one toe on left foot. Resolved in 2-3 days. When warm discoloration noted, when cold discoloration appears to resolve. No pain or numbness 2/27/21 - Discoloration (deeper purple in color) in toes bilaterally, again worse on outside pinky toes. Worse on right foot then left. Resolved in 2-3 Days. Discoloration unchanged with temp changes. No pain or numbness. 3/18/21 - Discoloration (dark purple, non blanching on right and left outer toes). Also extending to inside of right foot by big toe and along the side of the foot at pinky toe. Starting to affect foot as well as toes. Non painful. Toes are purple in color despite being warm or cold. Warming toes does not change appearance. At 4 days outer pinky toes are light red in color and feet appear dusky. No pain or numbness.
41 2021-03-22 injection site pain Became extremely sleepy around 5 PM. Around 8 PM, started vomiting, diarrhea, fever, chills, shakes,... Read more
Became extremely sleepy around 5 PM. Around 8 PM, started vomiting, diarrhea, fever, chills, shakes, body aches. Felt better by 6 AM Saturday except sleepiness and body aches. Sleepiness/achiness stopped around 4:30 PM Saturday. Injection site sore from shot until Sunday evening.
41 2021-03-22 itchy skin Lip tingling 15 minutes after vaccine administration, which then led to constant full body itching; ... Read more
Lip tingling 15 minutes after vaccine administration, which then led to constant full body itching; worse around lymph nodes (axillary, neck, and inguinal). No rash, fever, shortness of breath, swelling of tongue/throat/lips, eye redness, palpitations, fever. Erythematous skin.
41 2021-03-22 rash Patient developed a rash on her face, arms and upper back post vaccination per her report. Tele-visi... Read more
Patient developed a rash on her face, arms and upper back post vaccination per her report. Tele-visit conducted on 03/18/2021 rash was resolved.
41 2021-03-22 injection site pain Patient has had continuous pain in her injected arm. She states that she can not lift her arm above... Read more
Patient has had continuous pain in her injected arm. She states that she can not lift her arm above her head. She spoke with a Tele Doc and then made an appointment with a provider
41 2021-03-22 injection site redness, injection site swelling, injection site warmth Red swollen warm sensitive spot too the side of where the injection was. Felt horrid with an upset ... Read more
Red swollen warm sensitive spot too the side of where the injection was. Felt horrid with an upset stomach all day yesterday. Felt feverish.
41 2021-03-22 injection site pain Within a couple minutes of receiving shot, felt pain at injection site that traveled up arm into nec... Read more
Within a couple minutes of receiving shot, felt pain at injection site that traveled up arm into neck. Heart rate went up to 122bpm. Left side of face felt puffy and numb. Left side of mouth and tongue were tingling. Reported this to vaccine giver, he had me wait about half an hour before suggesting Benadryl. Half an hour after 25mg Benadryl, symptoms were almost completely resolved. The next day (3/14) I felt tired. The day after (3/15) I felt hot and my skin was flushed. I was not running a fever. I generally felt unwell that day. I felt better by the time I woke up on 3/16. I also had a bad/metallic taste in my mouth through 3/21, which has resolved. My nurse practitioner suggested that I take Benadryl before I receive my second vaccine dose on 4/3/21.
41 2021-03-23 rash Extreme joint pain in my right elbow that worsens when my arm is bent for any length of time. Still... Read more
Extreme joint pain in my right elbow that worsens when my arm is bent for any length of time. Still in pain and 2 1/2 weeks later. Rash that began on 3/19/2021.
41 2021-03-23 itchy skin Pfizer-BioNTech Covid 19 Vaccine EUA Tight throat about an hour after vaccine injection. Tight throa... Read more
Pfizer-BioNTech Covid 19 Vaccine EUA Tight throat about an hour after vaccine injection. Tight throat lasted 14 days. Took ibuprofen . Itchy all over after 24 hours. Lasted 14 days
41 2021-03-24 rash 5 days after the shot, severe rash appeared all over upper body. Scalp, face, neck, ears, upper back... Read more
5 days after the shot, severe rash appeared all over upper body. Scalp, face, neck, ears, upper back and upper chest. Also one small patch on lower arm. Ears became swollen. Swelling of lymph node in neck on left side (same side as the shot). Took Benadryl for 4 days but rash and swelling remained unchanged. Went to doctor on 4th day after the rash started (9 days after the shot) and she prescribed Hydroxyzine for rash. Follow-up visit scheduled for 3/31/2021.
41 2021-03-24 hives Immediately L arm numbness, then whole L side numbness which was monitored for 30 mins post 1st dose... Read more
Immediately L arm numbness, then whole L side numbness which was monitored for 30 mins post 1st dose by on site healthcare person then released. Numbness subside by next day except near site. Next day grouped hives on whole L leg appears then disappears 2-3x in row for 1-2mins. On & off Chills and goose bumps on L side of body & fatigue, which dissipated after about 1-2wks.
41 2021-03-24 itchy skin Patient experienced itching on her skin and in her throat. She was given 25mg of diphenhydramine IM... Read more
Patient experienced itching on her skin and in her throat. She was given 25mg of diphenhydramine IM. Symptoms resolved after diphenhydramine administration.
41 2021-03-24 rash, vaccination site pain Ringing in ears; Urinary incontinence; Urinary frequency; Flank pain; inability to control temperatu... Read more
Ringing in ears; Urinary incontinence; Urinary frequency; Flank pain; inability to control temperature; Sweating; she was having hot or cold; Wheezing; falling down stairs; Muscle weakness; Blurred vision; Double vision; Inability to work; Rash; Injection site pain; Runny nose; runny eyes; cough with taste of blood; Shortness of breath; Fatigue; Fever; Chills; Dizziness; This is a spontaneous report from a contactable Nurse. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration in left arm on 08Jan2021 at 08:00 AM (at the age of 41-years-old) at single dose for covid-19 immunisation. The patient received the first dose vaccine BNT162B2 (LOT: EK5730 and EXP: Mar2021) on 18Dec2020. The subject had a history of ongoing Migraine. Relevant concomitant medications were unknown. The patient stated that after her second dose on 08Jan2021, the reaction started at 06:00PM that night. She says she had a rash and injection site pain that went her arm to her shoulder and neck. She says she had a runny nose, runny eyes, cough with taste of blood, shortness of breath, fatigue, fever, chills, and dizziness that night. She says she did not do any treatment that night, she thought the fever would run its course. Caller says that the next day she had severe fatigue, shortness of breath, wheezing, runny nose and eyes, and she also started to fall down stairs and had muscle weakness. She says she had blurred and double vision, and ringing in her ears. She says she progressed from that in a week to having urinary incontinence, intermittent frequency at night, flank pain, and an inability to control her temperature. She says she was having hot or cold sweats and chills which continued quite a while. She also reported that she has gained back muscle control, though she still has days where she is extremely weak, and her dizziness comes and goes. She says that the ear ringing has stayed the same, and her shortness of breath has stayed the same. She says that as of Mar 2nd she has been diagnosed with severe asthma, and she has never had any type of asthma or breathing problems before. The reporter stated that that this was disabling, she hasn't been able to work since 08Jan2021. The reported events were inability to work (impaired work ability) on 08Jan2021, rash on 08Jan2021, injection site pain (vaccination site pain) on 08Jan2021, runny nose (rhinorrhea) on 08Jan2021, runny eyes (eye discharge) on 08Jan2021, cough with taste of blood (haemoptysis) on 08Jan2021, shortness of breath (dyspnea) on 08Jan2021, fatigue on 08Jan2021, pyrexia on 08Jan2021, chills on 08Jan2021, dizziness on 08Jan2021, falling down stairs (fall) on 09Jan2021, muscular weakness on 09Jan2021, vision blurred on 09Jan2021, double vision (diplopia) on 09Jan2021, ringing in ears (tinnitus), urinary incontinence, urinary frequency (pollakiuria), flank pain, inability to control temperature (body temperature abnormal), sweating (hyperhidrosis), wheezing on 09Jan2021 and feeling of body temperature change. Clinical outcome of the event inability to work was not recovered, while clinical outcome of all other events was unknown. Laboratory data included pulmonary function test, result: 40%.; Sender's Comments: Based on the current available information, the event Inability to work is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
41 2021-03-24 vaccination site pain, rash Severe Asthma; pain at injection site; Rash at I she tin site the went down left arm, up shoulder an... Read more
Severe Asthma; pain at injection site; Rash at I she tin site the went down left arm, up shoulder and into neck; SOB; weakness; Coughing with taste of blood; running nose; watery eyes; fever; chills; muscle weakness to the point of falling down and dropping item; pain; numbness and tingling throughout body; numbness and tingling throughout body; flank pain; intermittent urinary inconstance; increased urination at night; nightmares; dizziness; blurred/double vision; ringing in ears; irregular body temperature; anxiety; depression; extreme fatigue; visual disturbance; I have been not been to work since second shot; This is a spontaneous report receive from a contactable consumer (Patient herself). A 41-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received first dose BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection with false Lot number: EK5730) via intramuscularly on 18Dec2020 at 08:00 am to right arm (at the age of 41-years-old) and second dose with lot number: EK9231 via intramuscularly on 08Jan2021 at 08:00am to left arm both at single dose for COVID-19 immunization. Medical history included Migraines. Concomitant medications were not reported. On 08Jan2021 at 06:00pm, the patient experienced pain at injection site, rash at injection site went down left arm, up shoulder and into neck, SOB, fatigue, weakness, coughing with taste of blood, running nose, watery eyes, fever, chills Day after and progression: muscle weakness to the point of falling down and dropping item, pain, numbness and tingling throughout body, flank pain, intermittent urinary inconstance, increased urination at night, nightmares, dizziness, blurred/double vision, ringing in ears, irregular body temperature, cough tasting blood, anxiety, depression Today: SOB, couch tasting blood, extreme fatigue, visual disturbance, nightmares, anxiety, depression and she said , that she had not been able to work since her second shot. On 13Jan2021 patient underwent lab test included swab test results as negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Mar21 new onset of severe asthma was diagnosed. Outcome of events was not recovered. Information about report seriousness has been requested; Sender's Comments: Considering the known safety profile of the drug and a plausible temporal association between the reported events and the suspect drug BNT162B2, a causal relationship cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
41 2021-03-25 injection site redness, injection site warmth, injection site swelling, injection site pain, injection site hardening Per Client received first Pfizer COVID 19 vaccine on 2/23/2021 in left arm, slight redness and tende... Read more
Per Client received first Pfizer COVID 19 vaccine on 2/23/2021 in left arm, slight redness and tenderness at site. Received second Pfizer COVID 19 vaccine on 3/24/2021 in left arm and old site became symptomatic not new site: Hot, red, swollen, painful, hard to touch two inches across site. Next day on 3/25/2021, chills, fever of 102, nausea, vomiting x 2, fatigue and sore left arm pit. Client reported taking Ibuprofen, applying cold and warm compresses to site and no follow up with PCP as of yet. Client reported still having symptoms and will plan to follow up with PCP if still having concerns on tomorrow. PHN encouraged Client to continue monitoring site and to follow up with PCP.
41 2021-03-25 injection site swelling, injection site redness, injection site nodule Redness, swelling, large knot/bump in arm at injection site about 2 in in diameter, Pain in arm when... Read more
Redness, swelling, large knot/bump in arm at injection site about 2 in in diameter, Pain in arm when touched or when I move it. headache & fatigue
41 2021-03-25 redness This could certainly represent allergic reaction which she has had the vaccines in the past. She ha... Read more
This could certainly represent allergic reaction which she has had the vaccines in the past. She has sensation of tongue edema and scratchiness in her throat, does have erythema of her face and anterior neck, has mild wheezing on exam. She is treated with epinephrine 0.3 mg IM, followed by IV, Solu-Medrol 125 mg, famotidine 20 mg, Benadryl 25 mg, NS 1 L, and improves over several hours. At no point did she worsen or express a desire to have an additional epinephrine dose. She was never hypotensive. She is cold and chilled, also complained of nausea, given Zofran and a bear hugger While the wheezing was treated with albuterol inhaler and resolved Ultimately discharged with her husband They will be picking up a EpiPen in route to home which is at a pharmacy, confirmed Prescriptions sent for Benadryl, 3 additional days of prednisone, Pepcid, albuterol inhaler Last Set of Vital Signs: Temp: 37.2 °C (98.9 °F) Pulse: 96 Resp: 12 SpO2: 100 % BP: 132/76
41 2021-03-25 skin warm Warm and tingly all over and blurry vision
41 2021-03-26 injection site rash, rash papular, rash with redness, injection site hives, injection site reaction Five days after the shot, I have a large rash/ hives on my left arm, but not at the injection site.... Read more
Five days after the shot, I have a large rash/ hives on my left arm, but not at the injection site. It is lower on the arm at the elbow. It is a large red, angry looking rash with elevated hives/urticaria. Zyrtec helps bring the rash down but showering / heat brings it back. It is painful to the touch.
41 2021-03-26 itchy skin Lip swelling, throat pain, itching
41 2021-03-26 injection site redness Red skin reaction at injection site. No treatments administered.
41 2021-03-26 rash Shot received 3/25/21. 3/26/21: fatigue, headache, pain in left arm and neck 3/27/21: rash on left a... Read more
Shot received 3/25/21. 3/26/21: fatigue, headache, pain in left arm and neck 3/27/21: rash on left arm and left leg, swollen lymph in left armpit
41 2021-03-27 rash Rash all over entire body
41 2021-03-28 injection site pain Minor muscle soreness several hours after vaccination. Tenderness at injection site only when pressu... Read more
Minor muscle soreness several hours after vaccination. Tenderness at injection site only when pressure applied (i.e. sleeping on side)
41 2021-03-28 itchy skin, hives urticaria-itching
41 2021-04-01 rash, itchy skin Patient developed rash, itching and throat swelling shortly after administration of 2nd Pfizer COVID... Read more
Patient developed rash, itching and throat swelling shortly after administration of 2nd Pfizer COVID vaccine dose. Treated with IV Benadryl 50mg, symptoms resolved within 15 min.
41 2021-04-15 pain of skin he evening of 3-4-21 when I got home from work, I ate dinner, then started shivering badly with temp... Read more
he evening of 3-4-21 when I got home from work, I ate dinner, then started shivering badly with temp of 100.5. The shivering quickly changed to more of a convulsing and temp got up to 104.7F. When I woke the next morning, temp was back down to 101-102F and most of shakes were subsiding. But I noticed that I had a deep, cutaneous pain reaction from head to toe when I awoke on 3-5-21. I could not brush my hair because my scalp was too tender. I couldn't let anything touch me and put pressure against any part of my body. Then at 3:30 that afternoon, I went to bathroom and had a bowel movement. It was so excruciating that I truly though my colon might have come partially out. I was in too much pain to flush, so I crawled across the house to my bed and laid on my side for an hour, crying. When I was finally able to go back to the bathroom to flush, I was expecting a large BM. It was not. It was about 2" x 1" and soft. There was no blood. It just felt like it tore me up. ****Then at 7:30 PM on 3-5-21 was when things got very serious. I was sitting down watching TV after a light meal. Suddenly, I started noticing discomfort deep in my upper back, between my shoulder blades. Within 5 minutes, it was at its worst....I was have rated it 11/10 pain. The pain was just very deep, behind the spine, about palm sized radius and unrelenting. My first thought was "maybe this is musculoskeletal since I've been in bed a lot because of the pain today." So I looked in my medicine cabinet for what I had and took 5 mg of Oxycodone and 10 mg of Cyclobenzaprine. An hour later, these meds hadn't touched it. I was beginning to really worry about an MI, or aortic dissection or pulmonary embolism (though I had no SOB). Lying flat on my back on a hard surface seemed to provide the only relief (though minimal relief, 9/10 pain). I called another provider who was on call and told her. She said that I could try taking 800 mg of Ibuprofen, but if I wasn't relieved in 1 hour, I needed to call 911 or have someone take me to the ER. I was asleep in an hour. I took it easy the next two days but started feeling back to normal during the days. I continued to sweat throughout the nights and skin pain continued so much that I had to cut some of my hair out. That following Tuesday, the deep upper back pain returned.
41 2021-04-16 rash, hives Short Summary: DVT followed by Multiple Bilateral Pulmonary Embolisms (significant blood clots in bo... Read more
Short Summary: DVT followed by Multiple Bilateral Pulmonary Embolisms (significant blood clots in both lungs). Context: After the first vaccine (about a week before my second vaccine), I self diagnosed myself with a calf injury due to extreme pain in my calf that felt like a continuous cramp. The extreme pain lasted until my second shot (about a week). When going for my second shot, I reported a rash with hives on my lower abdomen that had appeared within five hours of my first shot, so they requested I stay a little longer for observation. That night I began having some breathing difficulties, but assumed they were to be expected. The breathing difficulties continued to get worse until my nurse practitioner told me to go directly to the nearest ER (2/16/21), where I was officially diagnosed with multiple bilateral pulmonary embolisms. I was admitted to healthcare facility for 24-48 hours, until an EKG revealed heart abnormalities that caused them to use a physician's transport to move me to another unit. I was discharged from the hospital on 2/2/21 after I stabilized from heparin shots, avoiding more invasive procedures. I have been in ongoing recovery since then, receiving ongoing care from a hematologist and pulmonologist. A little extra context for you - I arrived to the hospital with diabetic ketoacidosis and have an endocrinologist since hospitalization that has diagnosed me with Type 1 Diabetes (previously misdiagnosed as type 2 - I'm now on insulin which is controlling my blood glucose well).
41 2021-04-19 hives, rash with redness, itchy skin Nausea, severe rashes (hives) red and burning and itchy throughout the body, second high fever that... Read more
Nausea, severe rashes (hives) red and burning and itchy throughout the body, second high fever that went up to 102.1 followed by chills and body ache, light headed ness and headache. Rashes occurred 10-12hrs after vaccine and got worse till was treated at a medical clinic and er. Had heavy heart rate of 120+ IV administered with diphenhydramine which is continued even now as slight rashes still exists and prednisone was given on Sunday April 19 2021 at 11:50am Later since rashes still persisted was advised by the urgent clinic to go to ER where hydroxyzine was given
41 2021-04-21 injection site pain - Almost immediate pain at injection site that moved around my arm, into my armpit, arm felt heavy -... Read more
- Almost immediate pain at injection site that moved around my arm, into my armpit, arm felt heavy -Rapid heartbeat 5-10 minutes after injection, along with dizziness, rapid pulse and nausea that lasted approximately 5 minutes -After than, body aches, nausea, arm pain and tiredness -Nausea, exhaustion, arm pain and body aches for 48 hours following injection -Started monthly period early, 4 days following vaccine, period started heavier than normal (started my period 1 week early which is VERY unusual for me) -Some of my vaccine reactions felt exactly like a condensed and much stronger version of PMS
41 2021-04-21 injection site redness, injection site warmth, injection site pain Chills, headache, body aches, nausea, soreness at injection site, heat at injection site, redness at... Read more
Chills, headache, body aches, nausea, soreness at injection site, heat at injection site, redness at injection site
41 2021-04-22 itchy skin Tongue felt like it was swelling; Itching; Tickle in her throat; This is a spontaneous report from a... Read more
Tongue felt like it was swelling; Itching; Tickle in her throat; This is a spontaneous report from a contactable pharmacist. A 41-year-old not pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN3518), via intramuscular route of administration in left arm on 02Feb2021 at 11:45 AM at single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: El1283), via intramuscular route of administration in left arm on 01Jan2021 at single dose for COVID-19 immunization and had no problem post 1st dose. Medical history and concomitant medications were not reported. The patient was allergic to shellfish anaphylaxis. On 02Feb2021 at 12:15 PM, the patient experienced tongue felt like it was swelling, tickle in her throat and itching. During observation period post second dose patient began itching and felt like she had a tickle in her throat. Patient began clearing her throat and asked for some water. RN noted she was rubbing throat and gave her water and benadryl 25 mg PO for itching. Patient noted that her throat was starting to feel funny like it might be closing up and her tongue felt like it was swelling. Epinephrine 0.3mg IM administered immediately after identifying these symptoms and patient wheeled down to ER for evaluation. Patient received IV benadryl in ER and famotidine. Observed for a couple of hours and then released. The outcome of the events was unknown.; Sender's Comments: A causal relationship between BNT162B2 and the reported events swollen tongue, pruritus and throat irritation cannot be excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate .
41 2021-04-24 hives, rash DVT; multiple bilateral pulmonary embolisms; rash; hives on my lower abdomen; calf injury due to ext... Read more
DVT; multiple bilateral pulmonary embolisms; rash; hives on my lower abdomen; calf injury due to extreme pain that felt like a constant cramp; This is a spontaneous report from a contactable Other HCP (patient) . A 41-years-old no pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 19Jan2021 16:30 (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunisation.Age at vacciantion:41 years. No other vaccine in four weeks. No COVID prior vaccination Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing , Hashimoto's Disease from an unknown date and unknown if ongoing. Concomitant medication(s) included metformin (METFORMIN) and levothyroxine (LEVOTHYROXINE) . The patient experienced DVT followed by multiple bilateral pulmonary . The clinical course was reported as follows:"Within 5 hours of the first dose I got a 3" in diameter rash and hives on my lower abdomen, which I reported when receiving my second dose. About a week before the second dose, I self-diagnosed myself with a calf injury due to extreme pain that felt like a constant cramp that lasted until my second dose. After the second dose, I was hospitalized 5 days (16Feb2021-20Feb2021) with multiple bilateral pulmonary embolisms/blood clots in both lungs after being sent to the ER by a nurse practitioner, and told that my previously self diagnosed leg injury was really DVT - I actually left the hospital with one blood clot still in my leg.Hospital's Cardiac ICU by physician's transport because my case was too to be treated at (Withheld). I am lucky to have survived this-please warn people of the symptoms" The patient underwent lab tests and procedures which included antiphospholipid antibodies (unknown date): unknown results (won't be in until mid-Jun because it requires testing 12 weeks apart)-tested negative for genetic conditions that could have caused the clots , sars-cov-2 test: negative on 16Feb2021.The events DVT and pulmonary embolism resulted in Emergency Room visti /Phisician office visit .The event "DVT" was treated with Heparin, still on blood thinner. The patient received the second dose on 08Feb2021 left arm (Lot#BL9269).The outcome of the event DVT was recovering.The outcome of the other events was unkonwn; Sender's Comments: Based on vaccine-event chronological association a causal relationship between events Deep vein thrombosis, Pulmonary embolism and Pain in extremity and BNT162B2 vaccine cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : same report/patient, different dose/AE
41 2021-04-24 blister hemorraging; Period was late; nausea; fatigue; headaches; irregular period; Erythema multiforme majo... Read more
hemorraging; Period was late; nausea; fatigue; headaches; irregular period; Erythema multiforme major; I broke out with multiple sores all over the left Breast; a strange Blister was on my left breast; Pain; This is a spontaneous report from a contactable consumer. A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 10:00 (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunisation. The patient has no medical history. Concomitant medication(s) included alprazolam (XANAX). On 08Mar2021 21:00, the patient became sick 11 hours after first dose and was ill for two days took a full week for nausea and fatigue and headaches to improve. On March 19th my period was late and by the 22nd when it started I had to be hospitalized for hemorraging and a strange Blister was on my left breast over the next two weeks I broke out with multiple sores all over the left Breast and still am and was diagnosed with Erythema multiforme major from an autoimmune response to the vaccine. Multiple ER and urgent care visits resulted as I was first misdiagnosed with Shingles. Then, I started bleeding again only 14 days after my period ended again. The pain and bleeding are as intense. I have never had irregular period in my life until the vax. The patient was hospitalized for hemorraging from 22Mar2021 to an unknown date for 1 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 31Mar2021 covid test type post vaccination=Nasal Swab, covid Test name post vaccination=Pi xel by lab, covid test date=31Mar2021, covid test result=Negative. The patient did not receive treatment for the events. The outcome of the events hemorraging, Erythema multiforme major, I broke out with multiple sores all over the left Breast, a strange Blister was on my left breast was not recovered, while recovering for the events nausea, fatigue, and headache, and unknown for the rest of the events. The patient second shot on March 29th and the skin lesions and sores continue to appear as well as fatigue, headache and joint pain. I was in good health before receiving the vaccine and never had skin issues or irregular or painful periods with this much bleeding.
41 2021-04-27 itchy skin, redness She received the vaccine via drive through at the local fairgrounds. Notes she developed swelling ar... Read more
She received the vaccine via drive through at the local fairgrounds. Notes she developed swelling around her eyes within an hour. After 24 hours, she turned red, developed swelling on her entire body, and itchiness on her entire body. Notes her joints were painful; unable to make a fist with her hands. Also had a fever. No asthma symptoms. She called Urgent Care for advice, was recommended to take cetirizine or other antihistamines and pain medications. Patient took cetirizine and ibuprofen, symptoms resolved within a few hours. Still has some residual swelling around her eyes but notes it isn't itchy.
41 2021-04-30 rash, itchy skin, hives bleeding; Rash; itching; hives; pain in head, shoulders; pain in head, shoulders; pain in head, shou... Read more
bleeding; Rash; itching; hives; pain in head, shoulders; pain in head, shoulders; pain in head, shoulders, arm; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 14Apr2021 at 15:30 (3:30 PM) (at the age of 41 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included asthma, allergies, and anxiety. Concomitant medications included bupropion; diphenhydramine hydrochloride (BENADRYL), and unspecified supplements. The patient previously took amoxicillin and experienced allergies. The patient experienced rash, hives, itching, bleeding, and pain in head, shoulders, arm on 14Apr2021 at 17:00 (5:00 pm). The patient did not receive treatment for the events. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. The patient is recovering from the events. Information on the lot/batch number has been requested.
41 2021-04-30 rash rash under armpits; it was my back went out; This is a spontaneous report from a contactable consume... Read more
rash under armpits; it was my back went out; This is a spontaneous report from a contactable consumer. This 42-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: Unknown), dose 1, administered in Arm Left on 05Feb2021 08:00 PM as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other vaccines within 4 weeks. On 05Feb2021, After going home and rest around 8 pm, the patient could not get out of sofa , her back went out and she had to crawl to bed and lay flat until Sunday. Then patient felt little better and then she had a rash under armpits.The patient underwent lab tests and procedures which included Nasal Swab: Positive on 18Feb2021. The patient did not receive any treatment for adverse event. The clinical outcome of the events was recovered. Information on lot number/batch number has been requested.
41 2021-05-04 shingles Acquired shingles within a week after and am on chemotherapy for multiple sclerosis.; This is a spon... Read more
Acquired shingles within a week after and am on chemotherapy for multiple sclerosis.; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Lot Number: ER8730) via an unspecified route of administration on 22Mar2021 at 09:45 (at the age of 41-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included multiple sclerosis and trigeminal neuralgia, both from unspecified dates and unspecified if ongoing. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 the patient experienced acquired shingles within a week after and am on chemotherapy for multiple sclerosis. The event required treatment with doxycycline and Valtrex. The clinical outcome of the event acquired shingles within a week after and am on chemotherapy for multiple sclerosis was recovering/resolving. Since the vaccination, the patient has not been tested for COVID-19.
41 2021-05-07 hives urticaria; allergic process urticaria; swelling of the face; cough; shortness of breath; high blood ... Read more
urticaria; allergic process urticaria; swelling of the face; cough; shortness of breath; high blood pressure; dizziness; This is a spontaneous report from a contactable Other HCP, the patient. A 41-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 09Apr2021 at 10:00 (Lot Number: Ew0150) as a single dose (at the age of 41-years-old) for COVID-19 immunisation. Medical history included allergy to animal from an unknown date and unknown if ongoing and COVID prior to the vaccination on an unknown date. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Concomitant medication included anti contraception (unspecified product). On 12Apr2021 at 01:00 the patient experienced allergic process urticaria on the body and swelling of the face, cough, shortness of breath, high blood pressure and dizziness. The events all required visit to emergency department. The clinical course is as follows: on 12Apr2021 the patient started with a allergic process urticaria on the body and swelling of the face and this condition was getting worse with cough shortness of breath and high blood pressure and dizziness when on 14Apr2021, the patient couldn't stand it and went to the hospital. The patient was medicated with antiallergics and corticosteroids, but the patient still didn't feel well, her pressure keeps going up she still feel dizzy. Therapeutic measures taken as a result of urticaria, swelling, cough, shortness of breath, high blood pressure, and dizziness included unspecified antiallergics and corticosteroids. The patient was tested for COVID post vaccination on 14Apr2021 with molecular test (Swab sample) with negative result. The clinical outcome of the events allergic process urticaria on the body and swelling of the face, cough, shortness of breath, high blood pressure and dizziness was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of urticaria, allergic reaction, swelling, cough, shortness of breath, high blood pressure and dizziness. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : PFIZER INC-2021477200 mother/baby
42 2020-12-31 injection site redness, injection site swelling, itchy skin, injection site pain I had sudden onset itching and tenderness, swelling, redness about 8 days after receiving the Pfizer... Read more
I had sudden onset itching and tenderness, swelling, redness about 8 days after receiving the Pfizer vaccine, about an inch below the injection site in a wide band across my outer upper arm. It was bad enough that cellulitis briefly crossed my mind bc the redness and tenderness continued spreading for about 24 hrs. It started resolving on post vaccine day 11, but I?m still having mild itching and redness on post vaccine day 12.
42 2021-01-01 injection site redness Immediately: headache, feeling off/loopy, mild shortness of breath 45 min later: dry mouth, tongue s... Read more
Immediately: headache, feeling off/loopy, mild shortness of breath 45 min later: dry mouth, tongue swelling, mild fatigue, sinus pressure , shortness of breath 1 day later: redness injection site, moderate swelling or arm, mild head cold 2 days later: mild fatigue, sinus pressure, pain arm and redness of injection site
42 2021-01-02 sensitive skin Woke up with severe chills, shaking, fever of 100.8, generalized body aches, generalized sensitive... Read more
Woke up with severe chills, shaking, fever of 100.8, generalized body aches, generalized sensitive skin, and mild headache. All symptoms resolved after 1 day.
42 2021-01-03 injection site redness, injection site swelling After patient received an injection, patient developed fever, body aches, body chills, and injection... Read more
After patient received an injection, patient developed fever, body aches, body chills, and injection site is red and swollen. Patient also mentioned that her arm pit area is also swollen.
42 2021-01-03 itchy rash, rash with redness, rash Got vaccine on 12-29 @ 9:40 , same day around 8pm had a rash with bumps from back of right arm down ... Read more
Got vaccine on 12-29 @ 9:40 , same day around 8pm had a rash with bumps from back of right arm down to wrist with little bumps, really red...had on left arm as well. next day on 12- 30 around 1:30pm co worker told me my neck was really red. I told her I was just hot from working, but by 3pm I had bumps, itchy, big raised red spots....right side was worse then left side but it did cross my whole neck. my arms cleared up but when I get hot it comes out enough to see where it was located. on sat Jan 2nd the bottom of my right ear swelled and had like a white like bump....but, as soon as I cooled off because I was hot it totally went away. today is Mon Jan 4th and my neck looks like the bad rash area has burned into my neck....I have been taking Benadryl crème on neck and Friday Dec 1st I started Benadryl pills but stop taking pills after sat Jan 2nd because I was just to tired.
42 2021-01-03 rash Severe rash; This is a spontaneous report from a contactable healthcare professional (patient). A 42... Read more
Severe rash; This is a spontaneous report from a contactable healthcare professional (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730 (pending clarification)), intramuscularly at the left arm on 21Dec2020 at 16:00 (04:00 PM) at single dose for COVID-19 immunization. The patient was vaccinated at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. The patient's medical history included Diabetic, type 1, allergies to penicillin, and the patient diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient previously took codeine and experienced allergies. The patient received other unspecified medications within 2 weeks of vaccination. The patient experienced severe rash on 23Dec2020 at 21:30 (09:30 PM). The adverse event resulted in emergency room/department or urgent care: the patient was treated at local ER with prednisone and benadryl. The event was reported as non-serious. The patient recovered from the severe rash on an unspecified date in Dec2020.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of severe rash. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
42 2021-01-04 injection site swelling, injection site pain Approximately 6.5hrs after vaccination, patient developed severe fatigue, some palpitations and dizz... Read more
Approximately 6.5hrs after vaccination, patient developed severe fatigue, some palpitations and dizziness. The next the morning, she had headache, nausea and strange feeling on the tip of throat and nose. She also had pain and swelling in the injection side, no erythema.
42 2021-01-04 vaccination site hardening, vaccination site redness, vaccination site swelling, vaccination site itchiness I had soreness; started with itching, redness and swelling at site of immunization.; started with it... Read more
I had soreness; started with itching, redness and swelling at site of immunization.; started with itching, redness and swelling at site of immunization./5.0 cm area of redness and induration; 5.0 cm area of redness and induration at site; started with itching, redness and swelling at site of immunization.; This is a spontaneous report from a contactable physician (patient herself). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ek5730, expiry date not reported), via an unspecified route of administration on the left arm on 17Dec2020 10:15 at single dose for COVID-19 immunisation. Medical history included food allergy, oral allergy, no anaphylaxis. Concomitant medications were not reported. On 26Dec2020 18:00, the patient started with itching, redness and swelling at site of immunization. Patient also had a 5.0 cm area of redness and induration at site. Patient also had soreness on an unspecified date but no other reaction. No therapeutic measure was taken as a result of the events. Clinical outcome of pain was unknown while for the other events was not recovered. Follow-up attempts are not possible. No further information is expected.
42 2021-01-04 vaccination site pain Nausea; vomiting; pain at injection site with paresthesias in the lower arm; pain at injection site ... Read more
Nausea; vomiting; pain at injection site with paresthesias in the lower arm; pain at injection site with paresthesias in the lower arm; neck pain on the injection side; severe fatigue; myalgia; Fever; chills; SOB on exertion; This is a spontaneous report from a contactable physician reporting for herself. A 42-year-old female patient received 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EH9899), via an unspecified route of administration at arm left, on 18Dec2020 at 02:30 PM, at single dose, for COVID-19 immunisation. Medical history included hypertension, obesity, mood disorder, latex allergy. Patient did not experience COVID-19 before vaccination. Concomitant medications included trazodone (unknown manufacturer), escitalopram (unknown manufacturer). On 18Dec2020 at 10:00 PM the patient experienced nausea with outcome of recovering, vomiting with outcome of recovering, pain at injection site with paresthesias with outcome of recovering, neck pain on the injection side with outcome of recovering, severe fatigue with outcome of recovering, myalgia with outcome of recovering, fever with outcome of recovering, chills with outcome of recovering, shortness of breath (SOB) on exertion with outcome of recovering. The patient underwent lab tests and procedures which included COVID-19 PCR test (nasal swab): negative on 25Dec2020. No therapeutic measures were taken as a result of the events. The events were considered non serious.
42 2021-01-04 injection site swelling arm pain all the way down to fingers unable to lift arm past head dizzy weak headache nausea chills ... Read more
arm pain all the way down to fingers unable to lift arm past head dizzy weak headache nausea chills no fever exhausted no appetite arm pain is 60% better today no redness at injection site mild swelling at injection site mentally foggy weak vision
42 2021-01-04 hives flushed; noticed some hives on forehead and forearm; This is a spontaneous report from a non-contact... Read more
flushed; noticed some hives on forehead and forearm; This is a spontaneous report from a non-contactable nurse. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EK5730), intramuscular on the left arm on 18Dec2020 09:30 at single dose for COVID-19 immunisation. Medical history included shellfish allergy. Concomitant medications were not reported. The patient previously took NSAIDS and experienced allergies. The patient flushed and noticed some hives on forehead and forearm on 18Dec2020 10:15. Therapeutic measure was taken as a result of the events that included Benadryl. Clinical outcome of flushing was not recovered while for hives recovered on Dec2020. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
42 2021-01-04 redness, itchy skin itching immediately after injection; then burning; then redness traveling up arm into chest; immedia... Read more
itching immediately after injection; then burning; then redness traveling up arm into chest; immediate onset of diarrhea; This is a spontaneous report from a contactable nurse(patient). A 42-year-old female non-pregnant patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=el0140), intramuscular on 26Dec2020 09:30 at left arm at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient had no known allergies and no other medical history. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient experienced itching immediately after injection, then burning, then redness traveling up arm into chest, and immediate onset of diarrhea. Adverse event start date was 26Dec2020 09:30 AM. The events result in emergency room/department or urgent care. Treatment of Pepcid, Benadryl and prednisone received. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered in Dec2020.
42 2021-01-05 injection site pruritus, injection site swelling 12 hours after injection, developed swelling at injection site that increased over two days to be ab... Read more
12 hours after injection, developed swelling at injection site that increased over two days to be about 1 1/2 inch in diameter that slowly decreased over 1 week. Developed muscle pain in left jaw, left neck, left chest for two days. Itching at site of injection lasted about 2 weeks.
42 2021-01-05 injection site hives 8 days after vaccine given (1st dose), urticaria around site of injection which resolved within 24 h... Read more
8 days after vaccine given (1st dose), urticaria around site of injection which resolved within 24 hours with 180mg fexofenadine.
42 2021-01-05 injection site pain Headache Injection site pain/soreness
42 2021-01-05 injection site pain Headache, Myalgia, NauseaVomiting, chills, pain at injection site Narrative: will report to work
42 2021-01-05 injection site redness Headache, Myalgia, fatigue,golfball size reddness at injection site
42 2021-01-05 rash, hives Hives and rash under armpits, up neck, and in groin area; Hives and rash under armpits, up neck, and... Read more
Hives and rash under armpits, up neck, and in groin area; Hives and rash under armpits, up neck, and in groin area; This is a spontaneous report from a contactable nurse (patient herself). A 42-Year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140 and expiration date unknown), via an unspecified route of administration at Left arm on 21Dec2020 07:15 AM at single dose for covid-19 immunisation; levothyroxine sodium (SYNTHROID), via an unspecified route of administration from an unknown date at 125ug daily for hypothyroidism. The patient medical history include hypothyroidism. The patient has no known allergies. The patient experienced hives and rash under armpits, up neck, and in groin area on 23Dec2020 with outcome recovered. Events were considered as non-serious with no treatment. The patient has not tested for COVID-19 before or after the vaccination. The action taken in response to the event for levothyroxine sodium was unknown.
42 2021-01-05 injection site hives delayed urticarial at site of injection, resolved within 24 hours with 1 dose of fexofenadine 180mg
42 2021-01-05 vaccination site pain vaccination site pain; Tiredness; Headache; Joint pain; Muscle pain; Night sweats; This is a spontan... Read more
vaccination site pain; Tiredness; Headache; Joint pain; Muscle pain; Night sweats; This is a spontaneous report from a contactable Pharmacist, the patient. This 42-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EK5730), intramuscularly in the right arm on 30Dec2020 at 16:30 (at the age of 42-years-old) as a single dose for COVID-19 vaccination. The patient's medical history included Graves' disease from an unknown date and unknown if ongoing, irritable bowel syndrome from an unknown date and unknown if ongoing and anxiety from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine (LEVOTHYROXINE), duloxetine (DULOXETINE). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. On 31Dec2020 at 02:00, the patient experienced vaccination site pain, tiredness, headache, joint pain, muscle pain and night sweats. No therapeutic measures were taken as a result of the events. The clinical outcome of the vaccination site pain, tiredness, headache, joint pain, muscle pain and night sweats was resolving. It was also reported that since the vaccination, the patient had been tested on 31Dec2020 for COVID-19 with results pending.
42 2021-01-06 rash, itchy skin, hives At 3:30 am 1/7/2021 I woke up to my whole body head to toe covered in hives/rash and my lips were sw... Read more
At 3:30 am 1/7/2021 I woke up to my whole body head to toe covered in hives/rash and my lips were swelling. I took 2 Benadryl and slept. At 6 am lip swelling went down but hives are all over still. At 8 am I took another Benadryl. It is now 12:30 and still there and itching.
42 2021-01-06 rash I had previous diagnosis of COVID-19 in September 2020. No one asked me that question prior to vacci... Read more
I had previous diagnosis of COVID-19 in September 2020. No one asked me that question prior to vaccination. After the vaccination, I had a fever for 1.5 days, muscle aches, weakness, nausea, diarrhea, headache, fatigue, cough. I had a rash that appeared after I got COVID-19, the rash never went away. After the vaccination, the rash became redder, enlarged, and spread.
42 2021-01-06 injection site warmth Injection site was at the top of the arm with possible injection into the shoulder joint. Approximat... Read more
Injection site was at the top of the arm with possible injection into the shoulder joint. Approximately 4 hours after the injection the patient began having severe pain and limited ROM of her shoulder.
42 2021-01-06 injection site nodule, injection site warmth, injection site pruritus, injection site redness Patient received the vaccine 12/30/20, her reaction began 1 week later on 1/6/21 in the afternoon. P... Read more
Patient received the vaccine 12/30/20, her reaction began 1 week later on 1/6/21 in the afternoon. Patient developed an itchy, red knot at injection site; 2 inches in diameter and warm to the touch. Patient still has the knot on her arm at the time I am reporting this. She has not taken any medication for it.
42 2021-01-06 redness, itchy skin, skin warm Patient reported swelling, redness, itching, hot to touch above her left breast. Patient took diphe... Read more
Patient reported swelling, redness, itching, hot to touch above her left breast. Patient took diphenhydramine
42 2021-01-06 rash, itchy rash Patient stated 15 minutes post vaccination she felt tingling to her right hand for about 4 hours. Re... Read more
Patient stated 15 minutes post vaccination she felt tingling to her right hand for about 4 hours. Reports palpitations 30 minutes post vaccine. Unknown duration as per patient.. Patient denies any palpitations, chest pain, or shortness of breath at time of phone interview. At about 9pm on the day of vaccine patient reports a rash all over her body. Describes it as bumpy and very itchy, getting worse. Patient reports taking Benadryl. States it helped with the itching but rash is continuing to spread. Denies respiratory complaints at time of phone interview. Patient instructed to see her provider as soon as possible for evaluation and treatment.
42 2021-01-06 rash, itchy skin, rash with redness SkinRash & Rash Narrative: Vaccine on 12/22/2020. That evening at 10:30PM, started w/ itching and ra... Read more
SkinRash & Rash Narrative: Vaccine on 12/22/2020. That evening at 10:30PM, started w/ itching and rash (erythematous) on chest and abdomen. Resolved with Benadryl 50mg.
42 2021-01-06 itchy skin, hives UrticariaPruritus SMALL HIVES
42 2021-01-07 injection site pain 1/06/2021: 0200-severe body ache, chills 0700 to 1100- 103.2 temp climbing with use of Tylenol and a... Read more
1/06/2021: 0200-severe body ache, chills 0700 to 1100- 103.2 temp climbing with use of Tylenol and aspirin. 1100 to 01/07/2021, 0200 severe lethargy lasting till around this time. Heart rate excess of 130, dizziness, severe weakness, muscle pain, fever 103 to 104 F. 650mg oral Tylenol and aspirin 325mg every 6 hours does not control temp. Intermittent periods of extreme perspiration. 0200 1/07/2021 to 1200, slow decline in body pain with ongoing Tylenol and aspirin every 6 hours. No more elevated temps. Injection site/arm remains painful.
42 2021-01-07 itchy skin, injection site pain, injection site swelling 3:00p fever, 99.2, 5:00p 100.2, Itchy, Tired, headache, stuffy nose, inj site pain, muscle and joint... Read more
3:00p fever, 99.2, 5:00p 100.2, Itchy, Tired, headache, stuffy nose, inj site pain, muscle and joint pain, chills, shot area is swollen, nausea, lymph nodes swollen and sensitive to touch. Face is tender. SOB with movement and dizziness. Patient is a cancer survivor and she said that it feels like she had a chemo treatment.
42 2021-01-07 itchy skin, rash After receiving the vaccination, when I stood up I felt a rush to my head. I went to sit in the wait... Read more
After receiving the vaccination, when I stood up I felt a rush to my head. I went to sit in the waiting area to be monitored and my tongue and lip started itching. I then started w/ a red rash to the R side of my neck. My body started to itch all over. I was brought into a treatment room and my vital signs were being taken when I started to have an increase in coughing, shortness of breath and vomiting. I was given an epipen and brought to the emergency room when I received Benadryl 50mg IV, Solumedrol 125mg IV, and Pepcid 20mg IV. Approximately 1 hour after receiving the medication my face again began to itch and I was given an additional dose of 25mg of Benadryl. My reaction resolved and I was discharged home with a prescription for prednisone.
42 2021-01-07 injection site bleeding Bleeding, Myalgia, tingling in the fingers of the right hand; fatigue Immediately upon vaccination -... Read more
Bleeding, Myalgia, tingling in the fingers of the right hand; fatigue Immediately upon vaccination - bleeding at the injection site which the employee reports as filling the bandaid over the site. When she got home in the evening and took it off blood ran down her arm but the bleeding stopped immediately. This has resolved. 12/29 at about 2:00 employee reports onset of tingling in the fingers of her right hand - index, middle, ring, and pinky. For about 2 hours the tingling was intense. As of 12/30 this has markedly improved and the tingling is intermittent. Later in the evening of 12/29 she noticed the onset of muscle pains throughout her body but especially in her feet. She also became very fatigued. These symptoms linger on 12/30. On 1/1 employee reports symptoms muscle soreness had resolved. 1/4 tingling in her fingers/arm has improved but is still present. She will follow-up with her PCP if this symptom persists beyond 2-4 weeks.
42 2021-01-07 injection site pain Chills; Soreness at the injection site; generalized body aches/Body aches; Shortness of breath; Asth... Read more
Chills; Soreness at the injection site; generalized body aches/Body aches; Shortness of breath; Asthma attack; Difficulty sleeping; Light headed and dizzy; Nausea; high BP 140's; HR 110's to 120s; Nasal congestion; Swelling of the face; Sore throat; This is a spontaneous report from a contactable nurse. A 42-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiration date not reported), intramuscular on the right arm on 31Dec2020 at 10:15 AM, at a single dose for Covid-19 immunization. Medical history included asthma, allergy, hypothyroidism, and some fish allergy. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). Patient previously took ibuprofen and experienced allergy. The patient is not pregnant. On 31Dec2020, after ten-15 minutes (10:30 AM) of receiving the vaccine, she was light headed and dizzy with some nausea. Monitored in the emergency room (ER) with high BP 140's and heart rate (HR) 110s to 120s. After an hour of saline bolus, she was better but she got nasal congestion and swelling of the face with sore throat. On 01Jan2021, after 24 hours, she got some soreness at the injection site with generalized body aches. Also she got some shortness of breath which lead to her asthma attack and difficulty sleeping. On 02Jan2021, after 48hours, she was feeling still light headed with some sore throat, chills, body aches and severe headache which lead her to go to the ER and got herself tested for flu, covid and strep, which came back all negative but her signs and symptoms (s/sx )still after discharge was getting worst especially the headache and generalized body aches. As well as congestion and sore throat. The patient had given "Ivf" for the events. The patient was not diagnosed with Covid prior to vaccination and was not Covid tested post vaccination. The outcome of the events was not recovered. The reporter assessed the events as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
42 2021-01-07 vaccination site pain Deep ache left deltoid at injection site with severe nerve pain when lifting left arm.; Deep ache le... Read more
Deep ache left deltoid at injection site with severe nerve pain when lifting left arm.; Deep ache left deltoid at injection site with severe nerve pain when lifting left arm.; Deep ache left deltoid at injection site with severe nerve pain when lifting left arm.; This is a spontaneous report from a non-contactable nurse. A 42-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on the left arm on 19Dec2020 11:30 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included levothyroxine. The patient experienced deep ache left deltoid at injection site with severe nerve pain when lifting left arm on 23Dec2020 16:30. The patient received no treatment. The outcome of the events was not recovered.
42 2021-01-07 sensitive skin Fever up to 100.8 (unknown unit); chills; shaking; general muscle aches; generalized sensitive skin;... Read more
Fever up to 100.8 (unknown unit); chills; shaking; general muscle aches; generalized sensitive skin; mild headache lasting 1 day; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EK5730, intramuscular on Right arm from 22Dec2020 09:45 to 22Dec2020 09:45 as single dose for COVID-19 immunization. Medical history included hypertension, and glaucoma. Concomitant medication included losartan (LOSARTAN), hctz (HCTZ), fluticasone propionate (FLONASE), and latanoprost (XALATAN). On 24Dec2020 08:30 am, the patient experienced fever up to 100.8 (unknown unit), chills, shaking, general muscle aches, generalized sensitive skin, mild headache lasting 1 day. The patient was not tested for Covid post vaccination. The patient is not pregnant. The outcome of the events was recovered on 25Dec2020. No treatment was received for the events.
42 2021-01-07 injection site redness, injection site hardening, injection site warmth I had my 2nd vaccine on 01/06/2021 and where the injection was done is now a big red spot around the... Read more
I had my 2nd vaccine on 01/06/2021 and where the injection was done is now a big red spot around the area and has spread a tiny bit and it's warm to the touch with a hard bump. No other symptoms, except tired. no fever ect
42 2021-01-07 injection site redness, injection site warmth ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, AND A GOLF BALL SIZED RED AREA AROUND INJECT... Read more
ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, AND A GOLF BALL SIZED RED AREA AROUND INJECTION SITE THAT IS WARM TO THE TOUCH. CURRENTLY AWAITING INSTRUCTIONS FROM PRIMARY PROVIDER.
42 2021-01-07 injection site redness, injection site warmth ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, AND GOLF BALL SIZED RED AREA AROUND INJECTIO... Read more
ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, AND GOLF BALL SIZED RED AREA AROUND INJECTION SITE THAT IS WARM TO THE TOUCH. AT THIS TIME AWAITING FURTHER DIRECTION FROM PRIMARY PROVIDER.
42 2021-01-07 injection site warmth, injection site redness ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, GOLF BALL SIZED RED AREA AROUND INJECTION SI... Read more
ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, GOLF BALL SIZED RED AREA AROUND INJECTION SITE WHICH IS WARM TO THE TOUCH. AS OF THIS REPORTING IS AWAITING A CALL FROM HER PRIMARY PROVIDER.
42 2021-01-07 hives Started with hives approximately 15 minutes after and then went into full Anaphylaxis. Required epi ... Read more
Started with hives approximately 15 minutes after and then went into full Anaphylaxis. Required epi and Benadryl.
42 2021-01-08 rash Rash and swelling around mouth, eyes, and behind ears
42 2021-01-09 injection site pain, injection site swelling, injection site redness Injection site is very red, sore, and has a very large bump. Pain spread to armpit area which is enl... Read more
Injection site is very red, sore, and has a very large bump. Pain spread to armpit area which is enlarged and bumpy.
42 2021-01-09 redness, hives Once injected felt dizzy then sat down, it was hard to breathe I can fell rapid heart palpatiions an... Read more
Once injected felt dizzy then sat down, it was hard to breathe I can fell rapid heart palpatiions and my my body get hot from the inside out. I started sweating and my skin was turning red. I notified staff and they kept me an additional 30 minutes. I started getting hives and my body felt hot. The fire fighters asked the nursing staff for Benadryl they advised they did not carry it and could not give it to me. I carry Benadryl in my work bag due to my list of allergies. Fire assisting at location advised me to take Benadryl. I notified my employer because Benadryl makes me sleepy. They sent me home and I continued Benadryl and missed work for three days. At this time I went to prestige emergency about 1200 pm because the hives, heat in my body did not go away. I was treated and placed on an iv cocktail and sent home with several medications. Diagnosed with urticaria allergic by DR. symptoms did not improve my skin was still red I felt hot, confused, dizzy and returned back to the same ER 01/09/2021 I was also involved in an unrelated motor vehicle accident earlier in the morning so got treated for that and continued my explanation and treatment of how my body is not doing well with the Covid 19 shot. I presented with tachycardia and was instructed to continue my medications prescribed from 1st visit on 1/7/2021. Today is 1/10/2021. My body still feels hot, fatigue, confusion and light headed. Remained out from work and continued bed rest.
42 2021-01-09 skin irritation Sore arm, cold chills, irritable skin all over, achy muscles, headache
42 2021-01-10 injection site discomfort About 48 hours after vaccination, I developed tender and swollen lymphadenopathy from my axilla down... Read more
About 48 hours after vaccination, I developed tender and swollen lymphadenopathy from my axilla down the bottom of my arm to my elbow on my right side. This is the same side the injection was given. The injection site is no longer tender to touch but it is difficult to raise my arm and hold it straight due to discomfort. My arm is visibly swollen compared to my left arm. I can feel shotty lymph nodes down my arm.
42 2021-01-10 hives, redness After receiving vaccine began to feel dizzy and lightheaded and sat in observation area and develop... Read more
After receiving vaccine began to feel dizzy and lightheaded and sat in observation area and developed a diffused urticarial rash and was sent to ED. She also C/O of difficulty swallowing. Erythema B/L cheeks, Rash diffused B?L chest and behind left ear Patient given Benadryl 25 mg IV at 11:15, Pepcid 20 mg IV given 11:15, SOLU-MEDROL 125 given at 11:30 13:20 feeling much better and has fontal headache discharged home at 14:20
42 2021-01-10 pain of skin, injection site redness Arm swelling, Red spot at site of vaccine. Diarrhea, Pain Scalp pain.
42 2021-01-10 rash, itchy skin Blotchy on chest/face Itching and rash on arms, legs, stomach and hips
42 2021-01-10 hives Hives, shortness of breath, treated at emergency department with Epinehrine & steriods
42 2021-01-10 redness, hardening Left axilla pain, left outer arm red, hot, firm.
42 2021-01-10 injection site warmth, injection site pruritus, injection site mass, injection site redness RED RAISED LUMP AT INJECTION SITE, HOT AND ITCHY ARM. HEADACHE. CHILLS.
42 2021-01-10 itchy skin lient's tongue became swollen within 20 min. of vaccination. Swelling did not resolve by 4:00pm, cl... Read more
lient's tongue became swollen within 20 min. of vaccination. Swelling did not resolve by 4:00pm, client seen at urgent care. Client treated with Prednisone 60 mg PO x1; client prescribed Benadryl Q 4-6 hrs. x2 days, Prednisone 20 mg PO BID x5 days. Client developed generalized pruritis and lip tingling approximately 12 hrs. post-vaccination. Tongue swelling improved but not fully resolved at this writing (72 hrs. post-vaccination).
42 2021-01-11 injection site redness, injection site pain 1/8 - Within 12 hrs had body, eye, and headache. Overall tired. Could not do normal daily things w... Read more
1/8 - Within 12 hrs had body, eye, and headache. Overall tired. Could not do normal daily things without feeling wiped out . 3 Advil did nothing- sat 1/9. Next day felt better.- sun 1/10. That evening low grade fever 99.6 and achy again., mostly eyes and head. Went to bed. Monday okay. But noticed right armpit a pit puffy.- same side as injection. Tuesday 1/12 woke up at 6:00am and had dull joint/bone pain bilaterally. Ranging from neck ache, to sternum/upper back, shoulders, triceps. Injection site still sore- slightly red off to the side. Did some stretches in bed and eventually got up. I am very in tune with my body- something is off. I never wake up feeling ?bad?. Fit, healthy and active normally. Almost like a bad nights sleep with a poor mattress but only affected my upper body. Took two Advil and hot shower- feel better but can tell something doesn?t feel right.
42 2021-01-11 injection site pain Headache, nausea, vomiting, dizziness, body aches, pain at injection site, chills,fatigue
42 2021-01-11 injection site swelling, injection site vesicles, injection site pruritus, injection site redness Large red swollen area on arm were vaccine was given. Redness and area increased the next 3 days aft... Read more
Large red swollen area on arm were vaccine was given. Redness and area increased the next 3 days after vaccine given, had some blister patches and then itched for 4 days.
42 2021-01-11 rash Rash on left arm and right wrist 48 hours after first dose of Pfizer-BioNTech COVID-19 vaccine 0.3 m... Read more
Rash on left arm and right wrist 48 hours after first dose of Pfizer-BioNTech COVID-19 vaccine 0.3 mL IM in left deltoid. Patient tool cetirizine PO and used triamcinolone cream topically. Appears to have resolved, but no further details in the patient's chart.
42 2021-01-11 injection site redness, injection site swelling Vomiting, Fever, Headache, Body aches, chills, fatigue, injection swelling and redness, red flush fa... Read more
Vomiting, Fever, Headache, Body aches, chills, fatigue, injection swelling and redness, red flush face
42 2021-01-11 rash While patient was receiving her second dose of the Pfizer brand Covid-19 vaccination (at 14:50), she... Read more
While patient was receiving her second dose of the Pfizer brand Covid-19 vaccination (at 14:50), she mentioned to me that she had a sustained local reaction to her first dose. Her arm had a hard, red, hot spot for approximately a week. At this time I told her we would like her to stay under observation for 30 Min instead of the normal 15 min. At approximately 25 min post vaccination, the pt reported the following: "arm felt heavy, both arms did, but more so the affected arm, instant headache, sore neck, vision went fuzzy, breathing wasn't difficult but felt labored, throat felt like it was closing/congested, rash on the inside of the affected arm".   Pt stated that her heart felt like it was "pounding".   VS: 162/96, 99% RA, HR in the 70's.   Patient was administered 50ml IM diphenhydramine and monitored for 90 minutes in the clinic area. Dr. was consulted and also spoke with the pt, advising her to continue with OTC diphenhydramine once at home.   The symptoms resolved after approximately 40 minutes. By 17:00 the patient was deemed stable to go home with the instructions to go immediately to ED should any further Sx present. It was verified that she did not live alone and would have someone with her that could assist.   Pt was subsequently followed up with a phone call on the next day by RN who relayed that she was very tired, but no other complications.  
42 2021-01-11 hardening, rash, itchy rash joint pain and muscle; joint pain and muscle; Vertigo; an itchy rash bilaterally on her arms; develo... Read more
joint pain and muscle; joint pain and muscle; Vertigo; an itchy rash bilaterally on her arms; developing swollen, tender, and hard lymph nodes under the Left subclavian area/ swollen left subclavian lymph nodes; developing swollen, tender, and hard lymph nodes under the Left subclavian area; extreme fatigue; Runny nose; Headache; This is a spontaneous report from a contactable nurse (RN) reporting for herself. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 23Dec2020 h 09:00 intramuscularly in left deltoid (left arm) lot number: EK5730 at single dose for COVID-19 immunization. Concomitant medications were not provided. Patient stated that she has had double mastectomy, and missing a lot of lymph nodes, states she got the first dose of Pfizer Covid vaccine on 23Dec2020, states it made her left subclavian lymph nodes swollen and hard. States that when she gets the flu vaccine at her hospital every year, she gets swollen lymph nodes ever since she had a double mastectomy and chemotherapy. She originally was wondering if she could get the vaccine in another large muscle group. States she even went as far as to cross reference flu shot ingredients with the Pfizer Covid ingredients to see if something in the vaccines were causing the swollen lymph nodes but was unable to come to any conclusion, the only think in common is the Sodium Chloride and she does not feel like that would cause any issue. States the swollen lymph nodes occurred after the Sanofi brand flu vaccine (no other information known or provided). Patient is on day 15 post vaccination and they are still swollen and hard, she is wondering if there is any data on how long this side effect can last. She made an appointment with her oncologist, she knows that the swollen lymph had the first dose, lymph nodes are still swollen and hard, knows it can cause swollen lymph nodes but wants to know what is the typically length of the event. Patient also experienced other side effects, on 30Dec2020 (last week), she developed vertigo that lasted through the weekend intermittently, states she at first thought she was having a stroke. States it seems to have subsided as of 05Jan2021 (yesterday). Patient also reported she had an itchy rash twice as part of her side effects reported from the COVID 19 vaccine. She noticed an itchy rash and it went away but she is unsure exactly the day or time. Stated she definitely remembered the rash on 28Dec2020 as she took pictures. It was gone in about three hours on the same day. She did not treat the rash because it was gone and not itching. The rash came and went and had not come back. It was mostly on the bends of the arms, bilateral arms. Patient reported developing swollen, tender, and hard lymph nodes under the Left subclavian area the day after the injection, on 24Dec2020. They were not as tender at the time of the report but were continuing and this was 15 days from her vaccination. Patient also experienced an itchy rash bilaterally on her arms that occurred twice and only lasted a few hours each time, onset date reported as 25Dec2020. She was advised to take diphenhydramine hydrochloride (BENADRYL) for it however she did not take it. On 23Dec2020 patient experienced headache. On 24Dec2020 patient experienced extreme fatigue, swollen left subclavian lymph nodes and runny nose. On 30Dec2020 patient experienced joint pain and muscle and vertigo. The events headache, experienced extreme fatigue, swollen left subclavian lymph nodes, runny nose, joint pain and muscle and an itchy rash bilaterally on her arms were considered serious as medically significant events. Patient had not recovered from swollen left subclavian lymph nodes, joint pain and muscle, extreme fatigue and swollen, tender, and hard lymph nodes under the Left subclavian area, she was recovering from headache, runny nose and vertigo and recovered completely from an itchy rash bilaterally on her arms on 28Dec2020.; Sender's Comments: The Causality between the events, headache, experienced extreme fatigue, swollen left subclavian lymph nodes, runny nose, joint pain and muscle and an itchy rash bilaterally on her arms, and the administration of the COVID 19 vaccine cannot be denied based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
42 2021-01-12 rash 1st injection on 12/20/20 with side effects of sore R arm and pain/stiffness at R hand for about 24 ... Read more
1st injection on 12/20/20 with side effects of sore R arm and pain/stiffness at R hand for about 24 hours. After 2nd injection on 1/10/21, I had soreness at R arm, fatigue on first day. 2 days after 2nd injection, I developed rash/swelling around both eyes, and on 3rd day had worse eye symptoms and rash across upper chest. I called employee health and my PCP to report symptoms.
42 2021-01-12 injection site tingling 2230 feeling of unease, body aches, site arm tingling, general mild aches 0220 awoke from sleep chok... Read more
2230 feeling of unease, body aches, site arm tingling, general mild aches 0220 awoke from sleep choking, having difficulty breathing, felt very SOB, worse with exertion or trying to speak, great difficulty swallowing and speaking even in brief words. Took 50mg of Benadryl PO and went to the ED, about a 15 minute car ride. Had tingling and numbness of the tongue and back of throat by arrival but still able to breath with focus. Exertion of just walking into the ED greatly increased the SOB. Was triaged, Benadryl starting to help, was able to speak a little better, 3-4 words without too much SOB caused. Was walked to a room, SOB milder with that exertion. Seen by Dr. Given IV Sol-u-Medrol and 50mg Benadryl. Was observed on cardiac monitor/Q15VS for a few hours and discharged home around 5:30. Given Rx of Prednisone 20mg -3tabs x2 days, 2tabs x5 days all once a days and told to take 50mg of Benadryl Q4H for the next 24 hours at least and to return prn. I did need to stay on Benadryl, as the Sol-u-Medrol wore off some of the swelling in thr throat did return but not severe, Benadryl did help, along with taking my Asthmnex I already had. I also continued my normal HS antihistamines. I had SOB on exertion, progressively better from the 6th-10th with it mostly resolved to yesterday. Body aches have continued but also progressively better. Yeasterday1/12/21 the Rx of prednisone was completed and I did have some mild swelling /tingling in the throat/face/mouth return in the evening, took Benadryl 50mg again and inhaler used. I have an appointment today to seek further care at my primary doctor's office. Asthmnax used again this morning as well, only mild tightness in the throat currently with mild body aches this whole time.
42 2021-01-12 redness, skin burning sensation, hives About ten minutes after administration I began to feel prickly, burning on my arms which gradually g... Read more
About ten minutes after administration I began to feel prickly, burning on my arms which gradually got worse over the next 20 minutes and spread to my hands, sides, back and legs. Arms were very red. Informed clinic medical provider who took vitals. blood pressure was 186/116 o2 sat were normal. was given an im shot of benedryl and water, vitals were continued to be monitored and blood pressure came down to 145/84. Prickly burning sensation and redness continued. Went home and examined body and did have several hives on back and upper arm. slept due to benedryl, woke up to a very sore arm, achy joints but the prickly burning had mostly resolved. next day still feel tired and achy in joints but burning is gone.
42 2021-01-12 itchy skin Day 1: headache immediately following vaccine, lasting about 24 hrs Day 2: diffuse muscle aches, las... Read more
Day 1: headache immediately following vaccine, lasting about 24 hrs Day 2: diffuse muscle aches, lasting about 24 hrs Day 3: pruitis affecting palms of hands and feet as well as the scalp, ongoing
42 2021-01-12 hives Hives appeared on day 12 post vaccination. Hives are on right arm and right shoulder blade and chest
42 2021-01-12 injection site swelling, injection site pain Injection site raised and pain upon touch - started 1/11 evening after vaccine dose 2. Then on 1/12 ... Read more
Injection site raised and pain upon touch - started 1/11 evening after vaccine dose 2. Then on 1/12 1600 noticed under arm swelling and discomfort - thinking it's lymphadenophathy just on left side. Took ibuprofen and no changed as of 1/13 am
42 2021-01-12 injection site pain weakness, breathlessness, pain at sight, body aches over two days I am not feeling better yet
42 2021-01-12 skin spots wednesday-dyspnea on exertion(took tylenol worked shift as nurse) thursday morning-joint swelling an... Read more
wednesday-dyspnea on exertion(took tylenol worked shift as nurse) thursday morning-joint swelling and pain thursday night-more dyspnea, joint pain, general swelling, joint pain (took tylenol worked shift as nurse) friday-fatigue, joint swelling, general swelling, dyspnea blanching (took tylenol and ibuprofen worked shift as nurse) saturday-extreme fatigue, joint pain and swelling, general swelling, dyspnea sunday, facial swelling, petichiae on legs and back, joint, pain and swelling, fatigue requiring visit to hospital
42 2021-01-13 skin spots Development of petechial rash to lower extremities, abdomen and L arm
42 2021-01-13 injection site pain, injection site warmth Flare of hidradenitis suppurativa in the left axilla, groin, labia and abdomen at once. Two of the ... Read more
Flare of hidradenitis suppurativa in the left axilla, groin, labia and abdomen at once. Two of the abscesses became infected with warmth around the site and causing extreme pain. General malaise was felt as well.
42 2021-01-13 injection site pain Injection site pain that lasted about three days, day one was the worst. Fever of 100.5F, muscle pai... Read more
Injection site pain that lasted about three days, day one was the worst. Fever of 100.5F, muscle pain, chills, and joint pain on the third day and lasted around six hours. Loss of appetite and nausea lasted about a week. Tiredness and headache lasted almost two weeks.
42 2021-01-13 injection site mass, injection site redness, injection site pain Pfizer-BioNTech COVID-19 Vaccine We are reporting a WRONG ROUTE vaccine administration error, NOT a... Read more
Pfizer-BioNTech COVID-19 Vaccine We are reporting a WRONG ROUTE vaccine administration error, NOT an adverse drug reaction. This occurred at hospital at the vaccine clinic for vaccinating co-workers. The co-worker is a nurse and received first dose of the COVID-19 vaccine 12/19 2020. She reported that the vaccination was given in her right arm, but was administered via subcutaneous route instead of IM. The immunization record shows "IM" as the route administered. Co-worker was concerned about efficacy of the vaccine via SQ route. Physician was made aware and inquired about recommendations for how to proceed. She received the second dose on 1/9/2021 in left arm via IM route. Co-worker did report minor injection site issue - sore, small lump, red, but this is not being reported as an adverse drug reaction; this report is for the wrong route vaccine administration error]
42 2021-01-13 injection site pain, injection site pruritus Received the second dose of the COVID vaccine on 1/8/2021. She had some side effects including inje... Read more
Received the second dose of the COVID vaccine on 1/8/2021. She had some side effects including injection site soreness, chills, and fatigue over the weekend following the vaccine. The fatigue has been present all week and got worse last night (1/13). Her temperature has been fairly normal since the second dose, but today (1/14), her temperature went up to 100.1 and has been fluctuating throughout the day, staying mostly at about 99.4. States she does not feel sick, but reports feeling "off." Reporting the symptoms because it feels like they are continuing well after receiving the vaccine. Also reports that her arm was a little itchy over the weekend around the area where she received the injection
42 2021-01-13 injection site pain Starting at 8 pm on 1/12/21 she began experiencing chills, headache, fever, muscle pain, injection s... Read more
Starting at 8 pm on 1/12/21 she began experiencing chills, headache, fever, muscle pain, injection site pain. The symptoms continued until 9 am on 1/14/21 and have now completely resolve. T Max was 102.4 (tympanic).
42 2021-01-13 rash The day of the vaccination blood pressure went up. Then on 01/13/2021 she developed some rash starti... Read more
The day of the vaccination blood pressure went up. Then on 01/13/2021 she developed some rash starting by earas, eyes and then all over body. Patient refers she also take Methotrexate for her medical conditions.
42 2021-01-13 injection site tingling, injection site numbness, injection site pruritus Tingling and numbness on the left side especially the fingers and toes(1/13/21). Burning sensation (... Read more
Tingling and numbness on the left side especially the fingers and toes(1/13/21). Burning sensation (1/13/21)on the left armpit and later on axillary lymph edema(1/14/21)and heaviness of the arm. Itching and joint pain on left arm. Muscle pain ,cold and injection site pain since the evening of 1/12/21.
42 2021-01-13 redness, hives URTICARIA, ERITHEMA
42 2021-01-13 injection site swelling, injection site pruritus, injection site redness headache; injection site is itchy and swelled up; injection site is itchy and swelled up; But this o... Read more
headache; injection site is itchy and swelled up; injection site is itchy and swelled up; But this one turned red; can't lift her arm it's heavy and painful; can't lift her arm it's heavy and painful; shortness of breath; palpitation; Dizziness, lightheaded/ feeling dizzy; Uneasiness; hands are so cold; nauseous; This is spontaneous report from a contactable nurse reported for herself. This 42-year-old female patient (No pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on Left arm on 29Dec2020 17:00 PM on left arm at single dose (Lot # EL1284) for COVID-19 immunisation. Medical history included None. No Allergies to medications, food, or other products. Concomitant medications included ascorbic acid, bioflavonoids nos, hesperidin, malpighia glabra, rosa canina, rutoside (VITAMIN C), collagen, colecalciferol (VITAMIN D), cynara cardunculus, malus spp. vinegar extract, taraxacum officinale (APPLE CIDER). No other vaccine in four weeks. The patient experienced Dizziness, lightheaded, palpitation, uneasyness, shortness of breath on 29Dec2020 17:15 pm. Then when the patient drove home, she felt so uneasy and hands are so cold, nauseous and feeling dizzy on 29Dec2020 17:15 pm. Felt the same way in the house for a good 2 hours after the vaccination. Drank water and didn't sleep right away. Tried to monitor herself. After that day the patient felt better but with bouts of headache and dizziness every now and then. The injection site was itchy and swelled up. But it went down if didn't scratch it. The patient didn't have allergies to any medications. But this one turned red. And the next day after the vaccination (30Dec2020) the patient can't lift her arm it's heavy and painful. Then pain went away. But now it was the itchiness in the site that bothered her. But the patient didn't scratch it. So it didn't swell up as much. Prior to vaccination, was the patient did not diagnose with COVID-19. Lab data on 07Jan2021 Nasal Swab post vaccination for Covid 19: result was pending. No treatments received for the events. Outcome of the events Dizziness, lightheaded/ feeling dizzy, palpitation, Uneasiness, shortness of breath, hands are so cold, nauseous was recovering. Outcome of the event pain in arm was recovered. Outcome of other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the dizziness, lightheaded, palpitation, shortness of breath and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray, EKG and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
42 2021-01-13 vaccination site pain her left, upper arm became bruised and sore; her left, upper arm became bruised and sore/muscle sore... Read more
her left, upper arm became bruised and sore; her left, upper arm became bruised and sore/muscle soreness, like from a flu shot; half of the vaccine came out at the injection site and she did not receive the full dose.; This is a spontaneous report from a Pfizer from a contactable nurse reporting for self. This 42-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: 31May2021) via unspecified route of administration on 06Jan2021 at single dose in left upper arm for COVID-19 immunisation. Medical history and concomitant medications were none. The patient previously received her first dose of BNT162B2 (Lot Number: EJ1685) on 18Dec2020 IM in her right deltoid muscle at single dose for COVID-19 immunisation at age of 42-year-old. She said when she received her first dose, the person who administered the shot used a 3-finger width distance from her right shoulder bone when administering the vaccine into her right deltoid muscle. She said after receiving the first dose, it was about 9 hours later before her right shoulder hurt. The patient received the second dose on 06Jan2021. She said at least half of the vaccine came out of her arm (came out at the injection site), so she did not receive the full second dose. She said when she received her second dose, the person who administered the vaccine used only a 2- finger width distance from her left shoulder, and administered the vaccine very high up on her left arm. She said her left, upper arm became bruised and sore within an hour after receiving the second dose of vaccine. She said her left arm is still hurting today, clarifying she had a muscle soreness, like from a flu shot. The events did not require a visit to emergency room or physician office. The outcome of events was not recovered. The reporter considered the relatedness of vaccine to all events was related, and considered event her left, upper arm became bruised and sore/ muscle soreness, like from a flu shot as not serious.
42 2021-01-14 itchy skin 10min post vaccine, patient reported feeling flushed, hot, and sweaty. No SOB nor difficulty breath... Read more
10min post vaccine, patient reported feeling flushed, hot, and sweaty. No SOB nor difficulty breathing. BP 132/82 normally 110/60s. HR 70. 30 min post vaccine, palms felt itchy and slightly more sweat but overall improved. Within the hour, symptoms resolved and patient returned to work
42 2021-01-14 injection site pain After normal soreness at the injection site, she started with tenderness under in the axillary area.... Read more
After normal soreness at the injection site, she started with tenderness under in the axillary area. States no change in skin; however, is tender to palpate or to have clothes rubbing
42 2021-01-14 hives, vaccination site pain Hives; Left arm 0.3mL/ sore ness on the arm Left; This is a spontaneous report from a contactable co... Read more
Hives; Left arm 0.3mL/ sore ness on the arm Left; This is a spontaneous report from a contactable consumer (patient). A 42-year-old (also reported as "41") female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248, Expiry Date: 30Apr2021, 3 mcg/ml), via an unspecified route of administration on 08Jan2021 08:40 at 0.3 mL, single dose at left arm ("Dosage text: Left arm 0.3mL") for COVID-19 immunization. Medical history included asthma. Concomitant medication included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA, reported as "BREO") for asthma. The patient was given 0.3mL, 30mcg of the COVID vaccine. The patient experienced sore ness on the arm left on 08Jan2021 and hives on 09Jan2021. She is calling about the Covid Vaccine, she got it on Friday 08Jan2021 at 8:40AM and she went home got soreness in arm (began the same day), it was a couple hours after at 10 or 11 and it stopped on Sunday 10Jan2021. She took pain killers. She woke up Saturday morning, and her whole body has broken out in hives, she has been taking Benadryl around the clock. She broke out in hives on 09Jan2021, it is still ongoing, its in between, she is still scratching and taking the Benadryl. Therapeutic measures were taken as a result of the events which included pain killers and Benadryl. The outcome of the event sore ness on the arm left was recovered on 10Jan2021, of hives was not recovered. She has never had a positive test for COVID prior to the vaccine. She has had an Antibody test 4 times and each time it was negative, she had her last antibody test in Nov2020. She has had no issues with vaccines in the past.
42 2021-01-14 cellulitis I developed cellulitis that evening on my right foot.
42 2021-01-14 injection site pain I experienced injection site pain in the left upper arm which seemed intense. I woke up at 0100 wit... Read more
I experienced injection site pain in the left upper arm which seemed intense. I woke up at 0100 with severe body aches, cold sweats and shivering. It was hard to walk the body aches were horrible. I checked my temp and it was 100.3 F
42 2021-01-14 hives Nausea and headache the evening of the vaccine. Chills, headache, aches and pains, nausea late that... Read more
Nausea and headache the evening of the vaccine. Chills, headache, aches and pains, nausea late that night into the early morning. Day 6 after receiving vaccine, lymph nodes swollen. Worsened on day 7 and 8. Day 8 after vaccine noticed hives on back. Still have headache and nausea off and on.
42 2021-01-14 rash, rash with redness Red blotchy rash to face and chest
42 2021-01-14 skin warm, injection site redness Right axillary swelling, pain and warmth, redness at the injection site. Treatment: Tylenol, heat. O... Read more
Right axillary swelling, pain and warmth, redness at the injection site. Treatment: Tylenol, heat. Outcome: Able to move extremity with difficulty. Able to complete ADLs with out difficulty . No improvement with treatment. Will continue to monitor.
42 2021-01-14 shingles Shingles dash developed within 3 days of the vaccine; This is a spontaneous report from a contactabl... Read more
Shingles dash developed within 3 days of the vaccine; This is a spontaneous report from a contactable nurse (patient) reported that a 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730, expiration date: not reported), via an unspecified route of administration on the left arm on 18Dec2020 16:45 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cyanocobalamin-tannin complex (B12 [CYANOCOBALAMIN-TANNIN COMPLEX]), ginkgo biloba and colecalciferol (VITAMIN D [COLECALCIFEROL]). Within 3 days of the vaccine, on 21Dec2020, the patient developed shingles rash with outcome of recovered. As treatment, patient received antiviral medication for 7 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 19Dec2020. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible; information about lot number was already obtained.
42 2021-01-14 redness, itchy skin Swelling red tender and very itchy.
42 2021-01-15 rash chills, followed by body aches and fever, rash on left arm- continued to develop on right arm and ne... Read more
chills, followed by body aches and fever, rash on left arm- continued to develop on right arm and neck/chest
42 2021-01-15 injection site pruritus fever, chills, & rigor for 24 hrs un resolved with ibuprofen muscle soreness and stiffness at inject... Read more
fever, chills, & rigor for 24 hrs un resolved with ibuprofen muscle soreness and stiffness at injection site for 4+ days itching at injection site for 7 days
42 2021-01-16 injection site hardening "I received my 2nd Covid vaccine on the morning of 1.14.21 in my left arm. Early yesterday morning I... Read more
"I received my 2nd Covid vaccine on the morning of 1.14.21 in my left arm. Early yesterday morning I awoke with chills and sweats. No fever. Felt crummy all day. Today I have left shoulder and arm pain, swelling in my left armpit and under my arm. I also have some numbness and tingling through my arm down to my hand. I have a hard knot at the injection site but its not red. I also continue to have occasional chills."
42 2021-01-16 injection site pain On 1/15/21, the day of the shot I had slight nausea, a sore arm around the injection site and fatigu... Read more
On 1/15/21, the day of the shot I had slight nausea, a sore arm around the injection site and fatigue in the evening. On 1/16/21, day two I had nausea after eating breakfast, extreme fatigue, muscle aches and joint pain. I also had a sore throat and odd sour taste in the morning, both days following the shot. This morning, day 3 I feel tired with less aches.
42 2021-01-17 hives, itchy skin About 20 minutes after Dose 1 of vaccine administration, pt developed urticaria to neck. Denies SOB,... Read more
About 20 minutes after Dose 1 of vaccine administration, pt developed urticaria to neck. Denies SOB, resp difficulty, swelling of oral mucosa. Visual inspection of upper torso and extremities, no further urticaria noted. 5 minutes later, urticaria more pronounced. Pt sent to convenient care. pt presented with hives in the neck, slightly itchy. Pt denies respiratory distress, swollen lips, swollen tongue. Pt does have a history of asthma and has been on prednisone many times. Pt had urticarial rash with erythematous patches on anterior chest that are blanchable. No welts anywhere. No rashes anywhere else. Pt was given diphenhyramine 25 mg IM x 1 and rash/itchiness started to get better. Pt discharged home with a prescription for prednisone 40 mg PO QD x 5 days and instructions to take diphenhydramine Q6h PRN. Pt already on loratadine. Pt instructed to f/u with PCP.
42 2021-01-17 rash Employee reported palpitations 5 minutes after vaccine was administered then began having rash on ch... Read more
Employee reported palpitations 5 minutes after vaccine was administered then began having rash on chest and tingling in lips and face. Benadryl 25mg and Epi-pen were administered. Symptoms got better and employee went home. Had to go back to Emergency Room for tingling all over and flushing to face.
42 2021-01-17 injection site pain, injection site rash, injection site pruritus Malaise, headache, muscle aches and all over body pain, fever of 101 (I think higher but that was hi... Read more
Malaise, headache, muscle aches and all over body pain, fever of 101 (I think higher but that was highest documented), arm pain in the arm I got the shot. I took Tylenol every 6 hrs for about 36 hrs. My fever "broke" and didn't return in the middle of the night on day 2. After that (so on day 2) my arm is still sore and I developed a red swollen, itchy rash about the size of my fist on my shoulder. I also have lymphadenopathy in the arm pit area that is making the whole arm and down that side sore and painful.
42 2021-01-17 hives Patient reports she stared experiencing hives 10 min after 2nd dose, was held in observation room fo... Read more
Patient reports she stared experiencing hives 10 min after 2nd dose, was held in observation room for high BP and was given 2 doses of Benadryl, was sent home after 1 hr, 2nd day reports severe HA which resolved same day with Aleve, today 1/18 reports still experiencing hives & continues to take PO Benadryl daily
42 2021-01-18 hives Hives on chest
42 2021-01-18 injection site pruritus, injection site pain, injection site redness, injection site warmth Mild (L) deltoid tenderness at injxn site on 1/11/21. (L) deltoid warmth, erythema, pruritis on 1/13... Read more
Mild (L) deltoid tenderness at injxn site on 1/11/21. (L) deltoid warmth, erythema, pruritis on 1/13/21-1/14/21. Self resolved. Developed another warm/red/itchy patch over injxn site on 1/17/21-1/18/21. No relief w/ Hydrocortisone cream
42 2021-01-18 itchy skin, rash, redness mild redness; mild swelling; itchy; burning; swelling to the eye; mild rash around her left eye; Thi... Read more
mild redness; mild swelling; itchy; burning; swelling to the eye; mild rash around her left eye; This is a spontaneous report from a contactable nurse reported for herself. This 42-year-old female patient (No pregnant) received the second dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 08Jan2021, 10:45 AM on Right arm at single dose for covid-19 immunisation. Medical history included juvaderm under her eye approximately 1 year and half to two years ago. Prior to vaccination, the patient did not diagnose with COVID-19. No Allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at age of 42-year-old on an 18Dec2020, 11:15 AM on Right arm at single dose for covid-19 immunisation. Day after the 2nd dose, the patient had a mild rash around her left eye only on 09Jan2021. 3rd day (11Jan2021) swelling to the eye. The day of this report is 4 days post vaccine (12Jan2021), the patient mild redness mild swelling but remain itchy and burning. The patient did not report to her dr as the symptoms seem to be resolving on its own. No covid tested post vaccination. No treatments were received. Outcome of the events was recovering. Information on the lot/batch number has been requested.
42 2021-01-19 itchy skin, injection site pruritus 5 mins: mild site itching 15mins: whole body itching mod 20 mins: tongue swelling, coughing 25 mins:... Read more
5 mins: mild site itching 15mins: whole body itching mod 20 mins: tongue swelling, coughing 25 mins: difficulty swallowing, tight breathing Pt was given 2nd round of 25 mg benedryl, epinephrine, Prednisone, albuterol breathing treatment and monitored for 3 hours. Sent home on 5 day course or prednisone
42 2021-01-19 itchy skin About 12 hours after injection I went to bed. No side effects noted during the day. During the nigh... Read more
About 12 hours after injection I went to bed. No side effects noted during the day. During the night I had insomnia for the entire night. Also noted excessive itching to entire body. No hives or welts. Still itching this morning
42 2021-01-19 redness, injection site pain DEVELOPED RED RASH (1" IN DIAMETER). PAIN AT INJECTION SITE. GAVE 25MG DIPHENHYDRAMINE AND MONITORED... Read more
DEVELOPED RED RASH (1" IN DIAMETER). PAIN AT INJECTION SITE. GAVE 25MG DIPHENHYDRAMINE AND MONITORED FOR 30 MINUTES AND THEN RESOLVED.
42 2021-01-19 injection site pain EE statement "I was given the COVID vaccine on Friday Jan 8th at around 12:30 pm. I starting tasting... Read more
EE statement "I was given the COVID vaccine on Friday Jan 8th at around 12:30 pm. I starting tasting metal in my mouth about an hour after the vaccine was given. Saturday 1/9, I woke up at 4am with left sided face numbness from my forehead to the middle of my neck. I also had a headache and some right arm pain at the site of the vaccine. These symptoms continued through Monday 1/11 when I reported to the Emergency Room at. I had a CT scan completed and release with negative results. I had a COVID test completed on Tuesday 1/12. I had an MRI on Wed 1/13 with negative results. I seen my primary physician on Thursday 1/14 as a follow-up. I was informed that I had a reaction to the vaccine and that my symptoms would properly last for 2-3 weeks, marked as Bells Palsy and put on prednisone. Today, I still have some left face numbness and my taste is coming back."
42 2021-01-19 hives Small hives around neck, face, tingling in lips.
42 2021-01-19 hardening Swollen lymph node under left arm- dime size, hard to touch, tender to touch
42 2021-01-19 itchy skin within 10 minutes of vaccine. I became nauseous, vertigo. BP 86/87 HR 90 I became very itchy all ov... Read more
within 10 minutes of vaccine. I became nauseous, vertigo. BP 86/87 HR 90 I became very itchy all over & I asked for Benadryl. I was taken to the ED dept. I was given zofran 4mg and Meclizine for vertigo and IV after 4 hrs. I Was told to go home and sleep it off. I've home with joint pain, muscle aches, nausea, abdominal pain, foggy mind, tiredness, weakness. Saw my PCP today. Rest, zofran and meclizine PRN hydration and rest.
42 2021-01-20 itchy skin 14 hours later I woke up seeing black spots and felt trembly. My BP was 187/92 and my pulse was 120.... Read more
14 hours later I woke up seeing black spots and felt trembly. My BP was 187/92 and my pulse was 120. I went home from work and became itchy to my neck and arms . At about 20 hours later I became short of breathe and pulse standing would go up to 140. I rested and continued taking Motrin and Tylenol as suggested . I ate minimally despite nausea . I messaged my Dr the next AM. By that time my glucose was settling down to normal and my Bp and pulse . The headache got worse and I had a pain in my axilla on the same arm I received the vaccine. I developed ?lymphadema? in that area which is sore to touch or move my arm. I reached out to infectious disease Dr at the hospital I work at and he suggested to continue Tylenol and Motrin and wait a week as this is due to vaccine. It is now Day 3 following vaccine and I am yet unable to work. My arm and axilla area is sore and I can?t lift my arm without pain, I have headaches and nausea as well.
42 2021-01-20 rash, itchy skin Itchy skin, rash on face, neck, upper chest, and upper back.
42 2021-01-20 vaccination site swelling, vaccination site redness Joint tightness/tightness of her joints and muscles; Muscle tightness/tightness of her joints and mu... Read more
Joint tightness/tightness of her joints and muscles; Muscle tightness/tightness of her joints and muscles; Tiredness/felt tired; fast heartbeat; Difficulty breathing; Dizzy; Nausea; Joint pain; Muscle pain; she was not feeling well; swelling and tightness in her left arm; swelling and tightness in her left arm; Injection site redness/redness of her left arm and injection site swelling; Injection site swelling; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date unknown), via an unspecified route of administration in upper left arm, on 08Jan2021 09:25, at single dose, for COVID-19 immunization, in a public health department. There were no medical history and concomitant medications. The patient did not receive prior vaccinations within 4 weeks. The patient reported she received the COVID-19 Vaccine on Friday, clarified as 08Jan2021 at 9:25 in her left upper arm. She stated experiencing a little bit of side effects since receiving the COVID-19 Vaccine. Shortly after receiving the COVID-19 Vaccine, on 08Jan2021, she was not feeling well. She said she had swelling and tightness in her left arm that started approximately a half hour (30 mins) after receiving the COVID-19 Vaccine on 08Jan2021. She then experienced redness of her left arm and injection site swelling on 08Jan2021. On 10Jan2021 (at night), she felt tired, and had tightness of her joints and muscles. She also experienced a fast heartbeat, and difficulty breathing last night, 10Jan2021. She said her dizzy feeling, nausea, tiredness, and joint and muscle pain were persisting at the time of the report. She reported she thought she was feeling fine up until Sunday, 10Jan2021. She stated her new symptoms started in the late afternoon, and the symptoms have stayed into the morning of 11Jan2021. She reported having previously scheduled a doctor's appointment for 22Jan2021 and will speak with her doctor at that time if she continues to have symptoms. The patient declined treatment for the events. The outcome of the events are joint stiffness, muscle tightness, fatigue, dizziness, nausea, arthralgia and myalgia was not recovered; peripheral swelling, musculoskeletal stiffness, heart rate increased and dyspnea were recovering; vaccination site erythema and vaccination site swelling were recovered on an unspecified date; and malaise was unknown.
42 2021-01-20 vaccination site pain Tiredness; muscle and joint pain; muscle and joint pain; injection site pain; nausea; multiple swoll... Read more
Tiredness; muscle and joint pain; muscle and joint pain; injection site pain; nausea; multiple swollen lymph nodes in the side of neck that are painful and the size of llama beans, nickels and dimes; multiple swollen lymph nodes in the side of neck that are painful and the size of llama beans, nickels and dimes; I fell like I have a bad flu; This is a spontaneous report from a contactable Nurse (patient). A 42-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: Ek5730, intramuscularly in left arm on 18Dec2020 10:30 AM at single dose for COVID-19 immunisation. Facility type vaccine was hospital. Medical history was none, no known allergies. The patient didn't have COVID prior vaccination. Concomitant medication in 2 weeks included ibuprofen, phentermine, paracetamol (TYLENOL), valacyclovir. The patient didn't have other vaccine in four weeks. The patient experienced tiredness, muscle and joint pain, injection site pain, nausea, multiple swollen lymph nodes in the side of neck that were painful and the size of llama beans, nickels and dimes. She felt like she had a bad flu. Adverse events start date was 02Jan2021 08:30 AM. It was unknown if treatment was received for the events. COVID was not tested post vaccination. Outcome of the events was recovering. The patient received the second dose of BNT162B2, lot number: Ek9231, intramuscularly in left arm on 08Jan2021, 06:15 PM.
42 2021-01-20 rash Vaccine received on Jan 18-- Jan 19th- body aches, fever,fatigue jan 20th- body aches, fatigue jan ... Read more
Vaccine received on Jan 18-- Jan 19th- body aches, fever,fatigue jan 20th- body aches, fatigue jan 21st-rash on left hand/arm- left arm pain
42 2021-01-20 hives minor allergic reaction; small hives on her thumb; skin was sensitive; This is a spontaneous report ... Read more
minor allergic reaction; small hives on her thumb; skin was sensitive; This is a spontaneous report from a contactable consumer reported for herself. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration at the right arm on 12Jan2021 15:15 at single dose for Covid-19 immunization in a hospital. Medical history included hyperthyroidism, allergies to medication, allergies to food. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included unspecified medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Jan2021 07:30, the patient thought she was having a minor allergic reaction, she had some small hives on her thumb earlier and her skin was sensitive. The patient has not been tested for COVID-19 since the vaccination. The patient did not received treatment due to the events. The outcome of the events minor allergic reaction, small hives on her thumb, and skin was sensitive was recovering. The reporter considered the events non-serious which did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect. Follow-up activities are possible, information on the batch number has been requested.
42 2021-01-20 injection site redness, injection site swelling, injection site warmth redness/swelling/warmth to injection site - right upper arm
42 2021-01-21 itchy skin, dry skin, skin warm 12/30/2020 Four hours after vaccination - left arm soreness, mild headache above right eye. Client ... Read more
12/30/2020 Four hours after vaccination - left arm soreness, mild headache above right eye. Client improved that evening. 1/20/2021 Four hours after second vaccine dose - Body aches, intense headache over right eye, The evening of the same day - Heaviness to left arm, increased pain to left arm radiating to hands, tightness to the left arm with a feeling of "electricity" in the arm. The pain increased in intensity to the left arm during the night. Unable to sleep due to intense pain to the left arm and axilla. 1/21/2021 In the morning, client experienced abdominal pain and diarrhea once (loose stool). She noted swelling to the left axilla, intense pain, swelling below the left jawline. 1/22/2021 Early morning nausea without emesis, itching of the right forearm and nape of the neck, throbbing pain to left axilla with itching, throbbing to the left ear, which has not been sensitive to pain due to deafness.
42 2021-01-21 itchy skin, rash Severe nausea, chills, joint pain, muscle aches, headache, itching. Still have the rash from prior v... Read more
Severe nausea, chills, joint pain, muscle aches, headache, itching. Still have the rash from prior vaccination so have MD visit later today for the nausea and rash/itching.
42 2021-01-21 rash nausea, rash, joint pain, muscle aches
42 2021-01-22 injection site pain Almost exactly 12 hrs after 2nd vaccine, had chills, moderate headache, nausea. Able to sleep but in... Read more
Almost exactly 12 hrs after 2nd vaccine, had chills, moderate headache, nausea. Able to sleep but in the AM had severe headache, nausea, malaise, muscle aches, soreness at injection site
42 2021-01-22 injection site pain, injection site tingling At minute 35 after the shot, I felt enough heaviness & pain near the injection site to take a 400 mg... Read more
At minute 35 after the shot, I felt enough heaviness & pain near the injection site to take a 400 mg Advil max. At minute 45 after shot, I began to feel light tingling under my skin near the injection site, which slowly progressed to my elbow then my shoulder then my wrist, then to my neck and chin (all on left side) at which point I asked the HCP who gave the shot if I should take an antihistamine, she asked me if I was having trouble breathing and I said no, she recommended I take 500 mg of Benadryl 3x every 8 hrs. I took the dose about 75 min after my shot, by which time I felt tingling in my foot and pain in my wrist, slight feverishness. Fell asleep, woke up 4.5 hrs after the shot. The tingling sensation was gone. Only some drowsiness and pain in my arm. Applied ice pack to arm, took 250 mg Benadryl at 9.5 hrs after shot and woke up next morning with negligible symptoms, mild arm pain.
42 2021-01-22 injection site pain, injection site redness, injection site mass Fever up to 100 degrees Extreme Fatigue Sore muscle with arm movement Pain to touch at injection sit... Read more
Fever up to 100 degrees Extreme Fatigue Sore muscle with arm movement Pain to touch at injection site Redness/ knot at injection site
42 2021-01-22 injection site pain Tenderness at injection site for approximately 3 days, vertigo like dizziness for 2 days (started ro... Read more
Tenderness at injection site for approximately 3 days, vertigo like dizziness for 2 days (started roughly 2 hours after vaccine was administered), moderate to severe headache for 2-3 days, also slightly lethargic for 2-3 days after injection.
42 2021-01-23 sensitive skin Blurred vision, headache, disorientation, fatigue, chest pain, chest pressure, shortness of breath, ... Read more
Blurred vision, headache, disorientation, fatigue, chest pain, chest pressure, shortness of breath, severe muscle and joint pain, hypertension, tachycardia, severe skin sensitivity, abdominal epigastric pain and spasms, severe cough, dizziness, lightheadedness. Reaction symptoms were not all immediate and developed over next 3 days requiring evaluation and treatment in the ER. I required decadron injection to stop inflammatory response and was sent home on oral decadron. I am still experiencing symptoms but not as severe. I have to take my albuterol inhaler so I can breathe easier. My monocytes count was elevated.
42 2021-01-23 hives Hives
42 2021-01-24 injection site pain 12/23/20 1st dose: very sore arm at injection site 1/14/21 2nd dose (lot: EJ1686): sore arm at injec... Read more
12/23/20 1st dose: very sore arm at injection site 1/14/21 2nd dose (lot: EJ1686): sore arm at injection site, extreme fatigue, high fever (103), shaking, muscle/body aches, nausea
42 2021-01-24 itchy skin About 8 minutes into shot, I got rapid heartbeats, sudden fatigue, chest pain, shortness of breath, ... Read more
About 8 minutes into shot, I got rapid heartbeats, sudden fatigue, chest pain, shortness of breath, and itching. I was taken to the hospital where I received Benadryl and compazine in an IV for nausea and headache and to fight reaction. Released at 5pm. Next three days felt like I was having panic attacks, very jittery, tired, body aches, nauseated, and a headache. Felt extremely bad. Today first day about to focus and fill out paperwork. I had COVID 10/27/2020. Fought it for 32 days and was given colchicine for paracarditist.
42 2021-01-24 skin warm, hives, pain of skin, injection site redness, redness, skin hardening Approximately 12 hours after receiving the second dose of Covid I begin having chills. Shortly after... Read more
Approximately 12 hours after receiving the second dose of Covid I begin having chills. Shortly after that I also experienced nausea bodyaches headache lack of appetite dizziness as well as a sore arm with redness at the injection site. My arm is red, warm to touch, firm and has gotten slightly larger since day 2. It is now day 4 and I still have this red welt on my arm that is tender to touch. The other symptoms resolved after 24 hours.
42 2021-01-24 injection site redness, injection site warmth, injection site swelling, injection site pain, injection site mass Chills, Fever (101.5F) lasted for 10-12 hours, pain at injection site, painful arm from elbow to sho... Read more
Chills, Fever (101.5F) lasted for 10-12 hours, pain at injection site, painful arm from elbow to shoulder, red swelling at injection site and hot to the touch, fatigue, and minor body aches. Pain at injection site started first at around 4pm on the day of the 2nd dose(Th). I woke the next morning (Fri) with arm pain and a little tired. Later that day around 4pm the fatigue, chills and fever started. Fever hit 101.5F overnight and then the fever broke by the morning (Sat). I felt a little tired on Sat, but all that remained as pain, redness and the feeling of a knot at the injection site (improved from Fri). Today (Mon) the knot still remains and the pain is gone. Slight pink around injection site, but much better.
42 2021-01-24 injection site pain I had soreness on the injection site and then about a week later I woke up with swollen glands/lymph... Read more
I had soreness on the injection site and then about a week later I woke up with swollen glands/lymph nodes on my left side, on my neck, on my chin and hey were tender and mobile. I consulted with my PCP who ordered some labs but all came normal.
42 2021-01-24 hives No initial symptoms other than a sore arm when i got my second shot on 1/8. On 1/21/21 started with ... Read more
No initial symptoms other than a sore arm when i got my second shot on 1/8. On 1/21/21 started with hives, uticaria, and mild angioedema that has not yet subsided despite having received treatment. was told it could be a late reaction and that i should report it.
42 2021-01-24 vaccination site pain Numbness to the left side of my face from the bottom of my eye to the middle of my neck; headache; m... Read more
Numbness to the left side of my face from the bottom of my eye to the middle of my neck; headache; metal taste in my mouth; some soreness at the site; diarrhea; This is a spontaneous report from a contactable Other HCP (patient). A 42-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular in the right arm on 08Jan2021 12:30 at single dose for COVID-19 immunisation at doctor's office/urgent care. Medical history was none. Concomitant medication included losartan (unknown manufacturer). On 09Jan2021 at 04:00 the patient experienced numbness to the left side of her face from the bottom of her eye to the middle of her neck, headache, metal taste in her mouth, some soreness at the site and diarrhea with outcome of not recovered. The events resulted in Emergency room/department or urgent care visit. The patient underwent sars-cov-2 test: negative on 11Jan2021, and computerised tomogram and magnetic resonance imaging with unknown results on unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19.
42 2021-01-24 itchy skin itching and the sensation of shortness of breath on vaccination date of 1/13/21.
42 2021-01-25 rash macular, rash with redness Allergic reaction; Red, blotchy rash on face and chest; Red, blotchy rash on face and chest; This is... Read more
Allergic reaction; Red, blotchy rash on face and chest; Red, blotchy rash on face and chest; This is a spontaneous report from a contactable health professional reported for herself. A 42-year-old non-pregnant female patient received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL1283), via an unspecified route of administration in the right arm on 11Jan2021 at a single dose for COVID-19 immunization. The patient was vaccinated in a hospital facility. Medical history included type 2 diabetes, hypothyroidism, and multiple food and med allergies. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient is taking unspecified concomitant medication/s (received within 2 weeks of vaccination). The patient previously received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL1283) in the right arm on 21Dec2020 05:00 PM at a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Jan2021 12:45 PM, the patient experienced allergic reaction of red, blotchy rash on face and chest. The adverse events resulted in emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. The patient received Benadryl/prednisone as treatments. The outcome of the events was recovering. The events were considered non-serious.
42 2021-01-25 rash macular, redness From top of leg to bottom turned red. No itching or burning. Skin is blotchy and red. Still occurrin... Read more
From top of leg to bottom turned red. No itching or burning. Skin is blotchy and red. Still occurring. County came in and administered the vaccine.
42 2021-01-25 rash, itchy skin Itchiness throughout body, swollen shots on wrists and under feet, tiny dots on arms Now resolved
42 2021-01-25 itchy skin My initial reaction was headache, body aches, and brain fog, lasted about a day and half. Then abou... Read more
My initial reaction was headache, body aches, and brain fog, lasted about a day and half. Then about a week later i started just itching on my for arms and torso. I have little bumps and they itch. It comes and goes.
42 2021-01-25 injection site redness, injection site pain ON 1/25/21 AT ABOUT 1145 PM PATIENT HAD REDNESS TO SITE OF INJECTION , SORENESS TO SITE , CHILLS, MU... Read more
ON 1/25/21 AT ABOUT 1145 PM PATIENT HAD REDNESS TO SITE OF INJECTION , SORENESS TO SITE , CHILLS, MUSCLE ACHES,, TROUBLE WITH RANGE OF MOTION OF NECK , FATIGUE, HEADACHE, NO SHORTNESS OF BREATH, REDNESS DID NOT SPREAD, NO RASH , NO CHEST PAIN, NO FEVER, PATIENT STATES WILL FOLLOW UP WITH HER PROVIDER. PATIENT EDUCATED ON ER FOLLOW UP OR PCP IF SYMPTOMS GOT WORSE , VERBALIZED UNDERSTANDING
42 2021-01-25 shingles Onset of shingles 16 days after 1st covid vaccine over L1 dermatone, mild discomfort with only a few... Read more
Onset of shingles 16 days after 1st covid vaccine over L1 dermatone, mild discomfort with only a few vesicles. No prior shingles outbreaks or known triggering factors. Treated with a course of Valtrex
42 2021-01-26 injection site pain About 7 hours after I started to get migraine/sinus pain Dizzy Exhausted Arm pain at injection site ... Read more
About 7 hours after I started to get migraine/sinus pain Dizzy Exhausted Arm pain at injection site Fever and chills that rolled in and out The above symptoms lasted for three days. The extreme exhaustion lasted for 9 days. I was sleeping the whole night and taking 2-3 naps throughout the day for 2-3 hours.
42 2021-01-26 injection site pain Exhaustion Migraine Pain at injection site My lips went numb My hands went numb Nauseous I slept fo... Read more
Exhaustion Migraine Pain at injection site My lips went numb My hands went numb Nauseous I slept for 16 hours
42 2021-01-26 rash, shingles Herpes Zoster (Shingles)- tingling, rash, sharp shooting pains all on left side of face. Acyclovir 1... Read more
Herpes Zoster (Shingles)- tingling, rash, sharp shooting pains all on left side of face. Acyclovir 1 GM tablet TID
42 2021-01-26 injection site redness, injection site mass, injection site swelling Patient developed a quarter sized lump at injection site the days after receiving the injection. Thi... Read more
Patient developed a quarter sized lump at injection site the days after receiving the injection. This was raised and red according to patient's report. It persisted for 4 days and resolved on its own. Patient also developed muscle aches, fatigue, and slight headache. These persisted for 1.5 days.
42 2021-01-26 injection site pruritus Sore Arm, itching on spot of Inj, headache , sore throat, chills, body ache, feeling very weak. Sti... Read more
Sore Arm, itching on spot of Inj, headache , sore throat, chills, body ache, feeling very weak. Still have headache not as severe and weakness a little less but still have all symptoms except chills.
42 2021-01-26 vaccination site itchiness, vaccination site swelling, vaccination site redness Swelling and redness and itching at injection site; Swelling and redness and itching at injection si... Read more
Swelling and redness and itching at injection site; Swelling and redness and itching at injection site; Swelling and redness and itching at injection site; product=COVID 19, brand=Pfizer, dose 1 administration date: 27Dec2020, dose 2 administration date: 13Jan2021; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 42-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 13Jan2021 at 17:00 at a single dose for COVID-19 immunization. Relevant medical history included thyroid cancer. The patient has no known allergies. Concomitant medications included thyroid (ARMOR THYROID) and ibuprofen (ADVIL). The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: expiry date: unknown) on 27Dec2020 at 10:00 A.M., in the left arm for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. The patient has not been tested for COVID-19 since vaccination. On 14Jan2021 at 09:00 A.M., the patient experienced swelling and redness and itching at injection site. The patient did not receive treatment for the events. Outcome of the events was recovering. Information on the lot/batch number has been requested.
42 2021-01-26 skin warm, injection site pain Within a few minutes right hand and forearm (shot arm) was numb then tingling and neck got hot. On ... Read more
Within a few minutes right hand and forearm (shot arm) was numb then tingling and neck got hot. On the drive home developed a headache. No fever. Day 2 migraine like headache most of the day and numb right hand when woke up, shot sight sore Day 3 better slight headache, shot site sore Day 4/5 woke both mornings by migraine like headache that went to neck (neck and shoulder pain) Day 6 okay so far
42 2021-01-27 itchy rash, rash, rash papular 4 days after second dose of Pfizer vaccine developed raised itchy rash on both arms and some on stom... Read more
4 days after second dose of Pfizer vaccine developed raised itchy rash on both arms and some on stomach. Began in the evening. Took some Benadryl and used some triamcinolone cream on itchiest raised areas. Went away in a couple hours. Rash returned the next evening about 24 hours later. Had not redosed with antihistamines or anything in between. Again dissipated with Benadryl and a little bit of triamcinolone cream. Took Claritin or Zyrtec doe next 4 days and rash never returned. Had not done or eaten anything different other than vaccine that could think of. Have not had rash like this before. Also in case important, had fairly strong expected reaction starting about 12 hours after vaccine w that includes fever up to 101.5, chills, myalgia, and headache. Had to have a covid test to go back to work due to fever which was negative. I just haven?t seen a lot of delayed hypersensitivity rashes (presuming thats what is) with Pfizer vaccine so thought would report.
42 2021-01-27 injection site pain After 10 days, still have fatigue and facial and scalp tingling (comes and goes). Pain in injection... Read more
After 10 days, still have fatigue and facial and scalp tingling (comes and goes). Pain in injection site reoccured overnight (night 10) and injection site is sore to the touch after 10 days. New feeling of some leg weakness today. First seven days included fatigue, chills, facial/scalp tingling, headache.
42 2021-01-27 vaccination site warmth, vaccination site pain Arm sore at injection site; Hot to touch at injection site; Knot at injection site; Slight fatigue; ... Read more
Arm sore at injection site; Hot to touch at injection site; Knot at injection site; Slight fatigue; Joint pain worse than normal; Occasional headache; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3248), via an unspecified route of administration in left arm, on 12Jan2021 at 10:30, at a single dose, for COVID-19 immunization. The patient's medical history included rheumatoid arthritis, eczema, depression, anxiety, slipped disc in back, overweight, and allergies to sulfa and latex. The patient had unspecified concomitant medications. The patient previously took the first dose of BNT162B2 (Lot Number: EJ1685) on 21Dec2020 (10:00 AM), for COVID-19 immunization (left arm). The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 13Jan2021 at 4 AM, the patient experienced arm sore, hot to touch, and knot at injection site; slight fatigue; joint pain was worse than normal; and occasional headache. No treatment was administered for the events. The patient has not been tested for COVID-19 post-vaccination. The patient had not recovered from the events.
42 2021-01-27 rash Headache 4 days, Fatigue 4 days, Rash X3 weeks, and Dizziness 4 days
42 2021-01-27 rash Rash on arms, abdomen, and back; This is a spontaneous report from a contactable other HCP. A 42-yea... Read more
Rash on arms, abdomen, and back; This is a spontaneous report from a contactable other HCP. A 42-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), intramuscular in left arm on 15Jan2021 16:00 at a single dose for covid-19 immunization. There were no relevant medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included vitamin d nos (VITAMIN D NOS), ascorbic acid (VITAMIN C), and fish oil (FISH OIL). The patient previously received the first dose of bnt162b2 on 26Dec2020, lot number: EH9899, in left arm for COVID-19 immunization. The patient experienced rash on arms, abdomen, and back on 17Jan2021 08:00. The outcome of the event was unknown. The event was assessed as non-serious. Since the vaccination, the patient has not been tested for COVID-19.
42 2021-01-28 rash A rash that was located on the neck,chest and back area; This is a spontaneous report from a contact... Read more
A rash that was located on the neck,chest and back area; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration on 08Jan2021 10:00 at a single dose on right arm for COVID-19 immunization. Medical history included type 2 diabetes mellitus. The patient was not pregnant at the time of vaccination. No known allergies. The patient was not diagnosed with COVID prior to vaccination. The patient's concomitant medications were not reported. The patient experienced a rash that was located on the neck,chest and back area on 08Jan2021 14:00. No treatment was given for the event. The patient has not been tested for COVID post vaccination. The patient recovered from the event on Jan2021.
42 2021-01-28 rash I developed a rash on my arms, stomach and back on Tuesday. I took Benadryl and it was effective. I... Read more
I developed a rash on my arms, stomach and back on Tuesday. I took Benadryl and it was effective. I again developed a rash on Wednesday and Thursday night. Went away with Benadryl. No rash today.
42 2021-01-28 skin warm, injection site rash, injection site warmth c/o weird taste in mouth, warm, rash on chest and right deltoid around injection site only, pt given... Read more
c/o weird taste in mouth, warm, rash on chest and right deltoid around injection site only, pt given benadryl 25mg , water, and ice pack, waited 30 minutes, rash subsided and pt feeling ok
42 2021-01-29 skin tightness 45 minutes after given the vaccine. Severe dizziness, stumbling, couldn't see straight, Had somewha... Read more
45 minutes after given the vaccine. Severe dizziness, stumbling, couldn't see straight, Had somewhat similar reaction to the first dose went down to the Emergency room on 12/31/20. They treated it as vertigo. gave zofran for nausea and valium to calm me down. Was sent home with Meclizine (motion sickness)meds. I am at 9 days after the vaccine administration and still having the vertigo and nausea due to being dizzy. I didn't go to the emergency room right away as I was treating it as they treated the first one. I fell asleep as soon as I got home from work at 130pm. I got the second dose at 0900 on 1/21/21. Fell asleep for several hours. Could barely wake up. Hands and feet were swollen. Couldn't make fists. Feet were tight. Stayed hydrated. since then for the past week I have been taking motion sickness meds the dizziness has not gone away. Went to the Emergency room on 1/28/21 as the symptoms still haven't gone away. They ruled me out for a stroke. I felt completely normal before the vaccine. I had CT scan done, MRI both came back normal. The diagnosis that was the outcome was vertigo.
42 2021-01-29 rash, itchy skin Just noticed a small rash on my right forearm and itching on my back. Lasted for like an hour on and... Read more
Just noticed a small rash on my right forearm and itching on my back. Lasted for like an hour on and off
42 2021-01-30 injection site swelling, injection site pain, injection site redness 1/29/21 4:26p received 2nd vaccine 8:10p became extremely tired 1/30/21 awoke t... Read more
1/29/21 4:26p received 2nd vaccine 8:10p became extremely tired 1/30/21 awoke to low grade temp, pain, swelling, red injection site, headache; rest of the day tiredness, chills, muscle & joint pain, nausea. Taking Tylenol for pain 1/31/21 awoke to low grade temp, tiredness and enlarged right under arm lymph node, size of an egg, very sore, injection site remains red, tender to touch and swollen, taking Tylenol for pain As of 12:49p no temp
42 2021-01-30 rash 12/26/20: rec?d 1st dose Pfizer Vaccine?shortly afterward, she noticed swelling to the affected area... Read more
12/26/20: rec?d 1st dose Pfizer Vaccine?shortly afterward, she noticed swelling to the affected area Jan. 2 & 3: didn?t sleep well Jan. 4: mental fatigued Jan. 7: fever 101.2F, shallow breathing, upper quadrant pain, rash on neck Jan. 8: rash on abdomen; right flank pain?spoke with her Endocrinologist who think reactions are auto-immune related Jan. 15: increased blood pressure?consulted a Cardiologist and was prescribed a medication Jan. 15: had labs drawn?IgG 69 Jan. 28: consulted with a Neurologist who think she may have acute encephalitis related to the vaccine and recommended not to get the 2nd dose
42 2021-01-30 hives Hives
42 2021-01-30 hives Shortness of Breath, Wheezing and Hives
42 2021-01-30 skin warm, injection site warmth, injection site rash, injection site pain, injection site hardening, injection site redness That evening I felt my arm painful, warm to touch and felt like a hard ball at the injection site wh... Read more
That evening I felt my arm painful, warm to touch and felt like a hard ball at the injection site while I was trying to sleep. The next day I looked and saw there was a red circle around the injection size about the size of a quarter, now it?s the size of a silver dollar still red, hot, hard, and painful.
42 2021-01-31 vaccination site pain Pain at injection; headache; fatigue; nausea; chills; brain fog; diarrhea; joint pain; This is a spo... Read more
Pain at injection; headache; fatigue; nausea; chills; brain fog; diarrhea; joint pain; This is a spontaneous report from a contactable other healthcare professional (hcp). A 42-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported), intramuscular on 18Dec2020 16:00 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included depression, anxiety, and known allergies to IVP dye. The patient was not pregnant at the time of the vaccination. The patient had no COVID prior to vaccination. Concomitant medications (reported as other medications in two weeks) included bupropion hydrochloride (WELLBUTRIN), sertraline hydrochloride (ZOLOFT) and unspecified multivitamin. The patient had no other vaccine in four weeks. The patient previously took cefalexin (KEFLEX) but had known allergies. On 19Dec2020 08:00 AM, the patient experienced pain at injection, headache, fatigue, nausea, chills, brain fog, diarrhea, and joint pain. No treatment received in response to the events. The patient was not tested for COVID post vaccination. The outcome of the events pain at injection, headache, fatigue, nausea, chills, brain fog, diarrhea, and joint pain was recovered on an unknown date. Information on the Lot/Batch Number has been requested.
42 2021-01-31 pain of skin, hardening Swollen, hard, painful lymph node on left side of neck. Left clavicle painful to touch and swollen.... Read more
Swollen, hard, painful lymph node on left side of neck. Left clavicle painful to touch and swollen. No redness at site or other symptoms noted.
42 2021-01-31 injection site pain Upper arm sore around injection site; Mild headache; Excessive tiredness; Bad taste in mouth. Sharp... Read more
Upper arm sore around injection site; Mild headache; Excessive tiredness; Bad taste in mouth. Sharp pain in collar bone around during the 15 min waiting period of after injection.
42 2021-02-01 vaccination site itchiness, vaccination site swelling 4 inch in diameter red hot swollen itchy at injection site, started on day 3 and currently on 8 days... Read more
4 inch in diameter red hot swollen itchy at injection site, started on day 3 and currently on 8 days after the vaccine; 4 inch in diameter red hot swollen itchy at injection site, started on day 3 and currently on 8 days after the vaccine; This is a spontaneous report from a contactable nurse. A 42-year-old non-pregnant female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL1283), intramuscular in the left arm on 12Jan2021 at 12:45 PM (at the age of 42-year-old) as a single dose for COVID-19 immunization. Medical history was none. Concomitant medication included ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN). On 15Jan2021, the patient experienced 4 inch in diameter red hot swollen itchy at injection site, started on day 3, and currently on 8 days after the vaccine. The clinical outcome of the events "4 inch in diameter red hot swollen itchy at injection site" was not recovered.
42 2021-02-01 rash After first vaccine had LR rash after second vaccine had Bell?s palsy possible stroke
42 2021-02-01 injection site pain I am going to describe all my symptoms so far in detail. Shortly after the shot in the medical obse... Read more
I am going to describe all my symptoms so far in detail. Shortly after the shot in the medical observation area I experienced mild nausea that went away for the rest of the day. About an hour after the injection, I experienced nasal drainage in the back of my throat that lasted about 30 minutes. 3 hours after my shot, the arm pain at injection site began, followed by 6 hours later moderate to extreme fatigue that did not cause me to be sleepy or drowsy--simply fatigued. I had enhanced sense of taste and smell. On Wednesday, 1/27 I woke up seeming okay and tried to work at my computer from home. I experienced light-headed and dizziness, and a headache that feels like pressure, and sinus pressure at the bridge of my nose. I had to disengage from work. After lunch around 2 PM I had extreme fatigue and had to lie down in bed the rest of the afternoon and evening. I have moderate nausea that comes in goes in waves. This morning, Wednesday, 1/28 I woke up with nausea and ate breakfast with a heightened sense of smell and taste. I logged into work and the lightheadedness and dizziness began again (also sort of in waves, though the headache is more pervasive and less wave-like than the nausea), along with waves of moderate nausea and headache. The arm pain at the sight of injection has significantly abated from a punch to mild pain. The "sinus" or sinus pressure on the bridge of my nose seems only a fraction improved. The headache or pressure has moved from the back of my head to the right side of my head. I had no body aches, but this morning has mild to moderate body aches this morning in my legs and hip bones. 1/29 I woke up with 20%-30% reduced symptoms of nausea and headache, but the dizziness and sinus pressure on the bridge of my nose remain the same. I still have enhanced taste and smell (a sensory plus it's not a distorted or odd enhancement, simply the same flavors and tastes enhanced). The ache that began yesterday in my lower body, my legs still ache, though it feels more like numbness than an ache. I tried doing some stretches which felt good, but my legs still feel the same after stretching. Pain at the site of injection is reduced 90%. There are some strawberries sitting next to me, and I can smell them acutely. Yesterday, 1/30, I woke up with mild nausea and fatigue. This nausea dissipated in the morning, but I felt too fatigued to do Pilates. The waves of dizziness and waves of nausea returned mid-day and I had a low-grade fever of 99.4 (my temp. Tends to run slightly lower than 98.6, as I take it regularly). The pain/pressure in the bridge of my nose has reduced 30%, but still remains. The ache or numbness in my thighs remains the same. This morning, 1/31, my temp is normal at 98.6, but I have mild waves of nausea and moderate waves of dizziness. The pain/pressure on my nose remains the same as yesterday. I have some mild ear pressure. My thigh weakness remains the same. I am too fatigued to attempt Pilates. Acute sense of smell and taste remains the same. The headaches or pressure also seem improved since Saturday 1/30. Monday, 02/01 - ah back to work I woke up with moderate nausea and pretty intense body fatigue and muscle aches in my lower body. I had to work, and I just wanted to crawl back into bed. I worked anyway, also the fatigue tends to worsen mid-day. The dizziness is moderate in waves, and the headache is still mild, along with that mild sinus pressure on my nose. I was in bed after dinner but could have rested all day. 02/02 I awoke with a very mild nausea! The intense fatigue (which worsened several days past my vaccine) was mild. I was ready to attempt my regular Pilates routine, and I did it! My muscle aches are mild to moderate (also, why are my muscle aches mostly confined to my thighs and hips I do have vague pain at the injection site, but its vague, and I use my whole body in Pilates) dizziness waves are back as I sit here typing and get ready to login online to my job staring at the computer screen is jarring to the dizziness waves and reminds me of the mild headache. This is the best I've felt since 1/27 through mid-day I tend to worsen and dizziness that is moderate is disturbing. The heightened sense of taste and smell also seems to have waned a bit in the past two days, back to what I was per usual? I tend to have an acute sense of smell and taste. *I would like it noted in light of new evidence that many people that have had COVID are experiencing intense reactions to the first dose that it is quite likely that I had COVID back in March when my learning center (I work with students age 4-adult, some of which are learning disabled and have autism) emergency closed because a client called to say she was positive for COVID. I had taken her sons temperature the day before. Me, and my two co-workers on my management team were also feeling sick. I had a sore throat and chest pains for approx. a month, but at the time COVID testing was not widely available. Since then, My co-worker has tested positive twice for the antibodies, and her husband, who was also sick at the same time, has tested negative twice. I tested negative once for the antibodies, though given my job, my commute on the subway during rush hour my co-workers positivity, and my intense reaction to the first dose I most likely had COVID. My boyfriend's roommate recently also revealed that he is positive to the antibodies, and he was literally sneezing and coughing in the same room with us this past summer and spring. I think a 2nd dose of the same vaccine will cause fainting and vomiting, and the need for two weeks off of my work. This dizziness is alarming. I'm also thinking not having antibodies means nothing in terms of my body and immune system recognizing the vaccine and the virus, making me more ill than when and if I actually had COVID in March or last year.
42 2021-02-01 rash with redness, itchy rash, hives Pt noted she "tingling" in her left hand and her arms/face/neck became very hot and flushed approxi... Read more
Pt noted she "tingling" in her left hand and her arms/face/neck became very hot and flushed approximately 20 min after injection . This progressed into red itchy bumps she described as "hive - like" 3 hours after vaccine administration. She did not seek medical attention and denies any tongue swelling or difficulty breathing. She took benedryl that helped with the itching. She notes the "tingling" resolved in 6 hours, "flushing" improved in 9 hours and the hives resolved as of 02/01/2021 at 1130 AM.
42 2021-02-01 injection site pain, injection site swelling approximately 15 minutes after vaccine I felt a headache and dizziness. A few hours later I felt my... Read more
approximately 15 minutes after vaccine I felt a headache and dizziness. A few hours later I felt my heart racing, throat swelling, chills,weakness, tired, pain and swelling at injection site(right arm)
42 2021-02-01 rash very tiny rashes on the back of her right hand; cannot see them but she can feel them since they are... Read more
very tiny rashes on the back of her right hand; cannot see them but she can feel them since they are drying , reports it is a burning sensation; This is a spontaneous report from a contactable consumer reporting for self. A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 30Dec2020 (Dose 1) as a single dose, right arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 31Dec2020 in the morning, she had very tiny rashes on the back of her right hand, opposite side of her palm; she received the injection in the right arm. The very tiny rashes were there for 4 or 5 days and then slowly disappeared. Then the same rashes came back again on the same hand. She stated she "cannot see them but she can feel them since they are drying;" she reported it as a burning sensation and she wished she could put something cool on there. At the time of the report, the rashes and burning sensation were going away(recovering). She took a picture of it and she can send that in. She can get the second dose today or tomorrow and wanted to know if it was ok for her to get the second dose. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
42 2021-02-02 itchy skin, skin warm, rash 20 hours after my first injection my entire body broke out into a rash. My skin was warm to the touc... Read more
20 hours after my first injection my entire body broke out into a rash. My skin was warm to the touch and itched. The rash lasted about 8 hours
42 2021-02-02 itchy skin, rash, rash macular 3 days later chest and left neck started to itch and macular red rash. A couple days later she dev... Read more
3 days later chest and left neck started to itch and macular red rash. A couple days later she developed a rash on the bilateral forearm. Rash area. very itchy, blotchy and raised- skin colored.- left greater than right. PMD ( phone visit) gave Benadryl and possibly hydroxyzine ( she is not sure). OTC hydrocortisone cream- no improvement. rash is still present 3 weeks later
42 2021-02-02 rash macular, redness Patient received her 2nd dose of the Pfizer Covid 19 vaccine at 8:30 am. At approximately 9:48 am sh... Read more
Patient received her 2nd dose of the Pfizer Covid 19 vaccine at 8:30 am. At approximately 9:48 am she returned appearing flushed and reporting that she felt very warm and was having trouble cooling down. She appeared 'blotchy' on her upper chest region, but no rash or hives anywhere else on her body. We had her lay down and checked a blood pressure, with a result of 132/70. Cold compresses were applied to the back of the neck and the forehead to help cool her down. Later rotated from the back of the neck to the upper chest/neck region. Patient was observed for 15-20 minutes by the administering pharmacist and nursing staff. During that time she appeared less flushed and redness on the chest region improved. She reported feeling improved and returned to work, with regular checks made by nursing staff to ensure symptoms did not return.
42 2021-02-02 rash Rash to left arm started about 10 minutes after injection
42 2021-02-03 skin discolouration, hives Both hands turned blue; broke out in hives; This is a spontaneous report from a contactable consumer... Read more
Both hands turned blue; broke out in hives; This is a spontaneous report from a contactable consumer (reported for herself). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EK9231; expiry date: not known), via an unspecified route of administration in the right arm on 17Jan2021 09:00 at single dose for COVID-19 immunization. There was no medical history. No known allergies. The patient is not pregnant. Concomitant medication included unspecified multivitamin (other medication taken in two weeks). The patient experienced both hands turned blue, broke out in hives on 17Jan2021 15:30. It was resulted in emergency room/physician office visit. The patient had no COVID prior to vaccination and had COVID tested post vaccination by nasal swab (COVID) on 17Jan2021 with pending result. Therapeutic measures were taken as a result of both hands turned blue, broke out in hives as the patient took Benadryl. The outcome of the events was recovering.
42 2021-02-03 injection site pain Fatigue - within one hour Injection site soreness - 4 hours later Upset stomach/stomach pain/diarrh... Read more
Fatigue - within one hour Injection site soreness - 4 hours later Upset stomach/stomach pain/diarrhea- within four hours, still present after 23 hours
42 2021-02-03 rash, rash macular Fever / Chills / Headache / Nausea all started on the same day as vaccine around 7pm. Resolved after... Read more
Fever / Chills / Headache / Nausea all started on the same day as vaccine around 7pm. Resolved after 36hours. On 1/29 noticed rash from mid neck to shoulder to upper torso, breast, ears. Red and splotchy but not itchy. Rash resolved by 1/30 after a dose of Benadryl.
42 2021-02-03 hives Hives, lethargic, tireness
42 2021-02-03 rash Rash
42 2021-02-03 rash Severe fatigue; body aches; chills; rash; This is a spontaneous report from a contactable Other HCP ... Read more
Severe fatigue; body aches; chills; rash; This is a spontaneous report from a contactable Other HCP (patient). A 42-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL9261, on 17Jan2021 08:30 at single dose on right arm for COVID-19 immunization. Medical history included Insomnia. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient had no Known allergies. Concomitant medications included colecalciferol (VITAMIN D) and hydroxyzine. The patient previously received first dose of BNT162B2 lot number: EL0140 on 27Dec2020 11:15 via Intramuscular route of administration on right arm for COVID-19 immunization. The patient experienced severe fatigue, body aches, chills, and rash on 17Jan2021 22:00. No treatment was received for the events. The outcome of the events was resolving.
42 2021-02-03 vaccination site pain severe body aches; site of injection severely sore; low grade fever; nausea; joint pains; felt terri... Read more
severe body aches; site of injection severely sore; low grade fever; nausea; joint pains; felt terrible like hit by a truck; This is a spontaneous report from a contactable other healthcare professional reporting for a patient. A 42-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) intramuscular at the right arm on 19Jan2021 14:30 at single dose for Covid-19 immunization in a hospital. Medical history was none. Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Historical vaccine included first dose of BNT162B2 via unspecified route of administration at the left arm on 31Dec2020 for Covid-19 Immunization and experienced had small joint pain on unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Jan2021 16:45 (within 3 hours of getting the 2nd shot), the patient experienced severe body aches, site of injection severely sore, low grade fever, nausea, joint pains, felt terrible like hit by a truck. The patient has not been tested for COVID-19 since the vaccination. The patient took Tylenol and didn't work. The outcome of the events severe body aches, site of injection severely sore, low grade fever, nausea, joint pains, felt terrible like hit by a truck was not recovered. The events were considered non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect. Follow-up activities are possible, information on the batch number has been requested.
42 2021-02-05 itchy skin Arm started to itch and neck started to itch
42 2021-02-05 rash Patient experienced a rash within 1 hour of receiving vaccination
42 2021-02-07 injection site pain, skin warm, itchy skin, injection site pruritus, redness 12-30-2020 Erythema, soreness and itching on right arm below the injection site. 12-31-2020 Nausea. ... Read more
12-30-2020 Erythema, soreness and itching on right arm below the injection site. 12-31-2020 Nausea. Itching and erythema. Ears began to swell and became hot and red. Face and neck uncomfortable. Took Benadryl when went to bed at midnight. 1-1-2021 In evening began severe itching and erythema form head to breasts including arms which lasted three hours. Right eat internal soreness. 1-2-2020 Fifteen minutes after eating began sudden stomach crapms and then larger amounts of diarrhea and vomiting. Later had another episode of vomiting and diarrhea. Felt weak with labored breathing, chills, Fever 100.2, another bout of diarrhea and vomiting. Productive cought that started in the evening with clear mucous.
42 2021-02-07 skin warm, rash, skin irritation, skin burning sensation, rash with redness PFIZER-BIONTECH COVID- 19 VACCINE EUA. PATIENT REPORTS RED RASH ON CHEST/NECK AREA THAT APPEARED 20... Read more
PFIZER-BIONTECH COVID- 19 VACCINE EUA. PATIENT REPORTS RED RASH ON CHEST/NECK AREA THAT APPEARED 20-30 MINS FOLLOWING VACCINATION AND WORSENED OVER A COUPLE OF DAYS. PATIENT DESCRIBES RED AREA AS HOT, BURNING AND IRRITATED LIKE SUNBURN OR BLISTERED. NO SWELLING OR ITCHING NOTED.
42 2021-02-07 itchy rash, rash Pfizer-BioNTech COVID-19 Vaccine Patient received 2nd dose of vaccine on 1/6/2021. Was sick the fol... Read more
Pfizer-BioNTech COVID-19 Vaccine Patient received 2nd dose of vaccine on 1/6/2021. Was sick the following 5 days with fever, dizziness, chills, severe malaise, and mild cough. Symptoms subsided after 5 days and rash developed from back of head, down the neck, back, chest, arms and hip. The rash progress over the last few weeks and it became extremely itchy and dispersing throughout the body. Saw Dermatologist and he said it was systemic reaction from the vaccine
42 2021-02-07 vaccination site swelling, vaccination site warmth Severe swelling surrounding injection site; hot to touch surrounding injection site; This is a spont... Read more
Severe swelling surrounding injection site; hot to touch surrounding injection site; This is a spontaneous report from a contactable 42-year-old female Health care professional who reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Fck9231) intramuscular at single dose for COVID-19 immunisation on 11Jan2021 at 12:00 pm. Relevant history included allergy with sulfa. Relevant concomitant drugs included lamotrigine (LAMICTAL), propranolol. The patient was not pregnant at the time of vaccination. The patient experienced severe swelling, hot to touch surrounding injection site since 11Jan2021 at 13:00. Symptoms remained for 11 days after administration. No treatment was received. The outcome of events was resolving. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19. Since the vaccination, the patient had not test for COVID-19.
42 2021-02-07 vaccination site pain Temp between 99.5 to 100.5 degrees Fahrenheit; Achy; Headache; Injection site pain; Difficulty lifti... Read more
Temp between 99.5 to 100.5 degrees Fahrenheit; Achy; Headache; Injection site pain; Difficulty lifting arm; stiff neck; Feeling of having the flu; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL8982/expiration date: not provided), via intramuscular route of administration, on 13Jan2021 at 09:15 AM (at the age of 42 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included gastritis, and COVID-19. The patient had known allergies to Bactrim. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medication included omeprazole 20mg daily, cetirizine hydrochloride (ZYRTEC) 10mg daily, vitamin D3 200 IU daily, and bifidobacterium bifidum, bifidobacterium lactis, lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lactobacillus casei, lactobacillus paracasei, lactobacillus plantarum, lactobacillus rhamnosus, lactobacillus salivarius (PROBIOTIC 10) 20 billion live probiotic cultures. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Jan2021 at 10:30 PM, the patient experienced temperature between 99.5 to 100.5 degrees Fahrenheit, achy, headache, injection site pain and difficulty lifting arm, stiff neck and feeling of having the flu. All symptoms lasting 48 hours. The events were reported as non-serious. The patient did not receive any treatment for these events. The outcome of the events temperature between 99.5 to 100.5 degrees Fahrenheit, achy, headache, injection site pain and difficulty lifting arm, stiff neck and feeling of having the flu was recovered on an unspecified date in Jan2021. Since the vaccination, the patient had been tested for COVID-19 which included a blood test on 21Jan2021 which was negative.
42 2021-02-07 injection site pruritus, injection site pain at first I had the expected reaction and feeling of being "hungover" on night after vaccine, 7pm on ... Read more
at first I had the expected reaction and feeling of being "hungover" on night after vaccine, 7pm on 1/29/2021. I felt better overall in 24 hrs, but I've continued to have mild arm pain at injection site. Now, over a week and a half later, on 1/8/2021, I have mild itching at injection site and moderate arm pain. V-safe check-in site I was using has stopped actively sending my daily checkins after a week, switching to weekly check-ins instead.
42 2021-02-07 skin warm blood pressure skyrocketed; body was really hot touch; Dizziness; Shortness of breath; Headache; Thi... Read more
blood pressure skyrocketed; body was really hot touch; Dizziness; Shortness of breath; Headache; This is a spontaneous report from a contactable consumer(patient). The 42-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 22Jan2021 13:10 at single dose for COVID-19 immunization. Medical history included ongoing injury to right foot. Concomitant drug included Steroid from 21Jan2021 and ongoing for injury to right foot. There was no prior Vaccinations within 4 weeks. On 22Jan2021, the patient experienced blood pressure skyrocketed and body was really hot touch with outcome of recovering, dizziness and shortness of breath with outcome of recovered on 22Jan2021, headache with outcome of not recovered. Patient went to Emergency Room for all events on 22Jan2021. It was reported that Patient received the first dose of the Covid-19 vaccine today. Patient had a severe reaction and went to the Emergency Room. Her blood pressure shyrocketed. She experienced dizziness, her body was really hot. You could feel it to touch. She had a headache and shortness of breath. Then She was given Benadryl, Zofran and steroids at the Emergency Room, no physician office. She was released because she was going home and going to bed. Information about Lot/Batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
42 2021-02-07 vaccination site pain injection site soreness; low grade fever; whole body muscle soreness; fatigue; headache; malaise; Th... Read more
injection site soreness; low grade fever; whole body muscle soreness; fatigue; headache; malaise; This is a spontaneous report from a non-contactable healthcare professional. A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EK9231, via an unspecified route of administration on 19Jan2021 10:00 at a single dose in left arm (Dose 1) for COVID-19 immunization. The patient was not pregnant. The patient did not receive any other vaccine in the 4 weeks prior to COVID vaccination. Medical history included irritable bowel syndrome, herniated disc issues, and migraine. There were no known allergies. The patient was not diagnosed with COVID prior to vaccination. Concomitant medication included tramadol, colecalciferol (VITAMIN D), vitamin C, magnesium, and probiotics. On 20Jan2021 at 14:00 , the patient experienced injection site soreness, low grade fever, whole body muscle soreness, fatigue, headache, and malaise. There was no treatment received for the events. The outcome of the events injection site soreness, low grade fever, whole body muscle soreness, fatigue, headache, and malaise was recovering. The patient was not COVID tested post-vaccination. No follow up attempts are possible. No further information is expected.
42 2021-02-07 shingles, rash rash across left Breast, under arm and across back on Sunday 1/31/21 @2100, dr visit on 2/2/21 diag... Read more
rash across left Breast, under arm and across back on Sunday 1/31/21 @2100, dr visit on 2/2/21 diagnosed with shingles . Started Valacyclovir 1gm Three times a day for 7 days. Emergency Room to follow up on dissemination of shingles 2/5/21, blood work no IV course needs. Given prednisone to take at home if needed , not taken
42 2021-02-08 itchy skin, redness After receiving dose one on Saturday Jan 30 2021 I was okay and a few days later about a week I noti... Read more
After receiving dose one on Saturday Jan 30 2021 I was okay and a few days later about a week I noticed swelling and redness on my left arm where the shot was administered. It itches really bad. I scratched it several times and then put rubbing alcohol on it to ease the itchiness. Currently my left arm is still red and swollen and itchy.
42 2021-02-08 itchy rash, rash, rash with redness Itchy red rash all over torso in 2nd to 3rd day. Congestion and repeatedly sneezing until my nose is... Read more
Itchy red rash all over torso in 2nd to 3rd day. Congestion and repeatedly sneezing until my nose is red on 5th day. I have had similar respiratory issues in past but, usually it's something I've breathed in the air. I've been taking Benedryl around the clock and keeping it to myself. Just thought you should know.
42 2021-02-08 itchy skin, redness Red, itchy face with mild burning feeling, swollen throat with itch, and tingling in tongue.
42 2021-02-09 rash Headache; muscle cramps; rash; This is a spontaneous report from a contactable other hcp (patient). ... Read more
Headache; muscle cramps; rash; This is a spontaneous report from a contactable other hcp (patient). This 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot # unknown), via an unspecified route of administration at single dose in the left arm on 13Jan2021 for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), venlafaxine hydrochloride (EFFEXOR). The patient previously took Keflex [cefalexin] and experienced drug allergy. On 13Jan2021, the patient experienced headache, muscle cramps, rash, all with outcome of recovering. No treatment required. The vaccine was administered at Hospital Facility. The patient had not been tested for COVID-19 post the vaccination. The patient was not pregnant at the time of vaccination. Information on the lot/batch number has been requested.
42 2021-02-09 injection site pain I started feeling off within a few hours of receiving the vaccine, but not bad enough to keep me in ... Read more
I started feeling off within a few hours of receiving the vaccine, but not bad enough to keep me in bed. This lasted the first couple days, along with being more tired, a sore throat, and injection site soreness. But I have continued to have a headache and felt lethargic since. Again, I am functioning, just not feeling good.
42 2021-02-09 rash, hives rash; hives; headache; neck pain; stiffness; sore throat; chills; fever; This is a spontaneous repor... Read more
rash; hives; headache; neck pain; stiffness; sore throat; chills; fever; This is a spontaneous report from a contactable nurse. A 42-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration in Jan2021 at single dose for COVID-19 immunization in hospital. The patient medical history was not reported. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications reported as no. Other vaccine in four weeks was unknown. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in Dec2020 at single dose for COVID-19 immunization and experienced no adverse events at 42-year-old. It was reported that 21 days later patient received 2nd dose in Jan2021 - within 1-2 hours after injection developed rash (undescribed to reporter) and hives which scattered across both arms and wrists. 3-4 hours after injection developed severe headache and approximately 12 hours later developed neck pain / stiffness- both lasting 3-4 days. Six hours after injection she reported a sore throat. 24 hours after injection temperature rose to 102 with chills, she took paracetamol (TYLENOL) and fever decreased within 8 hours. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events included paracetamol (TYLENOL). The outcome of the events was recovered in Jan2021. Information on the lot/batch number has been requested.
42 2021-02-10 rash with redness, itchy skin, rash About 10 min post vaccination start feeling tingling in your hands and fingers. Consulted with MD on... Read more
About 10 min post vaccination start feeling tingling in your hands and fingers. Consulted with MD on site that had stated others had complained about same reaction and was told to just observe. At night, I started itching really bad around 10:30PM and then I noticed a rash all over my body, both legs, specifically the right was worse. I also had patches on my arms and shoulders, also my chest and abdominal area. The rash was really read and bumpy. (I took pictures of the progression of the rash if interested). I took Benadryl and it barely helped me. Consulted with Employee Health who told me to consult with her PCP for advice. He prescribed Prednisone for a week and did some labs. And to do a FU in a week. The itching was unbearable. I even have like an electrical shock feeling in my skin since I started with this rash. I still feel it from time to time. On my FU with Dr. he noticed the rash was worse so he made me stop the Prednisone and wanted to do a biopsy from the tissue in my legs. Since I had the Prednisone in my system, I couldn't do it immediately, but was able to do it on 01/22/2021. Got my results the day before yesterday. It showed that I have what is called a Spongiopic dermatitis. Dr called me and prescribed me bleach baths 3 times a week and another antibiotic. I am scheduled for my second dose on 02/16/2021.
42 2021-02-10 redness, hives Employee states she developed a migraine the evening after receiving her 2nd COVID vaccine. She to... Read more
Employee states she developed a migraine the evening after receiving her 2nd COVID vaccine. She took medication which help dull the headache. She woke up the morning of 2/11/21 with hives on her face. She states her face was red and her eyelids swollen. The left eye lid more than the right. Employee took benedryl which helped, but her left eyelid remains red and swollen. Advised employee to contact her PCP.
42 2021-02-10 redness, rash, itchy rash I started to have rash on my right arm with pumps showing up and is very itchy, itchy and redness wi... Read more
I started to have rash on my right arm with pumps showing up and is very itchy, itchy and redness with bumps on the right side of my lower face.
42 2021-02-14 itchy skin, injection site swelling, injection site redness, injection site pain Approx 10- 12 hours after the shot was given, patient was home and in severe pain deep joint and mus... Read more
Approx 10- 12 hours after the shot was given, patient was home and in severe pain deep joint and muscle pain, shivering, sweating, freezing, low grade fever, severely weak, collapsed to the floor the first morning after receiving the 2nd dose shot bc she couldn?t make it back upstairs on her own. Injection site was red and swollen with a defined border. Severe pain at injection site as well. All symptoms listed to this point lasted for 48 hrs. After that severe joint and muscle pain diminished and pain medication (ibuprofen 800mg) was no longer being taken. However, severe arm soreness, tenderness, redness, swelling and itchiness remained/started on day 3. Itchiness spread from only the arm to entire body by day four. Patient went to hospital on day 4 but did not get admitted because they wanted to care for her in the Covid unit without knowing if she had Covid or not. Patient administered self-care by taking Benadryl continuously for approximately 48 hours starting on day 4. She stayed home after attempting to get help from redlands community hospital ER because she didn?t feel comfortable being told she could only get care if she went into the covid unit without a covid test being offered or done to her first. Patient was bedridden and severely sick from February 1 through February 7 2021. Feb 11 2021 patient took a covid test to rule out covid as the reason she felt so bad. Test result for covid was negative.
42 2021-02-15 rash, skin spots I noticed on Thursday afternoon - Petechiae - rash on both legs, one area on arm and abdomen. I wen... Read more
I noticed on Thursday afternoon - Petechiae - rash on both legs, one area on arm and abdomen. I went to Clinic - walk-in care and was seen - the day of the 7th and I went back on the 9th (because more areas popped up). I developed extreme anxiety. The extreme anxiety lasted for about a week. I was seen in ER - twice (Jan 14 and 15)- I was treated with anxiety medicine for anxiety and panic attacks- Essoxer and Xanex. Petechiae rash is still there - lightened up but it's still there some. Did not get the second vaccine per doctor's advice.
42 2021-02-17 vaccination site swelling I now have a large discolored area on my arm post vaccine; I had a large area the was swollen on my ... Read more
I now have a large discolored area on my arm post vaccine; I had a large area the was swollen on my right arm; This is a spontaneous report from a contactable nurse reporting for herself. A 42-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot number EL1283, Expiration date Apr2021, in Hospital, via intramuscular route in right arm on 10Jan2021 at 08:45 (at 42 years of age) at single dose for COVID-19 immunization. Medical history included asthma from an unknown date. The patient was not pregnant at the time of the report. She has not been tested for COVID-19 since the vaccination. The patient had received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot number EJ1685, via intramuscular route in left arm on 20Dec2020 at 10:00 AM. There were no concomitant medications. On 15Jan2021 the patient experienced a large discolored area on her arm and a large swollen area on her right arm. She wrapped it and applied an ice pack for 10 minutes on day 5 post vaccination. The darker area appeared after she iced it and has not gone away. The reported event had not resolved yet at the time of the report.
42 2021-02-17 itchy skin Itching and feeling off over a week post second dose. The following day I was extremely tired and we... Read more
Itching and feeling off over a week post second dose. The following day I was extremely tired and weak. By that evening, day 9 or 10, I began vomiting followed by horrible diarrhea that lasted about 12 hours. I never thought it was related to the vaccine until I heard from others that had the same symptoms days after their vaccine.
42 2021-02-17 vaccination site pain fatigue; chills; mild persistent headache (checked but, no fever); severe arm soreness at injection ... Read more
fatigue; chills; mild persistent headache (checked but, no fever); severe arm soreness at injection site/could not lift arm; severe arm soreness at injection site/could not lift arm; This is a spontaneous report from a contactable healthcare professional (patient). A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration at right arm on 08Jan2021 at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The patient had no allergies to medications, food, or other products. Concomitant medications included ethinylestradiol, levonorgestrel (ALESSE) for birth control, ascorbic acid, biotin, boron citrate, calcium pantothenate, calcium phosphate, choline bitartrate, chromium picolinate, colecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, inositol nicotinate, potassium iodide, pyridoxine hydrochloride, retinol palmitate (VITAFUSION WOMEN'S) and cetirizine. The patient previously received BNT162B2 (COVID Pfizer) first dose in Dec2020 for COVID-19 immunization. On 09Jan2021, the patient experienced fatigue, chills, mild persistent headache (checked but, no fever), severe arm soreness at injection site and could not lift arm. Symptoms began about 12 hours after vaccination. The patient did not receive treatment for the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovered in Jan2021. Information on the lot/batch number has been requested.
42 2021-02-18 hives, injection site redness, injection site warmth, injection site rash, injection site pruritus 7 days after injection, I have a red welt about 2" x 4" at the injection site. It is warm to the tou... Read more
7 days after injection, I have a red welt about 2" x 4" at the injection site. It is warm to the touch and itchy. As of today, the size has grown outside of the initial area that we marked on my arm with a pen by about 1/4".
42 2021-02-18 injection site pain I got the shot at noon on Friday, February 12th. Felt pretty well with arm pain at injection site a... Read more
I got the shot at noon on Friday, February 12th. Felt pretty well with arm pain at injection site and flush face the rest of the date. On Saturday, the 13th, I was fatigued, extreme arm pain at injection site, flush face, and cold all day. Sunday, the 14th, much the same as Saturday until evening when extreme dizziness and diarrhea set in. Woke up in the night with extreme dizziness and nausea. All day Monday, 2/15, I had lethargy, lightheadedness, dizziness, flush face, body aches and chills. Tuesday, 2/16, same exact symptoms as Monday. Wednesday, 2/17 was still mild body aches and flush face. Thursday, lesser body aches but still flush face. Today, 2/19, I still have flush face and fatigue.
42 2021-02-18 injection site rash, injection site pain Immediately following the vaccination, I had some site pain. I felt tired that evening and went to b... Read more
Immediately following the vaccination, I had some site pain. I felt tired that evening and went to bed early, sleeping well (Wednesday night). Approximately 20 hours after receiving my 2nd vaccine (10am Thursday), I developed a low fever (99`), extreme lethargy, chills, and overall body aches. These symptoms lasted approximately 13 hours. When my fever broke (approximately midnight Thursday), the body aches and chills went away as well. The next day (Friday), I woke up to significant arm pain, severe headache, tingles in my arm, swollen lymph nodes in my arm pit and neck, as well as a rash on my upper arm around the injection site. These symptoms persisted until Sunday. The rash and swollen lymph nodes disappeared Sunday night/Monday morning. Since Monday, however, the headaches, arm pain, and some tingles in my arm have persisted all week. Motrin curbs the pain of the headaches and arm pain, but as it wears off the pain resurfaces.
42 2021-02-18 hives, rash with redness could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; ... Read more
could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; hives; hard to swallow; weird taste in mouth; a high grade fever over 103, went down on 03Feb2021 to 102, 101, 99, then 98.6; chills uncontrollably; heart racing a bit; joint-muscle pain; headache; dizziness; swollen lymphnodes; red rash on chest/arms/stomach with some hives; This is a spontaneous report from a contactable consumer reporting for herself. This 42-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN9581) on 02Feb2021 at 10:30, in left arm, for COVID-19 immunisation. The first BNT162B2 vaccine dose was administered on 12Jan2021 at 13:30, lot number EL3246, in left arm, for COVID-19 immunisation. Medical history included heart murmur, acute sinusitis, allergies to acetaminophen/oxycodone (PERCOCET), cephalexin (KEFLEX), codeine, trees, pollen, grass, mold, cats, some dogs. The patient had no COVID prior to vaccination and COVID was not tested after vaccination. Concomitant medications were not reported. The patient received the second vaccine dose on 02Feb2021 at the hospital and was monitored for 30 minutes. Within that time her tongue started to be tingly, she experienced fuzzy feeling, tongue swollen a bit with hives, hard to swallow, weird taste in mouth. The nurse on staff walked her to the ED, she was admitted and treated for allergic reaction to the vaccine and received prednisone for 5 days and diphenhydramine (BENADRYL). Epipen if needed. Later that night, on 02Feb2021, the patient had a high grade fever over 103, chills uncontrollably, heart racing a bit, could not lift arm/move body, joint-muscle pain, headache, dizziness, swollen lymphnodes, hard to swallow, every side effect on sheet just really bad. Her fever eventually went down on 03Feb2021 to 102, 101, 99, then 98.6. She still had all other symptoms not as severe, later that night she had a bit of a red rash on chest/arms/stomach with some hives, swallowing was still a bit hard. She continued to take BENADRYL and steroid. 06Feb2021 was her last day of steroid. As of 06Feb2021 she was feeling a bit better with no fever, swallowing a bit hard but other symptoms were less. The events resulted in Emergency room/department or urgent care. Fever resolved on an unspecified date in Feb2021. The other events were resolving.
42 2021-02-19 injection site swelling, injection site redness For 3+ days post injection: Significant lymph node swelling in left armpit, severe swelling and redn... Read more
For 3+ days post injection: Significant lymph node swelling in left armpit, severe swelling and redness at injection site ( walnut sized), 1 day only post injection: mild fever, chills, muscle and joint pain, fatigue
42 2021-02-21 itchy skin, hives Generalized Pruritic hives
42 2021-02-21 hives, itchy skin I developed hives, itching from head to toe and throat felt restricted. I went to 2 ER visits was gi... Read more
I developed hives, itching from head to toe and throat felt restricted. I went to 2 ER visits was given IV and steroids. The symptoms lasted for 6 weeks.
42 2021-02-21 itchy skin, injection site warmth, injection site swelling, injection site redness Itching in arm and torso immediately after injection-took standard dose of Benadryl 24 hours after i... Read more
Itching in arm and torso immediately after injection-took standard dose of Benadryl 24 hours after injection, headache and some fatigue-took Ibuprofen 36 hours after injection, migraine, arm pain, fatigue, nausea-took flexiril, Zofran, and Ibuprofen 48 hours after injection, fever of 101, armpit pain, arm pain, fatigue-took Ibuprofen 72 hours after injection arm swollen in 3"x5" oval, bright red, hot to touch, armpit very tender, mild headache-took Ibuprofen
42 2021-02-21 hives, itchy skin, injection site tingling, redness, rash Patient reports that she received dose one of the Pfizer COVID-19 mRNA vaccine last Friday, February... Read more
Patient reports that she received dose one of the Pfizer COVID-19 mRNA vaccine last Friday, February 5, 2021 at 2:03 PM. She received this here at facility campus vaccine clinic. She felt a strange tingling sensation immediately upon receiving the injection that extended from the injection site across her upper back but otherwise tolerated the injection well. Because of her history of food allergy she was advised to remain at the vaccination clinic for 30 minutes. During that 30-minute wait period she felt generally well however began to develop pruritus at her back in the legs. She did not mention this to the staff at the vaccine clinic and did not look at her skin. The pruritus was not too bothersome and she left the vaccine area after 30 minutes and walked down to our clinic to return to work. Her pruritus intensified very quickly upon returning to her desk and within a few minutes of after her return she went into the bathroom to look at her back and had patches of red, raised, urticarial lesions across her back. She began to feel itchy all over her body. She remained at work and did not take any medication or seek any medical help. She did not look at her legs. The pruritus intensified and when she looked at her skin of her legs approximately 1 or 2 hours later she had developed urticaria essentially head to toe. She had large confluent patches of urticaria at bilateral thighs, urticaria at her face, trunk, arms, legs.   At this point she felt otherwise well. She went home and took 10 mg of Claritin and applied a topical Benadryl cream to her skin. This was not helpful. She had severe pruritus of her eyes and eyelids. She took 50 mg of oral Benadryl which also was not particularly helpful. Sometime in the middle of the night that night she developed chills, felt feverish, and developed intense muscle and joint aches. She took an unknown dose of ibuprofen with minimal improvement in muscle and joint pain. She did have improvement in fever. Following day was Saturday, she spent the whole day in bed in extreme pain. She describes the pain at her wrists as feeling as though "somebody was breaking my bones" with any movement of her wrists. She had pain even laying flat in her bed and had severe pain at all of her joints with movement. She tried taking a flexeril with no improvement. She recalls a T-max of 102 sometime on Saturday or Sunday. At that time she had been taking ibuprofen around-the-clock. She also took 10 mg of Claritin approximately every 4 hours. Each night she also took 50 mg of Benadryl. She continued to experience urticarial skin rash and intense pruritus of the skin. The urticaria waxed and waned during this time. She also developed a fever blister at her lower lip. She spent most of Sunday in bed also. She was feeling a bit better by Monday however still had intense pruritus. Skin rash was much improved at most of her body however she still had mild urticaria at her face. She did not have a fever on Monday but was continuing to take ibuprofen around-the-clock. She discontinued ibuprofen yesterday and has not had fevers or chills since Sunday. At this point her urticaria has essentially resolved. She continues taking claritin 10mg BID to 3 times a day and also 50mg bendaryl at bedtime.   She did not experience any bruising related to this rash however did have excoriation from scratching particularly at her face.   Throughout the course of these days she did not have any episodes of angioedema of the lips, tongue. She denies difficulty breathing, cough, wheezing, shortness of breath, throat tightening, nausea, vomiting, diarrhea, dizziness, lightheadedness, syncope.   She has a history of oral allergy syndrome with peanut. Promethazine has caused diplopia, weakness. Simvastatin caused muscle weakness. She has never had any issues with vaccines. She has been getting a flu shot yearly with no difficulty. Her most recent vaccine was October 8, 2020, quadrivalent influenza vaccine.   No known history of allergy to polyethylene glycol.   No history of chronic urticaria. She takes NSAIDs frequently without any difficulty. She has not taken any NSAIDs prior to receiving this injection or developing this urticaria. She had however taken 10 mg of Claritin prior to receiving this injection.   She has no history of anaphylaxis. She has undergone surgery under general anesthesia on more than one occasion without issue. No history of reaction to stinging insect venom. She receives immunotherapy for inhaled environmental allergens here in our office and has done well with this.   She denies any recent medication changes or new over-the-counter medications.   She has not previously been diagnosed with COVID-19.
42 2021-02-21 hives hx of hives already which worsened responded to antihistamines-Which resolved.
42 2021-02-21 itchy skin itching 10 minutes after administration of vaccine no tongue or lip swelling benadryl 50 mg X1
42 2021-02-22 rash Per patient report, 7 mins after vaccine she felt a head rush and felt faint. had a rash on chest, ... Read more
Per patient report, 7 mins after vaccine she felt a head rush and felt faint. had a rash on chest, increased HR and BP. Given Benadryl, was monitored and released. She felt normal from 2/15 to 2/18. Then on 2/19 she felt dizzy, tongue felt fuzzy, heart rate erratic. Came to the ED. Had normal labs. Vitals normalized. Went home. Thereafter from 2/19 to 2/23, felt dizzy, had erratic heart rate, was light headed and was having a hard time focusing. Came back to the ED on 2/23 and had a HR of 135 and BP of 177/108. Got IV fluids and vistaril. Her HR improved to 119 and her BP improved to 161/98.
42 2021-02-22 itchy skin, injection site redness Pfizer-BioNTech COVID-19 Vaccine EUA: shortly after vaccination patient reported itching and injecti... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: shortly after vaccination patient reported itching and injection site redness. Vital signs within normal ranges except heart rate 102 beats per minute. Patient administered oral diphenhydramine and observed. Symptoms improved and repeat vital signs all within normal ranges. Patient was discharged from vaccine clinic stable with symptom improvement.
42 2021-02-22 injection site pain Site: Pain at Injection Site-Medium, Systemic: Weakness, Error: Wrong Dose of Vaccine - Too High
42 2021-02-23 itchy skin anaphylactic reaction; Flush face with itching; Flush face with itching; throat became itchy; tongue... Read more
anaphylactic reaction; Flush face with itching; Flush face with itching; throat became itchy; tongue tingled; sore/scratchy throat; metal taste in mouth; shakiness (like internal vibration); This is a spontaneous report from a contactable other hcp. A 42-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration arm left single dose on 03Feb2021 08:00 for covid-19 immunisation. Medical history included depression, anxiety, drug hypersensitivity to codeine, sulfa meds, influenza vaccine, food allergy to quinoa. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), colecalciferol (D3), docosahexaenoic acid, eicosapentaenoic acid, tocopherol (OMEGA 3), probiotics. The patient experienced anaphylactic reaction on 03Feb2021 08:30, flush face with itching on 03Feb2021 08:30, throat became itchy on 03Feb2021 08:30, tongue tingled on 03Feb2021 08:30, sore/scratchy throat on 03Feb2021 08:30, metal taste in mouth on 03Feb2021 08:30, shakiness (like internal vibration) on 03Feb2021 08:30. Patient went to Emergency Room and was treated with Benadryl, Pepcid C, Decadron, Epi. The outcome of the events was not recovered. Information on the lot/batch number has been requested; Sender's Comments: Based on the available information, a possible contribution of the drug to the event anaphylactic reaction cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
42 2021-02-23 hives per patient she experienced nausea and pain after 1st dose received on 1/14/2021 patient states that... Read more
per patient she experienced nausea and pain after 1st dose received on 1/14/2021 patient states that after her second dose she experienced facial swelling, hives, chest pain , joint pain and feels tingling in her body
42 2021-02-24 injection site swelling Chills, headache and Fever 100.4 at 9pm on 2/23/2021. Sore arm. Swelling below injection site 2/24/2... Read more
Chills, headache and Fever 100.4 at 9pm on 2/23/2021. Sore arm. Swelling below injection site 2/24/2021. Swelling is spreading further down the arm 2/25/2021.
42 2021-02-24 injection site pain Painful injection site after 10 minutes of injection that lasted for about 2 hours, then it was only... Read more
Painful injection site after 10 minutes of injection that lasted for about 2 hours, then it was only sore. After about 2 hours, I started to had a bad headache and pain and numbness under my left jaw.
42 2021-02-24 itchy skin, rash, skin spots Rash began on left leg on 01/14/21; rash progressively spread to entire both legs and left neck; bec... Read more
Rash began on left leg on 01/14/21; rash progressively spread to entire both legs and left neck; became very itchy and nothing over-the-counter (topical or oral) helped or reversed symptoms; rash continued for over 5 weeks; also experienced dull, around-the-clock headache during this time; On the morning of 02/21/21 awoke to petechial rash on bilateral eyelids, cheeks, left and right neck; went to urgent care; placed on steroids- Steroid IM injection given on 02/21/21, Medrol Dose pack started on 02/22/21- all symptoms resolved quickly with steroid dosing
42 2021-02-24 injection site tingling Right arm and hand felt tingling right away then neck got hot and a headache started within 5 minute... Read more
Right arm and hand felt tingling right away then neck got hot and a headache started within 5 minutes. Monday 2/12 muscle fatigue and joint pain until current date 2/25 (I work out every day. After the first dose I was okay (after headaches subsided) but this time my muscles while working out have been very fatigued and spasm and cramp during workouts. Joints have been sore too)
42 2021-02-24 vaccination site pain tachycardia up to 201; up to BP 210/101; chest pain; Extreme weakness; slept 36hrs; nausea; no appet... Read more
tachycardia up to 201; up to BP 210/101; chest pain; Extreme weakness; slept 36hrs; nausea; no appetite; stomach cramping; headache; site soreness; dizziness; full body aches; chills; diarrhea; This is a spontaneous report from a non-contactable nurse who reported for herself, a 42-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 21Jan2021, at the age of 42 years, at a single dose for COVID-19 immunization. Medical history included depression. Patient had no cardiac history. Patient had no COVID prior vaccination, and was not COVID tested post vaccination. The patient was not pregnant, and not pregnant at time of vaccination. Concomitant medication included celecoxib (CELEXA). On 22Jan2021, the patient experienced extreme weakness, slept 36hrs, tachycardia up to 201, up to BP 210/101, nausea, no appetite, stomach cramping, headache, site soreness, dizziness, chest pain, full body aches, chills, and diarrhea. No treatment was received for the events. The outcome of the events was recovering. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: The reported events including serious events hypertension, tachycardia, and chest pain were likely related to due to plausible temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
42 2021-02-25 itchy rash, itchy skin AT 17:40 -PATIENT STATES SHE HAS SMALL AREA RASH AND ITCH ON RIGHT ARM. NO APPARENT DISTRESS. AT 17:... Read more
AT 17:40 -PATIENT STATES SHE HAS SMALL AREA RASH AND ITCH ON RIGHT ARM. NO APPARENT DISTRESS. AT 17:50 LEFT ARM NOW ITCHES, BUT STILL NO LIPS, TONGUE OR THROAT DIFFICULTIES. AT 18:00 RASH AND ITCH HAS NOT INCREASED. PATIENT HAS BENADRYL AND ZANTAC AT HOME INSTRUCTIONS GIVEN. PATIENT REFUSED TO GO BY DCH ER, BUT WILL STOP AT ER OR MEDCENTER NORTH IF WORSENS BEFORE SHE GOES HOME. NO APPARENT DISTRESS UPON DISCHARGE
42 2021-02-25 itchy skin Itching on neck, arms, face, ears, chest-burning. then tongue, throat itching client treated self wi... Read more
Itching on neck, arms, face, ears, chest-burning. then tongue, throat itching client treated self with 25ml of Atarax saw improvement after 10 minutes; left on own accord.
42 2021-02-26 injection site redness, injection site pain, injection site hives Severe headache, red welt at injection site, pain at injection site
42 2021-02-27 sensitive skin 9 hours after vaccine: Unable to lift arm more than 30 degrees up. 12 hours after vaccine: fatigue... Read more
9 hours after vaccine: Unable to lift arm more than 30 degrees up. 12 hours after vaccine: fatigue 15 hours after vaccine: fever 100.3-100.6. severe body aches. chills. elevated heart rate (100bpm), extreme fatigue. arm pain. unable to sleep 24 hours after vaccine: body aches, fatigue, skin did not want anything on it. general feeling unwell 36 hours after vaccine: fatigue 48 hours after vaccine: no symtoms
42 2021-02-27 injection site hives, hives, injection site swelling Woke up 2 days later with red eyes and hives near the injection site. Throughout the day, the hives ... Read more
Woke up 2 days later with red eyes and hives near the injection site. Throughout the day, the hives traveled down the left side of my body. I sought treatment at Urgent Care. They prescribed 4 mg pack of 5 day steroid. On Saturday morning, the hives returned worse and covered my entire body except my face. The injection arm was swollen and red. I also begin to have shortness of breath. I went to the ER and they gave me an IV of benedryl and prednisone. I was released with another 4 day course but with 20 mg of steroid .
42 2021-02-28 itchy skin, hives Itchy welt 1 inch in diameter about 10-12 hours after vaccination. It then grew to about 6 inches in... Read more
Itchy welt 1 inch in diameter about 10-12 hours after vaccination. It then grew to about 6 inches in diameter by about 36 hours after vaccination. (Covid arm).
42 2021-02-28 vaccination site pain Persistent arm and shoulder pain. Cannot lift arm above shoulder without causing pain. Also painfu... Read more
Persistent arm and shoulder pain. Cannot lift arm above shoulder without causing pain. Also painful when laying on the right side. Symptoms have been present since the day of the vaccine. Initial arm tenderness at the vaccine site has gone away.
42 2021-02-28 rash papular, injection site rash, injection site reaction, injection site redness Red raised circular rash at injection. Treatment: Benadryl Outcome: Rash has not spread, does not in... Read more
Red raised circular rash at injection. Treatment: Benadryl Outcome: Rash has not spread, does not interfere with ADLs.
42 2021-02-28 injection site pain, injection site pruritus, skin warm, hives Warm to the touch red welt that appeared 8 days after the vaccine was received; accompanied by pain ... Read more
Warm to the touch red welt that appeared 8 days after the vaccine was received; accompanied by pain around the injection site and area is very itchy; welt started out around 1 inch in diameter this morning and is currently about 3 inches in diameter.
42 2021-02-28 itchy skin Within 5 minutes of getting the vaccine, felt HR going up. Walked straight for the door as she thou... Read more
Within 5 minutes of getting the vaccine, felt HR going up. Walked straight for the door as she thought fresh air might help. Felt shaky and cold sweats. Was very itchy. No visible rash. Felt a lump in her throat and tightness in her chest. Paramedics sat with her outside. Dizzy and confused and had to sit for an hour before feeling comfortable driving home. Then slept for the entire day. Felt heart palpitations throughout the day. HR was up to 128 at home. 2 days later started to feel better. Felt normal 4 days later.
42 2021-03-01 itchy skin About 10 minutes later become itchy upper body and mild asthma. Vitals taken by observation Medic we... Read more
About 10 minutes later become itchy upper body and mild asthma. Vitals taken by observation Medic were normal. No respiratory distress. After 30 minutes of observation, I left back to my work unit within the hospital and walking back I became dizzy, felt faint and weak. Developed a headache and felt mentally foggy. It lasted about 2-4 hours. No further medical attention seeked at that time. 3 days later at rest at home about 6/7pm, I experienced dizziness, headache, pain to base of neck R side, pain down my spine and lateral back. Numbness to R cheek bone. Twitching to L hand. Numbness, tingling and weakness to L arm. Tightness to chest and back. Emergency department diagnosed degenerative cervical disk disease. Negative on neuro exam.
42 2021-03-01 injection site pain Arm soreness at injection site. Started approx 4 hours after injection. Much worse upon waking. Fati... Read more
Arm soreness at injection site. Started approx 4 hours after injection. Much worse upon waking. Fatigue started next day upon awakening, but got much worse about 19 hours later. Soreness started feeling better 24 hours later, but exhaustion continues.
42 2021-03-01 injection site redness, injection site pruritus, injection site pain Large red circle around the site. Arm very sore and itchy. Taking antihistamine reduced symptoms. Ci... Read more
Large red circle around the site. Arm very sore and itchy. Taking antihistamine reduced symptoms. Circle about 4 inches in diameter.
42 2021-03-01 injection site numbness, injection site pain Received vaccine 1/07/2021. 1/08/2021 had soreness to the injection site and the soreness continues... Read more
Received vaccine 1/07/2021. 1/08/2021 had soreness to the injection site and the soreness continues Numbness then developed 5 days later on 1/12/2021. Numbness starts at the infection site and runs down the arm and numbness extends to the left thumb and part of the left index finger. 1/18 Left thumb ridge started. 1/19/2021 PCP advised take naproxen 500 twice a day, vitamin B12, EKG unremarkable; 1/28/2021 reported to ED 5:00am as began experiencing numbness sensation on the bottom aspect of her face, bilaterally about 4 hours ago while working. Still having persistent numbness in left arm. Arm swelling. CT unremarkable; 1/29/2021 Neurologist believes related to the vaccine and order EMG, treating conservatively; 2/17/2021 had EMG that was unremarkable
42 2021-03-01 rash The next day of vaccine on 1/12/2021 I felt fatigue lasted about 24hrs. Then on the 1/13/2021 I had ... Read more
The next day of vaccine on 1/12/2021 I felt fatigue lasted about 24hrs. Then on the 1/13/2021 I had a rash that started on my breast it moved its way to my back it was pretty much the whole torso. I took Benadryl by the next morning it was gone. Also when I felt very grumpy and I'm not a very grumpy person. I reported to my work so I seen Employee health.
42 2021-03-02 vaccination site pain Bad headache; pain at location of injection; diarrhea; This is a spontaneous report from a contactab... Read more
Bad headache; pain at location of injection; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number E13302), via an unspecified route of administration (arm right) on 15Jan2021 11:30 SINGLE DOSE for covid-19 immunisation, at 42 years old. Medical history reported as none. The patient is not pregnant. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient has no reported allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE), therapy date and indication unknown (received withing 2 weeks). The patient experienced bad headache lasting over 24 hours, pain at location of injection for two days, and diarrhea on 15Jan2021 11:30. Treatment was not given. Outcome of the events was recovered on Jan2021. The reporter considered the events as non-serious.
42 2021-03-02 skin discolouration tingling in vaccine arm grey tinge to hand on vaccine arm fatigue pain across shoulders pain down bo... Read more
tingling in vaccine arm grey tinge to hand on vaccine arm fatigue pain across shoulders pain down both sides of spine - Severe pain to adjust head on pillow or shift in bed even the slightest bit felt no need to blink for a few hours slept from 8pm Saturday until 10am Monday - Sleep was the only way to avoid the pain Alleve didn't touch the pain Tylenol began to help after 24 hours low fever around 100.4 skin was super-sensitive to touch swollen lymph nodes in neck on vaccine side swollen lymph nodes under arm on vaccine side - baseball-sized and painful to the touch
42 2021-03-03 injection site redness, injection site pain, injection site hardening Large area (approx 8cm x10 cm) of redness, induration at injection site, pain, tender to palpation n... Read more
Large area (approx 8cm x10 cm) of redness, induration at injection site, pain, tender to palpation noticed in afternoon, approx. 1730 on day of injection. Continuing through post-injection day 1 and 2 with decrease in size/induration and pain on day 3 but with general myalgia primarily in lower extremities. No fever or chills.
42 2021-03-03 rash macular Lightheaded, heaviness in upper and lower extremities, tightness in throat, blotching rash to neck
42 2021-03-03 itchy skin Pt reported itching on left arm, numbness left hand. MD offered Zyrtec, pt refused.
42 2021-03-03 vaccination site pain Sore arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 42... Read more
Sore arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the right arm, on 02Feb2021 at 10:00 (at the age of 42-years-old) at a single dose for COVID-19 immunisation. Medical history included asthma, allergy to animals, allergy to pineapple, and allergy to raw onion. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications, taken within two weeks of vaccination, included levocetirizine dihydrochloride (XYZAL). The patient previously took ibuprofen (MANUFACTURER UNKNOWN) and experienced allergy. The patient experienced sore arm at injection site on 02Feb2021 at 17:00. The event was reported as non-serious. The patient did not receive any treatment for the event. The clinical outcome of sore arm at injection site was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
42 2021-03-03 itchy skin, rash with redness overall parathesenia, inflammation, red rash, itch, scratchy throat, ?hot throat?, ?warm lungs?, flu... Read more
overall parathesenia, inflammation, red rash, itch, scratchy throat, ?hot throat?, ?warm lungs?, flushing, dizziness; prickly sensations
42 2021-03-04 injection site redness, injection site inflammation 42 year old female left arm was red and inflamed as of 3/5/21. Vitals were normal. Dr's opinon was i... Read more
42 year old female left arm was red and inflamed as of 3/5/21. Vitals were normal. Dr's opinon was it was infected & referred to occupational health for prescription.
42 2021-03-04 injection site pruritus Post vaccination, pt. complaints of L arm pain and numbness, light headedness. VS 108/72, o2 sat at ... Read more
Post vaccination, pt. complaints of L arm pain and numbness, light headedness. VS 108/72, o2 sat at 97% on RA, HR 76. Pt. alert and oriented, with her husband @1139 patient complained of LA and LL numbness and mild itchiness of the injection site. At 11:58 patient said she feels better and is ready to leave the facility, very mild numbness on the left arm. Health teachings provided with emphasis on following up to their PCP for evaluation or calling 911 PRN. Released with Husband.
42 2021-03-06 rash, itchy skin 03/07/2021: After 15-45 mins of receiving vaccine, felt dizzy and light-headed sensation, which subs... Read more
03/07/2021: After 15-45 mins of receiving vaccine, felt dizzy and light-headed sensation, which subsided after 1 hour. Later in the evening, around 19:00 pm; skin started feeling itchy which lasted overnight and adhoc period the next day - would describe ad mild to moderate. presented as fine rash on stomach and tors, itchy back, arms, face around cheeks and jaw line, and ankles. Also felt slightly nauseas from around 10pm on 03/07/2021. On 03/08/2021: Skin itchiness continued, describe as mild. Called Primary care doctor who recommended taking 1 Zyrtec per day to alleviate the itching; registering the adverse reaction, and seeing an allergist prior to considering taking the second dose of Pfizer.
42 2021-03-06 injection site pruritus, injection site warmth, injection site rash Rash around injection site after 5 days. Itchy and hot to touch
42 2021-03-06 hives, injection site pruritus, injection site swelling, injection site reaction Sven days after the 1st shot I experienced swollen, welt, itchiness at the injection site.
42 2021-03-07 vaccination site pain Fever; chills; soreness at injection spot; body and joint aches; body and joint aches; headache; nau... Read more
Fever; chills; soreness at injection spot; body and joint aches; body and joint aches; headache; nausea; eye ache and watery; eye ache and watery; This is a spontaneous report received from a non-contactable consumer (patient). A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9267, expiry date: unknown), via an unspecified route of administration in the left arm, on 13Feb2021 09:30, at single dose, for COVID-19 immunization, at the hospital. There were no medical history and concomitant medications. The patient has no allergies to medications, food, or other products and was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9261, expiry date: unknown) received at 42 years of age, via an unspecified route of administration in the left arm, on 23Jan2021 09:30, at single dose, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 13Feb2021 at 18:00, the patient experienced fever, chills, soreness at injection spot, body and joint aches, headache, nausea, and eye ache and watery. No treatment was given for the events. The patient recovered on an unspecified date in Feb2021. The reporter assessed the events as non-serious. No follow-up attempts are possible. No further information is expected.
42 2021-03-07 rash Fever; chronic headaches; muscle aches; rash; This is a spontaneous report from a contactable consum... Read more
Fever; chronic headaches; muscle aches; rash; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: El9264), via an unspecified route of administration on 05Feb2021 at 10:30 on the right arm at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient had no known allergies. Prior to vaccination the patient has not been diagnosed with COVID-19. Concomitant medication included chlorthalidone (manufacturer unknown), enalaprilat (VASOTEC), levothyroxine sodium (SYNTHROID) and diltiazem (manufacturer unknown). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced fever, chronic headaches, muscle aches and rash on 05Feb2021 at 12:30. The events required a doctor or other healthcare professional office/clinic visit. The patient received unspecified treatment for the events. The patient recovered from the events with lasting effects. The events were reported as non-serious.
42 2021-03-07 injection site swelling, injection site redness, injection site warmth, injection site pruritus On day 9, the injection site swelled, became raised red and splotchy, itchy, and hot.
42 2021-03-07 itchy rash Patient states she developed pain in left armpit and around left breast that started the evening she... Read more
Patient states she developed pain in left armpit and around left breast that started the evening she received vaccination about 9:30 PM. Next day developed left sided torso pain and extreme fatigue over weekend. Noticed today, 3/8/2021, she has a small rash on left side torso that is itchy.
42 2021-03-08 injection site redness, injection site hardening, injection site warmth 30 hours after vaccine a warm, red, hard marking, approximately 3 inched in diameter , appeared at t... Read more
30 hours after vaccine a warm, red, hard marking, approximately 3 inched in diameter , appeared at the injection site. Treatment was Ibuprophen and Ice. The next morning the mark spread, appeared lighter, warm and hard to the touch. As the day progressed my arm felt heavy, by the afternoon my arm and hand (not the red spot) felt cold. That evening my shoulder to my fingertips were numb with a "falling asleep" sensation. I still had control of movement but was unable to feel any touch. I wrapped a heating pad around my arm for two hours, unable to feel the heat, and took Ibuprofen and Benadryl. Around 11:00 that night I was able to feel my pinky finger. Continued to apply heat every 20 minutes for 20 minutes throughout the night and continued with ibuprofen and Benadryl. The next morning I was able to feel my ring finger, the red spot had disappeared, and the hardness was decreasing. That evening, continuing with heat, Ibuprofen, and Benadryl, I was able to feel 4 fingers. Continued into Sunday with same treatment and by Sunday morning I was able to feel my entire hand and wrist. As the day progressed I regained feeling up to my elbow and the shoulder by the night. Monday I discontinued treatment. Had full feeling of my arm, with pain in my elbow and shoulder. Tuesday morning all was back to normal.
42 2021-03-08 injection site swelling Chills, muscle aches, swelling at injection site
42 2021-03-08 itchy rash, shingles, rash On Feb 8, 6 days after dose 1 of the phizer vaccine, I developed a small patch of itchy bumps on my ... Read more
On Feb 8, 6 days after dose 1 of the phizer vaccine, I developed a small patch of itchy bumps on my chest, very slightly to the left of center. On February 14, I developed three more patches of itchy, painful vessicles on my left arm, along a single dermasone. My doctor and I suspected shingles, and the diagnosis was confirmed by a blood test. As of March 9, the patches are still visible but much improved, nearly gone but still a bit red and mildly itchy.
42 2021-03-08 hives Puffy, swollen eyes. Hives all over body. Every single part of my body. Been going on for 36 straig... Read more
Puffy, swollen eyes. Hives all over body. Every single part of my body. Been going on for 36 straight hours now. No relief. Treating with calamine lotion and round the clock benedryl. No breathing issues.
42 2021-03-08 hives Tachycardia, Urticaria
42 2021-03-09 hives Allergic reaction 12 hours after vaccination. Diahrea, hives, flushing, rapid heart rate, swollen li... Read more
Allergic reaction 12 hours after vaccination. Diahrea, hives, flushing, rapid heart rate, swollen lips
42 2021-03-09 itchy skin sensation that something was stuck in her throat (similar to when a tonsil stone is present); Stiffn... Read more
sensation that something was stuck in her throat (similar to when a tonsil stone is present); Stiffness at injection site; Itching; Sore muscle; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL6269), via an unspecified route of administration in the right arm on 06Feb2021 08:15 at a single dose for COVID-19 immunization. The patient's medical history included sulfa allergy. The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced sore muscle on 06Feb2021 23:15, stiffness at injection site on 07Feb2021 04:15, itching on 07Feb2021 04:15, and sensation that something was stuck in her throat (similar to when a tonsil stone is present) on 07Feb2021 08:15. No treatment was received for the adverse events. Outcome of the events was recovering.
42 2021-03-10 rash, hives 20-30 hours post vaccine developed hive on face, then abdomen & chest. This was after 50mg Diphenhyd... Read more
20-30 hours post vaccine developed hive on face, then abdomen & chest. This was after 50mg Diphenhydramine administered. Sandpaper rash 48 hrs post vaccine
42 2021-03-10 redness Faint, hot and red head, painful heart, nausea, shaky, dizziness, weakness, headache,, stiff neck.... Read more
Faint, hot and red head, painful heart, nausea, shaky, dizziness, weakness, headache,, stiff neck.It happened about 20 to 30 seconds after shot. After my bandage was on and we were checking why I hadn't received a text reminder to sign up for 2nd dose. Nurses put me in wheelchair and took me to bed. Kept me for 30 mins. Its been 1.5 hours since shot and I'm still dizzy, weak and I have joint pain. I threw up. I still have headache and my heart still hurts.
42 2021-03-10 itchy skin Itchiness dizziness fatigue headache
42 2021-03-10 injection site pain Significant headache, body aches, and body chills began onset at 8:30 pm and persisted until 12:00 p... Read more
Significant headache, body aches, and body chills began onset at 8:30 pm and persisted until 12:00 pm on Thursday 3/11. Soreness at site of injection also occurred.
42 2021-03-11 injection site pain Extreme muscle soreness at injection site. Headache. Fatigue.
42 2021-03-11 redness Extreme neck pain, difficulty moving neck, gout like symptoms in feet, extreme fatigue, shakiness, f... Read more
Extreme neck pain, difficulty moving neck, gout like symptoms in feet, extreme fatigue, shakiness, flu like symptoms, swollen red knuckles on left hand that were stiff and painful, fainted, dizziness, vision disturbances
42 2021-03-11 injection site pain Pfizer-BioNTech COVID-19 Vaccine EUA Had vaccine shot on Thursday 3/4/21 around 8:50am. The shot spo... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Had vaccine shot on Thursday 3/4/21 around 8:50am. The shot spot was sore for the next couple days and no other symptoms. Then on Sunday 3/7/21 night, I started having pain on the left side of my body (same side where the shot was administered). The pain was mainly from neck to should blade area first for the next couple of days, then it traveled down from my shoulder to my hand. As of the night of Thursday 3/11/21, the pain (comes on when I move my body) gets worse and I was not able to get up from bed without other's assistance. Then throughout this morning Friday 3/12/21, it seems a bit better during the day, with still pain from neck, shoulder, shoulder blade, down to the left arm and hand.
42 2021-03-11 rash macular Pt received vaccine and reported red blotches on arms and started feeling faint. Pt reported dizzine... Read more
Pt received vaccine and reported red blotches on arms and started feeling faint. Pt reported dizziness and headache as well as difficulty breathing. Vitals: 1156 112/71, HR 62; 1208 116/72, HR 62. Pt observed for 30 minutes on stretcher. At 30 minutes, pt reported feeling ok to leave and was wheeled out of facility and ambulated to car.
42 2021-03-12 rash Covid arm rash which went away, but now..... non stop heart palpitations from 5-8pm. Very scary. The... Read more
Covid arm rash which went away, but now..... non stop heart palpitations from 5-8pm. Very scary. These started a few days after the injection. Never had one in my life before this shot.
42 2021-03-14 rash 3-13-21 2:30PM RASH TO FACE & NECK. NO SOB/DYSPNEA, NO PAIN. 2:32PM BENADRYL 50MG PO. 2:36PM STATE... Read more
3-13-21 2:30PM RASH TO FACE & NECK. NO SOB/DYSPNEA, NO PAIN. 2:32PM BENADRYL 50MG PO. 2:36PM STATES SHE IS 'OK AND READY TO GO HOME'. NO ACUTE OR OBVIOUS DISTRESS. A/O X3, PINK, W/D, RESP REG WITH EASE. NO CHANGE IN RASH AT THIS TIME. AMBULATORY, GAIT BRISK AND STEADY. 3-15-21 9:30AM TC: STATES 'RASH IS GONE, EARS STILL FEEL RAW AND STILL TAKING ALLEGRA'. WILL CHECK WITH PCP R/T DOSE #2.
42 2021-03-14 skin hardening Patient reported arms and legs being itchy approx. 10 min post-injection. Administered 50mg Benadryl... Read more
Patient reported arms and legs being itchy approx. 10 min post-injection. Administered 50mg Benadryl orally. Patient also complained of tightness in throat, which improved after Benadryl. Vitals did not indicate anaphylaxis, continued to monitor BP over course of symptom reporting. Also applied ice pack to left forearm and back of neck. EMTs arrived to check vitals and reported no signs of anaphylaxis, inquired if patient wanted to return home or wanted to get higher level of care, and she chose to go to the hospital. There, the providers found no emergent medical issues. Nurse called and checked on patient 4pm same day, the patient reported no issues and all concerns were resolved.
42 2021-03-14 injection site redness Swollen bottom lip Major swelling more than my normal in my legs and hard to move knees Around injec... Read more
Swollen bottom lip Major swelling more than my normal in my legs and hard to move knees Around injection site big red area showed up about 2 weeks after 1st dose
42 2021-03-14 bruising unexplained bruising; hypotension; pale face; diarrhea; facial numbness; nausea; general weakness/Lo... Read more
unexplained bruising; hypotension; pale face; diarrhea; facial numbness; nausea; general weakness/Low energy; dizzy; mild headache/severe headache; Sore arm; tired/Fatigue; This is a spontaneous report from a non-contactable Pharmacist reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), via an unspecified route of administration at right arm on 29Jan2021 13:45 at single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Hospital. The patient's medical history included allergies to Sulfa, PCN, Ceph. Concomitant medications included calcium, colecalciferol (VITAMIN D) and Multivitamin. Patient was not pregnant. On 29Jan2021 07:00 PM: Sore arm, tired at night, 30Jan2021: Sore arm, fatigue, mild headache, 31Jan2021: Fatigue, severe headache, hypotension, pale face, diarrhea, facial numbness, nausea, general weakness, dizzy, 01Feb2021: Fatigue, severe headache, unexplained bruising, facial numbness, nausea, general weakness, dizzy. Employee Health sent patient for COVID testing at 13:20 (result: Negative). 02Feb2021: Fatigue, severe headache, facial numbness, nausea, general weakness, dizzy. 03Feb2021- 12Feb2021: Fatigue, severe headache, facial numbness, nausea, general weakness, dizzy. 11Jan2021: Fatigue, facial numbness. 12Feb2021: Fatigue, severe headache, facial numbness, general weakness. 23Feb2021 - Present: Low energy, intermittent mild-medium headaches. Adverse events resulted in: Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Therapeutic measures were taken as a result of sore arm and headache included Pain relievers. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: Considering temporal association and lacking of alternative explanation, a possible contributory role of BNT162B2 to all reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
42 2021-03-15 bruising Developed Large Bruise on inside calf left leg after 1.5 day.s. Large bruise above inside left ankle... Read more
Developed Large Bruise on inside calf left leg after 1.5 day.s. Large bruise above inside left ankle on day 16 after 1st shot.
42 2021-03-15 hardening, skin warm, redness Immediate large local reaction, 4" area induration/erythema/swelling/tenderness/warmth, no systemic ... Read more
Immediate large local reaction, 4" area induration/erythema/swelling/tenderness/warmth, no systemic sx
42 2021-03-15 rash Patient developed a rash to B\L upper extremities and back area within 15 minutes of vaccination. Pa... Read more
Patient developed a rash to B\L upper extremities and back area within 15 minutes of vaccination. Patient also reported having some itchiness in the throat. Patient given Benadryl 50mg IM, VS monitored and all WNL. Discharged when symptoms improved. Patient is flagged for second vaccine and has/will not received from us. Patient informed about not being able to receive 2nd dose.
42 2021-03-16 injection site pain Sore arm, joint pain, nausea, fever. But later that afternoon EXTREME fatigue set in. I have slept f... Read more
Sore arm, joint pain, nausea, fever. But later that afternoon EXTREME fatigue set in. I have slept for the majority of the last 3 days. I wake up foggy and disoriented. Takes a while to focus and become alert. I use the restroom and maybe I'm able to be active for 15- 20 minutes then I'm back asleep, or too tired to keep my eyes open. Today is the first day I have been able to stay awake more than an hour. I had energy for about an hour and then felt like I was unplugged I'm just too tired to function. All I can do is go back to bed.
42 2021-03-17 rash, hives, dry skin, skin peeling After I received the 2nd vaccine I experienced chills and fatigue for two days. 2 weeks after the 2n... Read more
After I received the 2nd vaccine I experienced chills and fatigue for two days. 2 weeks after the 2nd dose I got a rash of tiny bumps starting around my neck and then spread across my entire body including my scalp. I had inflamed lymph nodes and a cyst near the lymph node was inflamed. The rash continued. I went to my family dr and she gave me 4 days of 20mg prednisone. That helped some. After I finished the medication the rash was healing and then I started having hives that covered my entire body. I am also having 'hotspots' that flare up daily. I have had at least 25 hotspots. my skin stays severely dry no matter what I try. I went back to the dr when the hives started and she gave me a heavy taper down series of prednisone. while it has helped some my body still has hotpots, under the skin is prickly, tingly, and my skin acts like it has been sunburned is is peeling off. I have sores and raw spots randomly over my body. I am also using benadryl to help.
42 2021-03-17 injection site pain Around 10:30pm, about 12 hours after receiving the 2nd injection (no adverse reaction to first), I w... Read more
Around 10:30pm, about 12 hours after receiving the 2nd injection (no adverse reaction to first), I woke up with chills, body aches, and a headache. I also had nausea that came in waves. After the 1st shot, I had minor injection site soreness, but the 2nd shot had soreness and periodic sharp shoulder pain. All symptoms and general fatigue continued throughout Tuesday, the day after the shot. All symptoms subsided Wednesday, except the arm was still sore, with less periodic sharp pain and occasional pain in the left armpit.
42 2021-03-17 skin burning sensation Burning sensation up neck and head after vaccine; severe pain in left arm in underarm area; fatigue
42 2021-03-17 hives Hives surrounding armpit area on both arms
42 2021-03-18 shingles I developed the shingles shortly after my second dose of COVID19 vaccine. See continuation page for ... Read more
I developed the shingles shortly after my second dose of COVID19 vaccine. See continuation page for more information.
42 2021-03-18 itchy skin Patient reported low grade itching almost immediately after the second dose on 3/17/21 and continued... Read more
Patient reported low grade itching almost immediately after the second dose on 3/17/21 and continued though date of incident. Headache started 3/18/21 and continued through date of incident. While sitting at work on 3/19/21, patient reported a sudden onset of sharp pain in her left sternum. CHS Healthcare Paramedic conducted an assessment and reports no dizziness or nausea, clear breath sounds O2 WNL, non-smoker, chest pain with a deep breath and while at rest. Provided 324 mg aspirin and 0.4 mg nitro with no resolution of symptoms. Patient transported to Unity Hospital for further evaluation.
42 2021-03-18 itchy skin Tiredness (1 week), muscle aches (48 hours) torso numbness in the skin (ongoing), itchy torso (ongoi... Read more
Tiredness (1 week), muscle aches (48 hours) torso numbness in the skin (ongoing), itchy torso (ongoing), swollen and sore lymph nodes under left arm (ongoing), large bump on back (ongoing)
42 2021-03-19 injection site pain After the first injection on February 25, about 45 minutes after injection, my lips and throat start... Read more
After the first injection on February 25, about 45 minutes after injection, my lips and throat started to tingle and I had slight trouble swallowing. Around 20 minutes later, all symptoms dissipated. After the second injection on March 18, other than the standard sore arm, I was very achy and fatigued the next day. My right armpit was also sore- I didn?t notice any swelling, just soreness.
42 2021-03-19 hives, rash Pt received her 1st Pfizer Covid vaccine on 3/17/21, but two days later she reported hives. Patient ... Read more
Pt received her 1st Pfizer Covid vaccine on 3/17/21, but two days later she reported hives. Patient reported hives on both of her wrists, Later that day she noticed she had hives on her abdomen and back. That same day in the evening she took some Benadryl and the next day the hives had cleared.
42 2021-03-20 skin warm, rash with redness, rash About 8 days after I received the vaccine, my arm developed a red, lumpy rash that tingles and is wa... Read more
About 8 days after I received the vaccine, my arm developed a red, lumpy rash that tingles and is warm to the touch.
42 2021-03-20 itchy skin Patient reported itching on arm and leg gave patient a diphenhydramine 50mg asked to sit and observ... Read more
Patient reported itching on arm and leg gave patient a diphenhydramine 50mg asked to sit and observed patient for 30 minutes for sign of allergy getting worse, did not get worse advised patient to urgent care or ER, patient got a ride to urgent care per patient
42 2021-03-21 injection site swelling, injection site rash, injection site pain Pink rash below injection site that is painful and slightly swollen
42 2021-03-21 rash maculo-papular, itchy skin Presents to virtual urgent care today with a macular papular rash and significant pruritus over her ... Read more
Presents to virtual urgent care today with a macular papular rash and significant pruritus over her arms and legs. She states this started on Sunday as some itchiness and then the rash has progressed. Patient denies any facial swelling, tongue swelling, throat swelling, difficulty swallowing or difficulty breathing. She has been using Claritin, Zyrtec, Benadryl, and topical cortisone cream with no significant improvement. There is no fevers chills or body aches. Received 2nd dose of pfizer covid vaccine on friday march 12. Advised to continue OTC treatment and monitor for improvement.
42 2021-03-21 rash Progress Notes PA-C (Physician Assistant) ? ? Family Medicine Cosign Needed Expand AllCollapse All ... Read more
Progress Notes PA-C (Physician Assistant) ? ? Family Medicine Cosign Needed Expand AllCollapse All COVID VACCINE CLINIC 3/22/2021 Date: 3/22/2021 Subjective Patient is a 42 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience racing heart and face tingling. She denied rash, difficulty breathing, difficulty swallowing, throat tightness and facial swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms, respiratory distress and skin changes. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, facial swelling, cough, chest tightness, shortness of breath, wheezing, rash, hives, dizziness and headaches +facial tingling: Previous Reactions: Denies Objective Vitals Vitals: 03/22/21 0811 03/22/21 0819 03/22/21 0834 BP: (!) 153/90 134/87 118/85 Pulse: 87 80 80 SpO2: 98% 100% 99% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema. Comments: No swelling or lips or tongue. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Assessment/Plan Treatment included: water and snacks Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Systemic reaction (hypoglycemia, hypotension, generalized rash) Her symptoms completely resolved prior to discharge. PA-C Electronically Signed 3/22/2021 9:02 AM
42 2021-03-21 injection site redness, injection site swelling, injection site warmth, injection site pain Pt reports "I was extremely weak, fatigued, high fever, swollen lymph nodes in my left arm pit and e... Read more
Pt reports "I was extremely weak, fatigued, high fever, swollen lymph nodes in my left arm pit and elbow. my right arm (injection site) is red, swollen, tender and warm to touch"
42 2021-03-21 injection site pain pain at injection site up through neck area and down into forearm chills headache body aches fatigue
42 2021-03-22 itchy skin, hives 90 minutes after vaccine administration, patient developed hives over neck and face and severe itchi... Read more
90 minutes after vaccine administration, patient developed hives over neck and face and severe itching on face, neck, and scalp, as well as a significant lump on the right side of neck; the following morning, severe facial swelling in cheeks and around eyes that made it difficult to open eyes; facial swelling and itching has improved but is still present (as of today, 3/23/21, four days after vaccine); lump on neck is still present but is smaller; patient has been taking Zyrtec, Benadryl, Tylenol, and topical cortisone cream.
42 2021-03-22 itchy skin Pt stated "my left hand is itching." Within a matter of minutes, pt stated, "my whole arm is itching... Read more
Pt stated "my left hand is itching." Within a matter of minutes, pt stated, "my whole arm is itching, now my right arm and legs are itching".
42 2021-03-22 itchy skin Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild
42 2021-03-22 injection site pain Vaccine admin. At 8:38 am at Vaccine Clinic. The nurse (I?ve forgotten her name - boomer aged, shor... Read more
Vaccine admin. At 8:38 am at Vaccine Clinic. The nurse (I?ve forgotten her name - boomer aged, short gray hair) was standing when she administered the vaccine, and I remember making a note of the whole situation because it was the first time that a nurse did NOT say, ?Relax your arm.? I thought that was odd. I felt nauseous and dizzy within 1-2 min., but after my 15 min. Waiting period was up, I was no longer feeling dizzy or nauseous so I left. Within 10 min. I felt an ache in my arm, deep in the bone, and different then the regular shot-site pain. This is a dull ache that is barely tolerable. A few hours later, my shoulders and neck were experiencing very extreme, sharp pain, and I can barely move my arm, neck, and head. It hurts to hold my head up straight. This pain continues for another 2 days. It is a very intense, throbbing ache, and worse after a fitful night of rest, due to the constant pain in my left arm and neck. 48 hours later, still in intense pain and got a massage. Helped briefly but pain returned within minutes. On day 3, I got another more targeted massage on my shoulders and neck, with only a brief amount of time free from the pain. Day 4, the pain is so intense and I can barely handle it. I make an appointment with a APRN. She does not mention SIRVA but prescribes 800mg of Ibuprofen every 4 hours as needed for pain, and Flexeril, a muscle relaxer. She also gave me a shot of Toradol for the pain. The Flexeril makes me drowsy, and the ibuprofen takes the sharp edge of the pain away, but does nothing to mask the dull, deep ache in my left arm and shoulder. Day 5, 6, 7 all the same. On day 7, a new tingling sensation and numbness in my left hand and fingers start. Contacted office again to request a referral for physical therapy, and also to make a note of SIRVA in my file. Got a prescription for a stronger pain medication; neurontin to hopefully make the pain more manageable.
42 2021-03-23 injection site pain 3/22/21 -- vaccine administered at approx 9:35am. Soreness near the injection site in the arm began... Read more
3/22/21 -- vaccine administered at approx 9:35am. Soreness near the injection site in the arm began at approx 4pm. Patient felt significant general fatigue beginning around 7:30pm, a sudden, overwhelming desire to sleep. Around the same time, the patient's upper left arm/shoulder area progressed to being too sore to be able to move the limb independently. Patient felt significant body aches (similar to what is commonly experienced with the flu) and chills by around 11pm and continued experiencing the drastic arm soreness. 3/23/21 -- by 1am, patient experienced mild nausea and also a big headache in addition to the symptoms previously listed. By 7am, the arm soreness had improved significantly, the nausea/chills were gone, but the headache and body aches were still present and significant. By noon, the headache was mostly gone, and the body aches had improved by 50%, and the arm soreness was almost gone. By 5pm, the body aches and headache were finally gone.
42 2021-03-23 injection site redness, injection site pruritus, rash papular, hives Red itchy raised welt at injection site. Welt is gradually receding over time but is still visible o... Read more
Red itchy raised welt at injection site. Welt is gradually receding over time but is still visible one week later. Finger joints on left hand are slightly swollen and sore also.
42 2021-03-23 injection site pain, injection site redness, injection site pruritus Red, sore, itchy spot about 1 inches big at vaccination injection site. Feels a little painful
42 2021-03-23 shingles Shingles showed up 4 days after vaccine on side of my nose... diagnosed by my doctor , I?ve been put... Read more
Shingles showed up 4 days after vaccine on side of my nose... diagnosed by my doctor , I?ve been put on antiviral medication. Nerve pain in my neck/headaches on my right side (same side as shingles).
42 2021-03-23 vaccination site pain swollen lymph nodes; Injection site pain; muscle pain/body aches; feeling unwell; This is a spontane... Read more
swollen lymph nodes; Injection site pain; muscle pain/body aches; feeling unwell; This is a spontaneous report from a contactable Other Health Professional. A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6201), intramuscularly, on 20Feb2021 at 12:00 (at the age of 42-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history included obesity, eustachian tube dysfunction. The patient is allergic to grass (fescue). Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN5318), intramuscularly, on 30Jan2021 at 12:00, intramuscularly in the right arm. The patient was not pregnant at the time of vaccination. The vaccine was administered at a workplace clinic. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were reported as "None." The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Feb2021 at 15:00 the patient experienced Injection site pain, muscle pain/body aches, feeling unwell, swollen lymph nodes. The patient did not receive any treatment for the events. The clinical outcomes of the events vaccination site pain, muscle pain/body aches, feeling unwell, swollen lymph nodes were reported as not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
42 2021-03-24 injection site pain 1) Sore arm at injection site. 2) Very swollen lymph nodes under arm. -took ibuprofen and used an i... Read more
1) Sore arm at injection site. 2) Very swollen lymph nodes under arm. -took ibuprofen and used an ice pack for the lymph nodes.
42 2021-03-24 itchy skin, rash 15 minutes after her vaccination, she started having itching and slight rash. She was given a dose o... Read more
15 minutes after her vaccination, she started having itching and slight rash. She was given a dose of benadryl and observed for 45 minutes total.
42 2021-03-24 vaccination site pain, rash Body aches; fatigue; chills; headache; rash on hands and arms; shaking; soreness at injection site; ... Read more
Body aches; fatigue; chills; headache; rash on hands and arms; shaking; soreness at injection site; This is a spontaneous report from a contactable healthcare professional (patient). This 42-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EN5318) via an unspecified route of administration on 11Feb2021 at 11:00 (at the age of 42-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient did not take any concomitant medications. The patient previously received acetaminophen, propoxyphene (DARVOCET), cephalexin, and pineapple and experienced allergy. The patient previously received dose 1 of BNT162B2 (lot number EL3249) on 21Jan2021 at 11:00 as a single dose in the left arm for COVID-19 immunization. After dose 2 of BNT162B2, on 12Feb2021 at 04:00 the patient experienced body aches, fatigue, chills, headache, rash on hands and arms, shaking, and soreness at injection site. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of body aches, fatigue, chills, headache, rash on hands and arms, shaking, and soreness at injection site were recovered. It was also reported that since the vaccine the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
42 2021-03-24 rash, rash with redness, itchy skin Returned to site after being released post-vaccine, went to car then noted rash to chest area and fa... Read more
Returned to site after being released post-vaccine, went to car then noted rash to chest area and face, +itchiness/warmth to upper extremities. On assessment well appearing, NAD airway intact/denied SOB throat irritation-visible rash (raised/reddened) to ant chest and upper back, warmth to arms bilaterally. Pt requested Benadryl, consultant with on duty Pharmacists who recommended Benadryl-Benadryl 50mg PO give, pt observed x 30 more minutes, all sx's resolved, well appearing. VSAFE hand-out given for self-reporting
42 2021-03-25 injection site pain After shot #1 on 3/5/21: tenderness at injection site lasted for weeks. Fatigue on 3/6/21 only. Inte... Read more
After shot #1 on 3/5/21: tenderness at injection site lasted for weeks. Fatigue on 3/6/21 only. Intermittent heart racing. After shot #2 on 3/25/21: pain at injection site. Severe depression and anxiety lasting the day of injection. Intermittent racing heart. Chills, fatigue, overall malaise starting 3/26/21. Moderate headaches starting 3/26/21. Numbness/tingling in tips of fingers on right hand starting 3/26/21.
42 2021-03-25 hives Hives on face, back, and upper torso
42 2021-03-26 rash In recovery pt stated "felt like numb head to feet I had cough and sore throat past couple days" (s... Read more
In recovery pt stated "felt like numb head to feet I had cough and sore throat past couple days" (spoke broken English Asian decent) brought to recovery area in wheelchair to lie down supine Assess: - LOC, -SOB, - N/V, slight pale - Rash. - facial swelling, - tongue swelling. stated she was anxious to get vaccine Left Deltoid site benign, VS 130/72, HR 95 reg strong, resp 12 reg non labored. Medical called to evaluate. Encouraged hydration, Provided reassurance monitored 1 hr (per pt request) No further symptoms developed. Advised if anything occurs later in day call 911 if life threatening or go to urgent care. sign to V-safe . Ok'd to exit 9:45 am
42 2021-03-26 injection site pain Muscle soreness at injection site, very tired, nausea
42 2021-03-27 injection site bruising Massive headache, dizziness, nausea, throat pain, swelling and bruising around injection site, body... Read more
Massive headache, dizziness, nausea, throat pain, swelling and bruising around injection site, body aches.
42 2021-03-27 rash with redness, rash Patient came to our clinic today because she is concerned with a rash on left left Deltoid appearing... Read more
Patient came to our clinic today because she is concerned with a rash on left left Deltoid appearing one day after she got vaccinated at pharmacy. She has swelling, redness, and pain on the affected site. She was advised to take Benadryl, avoid scratching area. She can also apply cortisone cream instead of scratching area. She was told to monitor and report any symptoms that occur.
42 2021-03-27 injection site bruising, injection site swelling Vaccine injection site high on shoulder. Severe arm pain, injection site bruising and swelling. Ner... Read more
Vaccine injection site high on shoulder. Severe arm pain, injection site bruising and swelling. Nerve pain, fever, muscle soreness, headache, nausea.
42 2021-03-29 redness extreme pain in left side of neck with difficulty moving; fainted; dizziness; Extreme pain in left s... Read more
extreme pain in left side of neck with difficulty moving; fainted; dizziness; Extreme pain in left side of neck with difficulty moving; gout-like reaction in feet; arm pain; fatigue; weakness; body aches; left hand knuckles swelled turned red stiff and painful; left hand knuckles swelled turned red stiff and painful; left hand knuckles swelled turned red stiff and painful; headache; vision disturbances; shakiness; This is a spontaneous report from a contactable other health care professional (patient). A 42-year-old female patient (non-pregnant) received first dose BNT162B2 (Solution for injection, COVID 19, Pfizer, lot number: EN6198) via Intramuscular in Left arm on 04Mar2021 at 10: 45 at single dose for COVID-19 immunisation. Patient medical history included Gluten allergy. Concomitant medications included Phentermine, hydrochlorothiazide, ibuprofen. On 04Mar2021 at 16:00, patient had extreme pain in left side of neck with difficulty moving, gout-like reaction in feet, arm pain, fatigue, weakness, body aches, left hand knuckles swelled turned red stiff and painful, fainted, headache, vision disturbances, shakiness, dizziness. Adverse events was not resulted in Emergency room/department or urgent care. treatment was not given. No covid prior vaccination and no covid tested post vaccination. Outcome of events were not recovered.; Sender's Comments: Based on temporal assosciation, the causal relationship between BNT162B2 and the serious event, syncope cannot be completely ruled out.The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.
42 2021-04-09 injection site discolouration I noticed after my 2nd shot in April 6 that at the 1st injection shot, there is no tissue for about ... Read more
I noticed after my 2nd shot in April 6 that at the 1st injection shot, there is no tissue for about 2 inches wide and at least an inch deep. The starburst brown discoloration is slightly going away..
42 2021-05-04 hives My right arm still has a red welt on it and it' 2/9.; This is a spontaneous report from a contactabl... Read more
My right arm still has a red welt on it and it' 2/9.; This is a spontaneous report from a contactable consumer (patient). A 42-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: En5318), via an unspecified route of administration on 30Jan2021 16:45 as SINGLE DOSE (at the age of 42-years) in Arm Right for covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient did not receive other vaccines four weeks prior to COVID vaccination. The patient did not receive other medications two weeks prior to COVID vaccination. Prior to the vaccination the patient was not diagnosed with COVID-19. On 30Jan2021, the patient's right arm still has a red welt on it and it' 2/9. The patient did not receive treatment for the event. Since the vaccination the patient had not been tested for COVID-19. The outcome of the event was recovered with sequelae on an unspecified date in 2021 (recovered with lasting effects).
43 2020-12-31 injection site pain Soreness at injection site 3 hours post injection. 30 hours post injection, pt experiences a huge bl... Read more
Soreness at injection site 3 hours post injection. 30 hours post injection, pt experiences a huge blood clot from vagina, about the circumference of a clementine. was not old blood, looked like frank blood. over the next 30 hours, pt experiences more clots, much smaller, about the size of a pea. pt has a headache and chills throughout. 48+ hours, experiencing what feels like menstrual cramps. no blood clots 72 hours post injection
43 2021-01-02 vaccination site swelling, vaccination site redness, skin warm, injection site reaction Swelling and redness at site of vaccine. Entire muscle of left arm swollen around injection site for... Read more
Swelling and redness at site of vaccine. Entire muscle of left arm swollen around injection site for 4 days. Painful to touch and hot. Increased tiredness within first 24 hours.
43 2021-01-03 hives, hives Hives
43 2021-01-03 injection site pain Vaccinated 12/19, had injection site pain for 2 days. Then on 12/25, developed cough, congestion, sh... Read more
Vaccinated 12/19, had injection site pain for 2 days. Then on 12/25, developed cough, congestion, shortness of breath, fatigue, muscle aches, chills, and headaches. Starting 12/26, managed symptoms with albuterol 6 times/day. By 12/28 symptoms improved.
43 2021-01-04 skin warm I had lymphadenopathy in my right armpit for three days post vaccine. I used a heating pad to treat.... Read more
I had lymphadenopathy in my right armpit for three days post vaccine. I used a heating pad to treat. I also developed swelling on my right forearm that was hot to touch with pain. I used a heating pad as well on my right forearm and took Tylenol for two days-it resolved.
43 2021-01-04 redness Rushing feeling-hands turned red and warm and face turned red and warm; Rushing feeling-hands turned... Read more
Rushing feeling-hands turned red and warm and face turned red and warm; Rushing feeling-hands turned red and warm and face turned red and warm; redness of hands; Rushing feeling-hands turned red and warm and face turned red and warm; Palpitations-increases heart rate; Palpitations-increases heart rate; Increased blood pressure; This is a spontaneous report from a contactable Nurse. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 24Dec2020 at 04:15 (at the age of 43-years-old) at an unspecified dose in the left arm for COVID-19 vaccination. The patient's medical history was not reported. The patient was allergic to morphine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in a workplace clinic. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Dec2020 at 04:30 the patient experienced a rushing feeling during which her hands turned red and warm and her face turned red and warm. At this same time, she also experienced increased blood pressure, palpitations and increases in her heart. The patient did not receive any treatment for the events. The clinical outcomes of rushing feeling during which her hands and face were warm and turned red, increased blood pressure, palpitations, increased heart rate were reported as recovered on an unspecified date in Dec2020. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
43 2021-01-04 rash, itchy rash Symptoms started day after receiving vaccine. Started with a rash on upper back that itched and burn... Read more
Symptoms started day after receiving vaccine. Started with a rash on upper back that itched and burned for a few days, followed by whole body burning and sweating with rash on lower arms and chest along with continued rash on upper back. These symptoms come and go and are worse on different days. This continues today and I have been advised by my healthcare provider not to receive second dose which was scheduled for today 1/5/21. I did take steroids for two days but then was advised by physician to allow my body to react if I can tolerate the symptoms. Symptoms are tolerable some days but not all. No fever with the burning and sweating. No other symptoms.
43 2021-01-04 rash developed rashes on the chest area, not spreading; This is a spontaneous report from a contactable n... Read more
developed rashes on the chest area, not spreading; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EK5730), via an unspecified route of administration into the left deltoid on 18Dec2020 as the first single dose for covid-19 immunization. Medical history was reported as none. Concomitant medication included rosuvastatin calcium (CRESTOR). The patient developed rashes on the chest area, not spreading on 22Dec2020. The event as reported between not serious and medically significant by the reporter. Details were as follows: and patient was a nurse that had her vaccine through her workplace on 18Dec2020, so she was 10 days out, and noticed a rash on her chest on day 4, which was still present. It did not seem to be spreading, and she could not think of any reason for the reaction. She was scheduled to receive the second dose in three weeks. The outcome of developed rashes on the chest area, not spreading was not recovered. The relatedness of the event to the suspect drug was reported as unknown from the reporter.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of rash. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
43 2021-01-04 rash, shingles rash; shingles; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A... Read more
rash; shingles; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable nurse reported that a 43-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced developed a rash and shingles in Dec2020. The action taken in response to the events for bnt162b2 was not applicable. The outcome of events was unknown. Information about batch/lot number has been requested.
43 2021-01-05 itchy skin, hives Itching and diffuse hives; Itching and diffuse hives; This is a spontaneous report from a contactabl... Read more
Itching and diffuse hives; Itching and diffuse hives; This is a spontaneous report from a contactable nurse. A 43-year-old female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EL0140) as the first dose via intramuscular in the left arm on 30Dec2020 11:45 for COVID-19 immunization. Medical history included multiple allergies. Concomitant medications were not reported. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient had itching and diffuse hives on 30Dec2020 12:15. Emergency department (ED) evaluation. Diphenhydramine hydrochloride (BENADRYL) and steroids prescribed. The event was reported as non-serious. The outcome of the events was recovering.
43 2021-01-05 vaccination site redness, vaccination site warmth, vaccination site itchiness, vaccination site swelling Itching; Redness; Swelling; it felt hot; This is a spontaneous report from a contactable other Nurse... Read more
Itching; Redness; Swelling; it felt hot; This is a spontaneous report from a contactable other Nurse(patient). The 43-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration by injection in the right deltoid on 21Dec2020 at single dose to protect herself from getting COVID. Medical history included ongoing chronic sinusitis , ongoing seasonal allergy. Concomitant medication included ongoing cephalosporin for Chronic sinusitis from 29Dec2020 which was the only thing new that she has been taking, but she had taken it in the past many times, ongoing cetirizine hydrochloride(ZYRTEC) for seasonal allergies, ongoing fluticasone propionate (FLONASE) for seasonal allergies which had been taking this for years. She got her first dose of the COVID vaccine last Monday, the Monday before Christmas on 21Dec2020. Yesterday(30Dec2020), in the exact spot that she received it, she was getting itching, redness, and swelling. She read and was told that that could happen, she just thought it would be sooner rather than 9 days later. She was calling to get this reported. Otherwise, she is fine. She had been using antihistamines and cortisone cream as treatments. She had been taking cetirizine hydrochloride for years. She normally took at night, but because of her arm she took it this morning.Last night(30Dec2020) she also put ice to the are as it felt hot. Outcome of events was not recovered. Events(itching, redness, and swelling) were assessed as non-serious.
43 2021-01-05 itchy skin Pt reported itchiness to her body and dizziness.
43 2021-01-06 hives Hives of right side of body , lower and upper body .. Also in armpits... Sore arm after injection f... Read more
Hives of right side of body , lower and upper body .. Also in armpits... Sore arm after injection for a few days
43 2021-01-06 injection site pain Intense pain at vaccination site, can't use my arm for anything, fever 38.9C that only goes down wit... Read more
Intense pain at vaccination site, can't use my arm for anything, fever 38.9C that only goes down with ibuprofen. Chills, pain all over the body, can't put my feet on the floor because of plantar pain on my feet. Rib pain and axillary pain on my left side, lack of appetite, throat pain, stomach pain
43 2021-01-06 hives, redness, itchy skin Pt received vaccine on 12/18 and developed erythematous, pruritic hives on 12/21. Was rx'd hydroxyzi... Read more
Pt received vaccine on 12/18 and developed erythematous, pruritic hives on 12/21. Was rx'd hydroxyzine without significant benefit (has brief relief is sx but recur before next hydroxyzine dos is due). Pt was seen twice in the ED for these sx. Pt was told sx were related to muscle strain. Pleuritic chest pain and cough. Ongoing cutaneous and respiratory adverse reaction.
43 2021-01-06 rash Rash over my back /neck/torso . Fever /body aches /left lower abdominal pain and cramping /diarrhea ... Read more
Rash over my back /neck/torso . Fever /body aches /left lower abdominal pain and cramping /diarrhea /lower back pain /headache
43 2021-01-06 rash anaphylactic reaction 2 hours post vaccine, given 2 rounds of epi in the ED in addition to allergic ... Read more
anaphylactic reaction 2 hours post vaccine, given 2 rounds of epi in the ED in addition to allergic reaction meds, still with rash.
43 2021-01-06 injection site redness, injection site swelling, injection site pain redness pain edema at inj site
43 2021-01-06 injection site pain report soreness at the injection started on 01/06/21 at 5:pm and today she began with achiness and h... Read more
report soreness at the injection started on 01/06/21 at 5:pm and today she began with achiness and headache with no fever which she states is tolerable at this time. There was no home remedies. continues to work and She will continue to monitor symptoms
43 2021-01-07 rash Developed face and chest rash accompanied by pronounced fatigue and stomach upset on 1/2 lasting two... Read more
Developed face and chest rash accompanied by pronounced fatigue and stomach upset on 1/2 lasting two days; Developed face and chest rash accompanied by pronounced fatigue and stomach upset on 1/2 lasting two days; Developed face and chest rash accompanied by pronounced fatigue and stomach upset on 1/2 lasting two days; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231), via an unspecified route of administration in right arm on 29Dec2020 07:30 at single dose for Covid-19 immunisation. Medical history included rosacea, depression, asthma. The patient was not pregnant. No Covid prior vaccination. No Covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included duloxetine hydrochloride (CYMBALTA), lisdexamfetamine mesilate (VYVANSE), spironolactone and multivitamin. The patient previously took cefalexin (KEFLEX) and experienced allergies: Keflex, rash. The patient developed face and chest rash accompanied by pronounced fatigue and stomach upset on 1/2 lasting two days on 02Jan2021 09:00 on 02Jan2021 09:00. No treatment received for the events. The events was reported as non-serious. No emergency room/physician office visit. The outcome of events was recovered on 04Jan2021.
43 2021-01-07 injection site pain FATIGUE, MALAISE, INJECTION SITE PAIN, VERTIGO, HYPOTENSION
43 2021-01-07 rash Fever, Angioedema, SkinRash & Rash Narrative:
43 2021-01-07 itchy skin Headache, Myalgia, Fever, chills, generalized itching 7 days later Narrative: Took Benadryl and Zyrt... Read more
Headache, Myalgia, Fever, chills, generalized itching 7 days later Narrative: Took Benadryl and Zyrtec for the itching.
43 2021-01-07 itchy skin, redness Itching and redness over whole body/I turned all red and was itching all over my body by about 10:30... Read more
Itching and redness over whole body/I turned all red and was itching all over my body by about 10:30- 10:45 am/I still have mild itching; Itching and redness over whole body/I turned all red and was itching all over my body by about 10:30- 10:45 am/I still have mild itching; Elevated heart rate and blood pressure; Elevated heart rate and blood pressure; Had an allergic reaction; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the first dose of bnt162b2 (BNT162B2) lot no: EK9231, via an unspecified route of administration in left arm on 30Dec2020 09:00 at a single dose for COVID-19 immunization. Medical history HTN and exercise-induced asthma, both from an unspecified date and unknown if ongoing. The patient was not pregnant at the time of vaccination. The patient had no covid prior to vaccination and was not covid tested post vaccination. Concomitant medication included colecalciferol (VITAMIN D), montelukast sodium (SINGULAIR), and biotin. No other vaccines were administered in four weeks. Known allergies include tapendalol (NUCYNTA) and trimethoprim/sulfamethoxazole (BACTRIM). On 30Dec2020 09:30, the patient experienced itching and redness over whole body, elevated heart rate, and blood pressure. The patient was given IV diphenhydramine (BENADRYL) 50 mg, IV famotidine (PEPCID), IV methylprednisolone (SOLU MEDROL), "flui" as treatment for AEs. The patient further clarified that she received the COVID 19 vaccine on 30Dec2020 at 9:00 and she had an allergic reaction. She turned all red and was itching all over her body by about 10:30- 10:45 am and was at the ER by about 11am. She started on prednisone 40mg for 3 days and diphenhydramine every 6 hours, as needed on 30Dec2020. On Sunday (03Jan2021), she was still severely itching and turning red so prednisone was continued for an additional 3 days and was switched to cetirizine (ZYRTEC) because she can't function on diphenhydramine. Cetirizine was not helping so she had to take diphenhydramine yesterday morning (04Jan2021). Last night (04Jan2021), she was ok without any diphenhydramine but this morning (05Jan2021), she still have mild itching, and no redness. The redness comes and goes; it is on the face, chest, arms, legs. When it first started, it was whole body redness. Then it moved to different areas on different days; she don't have a rash or hives, just redness. She had a 4 inch band of redness on both arms one day. The events were reported as non-serious. The patient had not recovered from the events.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of allergic reactions cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition of drug allergies to multiple materials may put the patient at high risk of allergic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
43 2021-01-07 vaccination site pain Left arm (site of injection) soreness/pain Left underarm; Swollen lymph nodes; This is a spontaneous... Read more
Left arm (site of injection) soreness/pain Left underarm; Swollen lymph nodes; This is a spontaneous report from a contactable Nurse (patient herself). This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0142X-31-21), via an unknown route, on 29Dec2020 at 21:30 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was not pregnant. Relevant medical history included hypothyroidism, hypertension and COVID-19 (prior to vaccination). Relevant concomitant medications included amlodipine. The patient was vaccinated at hospital, age at vaccination was 43-year-old. No other vaccine was received in four weeks. On 30Dec2020 at 12:30 the patient developed 'left arm (site of injection) soreness/pain left underarm' and 'swollen lymph nodes'. Post-vaccination COVID test was not performed. The patient was not treated for the events. She was recovering from the events.
43 2021-01-07 vaccination site swelling, vaccination site pain Nausea; malaise; injection site pain; injection site swelling; This is a spontaneous report from a c... Read more
Nausea; malaise; injection site pain; injection site swelling; This is a spontaneous report from a contactable physician (patient herself). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730; expiry date: unknown) via an unspecified route of administration (arm right), on 04Jan2021 at 15:00, at a single dose, for COVID-19 immunization. Relevant medical history included migraines, seasonal allergies, and history of breast cancer in remission. The patient has no known allergies. Concomitant medication included (FLONASE) fluticasone propionate. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. On 04Jan2021, at 16:45, the patient experienced nausea, malaise, injection site pain, and injection site swelling. The patient did not receive treatment for the events. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since vaccination.
43 2021-01-07 skin warm, redness, cellulitis One week after receiving the Covid vaccine, pt was seen by telemedicine in our clinic with symptoms ... Read more
One week after receiving the Covid vaccine, pt was seen by telemedicine in our clinic with symptoms of local cellulitis. The area was red, swollen and warm to touch.
43 2021-01-07 vaccination site pain Pain on injection site in couple of days; tiredness; headache; muscle pain; joint pain; weakness; mi... Read more
Pain on injection site in couple of days; tiredness; headache; muscle pain; joint pain; weakness; mild fever; sore throat; profused sweating; This is a spontaneous report from a contactable nurse. A 43-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot EL0140, expiration date unspecified), via an unspecified route of administration on 29Dec2020 10:30 at single dose at left arm, for COVID-19 immunization. Medical history included allergies to seafoods occasionally. There were no concomitant medications. The patient was not pregnant at the time of vaccination. On 31Dec2020 23:00, the patient experienced pain on injection site in couple of days, tiredness, headache, muscle pain, joint pain, weakness, mild fever, sore throat and profuse sweating. Therapy for the events included Tylenol 500 mg. It was reported that the patient was vaccinated at the hospital. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine and no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had been tested for COVID-19. The patient underwent a lab test and procedure which included nasal swab which was negative on 11Nov2020. Outcome of events was unknown.
43 2021-01-07 hives Patient develops mild hives and flushing of the neck and face approx. 1 hour after receiving dose #1... Read more
Patient develops mild hives and flushing of the neck and face approx. 1 hour after receiving dose #1 of the Pfizer-BioNTech COVID-19 vaccine. She self-ambulated to the clinic where she was assessed, vitals taken (which were stable), and offered an injection of Benadryl 25mg IM, which she accepted. Patient was continually monitored and reassessed 15, 30, and 60 minutes after her arrival at which time she was starting to feel better, less flushed, with a visible reduction in her mild hives. Patient was released to her own self-care and stated she would be calling her husband to pick her up from work.
43 2021-01-07 hardening, injection site warmth, injection site pain Per patient report: "Received my 2nd dose Jan. 5,2021 @ 1020 noticed pain and tenderness in Left arm... Read more
Per patient report: "Received my 2nd dose Jan. 5,2021 @ 1020 noticed pain and tenderness in Left arm injection site, armpit of the same side and radiating pain across neck and shoulder to right side by the next morning Jan.6. Late afternoon pain increased in left armpit significantly and noticed swelling, warmth and hardness along with stabbing pains in left forearm and hand throughout the night. "
43 2021-01-07 hives, rash, itchy skin Rash & UrticariaPruritus Narrative: Employee states she took Benadryl, Pepcid and zantac on her own... Read more
Rash & UrticariaPruritus Narrative: Employee states she took Benadryl, Pepcid and zantac on her own.
43 2021-01-07 injection site pain pain at injection site. Just below left elbow to the tip of fingers c/o burning and has shooting pai... Read more
pain at injection site. Just below left elbow to the tip of fingers c/o burning and has shooting pain sensation.
43 2021-01-07 itchy rash, rash, rash with redness rash on chest and back - light red, mildly itchy
43 2021-01-08 shingles 5 days after injection trigeminal facial neuropathic shingles, left side of face, C3, r arm, side
43 2021-01-08 injection site pain Headache fatigue, injection site pain/arm soreness more severe than the 1st dose Narrative: Was abl... Read more
Headache fatigue, injection site pain/arm soreness more severe than the 1st dose Narrative: Was able to sleep off her side effects. Took 800mg Ibuprofen OTC which helped. Afebrile.
43 2021-01-08 hives Hives began on hands early morning Wednesday. Friday hives on legs. Saturday both arms, legs, feet h... Read more
Hives began on hands early morning Wednesday. Friday hives on legs. Saturday both arms, legs, feet have hives. Have headache since receiving vaccination. Swollen, painful axillary lymph nodes on side of injection from Monday and still sore today on Saturday.
43 2021-01-08 injection site warmth, injection site redness, injection site hardening the area got hardened, hot and red.
43 2021-01-09 injection site pruritus, injection site redness About a day after the shot, I got a red circle a little bigger than a quarter around the injection s... Read more
About a day after the shot, I got a red circle a little bigger than a quarter around the injection site and the area was very itchy. This lasted several days. I have to assume it was an allergic reaction. Since then it has gone away however I am not sure if I should get the 2nd shot. The vaccine was Pfizer.
43 2021-01-09 skin warm, hives, itchy skin Hives (face, neck, ribcage, stomach, arms, hands, back, legs, underarms, elbows), Swollen eyes; Swol... Read more
Hives (face, neck, ribcage, stomach, arms, hands, back, legs, underarms, elbows), Swollen eyes; Swollen lips; Hard Ears; Warm Skin; Itching; Wheezing.
43 2021-01-09 injection site swelling, injection site pain Moderate to sever Joint pain HA PHOTOPHOBIA Moderate soreness and swelling at injection site
43 2021-01-09 hives, redness Received vaccine on 1/4. Started with hives on 1/6 am. Facial swelling on 1/7. Has been taking Benad... Read more
Received vaccine on 1/4. Started with hives on 1/6 am. Facial swelling on 1/7. Has been taking Benadryl 50 mg at night since 1/6. Facial swelling continues. Hives reduced, but redness continues.
43 2021-01-10 injection site rash Diarrhea, lasting 15 minutes. Skin rash at site of injection
43 2021-01-10 redness Erythema and tenderness with reactive lymph nodes left axillary area The size of erythema is 18x8 cm
43 2021-01-10 injection site pain I had arm pain that radiated from the injection site down to my elbow. I was unable to raise my arm ... Read more
I had arm pain that radiated from the injection site down to my elbow. I was unable to raise my arm or move it in any direction for 3 days.
43 2021-01-10 itchy skin Itching (not at injection site) on eye, forehead, and scalp. Mild on day of shot, but worse the fol... Read more
Itching (not at injection site) on eye, forehead, and scalp. Mild on day of shot, but worse the following 2 days. The only thing I am allergic to is Neosporin, so I don't know if any of those ingredients are in the Pfizer vaccine.
43 2021-01-10 injection site pruritus, injection site rash Itching and rash at injection site. Given IV Benadryl, solumedrol, Pepcid. Rash resolved after tre... Read more
Itching and rash at injection site. Given IV Benadryl, solumedrol, Pepcid. Rash resolved after treatment.
43 2021-01-10 itchy rash, rash Itching, rash to bilateral upper extremities, chest, and neck.
43 2021-01-10 itchy skin Severe itching (not at injection site), but on eye, forehead, and scalp. Mild itching sensation on ... Read more
Severe itching (not at injection site), but on eye, forehead, and scalp. Mild itching sensation on the day of vaccination, but it got worse the next 2 days. The only medication I am allergic to is Neosporin, so I don't know if the vaccine has components of this in it.
43 2021-01-10 redness, skin warm Swelling, pain, muscle weakness, redness, heat
43 2021-01-10 injection site swelling injection site armpit/ lymph node swelled and was EXTREMELY palpable and painful... unable to clos... Read more
injection site armpit/ lymph node swelled and was EXTREMELY palpable and painful... unable to close my armpit as of today 1/11/2021, swelling has reduced but still painful
43 2021-01-11 injection site warmth, injection site pain, injection site swelling, injection site redness After almost 24 hours, there was fever 100.2F, headache, joint pain, redness pain and swelling at th... Read more
After almost 24 hours, there was fever 100.2F, headache, joint pain, redness pain and swelling at the injection site. The pain and swelling has continued to grow every day until now my arm is swollen from the shoulder to the elbow and around to the inner arm. It is hot, hard to the touch, very swollen, and painful to any touch including clothing. It is now 96 hours later.
43 2021-01-11 itchy skin C/O neck pain followed by headache , nausea, vomiting, respiratory issues, itching, benedryl 50mg im... Read more
C/O neck pain followed by headache , nausea, vomiting, respiratory issues, itching, benedryl 50mg im given, VS, med called, started IV, BP 189/102, HR 80 Temp 98.5, 98.1, sent to ED
43 2021-01-11 injection site redness, rash vesicular, rash Rash Back (L) arm chest pruritic Nausea & vomiting. Swelling (L) arm Exam Rash as above external ves... Read more
Rash Back (L) arm chest pruritic Nausea & vomiting. Swelling (L) arm Exam Rash as above external vesicle Txt corticosteroid, antihistamines
43 2021-01-11 rash, vaccination site mass, vaccination site redness Redness and hard lump at injection site; Redness and hard lump at injection site; Warm to touch; Sig... Read more
Redness and hard lump at injection site; Redness and hard lump at injection site; Warm to touch; Significant discomfort or pain in right arm; Rash on face and neck; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899), via an unspecified route of administration in right arm, on 05Jan2021 at 07:30, at a single dose, for COVID-19 immunization. The patient's medical history included allergies to shellfish, dust mites, cats, cockroach dander, grass, trees, and pollen. The patient's concomitant medication included cetirizine hydrochloride (ZYRTEC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital. On 05Jan2021, the patient experienced redness and hard lump at injection site, warm to touch (no site reported), significant discomfort or pain in right arm, and rash on face and neck. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.
43 2021-01-11 hives, itchy skin first day after shot, nausea, body aches, 2nd day Sunday headache, Monday 5 am woke up itching, the... Read more
first day after shot, nausea, body aches, 2nd day Sunday headache, Monday 5 am woke up itching, then 9 am hives everywhere, trouble breathing, anaphylaxis, went to ER, got epi X 2, solumedrol, benadryl, pepcid, then still with hives, tachycardia, dyspnea, iv fluids were influsing and epi drip started, went to ICU
43 2021-01-11 hives urticaria angioedema
43 2021-01-11 rash, vaccination site redness, vaccination site warmth welt on the injection site that was very hot and red; welt on the injection site that was very hot a... Read more
welt on the injection site that was very hot and red; welt on the injection site that was very hot and red; welt on the injection site that was very hot and red; rash all over the body; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 43-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration in the left arm on 24Dec2020 (as reported) at 07:45 at 43-years-old at a single dose for COVID-19 immunization. Medical history included fibromyalgia, hypertension, and shellfish allergy; all from an unknown date and unknown if ongoing. Concomitant medications included escitalopram (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), ergocalciferol (VIT D); all taken for an unspecified indication from an unspecified date to an unspecified date (received within two weeks of vaccination). The patient previously took iodine (MANUFACTURER UNKNOWN) and experienced iodine allergy, and codeine (MANUFACTURER UNKNOWN) and experienced codeine allergy; both from an unspecified date to an unspecified date. On 17Dec2020 at 13:15 (as reported), the patient experienced: welt on the injection site that was very hot and red, and rash all over the body. The patient also reported, "I have all the symptoms of COVID-19." It was unknown if the patient received treatment for the adverse events. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included Rapid test (SARS-CoV-2 test): negative on 04Jan2021. The clinical outcome of the events was not recovered. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
43 2021-01-12 injection site pain Chills, upset stomach, soreness at injection site, abdominal gas pain
43 2021-01-12 injection site pain Fever, Chills, severe body aches, sleepiness, arm soreness at injection site for about 40 hrs.
43 2021-01-12 rash I am feeling like I have flu; Rash; Chills; Low fever; Muscle pain; Joint pain; This is a spontaneou... Read more
I am feeling like I have flu; Rash; Chills; Low fever; Muscle pain; Joint pain; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose (first dose) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated, "I want to ask of side effect on Covid Vaccination (captured as Covid Vaccine) because I have already got first dose yesterday and like after few hours I got chills, low fever and the chills, it was like muscle pain, joint pain about today morning it was worse and I am feeling like I have flu already. It is like the same symptoms but muscle, joint pain. I got a little rash on my skin. I ask my doctor he said its better to call them and ask like what's going on that I supposed to do or just wait." The outcome of the event rash and Flu like symptoms was unknown, while the outcome of the other events was not resolved. Information on the lot/batch number has been requested.
43 2021-01-12 injection site rash, injection site pain I had a rash on the arm from the injection site to half way down my arm. I had a weird headache. I w... Read more
I had a rash on the arm from the injection site to half way down my arm. I had a weird headache. I was tired, and had no smell and slept all weekend. My arm was very, very sore. The rash lasted until 12/23/2020.
43 2021-01-12 hives I received my covid vaccine on 12/29/2020 at 4:42pm. In 10 minutes after the shot, I went into anap... Read more
I received my covid vaccine on 12/29/2020 at 4:42pm. In 10 minutes after the shot, I went into anaphylactic shock, I broke out in hives, and my throat was closing
43 2021-01-12 bruising I received the vaccine 1/7. I had mild arm soreness for 1.5 days. I had a mild headache at 1pm 1/9... Read more
I received the vaccine 1/7. I had mild arm soreness for 1.5 days. I had a mild headache at 1pm 1/9 and took an aleve at 3pm. at 4pm i noticed mild left undereye tenderness to palpation. at 11pm i noticed left undereye swelling and and bruising. i iced and took a zyrtec. by morning on 1/10 the swelling was worse and i called my dermatologist. she felt it was a reaction to the undereye filler i had >2.5 years ago. she started me on a medrol dose pack. the swelling resolved by the morning on 1/11.
43 2021-01-12 injection site pain Pain at site of injection, L shoulder, started several hours after injection, worsened by the end of... Read more
Pain at site of injection, L shoulder, started several hours after injection, worsened by the end of the day to the point that it was difficult to use L arm. In addition, there were diffuse body aches, chills and fatigue overnight. Chills resolved by next morning. Body aches and fatigue still present.
43 2021-01-12 itchy skin, rash, skin irritation Patient started with rash and pruritus, that started in both hands and then disseminate trough all b... Read more
Patient started with rash and pruritus, that started in both hands and then disseminate trough all body and face. Pruritus got worst as time passed. The patient visited a medical office and an emergency room at the Hospital. A week after symptoms continues (dermatitis over skin and some pruritus, even with the use of antihistaminic).
43 2021-01-12 injection site redness, injection site swelling Red raised circle with severe swelling in the upper arm, chills in the morning, whole body muscle pa... Read more
Red raised circle with severe swelling in the upper arm, chills in the morning, whole body muscle pain, and nausea starting Thursday afternoon. Started a fever of 100 f and a headache Thursday night. The headache, nausea, and swelling in the arm lasted until Sunday night.
43 2021-01-12 itchy skin, vaccination site itchiness felt a little itching around the injection site; she was itching from head to toe; This is a spontan... Read more
felt a little itching around the injection site; she was itching from head to toe; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 43-year-old female patient (not pregnant) received her first dose of bnt162b2 (BNT162B2, also reported as COVID 19, brand Pfizer, lot EL1284), intramuscularly in the left arm on 06Jan2021 15:45 at single dose, for Covid-19 immunisation. She received the vaccine in a hospital. Medical history included allergy to lima beans, grapes, cucumbers, celery, melons, kiwi. No other vaccine in four weeks. No Covid and Covid test prior to vaccination. Concomitant medications included propranolol, escitalopram, spironolactone, cetirizine hydrochloride (ZYRTEC), ethinylestradiol, ferrous fumarate, norethisterone acetate (LARIN FE), biotin and sambucus nigra fruit (ELDERBERRY [SAMBUCUS NIGRA FRUIT]). The patient previously took CEFTIN (ceftriaxone) and sulfa and had drug allergy. The patient informed that once she got the shot (06Jan2021), she felt a little itching around the injection site a few minutes later. Later on that evening, she was itching from head to toe without any swelling or rash. No treatment was given. The patient recovered from the events.
43 2021-01-12 injection site pain soreness to injection site for two days, fatigue, headache, elevated temperature, sore throat, musc... Read more
soreness to injection site for two days, fatigue, headache, elevated temperature, sore throat, muscle aches
43 2021-01-13 injection site pain 8hrs Post vaccine- Fatigue/mild chills/ leg aches 12hrs Post vaccine-Vertigo/nausea lasted 24hrs 54... Read more
8hrs Post vaccine- Fatigue/mild chills/ leg aches 12hrs Post vaccine-Vertigo/nausea lasted 24hrs 54hrs post vaccine-Pounding Migraine that lasted 24hrs Pain at injection arm 24 hrs post vaccine.
43 2021-01-13 rash, rash with redness, itchy rash Began with tingling/itching to tongue and roof of mouth approx 15 minutes after administration, prog... Read more
Began with tingling/itching to tongue and roof of mouth approx 15 minutes after administration, progressed to tingling of lips, was sent to the ED for observation. Within 20-30 minutes developed cough, throat tightness, difficulty swallowing, breathing, vomiting, shortness of breath. Noted to have uvular swelling and wheezing on examination. Given Benadryl, Pepcid, Solumedrol, Zofran, Albuterol MDI, Epi IM. within a few minutes symptoms returned and were worse where I felt like I could not breathe, throat was closing, could not talk. Noted to be pale, HR in 140?s. Given second dose of epi IM and symptoms improved. Was transferred to Obs Unit., within 2 hours (approx 6 hours after administration), developed SOB, throat tightness, cough, vomiting, difficulty breathing. Again noted to have swelling of uvula, wheezing on exam. Given Solumedrol, Benadryl, SQ epi, Albuterol, Racemic Epi nebulizer. Was transferred to ICU, all meds held except Pepcid. Day #2 ~10 am (25 hours from administration) developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and wheezing. Given Solumedrol, Benadryl, Pepcid, Albuterol MDI, Racemic Epi neb. Solumedrol started q12hour dosing. Strange feeling/fullness in throat continued all day, got additional racemic Epi neb that night with improvement of symptoms. Following morning (day#2 after vaccine) noted to have diffuse red rash to chest and face, spread to arms, then began coughing. Given Solumedrol, Pepcid, Benadryl, Advair, Racemic Epi nebulizer. Solumedrol changed to q8 dosing. Approx 4 hrs later nurse noted rash worse on face, associated with itching, throat tightness. Given additional Benadryl, Racemic Epi neb with improvement. Rash continued that night with throat tightness, got additional Benadryl and Racemic Neb that night (total of 3 Racemic nebulizer on Day#2 post vaccine). Transferred to telemetry floor. Day#3 post vaccine rash improved, but still present to chest and face. Throat fullness present, especially after drinking. Am still hospitalized while writing this report
43 2021-01-13 hives, itchy skin Employee received 2nd dose of Pfizer vaccine. After about 13 minutes, patient returned to vaccinatio... Read more
Employee received 2nd dose of Pfizer vaccine. After about 13 minutes, patient returned to vaccination station with complaints of itching and mild hives noted to left forearm. Benadryl 50mg po dispensed at 1345. Pulse Ox: 94%, HR: 70. Pt stated Pulse ox normally runs at this level due to hx of asthma. Itching continued to progress up left arm and down left leg. Denied any reaction after first dose. Vaccine Clinic staff notified. Pt escorted by staff to convenient care at 1353.
43 2021-01-13 rash papular, itchy rash, rash I developed a spotty rash on my face and ankle Wednesday afternoon. By the evening, it had spread t... Read more
I developed a spotty rash on my face and ankle Wednesday afternoon. By the evening, it had spread to my hands and arms. I woke up in the middle of the night and my hands,face,scalp,ears,wrists knees and ankles were covered by a raised blotchy painful , itchy rash. I took a. Claritin, famotadine and a Benadryl with some minor relief. I have not had a formal eval yet.
43 2021-01-13 redness, skin warm I woke up with excruciating pain heat and redness in my right toe, which did have what I assume is a... Read more
I woke up with excruciating pain heat and redness in my right toe, which did have what I assume is a fungal infection of the nail, however it had felt fine until it woke me up in the night. I thought I had developed cellulitis. However by the next morning it was completely gone back to how it was which is a little painful and irritated but not bad at all.
43 2021-01-13 injection site pain Injection site pain Tender/tight lymph nodes (L axillaire, L neck, L jaw) Muscle Aches (whole body, ... Read more
Injection site pain Tender/tight lymph nodes (L axillaire, L neck, L jaw) Muscle Aches (whole body, esp L shoulder, L upper back, L neck, L jaw) Joint aches (whole body, esp L shoulder, L jaw) Fatigue Sharp, intermittent shooting pain in shoulder Headache Effects most pronounced night of and day after vaccine, but persisting to lesser degree still on day 3 (today)
43 2021-01-13 injection site pain Pain at the injection site. That night and next day I felt fatigue and slept most of the day. I had... Read more
Pain at the injection site. That night and next day I felt fatigue and slept most of the day. I had no appetite and had nausea that would come and go. Decreased exercise for a couple days after. The following Monday I still had some fatigue but felt tired and low level nausea and not really hungry, There were waves when I felt like I was coming down with something. I felt tired enough that I went home early from a shift and tested for Covid. Test came back negative.
43 2021-01-13 injection site pain, injection site swelling Soreness and swelling at injection site. Chills at about 34 hours post-injection. Fever (100.5) at a... Read more
Soreness and swelling at injection site. Chills at about 34 hours post-injection. Fever (100.5) at about 34 hours post-injection.
43 2021-01-13 itchy rash, rash, rash, itchy rash We have an employee who was vaccinated with Pfizer on 12/28/20. That evening she developed a rash on... Read more
We have an employee who was vaccinated with Pfizer on 12/28/20. That evening she developed a rash on her arms that progressed to her legs and torso. The rash it itchy and burns. She still has the rash today. The next day after vaccination she experienced headache and aching that subsided within 3 days. This employee has a history of Lupus and breaking out in a rash is not uncommon for her, it is actually sort of common. When asked if this is the same sort of rash she experiences after too much sun exposure or stress (due to the Lupus) she says she would describe it as the same. She did miss one day of work due to the headache, aching, and just being miserable with the rash on top of it. She did not experience hives, trouble breathing, or swelling.
43 2021-01-13 redness, skin warm, itchy skin arm is red, warm, and itchy; arm is red, warm, and itchy; arm is red, warm, and itchy; Chest tightne... Read more
arm is red, warm, and itchy; arm is red, warm, and itchy; arm is red, warm, and itchy; Chest tightness; bitter taste in her mouth; funny feeling; arm was hurting; swelling; patient thinks the vaccine was given to her subcutaneously instead of intramuscularly; This is a spontaneous report from a contactable nurse (reporting for herself). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231), subcutaneously in the left arm on 05Jan2021 15:00 at 0.3 mL, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included an unspecified multivitamin, taken at one tablet daily by mouth for supplementation therapy. The patient previously took the flu vaccine (MANUFACTURER UNKNOWN) in 2016 for immunization and experienced chest tightness, which she took diphenhydramine hydrochloride (BENADRYL). The patient experienced arm is red, warm, and itchy on 05Jan2021, which was reported as being medically significant. On 05Jan2021, the patient experienced chest tightness, bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly. On 06Jan2021, the patient experienced arm is red, warm, and itchy was reported as worsened. The outcome of arm is red, warm, and itchy, chest tightness and arm is red, warm, and itchy was reported as worsened was not recovered and of bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly was unknown. The reporter assessed the relatedness to the event, arm is red, warm, and itchy to the Covid-19 Vaccine as related; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events pruritus, erythema and feeling hot cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
43 2021-01-13 hives reported uriticaria and lip/tongue tingling. po benadryl administered.
43 2021-01-14 rash, hives 07:00 AM six days later 12/24/2020 awoke with hives on the right side of face, neck, and ended u... Read more
07:00 AM six days later 12/24/2020 awoke with hives on the right side of face, neck, and ended up spreading all over the face, neck, patches on belly and leg. ER . ER treated with 40 IV and oral Prenazone 40 mg for three days 30, for three days then 10 for three days
43 2021-01-14 injection site pain, injection site redness, injection site hardening, injection site swelling 12 hours after injection writer experienced high fever, chills, leg aches, low back pain, headache, ... Read more
12 hours after injection writer experienced high fever, chills, leg aches, low back pain, headache, and the feeling of dizziness or fogginess for 36 hours. Writer missed 2 days of work due to symptoms. Continued symptom - injection site is swollen, red, firm, tender to touch, arm sore to lift, and pain noted in arm pit.
43 2021-01-14 rash with redness, rash papular, itchy skin 3 days of erythematous, pruritic, dry papules on abdomen, axilla, back, neck.
43 2021-01-14 hives, rash 5 minutes after receiving dose 2 of Pfizer COVID-19 vaccine started getting hives rash shortness of ... Read more
5 minutes after receiving dose 2 of Pfizer COVID-19 vaccine started getting hives rash shortness of breath tachycardia, nausea. Taken to ER and given IM Epi, IV Benadryl, Solumedrol, Pepsi?s, albuterol and racemic epi breathing treatments and put on Epinephrine IV drip to treat anaphylactic reaction
43 2021-01-14 itchy skin, redness Approximately 30 minutes after receiving the vaccine, pt. c/o itching and redness on neck and arms. ... Read more
Approximately 30 minutes after receiving the vaccine, pt. c/o itching and redness on neck and arms. Pt. also c/o "tongue tingling." Blood pressure: 192/96, Heart Rate: 78, O2 sats: 97% on room air. Assessed by APN. No Epinephrine or Benadryl given at POD. EMS took patient via ambulance to be evaluated at Medical Center.
43 2021-01-14 hives, itchy skin Began with hives, itching. Quickly progressed to difficulty breathing. Brought to ER, IM Epi given i... Read more
Began with hives, itching. Quickly progressed to difficulty breathing. Brought to ER, IM Epi given in ER triage. Caregiver given racemic Epi and another dose of IM Epi in ED. Further care please refer to ED MD
43 2021-01-14 rash, hives During 30 minute observation period patient began to have a rash across their chest consistent with ... Read more
During 30 minute observation period patient began to have a rash across their chest consistent with hives and reported numbness and tingling of the R arm. Denied any other symptoms including SOB. Patient was taken to the ER for further observation where 50mg PO Benadryl was given.
43 2021-01-14 redness HA, eye puffiness and redness, generalized body aches, malaise. Treatment - Ibuprofen. Outcome- does... Read more
HA, eye puffiness and redness, generalized body aches, malaise. Treatment - Ibuprofen. Outcome- does not interfere with ADL's continue to work. No improvement in symptoms will continue to monitor.
43 2021-01-14 hives Headache that began on 4 days later. Treatment was ASA with mild improvement and report hives on fa... Read more
Headache that began on 4 days later. Treatment was ASA with mild improvement and report hives on face after taking ASA lasting for 30 minutes and resolved. Outcome: Continue working did not interfere with ADL's.
43 2021-01-14 hives, itchy skin Immediate itching and hives. Progressed quickly into anaphylaxis - stridor, difficulty breathing. Ta... Read more
Immediate itching and hives. Progressed quickly into anaphylaxis - stridor, difficulty breathing. Taken immedietly to ER, O2 sats observed of 84%. Given IM Epi in ER triage area. Brought back to room, racemic epi started and given additional IM dose. Please refer to ED for further treatment.
43 2021-01-14 vaccination site pain Injection site soreness that developed to arm soreness with both doses.; Injection site soreness tha... Read more
Injection site soreness that developed to arm soreness with both doses.; Injection site soreness that developed to arm soreness with both doses.; This is a spontaneous report from a contactable nurse, the patient. A 43-year-old non-pregnant female patient received the patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3249), via unspecified route of administration in the right arm on 10Jan2021 at 14:45 PM (at the age of 43-year-old) as a single dose; the patient previously received the first dose of BNT162B2, Lot number: EK5730), via unspecified route of administration in the left arm on 20Dec2020 at 12:30 PM (at the age of 43-year-old) as a single dose; both for COVID-19 immunization. Medical history included asthma, obesity, hypothyroidism, hypoglycaemia, attention deficit hyperactivity disorder. The patient had allergy to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included ibuprofen, liraglutide (SAXENDA). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Jan2021 at 20:00 PM, the patient experienced injection site soreness that developed to arm soreness with both doses. The events were reported as non-serious. The patient did not receive any treatment for the injection site soreness that developed to arm soreness with both doses. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events injection site soreness that developed to arm soreness with both doses was recovering.
43 2021-01-14 vaccination site pain Metal taste back of mouth; Burning Heat; pain radiating down arms with nerve pulling/moving sensatio... Read more
Metal taste back of mouth; Burning Heat; pain radiating down arms with nerve pulling/moving sensation to tips of fingers; pain radiating down arms with nerve pulling/moving sensation to tips of fingers; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: ejko85, intramuscular on 22-DEC-2020 11:45 (at the age of 43-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history had known allergies to latex. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 22Dec2020 01:15AM, the patient experienced metal taste back of mouth, burning heat, pain radiating down arms with nerve pulling/moving sensation to tips of fingers. The metal taste back of mouth, burning heat, pain radiating down arms with nerve pulling/moving sensation to tips of fingers did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events metal taste back of mouth, burning heat, pain radiating down arms with nerve pulling/moving sensation to tips of fingers. Outcome of the events metal taste back of mouth, burning heat, pain radiating down arms with nerve pulling/moving sensation to tips of fingers. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
43 2021-01-14 hives, injection site redness, injection site pruritus Raised welts, redness and itchy around the injection site. Treatment: none. Outcome: does not interf... Read more
Raised welts, redness and itchy around the injection site. Treatment: none. Outcome: does not interfere with ADLs continue to work.
43 2021-01-14 rash with redness Rash on chest and back - light red, mildly itchy; This is a spontaneous report from a contactable ot... Read more
Rash on chest and back - light red, mildly itchy; This is a spontaneous report from a contactable other health care professional. A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EJ1685), intramuscular on 06Jan2021 at single dose at arm right for COVID-19 immunization. Medical history included Multiple Sclerosis, hypertension, depression/anxiety, chronic sinusitis. Concomitant medications included dimethyl fumarate (TECFIDERA), gabapentin, buspirone hydrochloride (BUSPAR), fluoxetine hydrochloride (PROZAC), losartan, fexofenadine hydrochloride (ALLEGRA), and montelukast sodium (SINGULAIR). The patient previously took benazepril and has Known allergies: Benazepril. On 08Jan2021, the patient experienced Rash on chest and back - light red, mildly itchy. The events were assessed as non-serious. The patient did not receive treatment for the adverse event. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event was unknown.
43 2021-01-14 injection site tingling Reports tingling in arm that she received the shot at entry site. Feels slightly dizzy. She reports ... Read more
Reports tingling in arm that she received the shot at entry site. Feels slightly dizzy. She reports she had similar reaction when she had gotten the Hep B shot. BP 137/93 HR 92 O2 97%. RR 16. Reports history of HTN. No SOB or tightness of throat. No other symptoms. Sat for 15 more minutes. BP 133/96 HR 88. No further issues except small amount of tingling at shot sites. Patient discharged from clinic with instructions to plan for 1/2 hour sit time with next shot. Any further issues to seek care through PCP.
43 2021-01-14 injection site pain Symptoms - ? Patient reports approx. 1 hour after vaccination, burning at injection site and burning... Read more
Symptoms - ? Patient reports approx. 1 hour after vaccination, burning at injection site and burning sensation up her arm and behind her L ear. Approx. 4 hours after vaccine, + fatigue, abd pain, abd cramping and chest tightness. Patient report cardiac hx. + nausea and feeling ?flu like?. Patient called off of work the night of 13th and 14th due to feeling unwell. Patient denies fever. At time of call, patient reports still feeling very fatigued, congested and abd pain/cramping. Patient denies COVID-19 exposure without proper PPE and travel. Last day of work and shift - ? 1/12 (night shift) Home remedies? - rest Any improvement? ? mild improvement Recommendation? Patient has been referred for testing. Patient reports previously tested in March (negative result). Patient encouraged to remain quarantine at home and to contact EH command center for assistance with testing. Patient verbalized back understanding and denied further questions at this time.
43 2021-01-14 injection site pain Symptoms - ? patient reports approx. 1 hour after vaccination, burning at injection site and burning... Read more
Symptoms - ? patient reports approx. 1 hour after vaccination, burning at injection site and burning sensation up her arm and behind her L ear. Approx. 4 hours after vaccine, + fatigue, abd pain, abd cramping and chest tightness. Patient report cardiac hx. + nausea and feeling ?flu like?. Patient called off of work the night of 13th and 14th due to feeling unwell. Patient denies fever. At time of call, patient reports still feeling very fatigued, congested and abd pain/cramping. Patient denies COVID-19 exposure without proper PPE and travel. Last day of work and shift - ? 1/12 (night shift) Home remedies? - rest Any improvement? ? mild improvement Recommendation? Patient has been referred for testing. Patient reports previously tested in March (negative result). Patient encouraged to remain quarantine at home and to contact EH command center for assistance with testing. Patient verbalized back understanding and denied further questions at this time.
43 2021-01-14 injection site redness approx 27 hours after dose #2 developed fever which reached 102 F, chills, body aches, lymph node te... Read more
approx 27 hours after dose #2 developed fever which reached 102 F, chills, body aches, lymph node tenderness. At present, large reddened area at and below injection site and lymph tenderness
43 2021-01-14 vaccination site pain, vaccination site swelling tiredness; headache; Injection site pain; injection site swelling; swollen lymph nodes under arm; mu... Read more
tiredness; headache; Injection site pain; injection site swelling; swollen lymph nodes under arm; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot/batch number not reported, via an unspecified route of administration from 07Jan2021 12:45 to 07Jan2021 12:45 as SINGLE DOSE for COVID-19 immunisation. Medical history Known allergies: penicillin, almonds, raw carrots. Other medical history: Thyroid cancer, seasonal allergies, asthma. The patient previously tested positive for COVID-19 prior vaccination. The patient is not pregnant. The patient's concomitant medications were not reported. On 07Jan2021 18:00, the patient experienced injection site pain, tiredness, headache, muscle pain, injection site swelling, swollen lymph nodes under arm. The outcome of the events was not recovered. Information about lot/batch number has been requested.
43 2021-01-15 injection site pain Fatigue, body aches, headache, injection site pain
43 2021-01-15 rash Rash, swollen lymph node, fever
43 2021-01-15 redness, hives Red skin/hives on my chest one-two minutes of vaccine administration. My muscle tensed up as the vac... Read more
Red skin/hives on my chest one-two minutes of vaccine administration. My muscle tensed up as the vaccine was injected and the person giving my shot said that she never experienced it before. Arm had a weak feeling. Runny nose as I was being taken down to the emergency room.
43 2021-01-16 skin warm, redness, cellulitis red area warm to touch first appearing 8 days after vaccine, doctor diagnosed as cellulitis/allergic... Read more
red area warm to touch first appearing 8 days after vaccine, doctor diagnosed as cellulitis/allergic reaction to COVID-19 vaccine. Was prescribed medrol dose pack and clindymiacin
43 2021-01-17 injection site redness Fatigue, redness at injection sight, fever at injection sight
43 2021-01-17 rash Fever for 5 days; rash on neck; body aches; sore throat; bloody nose; cough; fatigue; This is a spon... Read more
Fever for 5 days; rash on neck; body aches; sore throat; bloody nose; cough; fatigue; This is a spontaneous report from a contactable nurse. A 43-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly on 05Jan2021 08:00 at single dose for COVID-19 immunization. The patient medical history was not reported. No known allergies. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), zolpidem tartrate (AMBIEN), cyanocobalamin (B12), lamotrigine (LAMICTAL), paracetamol (TYLENOL), vilazodone hydrochloride (VIIBRYD), colecalciferol (VITAMIN D). The patient experienced fever for 5 days, rash on neck, body aches, sore throat, bloody nose, cough, fatigue, all on 06Jan2021 04:00. The adverse events resulted in Emergency room/department or urgent care. No treatment received. This is a non-serious repot. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19: Nasal Swab on 08Jan2021, test name: PCR, pending result. The outcome of the events was recovering. Information on the lot/batch number has been requested.
43 2021-01-17 itchy skin Itching started at vaccination site about 20 mins after vaccination, then progressed to scratchy thr... Read more
Itching started at vaccination site about 20 mins after vaccination, then progressed to scratchy throat, face itching, tongue tingling. This was the individual's second dose, she had no issues with the first dose. She has history of allergy to IV contrast dye, but no previous issues with vaccines. Provided 50 mg Benadryl onsite and had no further issues, monitored for over one hour, symptoms improved, and drove herself home from vaccination event.
43 2021-01-17 hives, rash papular, itchy skin On the morning of 1/12/2021 I had some itching on bilateral elbows and some faint red raised areas o... Read more
On the morning of 1/12/2021 I had some itching on bilateral elbows and some faint red raised areas on my thighs that were not pruritic. I was able to go to work, however towards the end of the day around 4pm more formal appearing hives appeared on my hands and pruritis increased throughout. I went home at the end of the workday and did a full body skin assessment. I had hives on bilateral arms and legs and several on my face. Pruitis was moderate to severe. I took 50mg of Benadryl and proceeded to the Emergency Department because it seemed to be getting worse quickly and I did not have any other interventions (epi-pen or steroids) on hand at my home.
43 2021-01-17 injection site pain Received vaccine on 1/4 in the morning and it was fine until the evening, then got the sore site and... Read more
Received vaccine on 1/4 in the morning and it was fine until the evening, then got the sore site and mild malaise, wen to be early and slept all night. Next several days feeling extra tired especially in the evenings. On 1/12 I got up at 05:30 feeling fatigued and super tired, i call out work. I slept for most of the day and called occupational health (OH) and they scheduled a PCR Covid test for the next day 1/13, which came back negative. (1/14) still feeling fatigued, having palpitations and noticed my heart rate increasing significantly with mild exertion such as walking and eating, so I reached out to my PCP, who ordered labs and a second PCR Covid test for 1/15. Labs returned the next day 1/15 with elevated WBC and second Covid test came back negative on 1/16. Felt a bit better on Sunday 1/17, but today 1/18, I am still very tired and my heart continues to increase when I get out of bed, eat, shower or do any simple thing, my heart rate jumps from 64-68 to 115-120s, called my PCP back and he is seeing me tomorrow morning for an EKG and other tests, and I have been out of work for a week. I take no prescriptions drugs and have no health problems.
43 2021-01-17 itchy skin Within 30 minutes of shot-Fleeting itching in both ears, fingertips, and soles of feet. Blurred per... Read more
Within 30 minutes of shot-Fleeting itching in both ears, fingertips, and soles of feet. Blurred peripheral vision in left eye only. Dizziness, wooziness. All resolved with 35 minutes of injection, initially. Within 4 hours of shot-Exponential increase in pain from waist down, including lower back pain. Took Motrin 600 mgs which resolved pain within 1 hour of taking it. Felt off/not myself-Felt foggy-headed-pressure in head and ears was not normal. 2100-0000 (Evening of shot)-Moderate sporadic dizziness that became moderate constant dizziness-Took 1 25 mg chewable Meclizine with 1 cup of water. Pain increased and Motrin wore off. Fatigue grew worse. 1/13/21-1/14/21-SEVERE back pain. Intense pain in legs and hips. Upper respiratory symptoms-Nasal congestion, ear pressure, sinus pain/pressure, chest and upper back discomfort, chest congestion, irritation, and aching. Cheeks and nose looked puffy/swollen. Eye pain, headache on and off. Fatigue, dragging. Felt feverish but no actual fever. Body aches-sides, legs-front, back, and sides, lower back, and glutes. Felt like arthritis from waist down, including lower back. Took nighttime cold syrup, etc. to be able to sleep and/or at least dull the pain. Also used heating massage pad to assist with pain relief. 1/15/21-1/16/21-Pain lessened in terms of intensity. Had longer spells of less intense pain. Also less pain with movement after resting/lying down. However, pain still intense at this point. Meds more helpful with the pain at this point as well. On Sat, felt dizzy and unwell all day, including extra tired. Hot, sweaty on Sat. Racing heart, chest tightness. Used inhaler and Metoprolol. 1/17/21-Felt unwell-intense pain still, dizziness, fatigue. Took Meclizine 25 mg that morning. Also took another 25 mg Meclizine later that afternoon. Nausea, dry heaving to the point I almost vomited 2x. After napping, nausea returned slightly but immediately went away. Felt very tired remainder of the evening. 1/18/21-Went to MD to get clearance to return to work. Dizziness prior to visit and took 1/2 25 mg Meclizine. Felt better until I got to doctor's office. While waiting to be called back, dizziness started up again and got severe. While waiting on MD to come in and talk to me, I got nauseated and felt like I might dry heave/vomit. I took another 1/2 Meclizine 25 mg and sucked on a mentholated cough drop to help with nausea, which did subside. Dizziness continued to be severe. MD took blood pressure, pulse ox, checked my ears, checked my pupils, listened to me breathe, asked me about my symptoms, return to work, and advised on safety of taking 2nd COVID injection when it is time but leaving it up to me in terms of if I feel benefits outweigh possible side effects of 2nd injection. He prescribed anti-nausea meds, pain meds, and stated he wants to see me for a follow-up visit in 1 week. He also prescribed steroid and pain med injections to be administered in office immediately, steroid injection sometimes contains Benadryl and based on how I felt after the shot, there may have been Benadryl in this one. He also requested I message him later in the day to let him know how I was feeling. Injections did GREATLY assist with pain and dizziness/foggy-headed feeling, once they kicked in. I did message him letting him know how I was feeling after napping. 1/18/21 evening-I am still feeling weak and tired and having stinging like pain in both legs along with minor lower back pain. Some chest and throat irritation as well as stomach discomfort. Going to take a gentle laxative as well as some of the nighttime cold medicine I purchased. Still also having dizziness on and off. I plan to return to work tentatively, on 1/19/21, per my return to work note from MD. I will keep my MD notified of how I feel between now and next Monday's follow-up.
43 2021-01-18 injection site pain 24 hours after receiving second dose of Covid Vaccine presented with soreness in the area of shot, m... Read more
24 hours after receiving second dose of Covid Vaccine presented with soreness in the area of shot, muscle aches upper back/neck, fever at max of 100.3. Ibuprofen or acetaminophen managed fever from baseline to 99.3 degrees. Fever and aches present day after vaccine. Second day after vaccine, aches and fever present but not as significant. Third day after vaccine, side effects subsided. Temp back to baseline.
43 2021-01-18 itchy skin, rash, redness About 7pm I began to have chills. Intense muscle aches and my knees and hips had severe joint pain.... Read more
About 7pm I began to have chills. Intense muscle aches and my knees and hips had severe joint pain. I was so cold I could not get out of bed to use the restroom and this continued until around 11am the next morning. I also had a headache and body aches. And about 6 days out my face turned red and was super itchy. I had a prednisone prescription that I began taking 1/18 because my legs started itching and the side effects were still horrible. It made the rash begin to clear up about 50% but its still there today. No hives this time.
43 2021-01-18 hives Bilateral facial/eye swelling; hives from scalp to tip of toes, hives on Fupa & lips, hives/welts wo... Read more
Bilateral facial/eye swelling; hives from scalp to tip of toes, hives on Fupa & lips, hives/welts worse on chest, bilateral arms, neck & back, left sided headache from behind eye to base of neck
43 2021-01-18 cellulitis Cellulitis at injection site. Treatment: Keflex 500 mg QID x 7 days. Site measures 13 cm x 9 cm. Wa... Read more
Cellulitis at injection site. Treatment: Keflex 500 mg QID x 7 days. Site measures 13 cm x 9 cm. Warmth and erythema at site. worsening over 24 hours.
43 2021-01-18 skin spots, hives, skin peeling I woke up on 12/24 with one hive on my chin which spreaded to the right side of my neck, up my face ... Read more
I woke up on 12/24 with one hive on my chin which spreaded to the right side of my neck, up my face into my hair line. I had petechi began to appear so I started taking 50mg of benedryl orally about every 6-8 hrs but it continued to spread to the other side of my face and was thickened and scaly still and on 12/25 sp I went to the ER and was given 40mg of IV solumedrol and was given a precription for oral prednisone and it took about a week to clear up. My face look like it had been burned and was peeling
43 2021-01-18 rash Rash on both arms and swelling in eyes
43 2021-01-18 itchy skin, rash, hives Swollen tongue, hives, red rash all over chest/neck/arms, burning and itching. IV of benedryl and Pe... Read more
Swollen tongue, hives, red rash all over chest/neck/arms, burning and itching. IV of benedryl and Pepcid and observation in ER for 3 hours. Rash, hives, burning and itching continue which worsen when exposed to someone with Covid.
43 2021-01-18 skin spots shortness of breath at the time of vaccine, petechiae appeared the next day
43 2021-01-19 injection site pain Body and muscle pain, joint pain, fatigue, site pain-started within 24 hrs of injection lymphadenopa... Read more
Body and muscle pain, joint pain, fatigue, site pain-started within 24 hrs of injection lymphadenopathy and nausea- started 48 hrs after injection
43 2021-01-19 injection site pain Fever 103, chills, shaking, major body and joint aches, pain at injection site, headache
43 2021-01-19 injection site swelling, injection site pain My right arm at injection site is swollen and hurts and my left side of my face is swollen.
43 2021-01-19 itchy skin, hives Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an ... Read more
Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an hour later, I started breaking out in hives and whole body itching. I went back in and they gave me to full strength Benadryl and it was not helping and my BP was 190/140 (stroke level) and they tried to bring that down. About 10:15 my face was starting to swell and I was short of breath and 10:30 they took me to ER - and gave me Cortisol shot. And IV fluids. And I was in ER for two hours. They wrote me a prescription for six days for 2 prednisone for every day for one week. The PA saw me at the ER and he prescribed. I went home but couldn't drive home because I couldn't see straight so got a ride home. They tested my O2 levels before they left me. Oxygen was 96. My blood pressure was down to 140/95 - so it was down but still elevated. I still had facial swelling for 3 days. But after three or four days it resolved the face swelling. Had a weakness from the shot and still itching but nothing like it was that day still after the four days. Dr. told me I couldn't get second dose. It was an anaphalactic reaction. Dr - prescribed me an EpiPen in case I have another bad reaction to anything.
43 2021-01-19 injection site hardening Swelling at left side of the neck. Hard area at injection site. Prescribed diphenhydramine and pred... Read more
Swelling at left side of the neck. Hard area at injection site. Prescribed diphenhydramine and prednisone
43 2021-01-19 rash, injection site pain, itchy rash near syncope w/in 30 min. of vaccine- taken to ER immediately monitored, EKG, and kept for observat... Read more
near syncope w/in 30 min. of vaccine- taken to ER immediately monitored, EKG, and kept for observation increased heart rate, light headed, orthostatic after vaccine continued w/ rapid heart rate, light headed and orthostatic for 3 days day 2 severe body aches, chills, fatigue and headache,, arm pain only at injection site, swollen lymph nodes- Tylenol taken but barely touched pain day 3 still joint aches and headache, fatigue and chills, slight arm pain only at injection site, swollen lymph nodes- Tylenol and rest day 4 felt better, rash began on torso and spread to arms, groin , neck, swollen lymph nodes day 4 rash which began to itch lasting day 4,5,6,7,8- took Benadryl so I could sleep, swollen lymph nodes Continue w/ intermittent chills, body aches, headache and light headed for day s 4,5,6,7,8 Continue w/ swollen lymph nodes under left and right arm and today is day 14
43 2021-01-19 redness, rash painfully sore left arm beginning the evening of the shot and continuing for 3 days. Pain radiated ... Read more
painfully sore left arm beginning the evening of the shot and continuing for 3 days. Pain radiated from elbow up to neck and caused limited range of motion light headed, headache, severe muscle ache every joint lasting 3 days rash on torso at day 3 not itchy but red
43 2021-01-20 injection site pain Fever 100.3, chills, headache, arm soreness at injection site., fatigue
43 2021-01-20 injection site pruritus, hives Hives on arms across shoulders and on neck within 30min of injection. No difficulty breathing or swa... Read more
Hives on arms across shoulders and on neck within 30min of injection. No difficulty breathing or swallowing. 50mg Benadryl taken, hives resolved, itching continued at injection site next day, no returning of hives noted
43 2021-01-20 injection site redness, injection site swelling Red, swelling and itching at injection site. Started 15 hours after injection and still present 57 h... Read more
Red, swelling and itching at injection site. Started 15 hours after injection and still present 57 hours after injection. Swelling of lymph nodes and pain in lymph node region in the same arm. Unable to turn a steering wheel due to pain or pick up objects with right hand. Reaction has followed the same time line as the arm. Pain is so severe that it prevents sleep.
43 2021-01-20 vaccination site swelling, vaccination site redness, vaccination site itchiness Redness, swelling and itching at injection site; Redness, swelling and itching at injection site; Re... Read more
Redness, swelling and itching at injection site; Redness, swelling and itching at injection site; Redness, swelling and itching at injection site; Redness, swelling and itching at injection site with joint pain going distally on arm; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular in left arm on 09Jan2021 10:30 at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included aspirin [acetylsalicylic acid], diphenhydramine hydrochloride (BENADRYL), ibuprofen and bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC). The patient previously took cephalexin, ciprofloxacin, neomycin and macrobid [clarithromycin] and experienced drug allergies. The patient had first dose of BNT162B2 (lot number: EK5730) via intramuscular in left arm on 19Dec2020 10:15 AM at single dose. On 10Jan2021 08:00 AM, the patient experienced redness, swelling and itching at injection site with joint pain going distally on arm. No treatment received for the events. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.
43 2021-01-20 injection site pain Swollen and pain lymph nodes in left armpit still 1/22, injection site pain still 1/22, joint pain s... Read more
Swollen and pain lymph nodes in left armpit still 1/22, injection site pain still 1/22, joint pain still 1/22, low grade fever ranging from 99.2-101 until only day after, headache still 1/22
43 2021-01-20 skin infection at injection site, redness, skin warm, hives secondary cellulitis s/p injection site reaction - softball sized erythematous wheel that is tender ... Read more
secondary cellulitis s/p injection site reaction - softball sized erythematous wheel that is tender to palpation, warm to touch, and spreading. Started on keflex
43 2021-01-20 vaccination site warmth, vaccination site pain, vaccination site swelling, vaccination site redness swollen lymph nodes in right armpit that were tender; swollen lymph nodes in right armpit that were ... Read more
swollen lymph nodes in right armpit that were tender; swollen lymph nodes in right armpit that were tender; Body ache; Had low grade temp fever 99-99.5; Terrible headache; Fatigue/ tiredness; Sore arm at injection site with warmth, swelling and redness; Sore arm at injection site with warmth, swelling and redness; Sore arm at injection site with warmth, swelling and redness; Sore arm at injection site with warmth, swelling and redness; This is a spontaneous report from a contactable nurse (patient herself). A 43-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the right arm on 29Dec2020 12:15 at single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medication included levothyroxine sodium (SYNTHROID). On 30Dec2020, approximately 12 hour started with body ache; from 18 hours to 30 hours, patient had low grade temp fever 99-99.5 (I usually run 97.50), body ache, terrible headache, fatigue, tiredness- slept all but 3 hours throughout day, sore arm at injection site with warmth, swelling and redness. On day 3-4, the patient had swollen lymph nodes in right armpit that were tender. By day 5, the patient felt back to baseline. No treatment was received for the adverse events. Clinical outcome of the events was recovered on an unspecified date.
43 2021-01-21 redness, hives, rash Rash on neck appeared 2nd morning after 2nd Pfizer vaccine given. She noted it really didn't itch u... Read more
Rash on neck appeared 2nd morning after 2nd Pfizer vaccine given. She noted it really didn't itch unless the area was touched or rubbed. Reported redness, "welps." Improved on its own after 1 week
43 2021-01-21 redness Vaccine given at 4:50pm, pt in observation area. C/o feeling hot/flushed, skin pink, ears bright pi... Read more
Vaccine given at 4:50pm, pt in observation area. C/o feeling hot/flushed, skin pink, ears bright pink. Asked to be taken to ED, stated "it could just be anxiety but I would rather be sure". Taken via wheelchair to ED immediately and placed in room on gurney. Seen by ED staff, give hydroxyzine 25mg PO at 1732. Discharged home from ED at 1847.
43 2021-01-21 rash Within 1 minute of my injection of the 2nd Pfizer dose, my throat started feeling itchy and scratchy... Read more
Within 1 minute of my injection of the 2nd Pfizer dose, my throat started feeling itchy and scratchy, I couldn't clear it, this was at 2:30. I was given a Claritin 10mg, 1 1/2 hrs later the sensation seemed to have cleared up. But 20mins later around 4:10pm my tongue started burning and tingling and within 15mins that sensation traveled to the back of my throat. Within 20mins from that I broke out in a rash on my chest, this was around 4:40. I was taken to ER and given 50mg Benadryl through the IV. My rash on my chest started going away but my throat and tongue still felt tingly and burning. It started barely clearing up around 8:45pm but it did not go away entirely, it is still here today 1/22/21 1:54pm, but not bothersome. It seems to be fading away as time goes. I will continue to take Benadryl at home every night until symptoms completely resolves.
43 2021-01-22 injection site rash, injection site warmth High Fever 104.6 degree Farenheit, Bad Headache back of head, between the eyes, body aches in should... Read more
High Fever 104.6 degree Farenheit, Bad Headache back of head, between the eyes, body aches in shoulders and back and throughout body. Fever lasted almost 48hours, fever would be about 101.8 to 104.6. would only go down a few points after tyelenol given, then motrin 2-3hrs later given, then back to tylenol, then back to motrin.....ect. I was drinking plenty of fluids, then resorted to cool showers, baths, and popsicles and freeze pops. Even yesterday 1.22.2021, had a low grade fever 99.2F. Arm is still currently sore, with giant red rash where injection was given, and extremely warm to touch. I tried to report, and it continually told me, my time has expired and comments were not accepted. 1.22.2021 took motrin and tylenol again due to eye pressure , headache and low grade fever. Finally felt better 130p.m 1.22.2021.
43 2021-01-22 injection site pain Injection site soreness for about 2 days. Day 5 developed bilateral calf pain. Not unbearable, it ju... Read more
Injection site soreness for about 2 days. Day 5 developed bilateral calf pain. Not unbearable, it just felt like I had worked out my calf muscles at the gym the day before or something & I hadnt done any exercise at all that week and not at the gym in years. It seemed worst when I first started moving snd seemed to get better as I warmed up and moved around. Lasted about three days. I do vascular ultrasound and so checked myself for blood clots and I was negative. The last symptom that I dont think Ive had before is this weird pulsing or rapid twitching sensation on the back/left side of my head. Like a nerve firing maybe? I dont know. Felt like one small focal area, like fluttering.. It was very fast. It would last for like a minute or two and then stop . That happened about 3-4 times. On different days, not sure what day. It was so short lived I didnt pay much attention to it. It happened sometime between 1/18/21 & 1/22/21. It only happened one time a day.
43 2021-01-22 injection site pain Myalgia Fatigue Headache Pain at injection site
43 2021-01-22 redness Throat tightening, very small area of erythema on chest. bBenadryl 50 mg IV, 1L NS IV.
43 2021-01-23 injection site mass, injection site redness, injection site pruritus I did have a scratchy throat and my arm was itchy at injection site. Next day I had a red spot and ... Read more
I did have a scratchy throat and my arm was itchy at injection site. Next day I had a red spot and lump around injection site. I did develop a migraine the day after but can't conclusively say it was from the vaccine since I get them somewhat frequently
43 2021-01-23 hives, itchy skin Seen in ED for hives, itching and feeling flushed. Given diphenhydramine 50mg with resolution. Dis... Read more
Seen in ED for hives, itching and feeling flushed. Given diphenhydramine 50mg with resolution. Discharged to home from ED
43 2021-01-23 itchy skin, hives, itchy skin, hives Seen in ED for hives, itching and feeling flushed. Given diphenhydramine 50mg with resolution. Dis... Read more
Seen in ED for hives, itching and feeling flushed. Given diphenhydramine 50mg with resolution. Discharged to home from ED.
43 2021-01-24 vaccination site pain Parsonage-turner syndrome, confirmed by neurologist and primary care provider. 5 days after 2nd dose... Read more
Parsonage-turner syndrome, confirmed by neurologist and primary care provider. 5 days after 2nd dose, the patient developed severe pain around vaccination site and arm, followed by muscle atrophy, weakness and clinical signs consistent with acute brachial neuritis.
43 2021-01-24 sensitive skin Received vaccine at 4pm. Woke at 1:30 on 1/23 with headache . At 4pm aches settled in. At 9am fev... Read more
Received vaccine at 4pm. Woke at 1:30 on 1/23 with headache . At 4pm aches settled in. At 9am fever of 101 started along with Hyper skin sensitivity and eye sensitivity and chills. Aches turned into actual pain in my thighs and calves. It literally felt like I was hit with a baseball bat in my thighs. Fever kept climbing all day to 103.9 at 3pm. Even though I was alternating Advil and Tylenol. During afternoon and evening I had extreme dizziness. Fever, chills, fatigue, hypersensitive skin and to sunlight with my eyes have persisted for another 24 hours. I am now snd 65 hours post vaccine and I?m still running fever 100-102. With fatigue and body aches.
43 2021-01-24 rash, skin burning sensation Red blood cells are a little low; Hemoglobin and hematocrit were slightly low; Hemoglobin and hemato... Read more
Red blood cells are a little low; Hemoglobin and hematocrit were slightly low; Hemoglobin and hematocrit were slightly low; fluttering in chest; Rash on left side of face and neck; skin started burning; Anxiety and fear; Anxiety and fear; Racing heart beat; Dizziness/Lightheadedness; Headache; Nausea; Has been on her period for three weeks/Is premenopausal/Was bleeding at time of vaccination; This is a spontaneous report from a contactable Nurse reporting for herself. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration at right arm on 06Jan2021 15:22 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital, No agency site. Medical history reported included breast implants, She was healthy and had no medical diagnoses. The patient's concomitant medications was reported as none, She took no medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient wanted to report a possible reaction to the COVID Vaccine. Has been to the ER three times. Had a racing heart beat, dizziness, lightheadedness, and nausea on 08Jan2021. Developed a rash and skin started burning on 11Jan2021. The rash was on the left side of her face and neck. Racing heart beat started first. Then dizziness, headache, lightheadedness, and nausea began. She also had anxiety and fear. All symptoms began on 08Jan2021. Went to the ER on 08Jan2021. Was discharged from the Emergency room. Last night, 11Jan2021, she felt fluttering in chest, but it wasn't as severe as two nights ago. Her EKG was normal. Patient Hoped nothing occurs today. Took three Benadryl last night. Racing heart beat, rash, dizziness, headache, lightheadedness, nausea were all ongoing. The patient was wearing a Halter monitor until 12Jan2021 at 15:00, total duration for Halter monitor is 24 hours. Seriousness: Definitely disabling. Sunday night she thought she might not wake up Monday. She was fearful of all of the weird. Investigations: The patient was advised her labs were ok. Red blood cells are a little low. Hemoglobin and hematocrit were slightly low. Thought hemoglobin was 10.7. EKG was normal, Chest X-Ray was negative. The patient was just trying to figure out why reaction occurred. She Had been on her period for three weeks, was pre-menopausal. Was bleeding at time of vaccination on 06Jan2021. She did have breast implants, and didn't know if that was related or not. The patient Would not be getting the second injection. The nurse assessed the events of Racing heart beat, Anxiety and fear and Rash on left side of face and neck as related. The outcome of the event fluttering in chest was recovering, the outcome of the events Racing heart beat, rash, dizziness/ lightheadedness, headache, and nausea was not recovered and the outcome of the other events was unknown.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cardiac flutter, palpitations, headache, dizziness and nausea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
43 2021-01-24 redness Severe joint pain, hands tingling and then after a few hours they started burning, severe headache, ... Read more
Severe joint pain, hands tingling and then after a few hours they started burning, severe headache, heart racing. These symptoms lasted throughout the night and the next morning the left side of my face was bright red and stayed that way throughout the day.
43 2021-01-24 injection site pain patient had fever of 2 days between 100.9-101.4. tylenol was given with some relief but temp went ba... Read more
patient had fever of 2 days between 100.9-101.4. tylenol was given with some relief but temp went back up again. patient had muscle aches and joint pains. pain at the injection site. tylenol was given with some relief. patient had severe fatigue for 2 days.
43 2021-01-25 injection site pain After 1st dose, had Injection site/arm sorenesss, slight headache and fatigue for one day afterwards... Read more
After 1st dose, had Injection site/arm sorenesss, slight headache and fatigue for one day afterwards. Tylenol relieved headache. Arm soreness lasted 2-3 days but was mild. After 2nd dose, had Severe chills, body aches, fever (did not take temp as I didn?t have a thermometer but body felt very hot) starting approx 9 hours afterwards. Had to alternate acetaminophen and ibuprofen every 3-4hours to keep symptoms at bay. Symptoms lasted a total of about 36 hours then just felt tired for about 5 days after injection.
43 2021-01-25 hives, itchy skin Hives; Itchiness; This is a spontaneous report from a contactable nurse. A 43-year-old female patien... Read more
Hives; Itchiness; This is a spontaneous report from a contactable nurse. A 43-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration from 04Jan2021 to 04Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing prediabetic and hyperlipidemia. Concomitant medication included metformin for prediabetic and pravastatin for hyperlipidemia; both ongoing. The nurse reports that the patient developed hives and itchiness 48 hours after the administration of the first dose. The patient received Benadryl and it is getting better with Benadryl. The outcome of the events was recovering.
43 2021-01-25 vaccination site pain Injection site pain; fever; chills; fatigue; myalgia; This is a spontaneous report from a non-contac... Read more
Injection site pain; fever; chills; fatigue; myalgia; This is a spontaneous report from a non-contactable pharmacist (patient). A 43-year-old female patient (no pregnancy) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at site of left arm at 13:30 on 08Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced injection site pain, fever, chills, fatigue and myalgia in Jan2021. Facility type vaccine was in hospital. No other vaccine in four weeks. Adverse reactions did not result any serious consequences. The patient received paracetamol (TYLENOL) as treatment for adverse event. No covid prior vaccination. No covid tested post vaccination. The outcome of events was recovered in Jan2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
43 2021-01-25 injection site swelling SIGNIFIGANT SWELLING AT VACCINE SITE, SWOLLEN LYMPH NODES UNDERARM AND UP NECK ON RIGHT SIDE, FATIGU... Read more
SIGNIFIGANT SWELLING AT VACCINE SITE, SWOLLEN LYMPH NODES UNDERARM AND UP NECK ON RIGHT SIDE, FATIGUE, LOW FEVER, ACHES & CHILLS, HEADACHE
43 2021-01-25 injection site pain Sever pain at the injection site and arm, chills, sever fatigue, arthralgia.
43 2021-01-25 rash, rash papular, itchy rash The next day when I woke up on 12/30/2020 I woke up with a rash all over my body but worst part was ... Read more
The next day when I woke up on 12/30/2020 I woke up with a rash all over my body but worst part was stomach. It was bumpy & itchy. I also had chills for about 1 day. I went to urgent care on 01/04/2020 & the doctor from said it could be pityriasis osis.
43 2021-01-26 hives, itchy skin Hives - full body, extreme itching
43 2021-01-26 rash Pinky toe pain on 1/21; fatigue 1/23; UTI 1/24; sacral pain 1/24-present; rash 1/24-present and stil... Read more
Pinky toe pain on 1/21; fatigue 1/23; UTI 1/24; sacral pain 1/24-present; rash 1/24-present and still spreading; lateral joint foot pain 1/27
43 2021-01-26 hives, rash Rash; Hives; Throat started to close up; Voice changed/ Functional dysphonia; This is a spontaneous ... Read more
Rash; Hives; Throat started to close up; Voice changed/ Functional dysphonia; This is a spontaneous report from a contactable other health professional reporting for herself. A 43-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL1284), intramuscular in the right arm, on 29Dec2020 at 16:42, at single dose, for COVID-19 immunisation. Medical history included diabetes from an unknown date and unknown if ongoing, blood pressure high from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing, migraine from an unknown date and unknown if ongoing, drug allergy to triptans from an unknown date and unknown if ongoing. Past drug event included drug allergy to Topamax and Rocephin both from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced rash on 29Dec2020 at 16:45 with outcome of not recovered, hives on 29Dec2020 at 16:45 with outcome of not recovered, throat started to close up on 29Dec2020 at 16:45 with outcome of not recovered. The patient was given Benadryl and EpiPen and was rushed to the emergency room (ER). The events needed emergency room visit and physician office visit. She was admitted into the hospital for 3 days and received Solu-Medrol and intravenous Benadryl every 6 hours until discharge. The reporter stated that after the reaction her voice changed. She was visited by an otorhinolaryngology (ENT) doctor on 19Jan2021 and she had functional dysphonia. Therapeutic measure included speech therapy. Outcome was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination the patient has not been tested for COVID-19.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events rash, hives and throat tightness. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
43 2021-01-26 itchy skin Soon after receiving this vaccination, she started reporting that her mouth was itching. The itchin... Read more
Soon after receiving this vaccination, she started reporting that her mouth was itching. The itchiness progressed to various places mostly around her head and upper torso. She took 50 mg diphenhydramine about 10 minutes after first reporting the symptoms. She reported feeling fine about 1 hour later.
43 2021-01-26 vaccination site warmth hot sensation/weird very hot rush down her right arm that was vaccinated and went up the back of her... Read more
hot sensation/weird very hot rush down her right arm that was vaccinated and went up the back of her neck only on the right side; dizzy; Heart racing; Her arm was very sore- it was difficult to lift it; Her arm was very sore- it was difficult to lift it; She did feel a little out of it, as it produced a little bit of anxiety; A mild allergic reaction; This is a spontaneous report from a contactable Other Health Professional (patient). A 43 years old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3248, Expiration Date: Apr2021), via an unspecified route of administration on 12Jan2021 at 13:22 at single dose on right arm for covid-19 immunisation. Medical history included vasovagal (she did have a history of vasovagal. She talked to her doctor about this prior to the vaccine. At first when she had it her previous doctor felt a little confused. She was unsure if it was vasovagal or a blood clot in her lungs. She did get it checked out with a cat scan and there was no clot. They had to have tested her for anaphylaxis at that time. It was not a clear diagnose. Then she saw a cardiologist. She was diagnosed with vasovagal at that time. It lasted only a few months and she was fully recovered). Concomitant medications included ongoing ergocalciferol (VIT D) and ongoing vitamins NOS (MULTIVITAMIN). Patient received the vaccine on Tuesday, 12Jan2021. Her appointment was at 12:54, but she got the vaccine at 13:22. She was looking at her phone to re-schedule her second dose. She felt totally fine. At 13:27 she had this weird very hot rush down her right arm that was vaccinated and went up the back of her neck only on the right side. She looked up from her phone and was very dizzy. She stood up and as she did her heart started to race. It was a really weird feeling that she has never felt. She was a little out of it. She had no trouble breathing. Within 30 seconds she was completely fine. She did feel a little out of it, as it produced a little bit of anxiety. She had no other symptoms. She stayed at the facility for 30 minutes. As she was leaving one person asked how she felt and she was told to let the EMTs know. She let them know what happened. One woman working there said it could have been an anxiety attack. She did not have a lot of anxiety but she did have some. It did not feel like that. She had never had the warm sensations or heart racing. She was totally fine when talking to the EMTs. They did not seem concerned and they let her schedule her second shot. She read on Pfizer about allergic reactions. She was assuming this was what happened. A mild allergic reaction. She had no breathing issues or hives. Her arm was very sore- it was difficult to lift it. She had also never had this type of soreness with vaccines. Dizziness: She has had the dizziness a couple of times. Twice now. One when she had gotten home. It was very mild and nothing compared to what she had when she got the vaccine. Then another last night at bedtime. It was a woosh of dizziness. Arm soreness: very improved now. felt like she would normally have after getting a vaccine. The first day was intense but after a few hours was less. The next day she woke up and it was pretty much gone. She still had a little but it has mostly improved. Caller stated she would still like to get the second dose but she was a little nervous. She had it maybe once or twice since then and it has been mild with no extreme pressure drops. They thought maybe it was a virus that affected her. Her reaction to the vaccine was different. The difference was pretty significant. Vasovagal felt like her heart will stop and she will pass out. After the vaccine she felt dizzy but didn't feel faint, and had a racing heart. Nobody seemed concerned about her reaction and getting the second dose. But she read that Pfizer does not recommend getting the second dose even if you had a mild reaction. She was wondering what she should do. Her second dose is scheduled for 02Feb2021. Outcome of hot sensation/weird very hot rush down her right arm that was vaccinated and went up the back of her neck only on the right side and heart racing was resolved on 12Jan2021, dizzy was resolved on 13Jan2021, outcome of anxiety was unknown, outcome of her arm was very sore- it was difficult to lift it and a mild allergic reaction was resolving.
43 2021-01-27 injection site bruising Had a mild reaction 10-15 min after vaccine. My throat felt tight and uncomfortable as I left vaccin... Read more
Had a mild reaction 10-15 min after vaccine. My throat felt tight and uncomfortable as I left vaccination clinic. I took an Aler-Tec pill and felt better 20 minutes after. My arm was sore for 2 days after and couldn?t sleep on Right side, arm hurt. Injection site was purple and bruised one week later but no pain.
43 2021-01-27 injection site swelling, injection site pruritus, injection site pain Pt had vaccine on Friday 1/22 and then had dermal filler on Monday 1/25. Patient had previously had... Read more
Pt had vaccine on Friday 1/22 and then had dermal filler on Monday 1/25. Patient had previously had filler with no reaction and at this treatment has significant swelling and pain in treated area along with itching of treated area and throat and tongue.
43 2021-01-27 rash, shingles Rashes; I developed some lump on my neck and then my left ear; Shingles; Pain; Headache; This is a s... Read more
Rashes; I developed some lump on my neck and then my left ear; Shingles; Pain; Headache; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number, expiration date unspecified), via an unspecified route of administration on 27Dec2020 at 16:25, at single dose for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. On 02Jan2021, the patient experienced shingles. On 06Jan2021, the patient developed some lump on neck and then on left ear. On 07Jan2021, the patient experienced rashes. The patient reported that she got her first shot 27Dec2020 and after six days she developed Shingles. She was a healthy person and then after four days, she developed some lump on her neck and then on left ear and then the next day she developed some rashes. After that, she talked to her doctor, for shingles, she gave her acyclovir medication and then she was recovering right now. According to the infection control doctor, they never heard that was the side effect. In Jan2021, the patient experienced pain and headache. Nurse stated that the primary doctor just prescribed last Friday Acyclovir, 1 gm tablet, three times a day. When she talked to her doctor, she stated that shingles was dormant, virus from the spine and when she got the vaccine, it woke up the virus from her body. It's like virus in your body, and she thought the virus reacted to this. Outcome of event shingles was recovering; and outcome of the rest of events was unknown. Information on the Lot/Batch number has been requested.
43 2021-01-27 injection site pain Significant swelling in armpit region of injection arm (- Approximately size of golf ball). Began u... Read more
Significant swelling in armpit region of injection arm (- Approximately size of golf ball). Began upon waking morning after injection, and still present at this time (72 hours later). Area is tender to touch.
43 2021-01-27 redness intermittent sharp pain in left arm, chest and shoulder blade; intermittent sharp pain in left arm, ... Read more
intermittent sharp pain in left arm, chest and shoulder blade; intermittent sharp pain in left arm, chest and shoulder blade; intermittent sharp pain in left arm, chest and shoulder blade; redness in face and eyes; redness in face and eyes; feels warm; This is a spontaneous report from a contactable consumer (patient is girlfriend). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EKH176), via an unspecified route of administration on 12Jan2021 morning at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of vaccine on unspecified date for covid-19 immunization. The patient medical history was none. There were no concomitant medications. The patient was currently having side effects, stated she was having on and off, intermittent, sharp pain in her left arm, left chest and left shoulder blade, feeling the pain all on her left side on 13Jan2021. The reporter stated the patient looked worse than she did 2 hours ago, that her face was turning red and her eyes were turning red and she felt a little warm on 12Jan2021. The reporter wants to know when she should take the patient to the hospital. The reporter was encouraged to reach out to a health care provider. The outcome of events was not recovered.
43 2021-01-28 injection site redness, injection site warmth, injection site pain, injection site mass Large golf ball sized knot to left deltoid - at injection site. Knot is warm to touch, red, tender. ... Read more
Large golf ball sized knot to left deltoid - at injection site. Knot is warm to touch, red, tender. Unknown is knot is hematoma, abscess or cellulitis at injection site. Symptoms started x 24 hours after injection. Arm was sore after shot but knot developed approximately 24 hours later.
43 2021-01-28 rash Pfizer-BioNTech COVID-19 Vaccine EUA, Full body rash on feet, arms, legs, chest and genitals, ongoin... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA, Full body rash on feet, arms, legs, chest and genitals, ongoing 4 days
43 2021-01-29 sensitive skin Fingertip sensitivity starting 1/21/2021-present
43 2021-01-29 skin warm, cellulitis, redness cellulitis in arm given an antibiotic and a steroid right arm is swollen red and hot cause pain to ... Read more
cellulitis in arm given an antibiotic and a steroid right arm is swollen red and hot cause pain to chest back and i developed a lump in a armpit
43 2021-01-30 pain of skin, injection site pain Around 8:00am, I started to feel tired and weak. Through the course of the day, I ran a fever of 102... Read more
Around 8:00am, I started to feel tired and weak. Through the course of the day, I ran a fever of 102.4. I had chills, a headache, very sore injection site, and the skin on my arms hurt. I was exhausted, but couldn't sleep. I took Tylenol, but it didn't seem to help much. I didn't have much of an appetite. Around 7:00pm, I no longer had chills but instead was very hot. About 2:00am, I woke up drenched in sweat, but felt so much better.
43 2021-01-30 injection site pain Headache Body aches Fever Gastrointestinal Soreness in injected arm
43 2021-01-31 itchy skin, hives 01/29/2021 930 noticed an itch on left thigh, like I wanted to hive - on various spots throughout t... Read more
01/29/2021 930 noticed an itch on left thigh, like I wanted to hive - on various spots throughout the day. 01/30/2021 very tired (to be expected), noticed I had burning in what feels like my gall bladder and developed an ?odd? stomach ache later in the day. Thought it had to do with something I ate, but consumed nothing out of the ordinary. Went to bed early, felt like I wanted to fever but never did. decided to take a tsp of children?s Allegra because I still felt ? itchy? at times. 01/31/2021 woke up to what felt like pressure on my chest, like someone was squeezing me. Thought that was odd and thought it was perhaps the way I slept. Was still tired (4AM) went back to sleep. Woke up again feeling more rested and the same feeling. It was an awful feeling. Grabbed my pulse oximeter and my oxygen was about 96 laying down. Called an. ER, thought maybe I had Covid or something as I have never felt that way before. Receptionist told me she felt the same way after she got the shot. I ate, felt better but then developed a horrific headache akin to a migraine that was so sensitive to any movement I made. Felt like someone was shaking my head, it was so painful and I became disoriented. Like. I would get confused in my thoughts. Became very sensitive to light and movement. Looking at Facebook, I had to stop because I felt like I was going to seizure. Had to really rest. Ate lunch and took a multivitamin to see if that helped. Eventually I felt better but had to be careful, take it easy. 02/01/2021 woke up this morning still tired, like my body is fighting something. And I could fell the headache coming on and noticed I was getting confused in my thoughts. I decided to stay home from work. The morning was very bad as I felt as though I wanted to seizure. Could not get a hold of my doctor. My head still hurts, not as bad, but after I eat, I get confused and can?t hold two thoughts at once if that makes sense. Head seems very sensitive to eye movement like yesterday. It?s a gross feeling, even in absence of the pain.
43 2021-01-31 injection site warmth, injection site redness, injection site swelling Swelling, redness, and warmth at and around injection site
43 2021-01-31 injection site redness have a knot in the injection site and it has redness in that area. Also have a knot in the arm pit ... Read more
have a knot in the injection site and it has redness in that area. Also have a knot in the arm pit that is as big as fist. no redness to it.
43 2021-02-01 injection site pain Headache; Pain at site of injection; Chills; This is a spontaneous report from a non-contactable hea... Read more
Headache; Pain at site of injection; Chills; This is a spontaneous report from a non-contactable healthcare professional (HCP) (Patient). A 43-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 15Jan2021 19:45 at a single dose in left arm for COVID-19 immunization. There were no medical history or concomitant medications. No known allergies. No other vaccine in four weeks and no other medications in two weeks. On 16Jan2021, the patient experienced headache, pain at site of injection, chills. No treatment received for events. The adverse event did not result in 'doctor or other HCP visit or emergency room or urgent care, hospitalization or prolongation, life threatening illness, disability or death or congential anomaly'. No COVID prior vaccination and no COVID tested post vaccination. The outcome of events was recovered on an unspecified date in Jan2021. No follow-up attempts are possible. Information about batch/ lot number cannot be obtained. No further information expected.
43 2021-02-01 injection site pain Injection site pain that occurred the day after receiving the vaccination.
43 2021-02-01 skin spots, bruising Petechiae and bruising without known injury; mostly on lower half of body - noticed 2 days post-vacc... Read more
Petechiae and bruising without known injury; mostly on lower half of body - noticed 2 days post-vaccine, nearly resolved at current time
43 2021-02-01 vaccination site pain, vaccination site swelling Tingling; site of injection was swollen and red; site of injection was swollen and red; Ache; Chills... Read more
Tingling; site of injection was swollen and red; site of injection was swollen and red; Ache; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) solution for injection, via an unspecified route of administration on left arm on 17Jan2021 07:00 at a single dose for Covid-19 immunization. Medical history included diabetes, cholesterol, and blood pressure. There were no concomitant medications. Patient received the first dose of the Pfizer COVID 19 vaccine on 17Jan2021 at 07:00AM in the left arm. She noticed she had aches and chills midday on Monday 18Jan2021 and also a headache all of which went away as of this morning 19Jan2021. Today (19Jan2021), this morning she woke up and her arm at the site of the injection was swollen and red. Later, she noticed she had tingling (19Jan2021) throughout the lower part of her arm and hand. The tingling was on and off and wasn't there right away. She was scheduled to receive the second dose of the vaccine 06Feb2021. Patient was looking for recommendation on second dose. Outcome of the event ache, chills, headache was recovered on 19Jan2021; tingling was not recovered; while injection was swollen and red was unknown. No follow-up activities are needed. No further information is expected.
43 2021-02-02 itchy skin, rash, hives Hives, Rash, itching, chest tightness, throat tightness, dry mouth, difficulty breathing
43 2021-02-02 redness I?m still not sure what to make of my reaction. Started to feel ?out of body?, slow and had left-sid... Read more
I?m still not sure what to make of my reaction. Started to feel ?out of body?, slow and had left-sided chest pain at around 8 minutes after administration. Then flagged down a nurse. They checked my blood pressure at 196/110 (first one may have been 210/110)- I was sort of disoriented. Sat there for about an hour with repeated blood pressure checks, until my pulse went from 118 down to 90. They let me go home at 170/100. I do t have hypertension. Then went and laid down in my office nearby and my left upper arm turned bright red and became painful and slightly swollen. Took five hours for my blood pressure to drop to 118/80- my normal is 114/78. Still have weird chest pain and some SOB with exertion (not normal for me).
43 2021-02-02 itchy skin Patient began itching all over after receiving vaccine. Benadryl 50mg administered IVP. Patient fel... Read more
Patient began itching all over after receiving vaccine. Benadryl 50mg administered IVP. Patient felt better. Refused transport to ER.
43 2021-02-02 injection site pain Severe body aches, chills, joint pain, neck pain, pain at injection site, headache, nausea, weakness... Read more
Severe body aches, chills, joint pain, neck pain, pain at injection site, headache, nausea, weakness, fever 100.4
43 2021-02-02 rash felt numbness in mouth; felt numbness in mouth. It spread to arms and hands; Eexperienced muscle twi... Read more
felt numbness in mouth; felt numbness in mouth. It spread to arms and hands; Eexperienced muscle twitching in hands; feel dizzy; A light rash covered my chest and arms; My heart rate and blood pressure were elevated; My heart rate and blood pressure were elevated; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 43-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 19:45 for covid-19 immunization, via Left arm in hospital. Medical history included arthritis from an unknown date and unknown if ongoing. She had no allergies to medications, food, or other products. Concomitant medication included probiotics (PROBIOTICS) and Multivitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 20 minutes following injection, the patient experienced felt numbness in mouth, felt numbness in mouth, it spread to arms and hands. She went to ER (Emergency room/department or urgent care) and started to feel dizzy and experienced muscle twitching in hands, a light rash covered her chest and arms, heart rate and blood pressure elevated, all on 19Jan2021 20:15 with outcome of recovering. She had no history of these symptoms and was in good health. The action taken in response to the event(s) for bnt162b2 was not applicable. She received Benadryl as a result of events.; Sender's Comments: The reported events were causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship and clinical course. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
43 2021-02-03 itchy skin Allergic reaction; Itchiness on right side of head, forehead, and eye; Itchiness on right side of he... Read more
Allergic reaction; Itchiness on right side of head, forehead, and eye; Itchiness on right side of head, forehead, and eye; Cluster headaches; This is a spontaneous report from a contactable consumer (patient). This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EJ1686) via an unspecified route of administration in the left arm on 08Jan2021 at 11:00 at single dose for COVID-19 immunisation. The patient was not pregnant. Relevant medical history included migraines. Concomitant medications included magnesium, vitamin B12 and vitamins NOS (MULTIVITAMIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took neomycin sulfate/polymyxin b sulfate (NEOSPORIN) and experienced allergy. On 08Jan2021 at 20:00, the patient experienced allergic reaction, itchiness on right side of head, forehead, and eye and cluster headaches. The events resulted in Doctor or other healthcare professional office/clinic visit. Corrective treatments taken as a result of the events included diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID) and sumatriptan. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The patient recovered with sequel from the events on an unspecified date.
43 2021-02-03 injection site pain CHILLS, HEADACHE, TIREDNESS, RUNNY NOSE, SCRATCHY THROAT, SORE AT INJECTION SITE DOWN TO ELBOW
43 2021-02-03 vaccination site pain Headache; Horrible calf pain bilaterally; I could barely walk; Horrible calf pain bilaterally; I cou... Read more
Headache; Horrible calf pain bilaterally; I could barely walk; Horrible calf pain bilaterally; I could barely walk; Major injection site soreness; my arm started getting super sore; Major injection site soreness; my arm started getting super sore; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) at left deltoid on 18Jan2021 12:45 PM at single dose for COVID-19 immunisation in Hospital. Medical history was none. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]), just the Vitamins and supplements. Patient was just calling to report the side effects to the Covid 19 vaccine, major injection site soreness, she was having headache today (19Jan2021) and horrible calf pain bilaterally. the first dose was 18Jan2021 and due date of second dose was 08Feb2021. As of causality, nurse practitioner stated Yes, yesterday (18Jan2021) her arm started getting super sore and it kept getting worse and then she woke up this morning and she could barely walk because her calf pain is so bad, in both of her legs. Treatment include she have taken Advil, she took 600 mg today and she took 400 mg last night. As Results of Lab work, she stated she don't have it. She asked if anyone had the calf pain with it. Patient was not recovered from the events. Event relatedness for Covid 19 vaccine with Major injection site soreness; my arm started getting super sore and Horrible calf pain bilaterally; I could barely walk were Related. Relatedness of drug to Major injection site soreness; my arm started getting super sore, Headache, Horrible calf pain bilaterally; I could barely walk per Source of assessment: Source of assessment. Method of assessment: Global Introspection. Drug result: Related.
43 2021-02-03 injection site pain Injection site pain (minor) the following morning. No other side effects.
43 2021-02-03 itchy skin METALLIC TASTE IN MOUTH, ITCHINESS / RASH TO LATERAL APECTS OF TONGUE TOWARDS TONGUE'S APEX BEGINNI... Read more
METALLIC TASTE IN MOUTH, ITCHINESS / RASH TO LATERAL APECTS OF TONGUE TOWARDS TONGUE'S APEX BEGINNING 1/30/2021 GENERAL MALAISE 2/2-2/3/2021; TEMP ON THESE DAYS 99.4 DEGREES AND 99.7 DEGREES RESPECTIVELY I TOOK ACETAMINOPHEN ON 2/2/2021 BENADRYL 2/4/2021 - ITCHINESS SUBSIDED POST (1) DOSE TONGUE RASH PERSISTS AT THIS TIME
43 2021-02-03 rash Rash two days after the vaccine
43 2021-02-03 skin reaction, injection site numbness Received covid vaccine #2 left deltoid yesterday ~ 9:40 am. Last evening she developed a feeling of ... Read more
Received covid vaccine #2 left deltoid yesterday ~ 9:40 am. Last evening she developed a feeling of numbness from injection site traveling down into her left thumb and fingers... "faintly feels like it's sleeping" denies discoloration, coolness to touch or difficulty with movement. Had slight localized reaction at injection site.
43 2021-02-03 redness Within 2 mins of shot: Tachycardia, dizziness, some mild shortness of breath/chest tightening, redd... Read more
Within 2 mins of shot: Tachycardia, dizziness, some mild shortness of breath/chest tightening, reddening of face/chest (and strange almost metallic taste in mouth). The metallic taste subsided quickly (within 2 mins) tachycardia subsided quickly (within 5-10min), and I felt dizzy for approx 30mins (the skin on my chest still looks slightly red approx 2 hours later). The next day/morning I awoke with slightly puffy/swollen face and upper lip lightly swollen/tingly
43 2021-02-03 vaccination site pain fever 99.1 Fahrenheit; shivers and chills; shivers and chills; body aches; Headache; dull chest pain... Read more
fever 99.1 Fahrenheit; shivers and chills; shivers and chills; body aches; Headache; dull chest pain; Fatigue; Injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK4176), via an unspecified route of administration, in the left arm on 15Jan2021 at 08:50 AM (at the age of 43-year-old) as a single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination On 15Jan2021, the patient experienced injection site pain. On 18Jan2021, the patient experienced fever 99.1 Fahrenheit, shivers and chills, body aches, headache, dull chest pain, fatigue,. The patient had lab tests which included: 18Jan2021: pyrexia: 99.1 Fahrenheit, 19Jan2021: pyrexia: 98.9 Fahrenheit. Treatment for the body aches included with Theraflu, and ibuprofen liquids for the headache. The clinical outcome of the event injection site pain was recovered on 16Jan2021, fever 99.1 Fahrenheit, and dull chest pain was recovered on 19Jan2021, shivers and chills was recovered on 20Jan2021. The clinical outcome of the body aches, headache, fatigue, was not recovered. It was also reported that since the vaccination, the patient had been tested for COVID-19 on 19Jan2021, the results of which was negative.
43 2021-02-04 rash 15 minutes after first Pfizer Covid injection, pt developed itchy throat, given benadryl 50 po and m... Read more
15 minutes after first Pfizer Covid injection, pt developed itchy throat, given benadryl 50 po and monitored. Continued to have itchy throat and some rash, felt like prior episodes of anaphylaxis, reported some sob though stable vital signs, sent to ED
43 2021-02-04 injection site pain In addition to severe pain in my left arm at and around the injection site, my left lower back - whi... Read more
In addition to severe pain in my left arm at and around the injection site, my left lower back - which had been being treated by a doctor for a couple of years and was not hurting anymore - is now ON FIRE! Like hot knives stabbing me constantly in the same spot that was initially problematic resulting in MRIs, physical therapy, and taking Meloxicam (which I had stopped taking). My arm and back have both gotten progressively worse throughout the day.
43 2021-02-04 injection site pain Severe pain in injection arm run from shoulder to fingers, eventually extended to chest wall on the ... Read more
Severe pain in injection arm run from shoulder to fingers, eventually extended to chest wall on the right side. Lymph node in right axilla sore, swollen and tender. Symptoms lasted 48 hours. Advil taken for symptoms.
43 2021-02-04 sensitive skin Swollen lymph nodes; sensitive skin; body aches; muscle aches and pain; prolonged headache (excess o... Read more
Swollen lymph nodes; sensitive skin; body aches; muscle aches and pain; prolonged headache (excess of 7 days); This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142), via an unspecified route of administration in the left arm on 14Jan2021 09:00 at a single dose for COVID-19 immunization. Medical history included hypothyroidism. The patient had no known allergies. Concomitant medication included levothyroxine sodium (LEVOXYL), liothyronine, and sertraline. Historical vaccine included first dose of PFIZER BIONTECH COVID 19 VACCINE on 28Dec2020 (lot number: EJ1685) at 09:30 AM, in the left arm for COVID-19 immunization when the patient was 43-year-old. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior to vaccination nor was she tested since the vaccination. The patient experienced swollen lymph nodes, sensitive skin, body aches, muscle aches and pain, prolonged headache (excess of 7 days), all on 14Jan2021 at 03:00 PM with outcome of not recovered. There was no treatment received for the events. The events were reported as non-serious.
43 2021-02-04 skin peeling, bruising skin was bruised; skin was scraping off; skin underneath is super white; This is a spontaneous repor... Read more
skin was bruised; skin was scraping off; skin underneath is super white; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Jan2021 at single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. Patient stated that she got the first dose of vaccination two weeks ago (as of 21Jan2021). Supposed to get second dose on Monday. Stated that she was bruised (skin was bruised) and after two weeks skin was scraping off and skin underneath was super white, in Jan2021. Stated was a reaction. Wanted to know if should get it again. Stated that she worked at hospital (stated that she does vascular and echo on heart and legs) and needed to get immune. Wanted to know if there was an email to show her pictures. The outcome of the events was unknown. Information on the lot/batch number has been requested.
43 2021-02-05 hives, rash, itchy skin, redness 0935 - Vaccination time 1003 - Arrived to medical response area reporting itchiness, visible hives/r... Read more
0935 - Vaccination time 1003 - Arrived to medical response area reporting itchiness, visible hives/redness/rash to right arm and abdomen, and diaphoretic. Benadryl 50MG PO given. 1003 - BP 170/106, HR 98, RR 20, SpO2 96% 1007 - BP 155/83, SpO2 98% 1012 - BP 130/73, HR 78, RR 16, SpO2 95% 1019 - BP 151/82, HR 91, RR 16, SpO2 94% 1028 - BP 140/78, HR 88, HR 16, Sp02 94% 1043 - Abdominal and right arm rashes almost totally resolved. No more itching. Still diaphoretic. D/ced home w/ husband to provide transport. Advised by to discharge with post-Benadryl instructions, husband to provide transportation, and the following: "Please follow-up with your PCP before your second vaccine dose. You might need to follow up with an allergist prior to receiving your second vaccination."
43 2021-02-05 redness Lymph nodes swollen over neck and axil of the left side, pain and redness on the shot side .
43 2021-02-05 injection site rash Received dose #2. Within 10 minutes, developed metallic taste. 4 hours later severe nausea and vomit... Read more
Received dose #2. Within 10 minutes, developed metallic taste. 4 hours later severe nausea and vomiting. Began alternating Tylenol and Ibuprofen 800mg. 6 hours to the following day- severe headaches, chills, body aches, all over joint pain. Around midnight on 1/6/21 pain in the arm that radiated up her neck. 1/7- fever of 101. Small rash around injection site and slightly down arm. Stiff neck and arm pain.
43 2021-02-06 rash, hives, itchy skin Rash and itching from head to waist 2 hours after vaccine. Benadryl 50mg oral taken and cool compres... Read more
Rash and itching from head to waist 2 hours after vaccine. Benadryl 50mg oral taken and cool compresses applied. An hour later rash was somewhat better but visual. Pepcid 20mg oral taken 2 hours after benadryl. Same result. 12 hours later itching again and rash still visual so benadryl 25mg oral taken. Mostly the rash disappeared. It's day 3 post vaccination and the rash is in a few places however I am.not treating it. The rash was like hives and appeared on my arms first and within minutes my face was covered along with my neck. Took about 20 min to spread to my abdomen and back.
43 2021-02-06 hardening, injection site redness, skin warm, redness, rash Small redness around injection site then large red area 2-3 inches below injection site that is cont... Read more
Small redness around injection site then large red area 2-3 inches below injection site that is continuing to grow. Area is red warm and hard/swollen. Scratchy throat, rash on abdomen and back with no itch. Feel crappy.
43 2021-02-07 injection site numbness, injection site tingling Numbness and tingling on set four hours after dose.
43 2021-02-07 injection site swelling, injection site pain Pain and swelling at site of injection. Fever, chills, headache, joint aches and muscle aches, start... Read more
Pain and swelling at site of injection. Fever, chills, headache, joint aches and muscle aches, started 12 hours after injection. Fever seems mostly at nights, accompanied by sweating. General fatigue. As of now for more than 48 hours.
43 2021-02-07 injection site pain soreness on the left side of head, neck, arm and upper abdomen 2 days after vaccine
43 2021-02-08 rash, itchy skin About 2 days after injection, a rash has appeared and the arm is itchy in that area. These condition... Read more
About 2 days after injection, a rash has appeared and the arm is itchy in that area. These conditions have persisted... it's now 4 days after.
43 2021-02-08 hives Acute onset urticaria present on neck, chest, and upper back.
43 2021-02-08 injection site pruritus, injection site redness, injection site swelling redness, swelling, itching at the site. seen on telehealth and referred to PCP
43 2021-02-09 rash maculo-papular, itchy rash, rash 1 day after COVID vaccine, patient developed a pruritic, painful maculopapular rash that started on ... Read more
1 day after COVID vaccine, patient developed a pruritic, painful maculopapular rash that started on her ankles and hips then spread to the rest of her body.
43 2021-02-09 injection site pain Fever/chills, body aches, headache, generalized malaise; pain at injection site
43 2021-02-09 rash with redness, rash, itchy skin Starting with itching on palms and then started to get worsen as days progressed. By Tuesday night t... Read more
Starting with itching on palms and then started to get worsen as days progressed. By Tuesday night the severity increased and started noticing red rashes. Went to ER Wed am and there were swelling noticed in palms and rashes through out the body.
43 2021-02-09 vaccination site warmth, vaccination site swelling, vaccination site pain Terrible headache/lingering headache; Body ache; Fatigue/tiredness; Slept on and off all day; sore a... Read more
Terrible headache/lingering headache; Body ache; Fatigue/tiredness; Slept on and off all day; sore arm at injection site with warmth, swelling and tenderness; sore arm at injection site with warmth, swelling and tenderness; sore arm at injection site with warmth, swelling and tenderness; This is a spontaneous report from a contactable nurse reported for herself. This 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3248, vaccine location=Right arm), via an unspecified route of administration on 19Jan2021 10:15 at single dose for COVID-19 immunisation. Medical history included Hypothyroid. No known allergies. Patient was not pregnant. Concomitant medications included levothyroxine sodium (SYNTHROID) and multivitamin 4 x week. The patient previously received first dose of BNT162B2 (lot number=EL0140, vaccine location=Right arm) on 29Dec2020 at 12:15 PM at single dose for COVID-19 immunisation. On 19Jan2021 06:00 PM (8 hours after injection until 36 hours), patient experienced terrible headache, body ache, fatigue, tiredness, slept on and off all day, sore arm at injection site with warmth, swelling and tenderness. 36-72 hours: back to baseline except lingering headache. No treatment received for events. Patient did not have COVID prior vaccination, and did not test COVID post vaccination. The outcome of events was recovered.
43 2021-02-09 itchy skin itchy skin; itchy throat; Dizziness; This is a spontaneous report from a contactable nurse reporting... Read more
itchy skin; itchy throat; Dizziness; This is a spontaneous report from a contactable nurse reporting for self. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# E19261, Dose 1, via an unspecified route of administration on 22Jan2021 13:30 (at the age of 43 years old) as a single dose in left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Medical history included asthma. The patient reported allergy to sulfa and amoxicillin sodium;clavulanate potassium (AUGMENTIN). The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA). On 22Jan2021, the patient experienced dizziness within 5 minutes after vaccine that lasted 2 hours, itchy throat started within 10 min and itchy skin started 2 hrs post vaccine. As treatment for the events, the patient received diphenhydramine (BENADRYL) at home. There was no hospitalization for the events. The events were reported as non-serious. The clinical outcome of the events dizziness, itchy throat, and itchy skin was recovering. Since the vaccination, the patient has not been tested for COVID-19.
43 2021-02-09 redness very flushed; perspiring; Feeling hot; Red face; chills; This is a spontaneous report from a contact... Read more
very flushed; perspiring; Feeling hot; Red face; chills; This is a spontaneous report from a contactable pharmacist reporting for herself. A 43-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacture Pfizer-BioNTech, lot# EL3249), via an unspecified route of administration, on 24Jan2021 at 14:30, at single dose, for COVID-19 immunisation. Medical history included endometriosis and migraine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included ibuprofen (MOTRIN) and unspecified oral contraceptives. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL1284), on 04Jan2021 at 01:00 PM, in left arm, for COVID-19 immunisation. The patient experienced very flushed, perspiring, feeling hot, red face and chills all on 24Jan2021 at 15:00 with outcome of recovered after about 1 hour. Since the vaccination the patient has not been tested for COVID-19.
43 2021-02-10 injection site swelling, injection site redness After the injection i had a lump for at least a week as well as redness. After about 1.5 weeks the ... Read more
After the injection i had a lump for at least a week as well as redness. After about 1.5 weeks the lump went away. But now on day 13 I have developed the red ring, well beyond the normal timeframe. It is about 3 inches in diameter.
43 2021-02-10 shingles, rash Received first Pfizer Covid-19 vaccine on 12/28/2020 and second dose on 01/18/2021. On 02/09/2021 I... Read more
Received first Pfizer Covid-19 vaccine on 12/28/2020 and second dose on 01/18/2021. On 02/09/2021 I was diagnosed with shingles on my left/mid back. I was able to send pictures to my doctor's office for diagnosis and am now on day two of treatment with Valacyclovir. Condition likely caught early, but symptoms (rash, pain) are worsening as of today.
43 2021-02-11 hives, itchy rash After the second dose I wasn?t feeling great, I slept an entire day and woke up Thursday feeling gre... Read more
After the second dose I wasn?t feeling great, I slept an entire day and woke up Thursday feeling great, Thursday evening I developed burning and itchy hives all over my neck chest and face, my face appeared swollen, I also had a smaller outbreak on my legs I took benedryl which seemed to calm the reaction some when I woke up the following morning, and another dose seemed to calm it some more
43 2021-02-11 rash Rash to arm 2 hours after vaccine, gone in 2 days
43 2021-02-14 redness Lips tingling; tongue felt full 4 mins after 1st injection; 24 hours later facial swelling and redne... Read more
Lips tingling; tongue felt full 4 mins after 1st injection; 24 hours later facial swelling and redness; 24 hours later facial swelling and redness; This is a spontaneous report from a contactable other health professional (HCP). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at 13:00 at a single dose for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD) and mild depression from an unknown date and unknown if ongoing. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX), pantoprazole sodium sesquihydrate (PROTONIX) and levonorgestrel (MIRENA). The patient experienced lips tingling, tongue felt full 4 mins after 1st injection. Given IV steroids in ER. Twenty-four (24) hours later facial swelling and redness, more steroids given, symptoms resolved. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 26Dec2020 (covid test type post vaccination=Nasal Swab). Therapeutic measures were taken as a result of lips tingling, tongue felt full 4 mins after 1st injection, 24 hours later facial swelling and redness, 24 hours later facial swelling and redness. The outcome of the events was recovered on an unspecified date. Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
43 2021-02-14 rash, itchy skin Pt at vaccine clinic for 2nd dose covid vaccine with a history of anaphylactic reaction to immunothe... Read more
Pt at vaccine clinic for 2nd dose covid vaccine with a history of anaphylactic reaction to immunotherapy. Pt presented with rash/itching on chest, tingling around ears and runny nose 20 minutes after vaccine administered.(0828) Doctor notified and Benadryl 25mg PO given VS at time 169/98, 60, 100%. 0847 pt c/o slight chest tightness, slight labored breathing, feeling of periorbital swelling,VS at time 173/91, 51, 99% Doctor again notified and an RN stat called, pt taken to the ER and report given to ER RN, pt appeared to be comfortable and feeling somewhat better
43 2021-02-14 rash, rash macular, itchy rash after second vaccine, itchy rash on body. Hive like spots on arms & trunk
43 2021-02-14 vaccination site swelling was administered into the Deltoid Tuberosity area instead of the deltoid itself; patient was concern... Read more
was administered into the Deltoid Tuberosity area instead of the deltoid itself; patient was concerned about the vaccine having been given SubQ instead of IM; there was a little bit of bleeding; the patient noticed a little bit of bruising; and a little bit of swelling; This is a spontaneous report from a contactable nurse. A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261, Expiry Date: May2021), subcutaneously on 28Jan2021 14:45 at 0.3mL single dose into the left deltoid tuberosity for COVID-19 immunization. Vaccination Facility Type was at Health Clinic. The patient's medical history and concomitant medications were not reported. Caller was an LVN and she had a vaccination clinic and there was an incident where one of the COVID vaccines that was administered to a patient, was administered into the Deltoid Tuberosity area instead of the deltoid itself. Caller stated that the patient was concerned about the vaccine having been given SubQ instead of IM. Caller was calling to find out how effective it would be if it was given SubQ. Caller stated that the patient was married to a doctor, and was a Nurse Practitioner herself, so she did not need to seek treatment. Caller stated that the patient was able to assess it herself, the patient noticed a little bit of bruising, but she suspected there would be, because there was a little bit of bleeding, and a little bit of swelling on 28Jan2021. The outcome of the events were unknown.
43 2021-02-15 itchy skin Patient states to get an itchy face and felt flush with chest heaviness. She was provided a Benadryl... Read more
Patient states to get an itchy face and felt flush with chest heaviness. She was provided a Benadryl and monitored for 30 minutes and was better after administration of the benadryl
43 2021-02-15 hives hives over multiple body areas (arms, legs, trunk)
43 2021-02-16 injection site pain, injection site swelling After receiving the second dose of the vaccine, I experienced severe pain at the injection site and ... Read more
After receiving the second dose of the vaccine, I experienced severe pain at the injection site and some swelling, a lot of muscle and joint pain overnight up until the next day. In addition I experienced body chills. After 2 hours of taking Tylenol the symptoms faded and the pain at the injection site also disappeared.
43 2021-02-16 injection site redness PATIENT CALLED AT 9AM 2/17 NUMBNESS TO FINGERS, VEINS IN HANDS EXPOSED AND SWOLLEN. BURNING SENSATIO... Read more
PATIENT CALLED AT 9AM 2/17 NUMBNESS TO FINGERS, VEINS IN HANDS EXPOSED AND SWOLLEN. BURNING SENSATION TO HANDS. REDNESS TO UPPER LEFT ARM.
43 2021-02-16 redness pt presented with erythema & swelling of face & periorbital regions C/O feeling fullness in tongu... Read more
pt presented with erythema & swelling of face & periorbital regions C/O feeling fullness in tongue & throat & some difficulty swallowing approx 30 - 45 min following vaccine Had also eaten a english muffin with plain cream cheese just prior to symptom onset She was noted to have mild swelling of her tongue & very sl lower lip She was administered 50 mg of diphenhydramine, 20 mg famotidine & 60 mg Prednisone & cold compress to face Was able to take all orally with water & had no difficulty -- after approx 30 minutes her s/s had much improved & her facial erythema & swelling had reduced no resp distress and O2 sat was 99%
43 2021-02-18 skin laceration, bruising A couple days after the vaccination I blacked out completely with no warnings signs or symtoms. I h... Read more
A couple days after the vaccination I blacked out completely with no warnings signs or symtoms. I had a head contusion and consuccion resulting in a few stitches in my head. Several test were ran but all were normal.
43 2021-02-18 itchy skin Within 5-10 minutes of injection initial sense of fullness in throat, throat clearing, mild difficul... Read more
Within 5-10 minutes of injection initial sense of fullness in throat, throat clearing, mild difficulty swallowing. No visible swelling. At 35 minutes after injection attempted to drink water, difficulty swallowing, coughing, no visible swelling. At 45-50 minutes post vaccine attempted to eat dinner (black beans and rice) difficulty swallowing, coughing. Again no visible swelling. Took Benadryl waited 15 minutes, able to eat dinner - resolved Other not resolved: Left arm pain referring up to neck and generalized swelling (loose shirt sleeve on Right is snug over left arm) , itchy ears
43 2021-02-19 injection site hives Tachycardia, agitation, hive on site of injection,
43 2021-02-21 rash Rash on back, started in the evening, was better by the next day but bumpy eczema type skin remains ... Read more
Rash on back, started in the evening, was better by the next day but bumpy eczema type skin remains on back and traveling up back of neck.
43 2021-02-22 itchy skin Generalized pruritis a few minutes following 2nd dose of Pfizer COVID vaccine; reported having throa... Read more
Generalized pruritis a few minutes following 2nd dose of Pfizer COVID vaccine; reported having throat fullness for 2 weeks following first dose of vaccine.
43 2021-02-22 itchy skin at 1430, pt. states she felt warm, went to screening station, temp was 99.5, went back to desk and f... Read more
at 1430, pt. states she felt warm, went to screening station, temp was 99.5, went back to desk and felt warm. States she started feeling pressure and warmth to her face with some itching. At 1500 she came to employee health. RN gave her 25 mg liquid benadryl. Her BP was 126/89, HR 87. No hives or swelling to Right arm noted. BP 117/80, HR 75. at apprx 1520, bp 137/85, HR 67. No other signs or symptoms noted. 1528, bp 121/82 At 1532, "patient states she feels good, almost back to normal".
43 2021-02-23 bruising Bone, joint, muscle aches. Headache. Weakness. 2/20/21 to 2/21/21 Swollen lymph nodes under arm and ... Read more
Bone, joint, muscle aches. Headache. Weakness. 2/20/21 to 2/21/21 Swollen lymph nodes under arm and into breast, bruising and tenderness. 2/20/21 to current Nausea and diarrhea 2/20/21 to current Exhaustion 2/20/21 to current
43 2021-02-23 vaccination site pain Injection site bruising and pain; Injection site bruising and pain; Nausea; This is a spontaneous re... Read more
Injection site bruising and pain; Injection site bruising and pain; Nausea; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL3248, vaccine location= Left arm), via an unspecified route of administration on 15Jan2021 08:00 AM at single dose for covid-19 immunisation. Patient was known allergies to penicillin. The patient's concomitant medications were not reported. Patient was not pregnant. The patient experienced nausea, injection site bruising and pain at 15Jan2021 09:00AM. No prior covid vaccination. No Covid tested post vaccination. Facility type vaccine was Workplace Clinic. No other vaccine in four weeks. Events resulted in none of the above. Patient was recovered in 2021. No treatment received for adverse events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021182443 same reporter, same patient, same product (different dose), different events
43 2021-02-23 vaccination site pain Nausea/Mild nausea; Severe headache; Dry mouth; General Malaise; fatigue; Nighttime sweats.; Likely ... Read more
Nausea/Mild nausea; Severe headache; Dry mouth; General Malaise; fatigue; Nighttime sweats.; Likely a low-grade fever; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3248, vaccine location=Left arm), via an unspecified route of administration on 04Feb2021 08:15 AM at single dose for covid-19 immunisation. Patient was known allergies to penicillin. The patient's concomitant medications were not reported. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL3248, vaccine location= Left arm), on 15Jan2021 08:00 AM for covid-19 immunisation and experienced nausea, injection site bruising and pain. Patient was not pregnant. The patient experienced injection site pain, severe headache, dry mouth, mild nausea, general malaise, fatigue, nighttime sweats and likely a low-grade fever all at 05Feb2021 04:00AM. No other vaccine in four weeks. No covid tested post vaccination. Events resulted in none of the above. No treatment received for adverse events. The patient was recovering; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021162107 same reporter, same patient, same product (different dose), different events.
43 2021-02-23 vaccination site rash Rash at vaccination site 9 days post injection
43 2021-02-24 skin discolouration A 43 y.o. female received her first dose of the COVID 19 vaccination. She was given the Pfizer vacc... Read more
A 43 y.o. female received her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness and feeling weak. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , hypotension, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. PMH: anxiety and bipolar. Takes Aripiprazole for this. No other medical history reported. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness (lightheaded), Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, cysts, itching of skin, abdominal pain, joint pain and headaches. Previous Reactions: none. Vitals -- 02/19/21 0350 02/19/21 1610. BP: 131/77 125/77. Pulse: 89 75. Resp: (!) 22 16. SpO2: 100% 100% Physical Exam--Vitals and nursing note reviewed. Constitutional -- General: She is not in acute distress. Appearance -- Normal appearance. She is well-developed. She is not ill-appearing, toxic-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear oral airway/intact Eyes: Conjunctiva/sclera: Conjunctivae normal. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal -- Cervical back: Neck supple. Skin -- General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological -- General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time; Gait: Gait normal. Psychiatric -- Mood and Affect: Mood is anxious; Behavior: Behavior normal; Thought Content: Thought content normal; Judgment: Judgment normal. Assessment/Plan -- Treatment included: water and snacks. Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP; Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health). Pt aware of monitoring symptoms at home. Follow up as needed with pcp. Recommend that she eat a snack and hydrate prior to next vaccine #2 of Pfizer.
43 2021-02-24 itchy skin About 45 to 50 minutes after vaccine was administered body and face felt warm and face was itching f... Read more
About 45 to 50 minutes after vaccine was administered body and face felt warm and face was itching for the rest of the afternoon. 02/23/2021 itching of face and genitals. 02/24/2021 mild rash appeared on hands and face and continues to itch. Advised to take Benadryl or Claritin to help the itch.
43 2021-02-26 itchy skin I immediately felt skin and eye itchy after I received the vaccines. Stayed in the waiting room for ... Read more
I immediately felt skin and eye itchy after I received the vaccines. Stayed in the waiting room for 30 mins, felt better. Next day skin itch got worse. Specially around my eyes.Eye itchy, rubbing, pain, vision blurry, puffiness, discharged, I bought some allergy drops but it didn?t get better. , on the 7 days after the vaccine, it was a Saturday, it got so much worse that I could barely open up my eyes. So I went to a clinic. The nurse practitioner gave me eyes drop for infection, it did not get better. She prescribed another eye drop, still not working. Now my eyes feel horrible,.
43 2021-02-26 shingles Shingles 8 days after vaccination. Talking valacyclovir now.
43 2021-02-27 injection site pain, itchy skin Although I felt nothing during the first dose, I DID feel a prick for my second dose. It was followe... Read more
Although I felt nothing during the first dose, I DID feel a prick for my second dose. It was followed by a little itch, but nothing unusual. I made sure to rub my arm and keep it moving until I went to bed a couple of hours later. The next day, I woke up with no issues, just a slight tenderness at the injection site that only really hurt if I touched it. At about 9:30 am, almost 12 hours after the second dose, I became a bit tired, had a little chill, and was a tiny bit achy. I took two Tylenol, and continued to hydrate. I could feel myself getting more uncomfortable as the day went on. By 3:00 pm, I was freezing, could not get warm, and running a fever of 100. I took more Tylenol, and got bundled up and took a nap. At 4:00 pm, I woke up and was even colder, and had a fever of 102.4. At this point, I got into bed and had continued to hydrate and take ibuprofen (I had run out of Tylenol) every four hours. The fever broke at some point in the night, as I woke up and was soaking wet, but by the time I woke up the fever had returned and was 101. I took more Ibuprofen and the fever dropped back to normal around noon on February 18. By far, the worst feeling, aside from the fever, was the extremely severe joint pain I had in my ankles, knees, hips, arms, and hands. It was painful to stand and to walk. By Friday, I felt better, but was weak. I felt back to 100% on Saturday morning.
43 2021-02-28 rash with redness, itchy skin, rash 25 minutes post Covid-19 vaccine, patient reported feeling "itchy." Red rash noted to neck, chest a... Read more
25 minutes post Covid-19 vaccine, patient reported feeling "itchy." Red rash noted to neck, chest and bilateral arms. Patient given IM Benadryl. Within 2 minutes, patient reported less "itchy" feeling. At 1550 patient reported no further "itchy" feeling. Patient denies any other issues. Patient sitting on stretcher talking with pharmacist. Patient reports full relief. No issues voiced. Patient educated to speak with her PCP prior to 2nd dose of Covid-19 vaccine and to report today's reaction to PCP. Patient states understanding of the above.
43 2021-02-28 itchy skin 30 minutes after injection I started itching (ears, nose, face, scalp, lips, various other body part... Read more
30 minutes after injection I started itching (ears, nose, face, scalp, lips, various other body parts) Treatment: Benadryl 25mg, I?ve continued to take as needed for itching.
43 2021-02-28 injection site mass, injection site swelling, injection site redness, injection site pain Lump, swelling, tender, redness all at injection site. Felt on first day, all have increased second ... Read more
Lump, swelling, tender, redness all at injection site. Felt on first day, all have increased second and third day.
43 2021-02-28 injection site swelling, injection site pain, injection site pruritus, injection site warmth, injection site redness, injection site mass Received first dose of vaccine on Jan 25th at 0940. Immediately noted itching, soreness at injection... Read more
Received first dose of vaccine on Jan 25th at 0940. Immediately noted itching, soreness at injection site. It continued to be itchy. On Feb 1st noted injection site to be swollen, itchy, red and hot to touch. This continued until I noticed on Feb 6th that the site was hot red and raised the size of a tennis ball shaped like a heart. This continued until Feb 8th Employee health was notified on Feb 8th. It seemed to dissipate on or about Feb 10th. Ice was used at the injection site
43 2021-02-28 shingles Shingles.
43 2021-02-28 rash, shingles Vaccine was on the 8th of January - Headache, rash on the top of my head and down on to my forehead... Read more
Vaccine was on the 8th of January - Headache, rash on the top of my head and down on to my forehead and around my right eye. Doctor visit on 11th. Diagnosed as Shingles. They put me on an anti-viral - Valtrex - for 10 days. It prevented it from spreading. I had the symptoms until about the January 27th.
43 2021-02-28 vaccination site pain she may have been panicked; she already has a pre-existing cardiac arrhythmia, but it seemed to have... Read more
she may have been panicked; she already has a pre-existing cardiac arrhythmia, but it seemed to have gotten worse after receiving the 1st dose/More arrhythmia problems; she already has a pre-existing cardiac arrhythmia, but it seemed to have gotten worse after receiving the 1st dose/More arrhythmia problems; left arm soreness; she felt ugh, like she was getting sick; sensation like she was going to pass out; Headache; This is a spontaneous report from a contactable nurse (patient). This 43-year-old female patient female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EM9810, intramuscular on left deltoid on 04Feb2021 as single dose (at the age of 43 years) for Covid-19 Immunization. No medical history reported, and no concomitant medication reported. Historical vaccine included BNT162B2 for Covid-19 Immunization. Medical history included Pacemaker in Jun2019 and ongoing, sick sinus syndrome, and pre-existing cardiac arrhythmia ongoing. Historical vaccine included Tetanus, Tetanus made her arm sore, the soreness from tetanus was worse than the soreness from COVID vaccine since it lasted a week with tetanus, no lot number reported. No concomitant medication was reported. The patient experienced she already has a pre-existing cardiac arrhythmia, but it seemed to have gotten worse after receiving the 1st dose/More arrhythmia problems on 05Feb2021 considered medically significant with outcome of not recovered, Within 15 minutes after receiving the vaccine she felt like she was going to pass out three times on 04Feb2021 considered medically significant and recovered on 04Feb2021, she may have been panicked on unspecified date with outcome of unknown, left arm soreness on 05Feb2021 with outcome of recovered on Feb2021, and she felt ugh, like she was getting sick on 05Feb2021 with outcome of unknown. The patient did not receive treatment for events. She stayed an extra 30 minutes to be monitored after the initial waiting of 15 minutes since she had to drive home, then she felt better. She has not called her cardiologist since she has the history of arrhythmias. She had the more arrhythmias start on the evening of the 05Feb2021, states it was weird because it seems to happen more in the evening between 6 and 9pm, sometimes as late as 10pm. However, 'yesterday' it started happening during the day, and it is more frequent, not constant, it just happens. States it is hard not think about it when her heart is having hiccups since that is what it feels like. She knows what it feels like because when her pacemaker goes off ventricularly she can feel it. She had arrhythmias before the vaccine but has not had issues with arrhythmias continuously. She was diagnosed with sick sinus syndrome and they do not know if it is cardiology or neurology, states it has been an issue for her for the last two years (2019). Lab data included weight of 284-286. She is asking if there is any data that supports her getting the second dose on 25Feb2021. She has read that some people tend to have more side effects with the second dose. The patient had no prior vaccinations (within 4 weeks).; Sender's Comments: Based on vaccine-event chronological association, a causal relationship between events worsening arrhythmia and pre-syncope and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
43 2021-03-01 blister A blister was noted 2 days after injection that was bigger than a pea but smaller than a dime.; The ... Read more
A blister was noted 2 days after injection that was bigger than a pea but smaller than a dime.; The injection appeared to be low than deltoid and concern it was subcutaneous rather than IM; This is a spontaneous report from a contactable pharmacist. A 43-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiration date: unknown), via subcutaneous route on her right deltoid from 25Jan2021 10:15 to 25Jan2021 10:15 at SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 04Jan2021 at 10:15 via intramuscular route on her right arm. On 27Jan2021 at 22:00, a blister was noted 2 days after injection that was bigger than a pea but smaller than a dime. The injection appeared to be low than deltoid and concern it was subcutaneous rather than intramuscular (IM). The outcome of the event was recovered on an unspecified date. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.
43 2021-03-01 rash Rash
43 2021-03-01 injection site pain Very 'heavy' legs, extreme sore arm in first dose Extreme headache lasting around a week, chills, fa... Read more
Very 'heavy' legs, extreme sore arm in first dose Extreme headache lasting around a week, chills, fatigue
43 2021-03-01 itchy skin, rash pt states that about a week after taking the covid vax that she became itchy and noticed a big red r... Read more
pt states that about a week after taking the covid vax that she became itchy and noticed a big red rash on her neck towards her shoulders and down to the breast. She took an antihistamine that did not help so she took a Levocetirizine which helped some. The red rash moved to both arms. She woke up the next day and the rash was gone. Once the medicine wore off that night the rash would come back. She took more Levocetirizine which helps make the rash disappear. Once the medicine wears off the rash comes back. She had her virtual doctor appt today 3/2/2021. Doctor thinks she is having a delayed reaction from the vaccination and to keep taking any medicine that seems to be helping her.
43 2021-03-02 itchy skin, injection site pain Fine after administration during the observation period. At 7 or 7:30 pm patient started itching on... Read more
Fine after administration during the observation period. At 7 or 7:30 pm patient started itching on face, back , arms and left leg. patient says the itching was mild to moderate. No visible rash. Patient compared the itching to what happened after she took codeine. Then throat started itching, no shortness of breath or difficulty breathing. Eye also started watering. At midnight the patient took a Benadryl and this help relieve the itching. all the patient noticed was the injection site pain. Today she is still itching, but it is mild and did not warrant Benadryl. Advised patient if she experiences any form of shortness of breath to go to the emergency room.
43 2021-03-02 injection site bruising Pain in left elbow and in anterior muscle from elbow to mid arm. Started day after receiving second... Read more
Pain in left elbow and in anterior muscle from elbow to mid arm. Started day after receiving second COVID vaccine. Bruise remains at injection site, lite purple and tender to touch.
43 2021-03-02 itchy rash, rash with redness Red flat itchy rash on torso, face, arms, legs; Red flat itchy rash on torso, face, arms, legs; faci... Read more
Red flat itchy rash on torso, face, arms, legs; Red flat itchy rash on torso, face, arms, legs; facial swelling; eyes swollen; itchy throat; cotton mouth; Received first dose on 25Jan2021 and second dose on 11Feb2021; Received first dose on 25Jan2021 and second dose on 11Feb2021; This is a spontaneous report from a contactable Other Health Professional. A 43-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9266), intramuscularly in Left arm on 11Feb2021 17:15 at single dose for covid-19 immunisation. Medical history included allergy to dairy products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262) at the age of 43 years old and Intramuscularly in Left arm on 25Jan2021 17:00 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Red flat itchy rash on torso, face, arms, legs; facial swelling; eyes swollen; itchy throat; cotton mouth on 12Feb2021 12:00. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Since the vaccination, the patient has been tested for COVID-19 via Nasal Swab on 02Feb2021 with result Negative. Therapeutic measures (reported as 'IV Epinephrine, Solumedrol, 'Pepcid', 'Benadryl', prednisone) were taken as a result of red flat itchy rash on torso, face, arms, legs, facial swelling, eyes swollen, itchy throat, cotton mouth. The outcome of the events was not recovered. This case reported as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and known safety profile of suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
43 2021-03-03 rash After the vaccine, patient started to experience rash on her hands. @1000 diphenydramine 50 mg IM w... Read more
After the vaccine, patient started to experience rash on her hands. @1000 diphenydramine 50 mg IM was given in the right arm; lot no 6124005 exp 4/2022. @1001 HR 71, SO2 99%.
43 2021-03-03 itchy skin, hives Developed hives on my neck and back and extreme itchiness - took 2 benedryl and it cleared up with... Read more
Developed hives on my neck and back and extreme itchiness - took 2 benedryl and it cleared up within 30 minutes, Have never had hives before. Some weird tongue sensation is lingering as well that has been lingering. Emailed Dr who said to avoid taking benedryl or steriods after second dose but it was ok to proceed with second dose.
43 2021-03-03 itchy skin Itchiness all over body 10 minutes after administering shot. Monitored patient for 30minutes, gave 1... Read more
Itchiness all over body 10 minutes after administering shot. Monitored patient for 30minutes, gave 1 diphenhydramine 50mg capsule to take when gets home to her family. Advised patient to call or go to ER if symptoms get worse.
43 2021-03-03 itchy skin Patient received the COVID-19 Pfizer vaccine at 9:06 am on 2/28/2021. Patient began to experience an... Read more
Patient received the COVID-19 Pfizer vaccine at 9:06 am on 2/28/2021. Patient began to experience an itchy throat and body. Benadryl IM Injection was given in the right arm at 09:32 AM lot number 6124005, EXP 04/22. Patient was also given a Kenalog 40mg IM at 10:10 AM. Kenalog lot number AP200265C, EXP 9/22.
43 2021-03-03 injection site redness, injection site swelling, injection site warmth Quarter size round red, swollen, warm to touch at injection site with smaller dime size round red sw... Read more
Quarter size round red, swollen, warm to touch at injection site with smaller dime size round red swollen warm to touch lump 1/4" under injection site
43 2021-03-03 hives, rash Rash, uticaria
43 2021-03-03 injection site redness, injection site swelling, injection site hardening, injection site pruritus Sweats, nausea, muscle spasms in the injected arm for 24 hours. Spasms went away and came back a co... Read more
Sweats, nausea, muscle spasms in the injected arm for 24 hours. Spasms went away and came back a couple of days later and have continued off and on. On 3/3/21 a mild fever and on 3/4/21 "covid arm" at the injection site. It is red, very itchy and hard and swollen.
43 2021-03-05 injection site pain 5 min after vaccine: nerve pain in upper right arm traveled in a line into right side of neck, up to... Read more
5 min after vaccine: nerve pain in upper right arm traveled in a line into right side of neck, up to just below the ear. Pain traveled directly from site of vaccine in arm and up through neck. 10 min after vaccine: Nerve pain down began in a line down right arm and into pinky and ring fingers of right hand. 20 min after vaccine: Tongue tingly (entire right side only, left side normal), pain in jaw, headache beginning in right temple. OTC Tylenol and then Ibuprofen taken 1 hour, 15 min after vaccine helped dull headache but not other symptoms. Nerve pain was intermittent until bedtime. The next morning, woke to right eye crusty from tearing, right eye tearing at corner (clear, like tears), consistently drippy right nostril (clear), loss of taste in tingly right side of tongue (could taste on left side of tongue), tingly right side of lips, slight drool right side mouth, outside of ear slight tingly. Headache returned, only in right temple extending to above right eye. Right side of face felt heavier than left side. Sensitivity to light, sound. Took Tylenol and Ibuprofen. Over 9 hour period (24-28 hours after vaccine given), most symptoms resolved, including taste. The next day (48 hours after shot), symptoms remaining are right eye has very slight tearing, right side of face feels a little "heavier" than left side, but drastically different from day before. I have NEVER had anything like this happen before after a vaccine or otherwise.
43 2021-03-06 itchy skin 2/26/21-3/1/21 left ear pain as if a pimple is inside 3/1/21-3/5/21 Left big toe and two toes next t... Read more
2/26/21-3/1/21 left ear pain as if a pimple is inside 3/1/21-3/5/21 Left big toe and two toes next to it painful, itchy, hurts when push on toenails, awoken from sleep needing Tylenol Both got better without medical treatment.
43 2021-03-08 injection site mass, injection site swelling, injection site warmth, injection site redness 104 constant fever 3 days with first vaccine; 4 days with second vaccine; Severe back pain and stiff... Read more
104 constant fever 3 days with first vaccine; 4 days with second vaccine; Severe back pain and stiffness unresolved and ongoing (now on day 7); arm swelling at injection site with second vaccine - hard knot the size of a small egg, hot to the touch, bright red coloration - unresolved and ongoing (day 7); numbness of the left arm, left side, and left leg - second vaccine- ongoing and unresolved (day 7); pain, tingling varying with numbness of the left hand and finger and left foot and toes- second vaccine - ongoing and unresolved (day 7); extreme fatigue - both vaccines - ongoing and unresolved (day 7); vomiting and nausea - unable to keep down solid food, can keep down cold liquids but nothing warmer than room temperature - ongoing and unresolved (day 7) recommendation to see PCP for referral to neurologist, immunologist as soon as possible.
43 2021-03-08 rash, rash with redness About Ten minutes after the shot my face became very flushed and I felt light headed. I had a strang... Read more
About Ten minutes after the shot my face became very flushed and I felt light headed. I had a strange swelling feeling around the backsides of my tongue, like the numbing feeling after a dentist visit. Then about 15 or 20 minutes later someone noticed a red slightly bumpy rash on my chest below my neck. It did not progress. I took Benadryl about 40 minutes after my shot and the rash and tongue feeling went away. I took Benadryl again 6 hours later . After that I had a mild headache and fatigue for two days. With some occasional nausea that would come and go for three days.
43 2021-03-08 rash Chills real bad still cold 3 days later face broke out real bad.
43 2021-03-08 redness, skin warm Started out as being light headed and tired. Then the next day noticed arm red and very sore. I watc... Read more
Started out as being light headed and tired. Then the next day noticed arm red and very sore. I watched it and monitored it. Then on the 8th I woke up to the red spot being bigger, warm to touch and very sore. I marked it with a pen to keep track of the red spot spreading. I took an Ibuprofen at night and put ice on the spot. Today on the 9th the red spot has spread a little, however the redness of the color has gotten lighter. It is still tender to the touch and the spot is still warm to the touch. I am going to continue to monitor it another day or two and if it gets worse I will call my doctors office to make a visit
43 2021-03-09 itchy skin 16:53 Pt states head, legs itchy 17:00 Given Zyrtec, 10mg PO 17:18 Benadryl 50mg, IM BP 125/63 HR 7... Read more
16:53 Pt states head, legs itchy 17:00 Given Zyrtec, 10mg PO 17:18 Benadryl 50mg, IM BP 125/63 HR 75 02 99% RA, 17:27 pt staes tongue starting to swell, 17:32 epi 1:1000 .5ml IM left thigh 17:39: tongue improving 02 sat 99% RA 17:58 pt stable for discharge home, provided transport to car pt
43 2021-03-09 rash macular Anaphylactic reaction, splotchy skin
43 2021-03-09 redness, skin burning sensation, itchy skin Redness, burning and itching to L hand. Evaluated by medics, cleared.
43 2021-03-09 vaccination site redness, vaccination site pain small red welt appeared at injection site; small red welt appeared at injection site; arm pain retur... Read more
small red welt appeared at injection site; small red welt appeared at injection site; arm pain returned; arm pain at site of injection; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9262), via an unknown route of administration on 29Jan2021 at 17:00 (at the age of 43-years-old) as a single dose in the left arm for COVID-19 immunization. The patient's medical history was not reported. The patient had allergies to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. Concomitant medications were not reported (did not have other medications in two weeks). The patient did not receive other vaccines within 4 weeks prior to vaccination. On 29Jan2021, the patient initially experienced arm pain at the site of injection; on 06Feb2021 at 08:00 (day 8 post vaccination) the patient experienced a small red welt at the injection site and arm pain returned. The patient did not receive any treatment for the events. The clinical outcome of the event vaccination site pain was recovered within approximately 36 hours; vaccination site erythema and vaccination site reaction was resolved on day 9; and pain in arm was recovering.
43 2021-03-10 rash, bruising Bruise & rash on left arm, below injection site- started 2 days after injection, getting better afte... Read more
Bruise & rash on left arm, below injection site- started 2 days after injection, getting better after 2 days Dizziness - starting 4 days after injection Face tingling - starting 5 days after injection
43 2021-03-13 skin warm, itchy rash Swollen, itchy, hot rash starting below eyes and continuing to spread down face. Swollen throat with... Read more
Swollen, itchy, hot rash starting below eyes and continuing to spread down face. Swollen throat with mild discomfort.
43 2021-03-14 rash macular Anaphylaxis: Closing throat, swollen mouth, sore throat, difficulty swallowing, difficulty breathing... Read more
Anaphylaxis: Closing throat, swollen mouth, sore throat, difficulty swallowing, difficulty breathing deeply, itchiness in mouth, blotching of skin
43 2021-03-14 itchy rash, rash PATIENT DEVELOPED A ITHCY RASH ON FACE AND NECK THAT WOULD COME AND GO THAT STARTED THE DAY AFTER VA... Read more
PATIENT DEVELOPED A ITHCY RASH ON FACE AND NECK THAT WOULD COME AND GO THAT STARTED THE DAY AFTER VACCINATION. was seen today, 3/15/21 day 10 after vaccination with rash still present. Will take Benadryl q 6 hours prn
43 2021-03-14 vaccination site pain felt very tired; Minimum pain at the injection site; This is a spontaneous report from a contactable... Read more
felt very tired; Minimum pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration in the left arm on 23Feb2021 11:45 at a single dose for COVID-19 immunisation. The patient's medical history included crohn's disease. The patient was not pregnant at the time of vaccination. Concomitant medications included azathioprine (IMURAN) and multivitamins. The patient previously took the first dose of bnt162b2 in the left arm on 03Feb2021 11:45 at the age of 42 years old for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 23Feb2021 15:00, the patient felt very tired and experienced minimum pain at the injection site. No treatment were received for the events. Outcome of the events was recovering. The events were considered non-serious. Information on the lot/batch number has been requested.
43 2021-03-14 rash, hives small hives; rash on lower abdomen; This is a spontaneous report from a contactable consumer (patien... Read more
small hives; rash on lower abdomen; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), via an unspecified route of administration in the left arm on 10Jan2021 15:00 at a single dose for COVID-19 immunisation. There were no medical history. The patient was not pregnant at the time of vaccination. Concomitant medication included multivitamin. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced small hives and rash on lower abdomen on 19Jan2021 08:00. Therapeutic measures were taken as a result of the events and included treatment with topical cream. Outcome of the events was recovering. The events were considered non-serious. The patient took the second dose of bnt162b2 (lot number: ENS318) in the right arm on 29Jan2021 15:00.
43 2021-03-15 hives, rash 43 YO F C/O NUMB SENSATION IN HER FACE SOME UNUSUAL SENSATION IN HER TONGUE FOLLOWING COVID SHOT. DE... Read more
43 YO F C/O NUMB SENSATION IN HER FACE SOME UNUSUAL SENSATION IN HER TONGUE FOLLOWING COVID SHOT. DENIES OTHER C/O TO INCLUDE DIFFICULTYBREATHING, SWALLOWING, SPEAKING, DENIES SWELLING IN OR AROUND FACE/MOUTH, NAUSEA, OR OTHER C/O. PT INITIALLY WAS WILLING TO GO TO ER BUT HER SXSUBSIDED WHILE WAITING FOR AMBULANCE AND SHE DECIDED TO AMA AND FOLLOW UP ON HER OWN. FOUND ABOVE PT A/O X4, NO OBV DISTRESS, NO OBVIOUS ANGIOEDEMA, SPEAKS IN FULL SENTENCES, CLEAR LS BILAT ALL, SOME HIVE LIKE RASH ON ANTERIOR CHESTBELOW THE CLAVICLES, EXTREM - PWD, GOOD PMS X4, MOVES ALL WITH PURPOSE
43 2021-03-15 injection site pain The time prior to the vaccine, I had no pelvic pain or limitations in physical activity. 1/7/2021 ... Read more
The time prior to the vaccine, I had no pelvic pain or limitations in physical activity. 1/7/2021 Received Pfizer Vaccine #1 experienced left arm soreness at the injection site. The evening of 1/7/2021 following the injection, developed dull lower pelvic pain. Pelvic pain worsened over the next two days 1/9/2021 Symptoms of pelvic pain intensified to now excruciating, sharp pain 1/10/2021 Seen at nearby urgent care and evaluated by healthcare provider; referred to nearby emergency department for further evaluation, work up and recommended imaging. Evaluated by emergency room physician, lab work collected and imaging were completed. CT scan showed 7cm mass in the right pelvis, small amount of pelvic fluid. Pelvic ultrasound was also completed and confirmed 7 cm round lesion in the right adnexa. Discharged home with pain medication and instructions for outpatient follow up. 1/12/2021 Seen by PCP and referral sent OB/GYN; Symptoms are now as dull pelvic pain, associated with rectal pressure and a pelvic pulling sensation position dependent, also associated with intense internal rectal pain at the time of bowel movements and weight loss. 1/14/2021 Seen by OB/GYN, repeat pelvic ultrasound ordered 1/22/2021 Repeat pelvic ultrasound completed showed 7.4 cm right adnexal cystic lesion increased in size 1/28/2021 Received Pfizer Vaccine #2, staff at vaccination clinic informed of pelvic pain onset after Vaccine #1 injection. Approximately 4 hours after Vaccine #2, I developed severe sharp pain again similar to after Vaccine #1 which required pain medication for relief. 1/29/2021 Pain improved with medication 1/30/2021 Symptoms have now returned to dull pelvic pain, associated with rectal pressure and a pelvic pulling sensation position dependent, also associated with intense internal rectal pain at the time of bowel movements and continued weight loss until scheduled surgery 2/26/2021. 2/12/2021 Seen by PCP, cleared for surgery; labs completed 2/17/2021 Seen by OB/GYN for preoperative visit 2/23/2021 Seen at hospital for COVID Preop Testing 2/26/2021 Surgery completed under general anesthesia ? Laparoscopic myomectomy with mini-laparotomy, lysis of bowel adhesions to degenerating fibroid tumor The time prior to the vaccine, I had no pelvic pain or limitations in physical activity.
43 2021-03-15 injection site pain fatigue 3 days, swollen painful lump lymph node under right arm 3 days, headache 1 day, painful at i... Read more
fatigue 3 days, swollen painful lump lymph node under right arm 3 days, headache 1 day, painful at injection site 4 days
43 2021-03-16 itchy skin First shot - slightly tight feeling in my throat about an hour after shot, low grade fever second da... Read more
First shot - slightly tight feeling in my throat about an hour after shot, low grade fever second day Second shot - tight feeling in throat about an hour after shot for about 4 hours, and light headedness; fever later in day, fell asleep early slept 10 hours; second day ok in morning then fever getting higher all day but now better (6:30 pm so 33 hours after shot), extreme itchiness today day 2, like fleas - took Benadryl at noon and need more now; stomach ache and diarrhea.
43 2021-03-16 injection site swelling Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness... Read more
Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium
43 2021-03-17 redness, itchy skin Patient reported feeling flushed, itching, and redness all over body about 30 minutes after injectio... Read more
Patient reported feeling flushed, itching, and redness all over body about 30 minutes after injection. 50mg of IM Benadryl given in the right deltoid. Patient tolerated well. No signs of respiratory distress. Observed 30 mins after Benadryl given. Patient alert and oriented. Left in accompany of coworker. Instructed to call 911 if signs of respiratory distress.
43 2021-03-17 injection site swelling, injection site redness, injection site warmth Swelling redness and heat at and around the injection site.
43 2021-03-18 itchy rash, rash A day later a rash appeared on my left arm. It was extremely itchy. It progressed to the tops of b... Read more
A day later a rash appeared on my left arm. It was extremely itchy. It progressed to the tops of both of my legs, my right arm, chest, stomach and back. It continued to spread even with Benadryl and Cortizone cream. I went to the clinic this morning and have been given prednisone.
43 2021-03-18 vaccination site pain Nausea and vomiting; Nausea and vomiting; headache; muscle aches; fever; chills; joint pain; sorenes... Read more
Nausea and vomiting; Nausea and vomiting; headache; muscle aches; fever; chills; joint pain; soreness at injection site; fatigue; This is a spontaneous report from a contactable nurse. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in right arm on 12Feb2021 (Lot Number: EL1283) as single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medications included colecalciferol (VITAMIN D) taken for an unspecified indication, start and stop date were not reported; ibuprofen (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported. The patient previously took ciprofloxacin hydrochloride monohydrate (CIPRO) and experienced allergy, BNT162B2 (Lot number EM9810) on 19Jan2021 for covid-19 immunization, hepatitis a vaccine for immunization on 04Jan2021. On 13Feb2021, at 03:00, the patient experienced nausea and vomiting; headache; muscle aches; fever; chills; joint pain; soreness at injection site; fatigue. No COVID test was completed post vaccination. The outcome of events was not recovered.
43 2021-03-19 injection site pain Strong, dull pain at injection site 12 hours after injection. Enough pain to wake from sleep.
43 2021-03-20 itchy skin I have been experiencing severe itchiness in various places over my body. After the first shot in th... Read more
I have been experiencing severe itchiness in various places over my body. After the first shot in the series, it happened for about 6-7 days after, since the second shot, I still continue to experience this itchiness. It has been 7 weeks. In addition to the antihistamines I take regularly, I have been supplementing with Claritin and Benadryl. I take both at least once per day to address the itchiness.
43 2021-03-21 redness Patient received Pfizer vaccine L Deltoid at 0950. At 1003 She complained of swollen, tingling, and... Read more
Patient received Pfizer vaccine L Deltoid at 0950. At 1003 She complained of swollen, tingling, and red hands b/l. No SOB, throat swelling, itching, scratching, no tongue swelling. AAO x 3. Talking with no difficulty. No known allergies. Benadryl 25 mg PO was administered. She was monitored. No further symptoms.
43 2021-03-21 itchy rash Pfizer-BioNTech Covid-19 Vaccine EUA
43 2021-03-22 itchy skin Itching all over.
43 2021-03-22 injection site discomfort Tachycardia one day after second vaccination, along with the normal side effects of body aches, feve... Read more
Tachycardia one day after second vaccination, along with the normal side effects of body aches, fever, chills, ache at vaccination site, nausea, fatigue. After the first vaccination, infected kidney from a prior UTI that took place two weeks prior to the first vaccine.
43 2021-03-23 itchy skin 1 day of itching on face and scalp
43 2021-03-23 itchy skin 3/23/21 - pt called the call center to inquire about J&J vaccine availability and to cancel 2nd dose... Read more
3/23/21 - pt called the call center to inquire about J&J vaccine availability and to cancel 2nd dose appointment. Pt reported that she had a reaction w/ pfizer vaccine. Received Pfizer vaccine on 3/2/21. From review of available outside records, pt called PCP (outside provider) on 3/5/21 reporting itchiness, lip swelling, tongue felt enlarged but no trouble swallowing or SOB 2 days post-vaccine. Pt was advised to continue benadryl and if s/sxs worsen to go to ED. Per pt, they later developed SOB and went to outside ED where she received epi-pen and prescribed prednisone course. Pt followed up with PCP on 3/11/21 and pt report improvement in symptoms. Pt was advised by PCP not to get 2nd dose of pfizer.
43 2021-03-23 injection site pruritus, injection site swelling, injection site warmth Received 2nd shot. Area where shot was injected is raised, warm and itchy. Size is about equal to a ... Read more
Received 2nd shot. Area where shot was injected is raised, warm and itchy. Size is about equal to a half dollar.
43 2021-03-23 hives, itchy skin, injection site hives, injection site pruritus Two days after shot got a strange round spot on my chest that looked almost like ring worm. Saw urge... Read more
Two days after shot got a strange round spot on my chest that looked almost like ring worm. Saw urgent care doctor and said was not ring worm as it was not at all itchy. Two days later started getting hives all over torso and back. Now have a hive at the injection site. They are slightly itchy and almost look like bruises.
43 2021-03-23 hives mildly faint, heavy, mild urticaria. Evaluated be EMS-Cleared
43 2021-03-24 itchy skin Itching; Burning in my throat and chest and arm; Burning in my throat and chest and arm; Throat swel... Read more
Itching; Burning in my throat and chest and arm; Burning in my throat and chest and arm; Throat swelling; Chest pain/burning in her throat and chest; Rapid heart beat; This is a spontaneous report from a contactable consumer (patient). This 43-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 16Mar2021 at 02:00 PM at single dose (lot number: EN6208, expiration date: 30Jun2021) for COVID-19 immunization. Medical history included known allergies to 32 meds and nuts and shellfish, asthma, COPD and seizures and chronic lung disease. Concomitant medications included prednisone and topiramate (TOPAMAX) in two weeks. The patient had no other vaccine in four weeks. The patient was not pregnant when vaccination. The patient was given the covid 19 shot and within mins. The patient tested the shot and started to have itching and burning in her throat and chest and arm and given 50 mgs of Benadryl in her inhaler then a hour later had to go to ER due her throat swelling closed and chest pain, rapid heart beat was given Benadryl n Prednisone. Events started from 16Mar2021 02:15 PM. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). The patient was recovered with lasting effects. Treatment was received for AE at ER 50 mgs Benadryl and 60 mgs of Prednisone. The patient had no Covid prior vaccination, no Covid tested post vaccination. Outcome of all events was recovered with sequel. Seriousness criteria was reported as life-threatening.
43 2021-03-24 itchy rash Patient called clinic with complaints of possible reactions to the second dose of the vaccine today.... Read more
Patient called clinic with complaints of possible reactions to the second dose of the vaccine today. States that after she was observed for 15 minutes following the second dose of the Pfizer vaccine, she went home and noticed some slight tongue tingling that lasted for a few minutes then went away. She had her second dose today at 0945. Denies any reactions after her first dose. States now she has bumps on her skin similar to a skin rash with some pruritus. Denies wheezing, dyspnea, SOB, lip/tongue swelling, throat tightness, dysphagia, chest pain, nausea, vomiting. States she did take Zyrtec 10 mg this morning which is normal for her as she has allergies. She was currently at work when calling. Advised Pt of the following for treatment: 1. Topical hydrocortisone 1% cream to affected areas for the itch. Cool compresses for swelling and the itch. 2. OTC Zyrtec-- advised her to take a second dose of 10 mg tonight when going to bed. Also advised her to take Benadryl 25 - 50 mg every 4-8 hours as needed, max 300mg daily. Can be sedating, do not take with driving or operating machinery. Decided it would probably be best for her to leave work and go home in case she gets sleepy. She denied needing a work note at this time. 3. Advised to call 911 if signs and symptoms worsen at any time. Advised Pt not to follow up at \center if having any red flag symptoms but rather go to the ED immediately. Red flag symptoms: SOB, wheezing, lip/tongue swelling, throat tightness, chest pain. Discussed reaction with collaborating physician who was also the clinical observer for the vaccines today. Also made clinic manager aware
43 2021-03-24 rash, itchy skin, redness, rash papular Pt has experienced a full body rash, not just one specific to injection site. Rash presents as raise... Read more
Pt has experienced a full body rash, not just one specific to injection site. Rash presents as raised red, itchy bumps covering arms, legs, and torso of body. Pt has also experienced a racing heart upon presenting to pharmacy with reaction; may or may not be related to vaccination.
43 2021-03-24 vaccination site pain Severe bodyaches and sore injection site; Severe bodyaches and sore injection site; This is a sponta... Read more
Severe bodyaches and sore injection site; Severe bodyaches and sore injection site; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant 43-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG201), via an unspecified route of administration in the left arm on 19Feb2021 at 14:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 prior to vaccination from an unknown date and unknown if ongoing. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included iron; vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); Vitamin D NOS; loratadine (CLARITIN); fluticasone propionate (FLONASE), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient previously took codeine and experienced drug hypersensitivity. On 20Feb2021 at 06:00, the patient experienced severe body aches and sore injection site. The patient did not receive any treatment for the events. The clinical outcomes of the severe body aches and sore injection site were recovered with sequelae.
43 2021-03-25 itchy rash, injection site mass, rash with redness, rash papular, injection site reaction, injection site pain Client report receiving second COVID vaccine on 03/22/21 at 1100. After first vaccine on 03/02/21, ... Read more
Client report receiving second COVID vaccine on 03/22/21 at 1100. After first vaccine on 03/02/21, she had hives that went away quickly. After second vaccine, client had a lump at site the size of a "half dollar" and very sore at injection site. On 03/24/21 noticed raised red, itchy rash on left arm, stomach and legs. Not seen by medical provider, treated at home with Benadryl, Zyrtec (during the day), Aleve and hydrocortisione on legs. Rash has improved today (03/26/21).
43 2021-03-25 hives Extreme allergy reaction, hives in mouth and lips, eyes and nose itchy I want to tear my face off. L... Read more
Extreme allergy reaction, hives in mouth and lips, eyes and nose itchy I want to tear my face off. Lips and lower face are becoming more swollen. I have no access to Health insurance so I will take a shower and some Benadryl, my only attainable recourse at this time.
43 2021-03-25 rash Rash on right forearm
43 2021-03-26 injection site pain By the next day, on the 26th I had mild injection site pain. During the night then between the 26th ... Read more
By the next day, on the 26th I had mild injection site pain. During the night then between the 26th and 27th a lymph node in the r. axilla became enlarged and sore. The entire r. arm is just achey other than the injection site pain and axillary discomfort. I do have a migraine as well, but I believe it is due to my mentrual cycle.
43 2021-03-26 injection site swelling Grade 3, swelling at injection site, arm pain after injection on Friday and today, Saturday after se... Read more
Grade 3, swelling at injection site, arm pain after injection on Friday and today, Saturday after second dose with LVN. The nurse LVN may not have injected it correctly. I struggled to do dishes after dinner. My arm pain kept me awake last night. I didn't have any arm pain or swelling at injection site with the first Pfizer dose with nurse. No Pain or side effects whatsoever with the first Pfizer vaccine. Vaccine may be fine. It might be the way the nurse injected it.
43 2021-03-26 hives, itchy skin Hives on skin, on arms, legs, chest, various areas on the body, itchiness on skin and hives.
43 2021-03-26 itchy skin Swelling & itching: hands feet & throat Chills: with uncontrollable shaking Fever from 100-103 with... Read more
Swelling & itching: hands feet & throat Chills: with uncontrollable shaking Fever from 100-103 with Tylenol for 48 hours Extreme muscle pain- not ache, it hurt to lay still Bones would hurting, especially if pressure was applied to move or walk Shallow breathing Extreme thirst Sharp stabbing pain in head: bottom left toward back of neck Large Swollen spot under left arm under arm pit Increased heart rate- approx 130 bpm Went to emergency room in around 8:30 PM on Thursday March 25th. Was given via UV: fluids, Benedryl, medicine for pain & swelling. Discharged around 11:00 PM. Have Remained sick with normal side effects, feeling flu like, and a low temp around 100. Much more manageable. Today is Saturday & I still feel very unwell but no longer feel like I?m dying.
43 2021-03-27 skin discolouration Fever, brisket, burn, skin coloration
43 2021-03-30 vaccination site warmth, vaccination site itchiness, rash Pain in left arm; Rash in neck and upper body; heat and itching in area; heat and itching in area; T... Read more
Pain in left arm; Rash in neck and upper body; heat and itching in area; heat and itching in area; This is a spontaneous report received from a contactable consumer reporting for self. A 43-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 07Mar2021 11:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Patient received the first dose on 14Feb2021. Medical history included asthma, lactose intolerance. Patient had allergies to Bactrim, Sudafed. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), diphenhydramine hydrochloride (BENADRYL), ibuprofen, colecalciferol (VITAMIN D [COLECALCIFEROL]), vitamins. The patient experienced Pain in left arm, Rash in neck and upper body, heat and itching in area on 08Mar2021 16:00. Outcome of events was not recovered. Information on the lot/batch number has been requested.
43 2021-04-01 shingles Shingles; Shingles/she was 7 years old she had her first shingles outbreak; burning sensation; They ... Read more
Shingles; Shingles/she was 7 years old she had her first shingles outbreak; burning sensation; They were flu-like symptoms; Diarrhea; Nausea; achiness; This is a spontaneous report from a contactable nurse (patient) from a Pfizer-sponsored program. A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6203, Expiry Date: unknown), intramuscular, administered in the right deltoid (also reported as right arm) on 03Mar2021 16:00 at a single dose for covid-19 immunisation. Medical history included patient had anxiety all her life (ongoing), but reported 'started the medication about 10 years ago for the first time'; and patient had hypothyroidism, which she found out when she was going through the in-vitro fertilization. It was further reported that she was diagnosed with hypothyroidism when she and her husband were going through In-vitro fertilization and were having trouble conceiving and her TSH levels were off (date unknown). She didn't feel any different and didn't feel any different now since being on Synthroid; that was the only reason she found out. She was fairly healthy. Patient mentioned that when she was 7 years old she had her first shingles outbreak. Concomitant medications included oral levothyroxine sodium (SYNTHROID) taken for hypothyroidism at 75 ug, daily from an unspecified start date (approximately started 3 years ago) and ongoing; and oral sertraline hydrochloride (ZOLOFT) taken for anxiety at 50 mg, once a day from an unspecified start date (started about 10 years ago) and ongoing. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. The patient had no prior vaccinations (within 4 weeks). Patient stated she do not want COVID and she is a pro-vaccines. Patient received first vaccine shot on 03Mar2021 and was diagnosed with shingles on the morning of 19Mar2021 and wanted to know if it was okay to take second dose of the vaccine next Thursday with active shingles diagnosis and being on antiviral medication, or should she wait. Patient stated that shingles, she was sure it was shingles, will not prevent her from getting second dose. She mentioned she was stuck, this was all new, and her doctor couldn't tell her because he didn't know. She was not sure what to do. She was not sure if she should delay getting the vaccine until she has stopped the antiviral medication, which she later clarified as Famciclovir. She stated initially her symptoms started Monday (Mar2021). They were flu-like symptoms on 17Mar2021. She was having diarrhea and feeling nauseated on 16Mar2021, thought coming down with the flu. On Wednesday (Mar2021), she felt pain, the shingles was on her buttocks. She went to the bathroom and saw red. Yesterday, 17Mar2021, she got a closer look because a burning sensation. When she looked closer, she realized it was shingles. It started more of a flu-ish feeling on Monday and noticed rash erupt on Wednesday. She also started to experience achiness on Monday (Mar2021). She was seen at her physician's office today, 19Mar2021 and was diagnosed with shingles this morning. The events shingles, nausea, diarrhea, flu-like symptoms and achiness were reported as not serious. The event burning sensation was reported as medically significant. Therapeutic measures were taken as a result of the events which included famciclovir, oral from 19Mar2021 and ongoing, at 500 mg, three times a day for shingles. The patient had not recovered from the events burning sensation (reported as worsened), shingles (reported as worsened), nausea, flu-like symptoms, and achiness. The event diarrhea was recovering. The events diarrhea, nausea, achiness, and burning sensation were reported as unrelated to the vaccine suspect product.; Sender's Comments: The events burning sensation, diarrhea, nausea and pain are considered not related to BNT162B2, but intercurrent medical conditions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
43 2021-04-02 injection site pain I received my first vaccine around 9:45 am on Tuesday March 30, 2021. My arm was sore at the site b... Read more
I received my first vaccine around 9:45 am on Tuesday March 30, 2021. My arm was sore at the site but by the next night it was painful to rotate my arm to get undressed around 8 or 9 pm. It was painful to lay on but I thought that was normal. By Thursday April 1, 2021 it had gotten more sore and more painful to move and rotate my shoulder to get dressed, do my hair, hold my children and just do normal everyday activities. Friday April 2, it got worse to where I did not even want to move it and could not reach my arm past my side to reach around and sleeping that night was horrible. Every time I would move the pain would radiate through the joint in my shoulder and I would have to try to brace it to move. I looked up shoulder pain after vaccine this morning April 3, 2021 and realized this was not normal. I also discussed my husbands reaction since he got his the day after mine. He said soreness at site but nothing in his actual shoulder and moving it. So now I reporting the pain as an adverse reaction and I will be making a doctor appointment today to have it looked at.
43 2021-04-07 redness, skin discolouration could not walk on her left foot; hot, painful patch on the inner left lower leg below the calf muscl... Read more
could not walk on her left foot; hot, painful patch on the inner left lower leg below the calf muscle; Left lower leg and foot bluer than right; vascular issue; pain and redness was present in the lower left calf/ a large red, hot, painful patch on the inner left lower leg below the calf muscle; pain and redness was present in the lower left calf/a large red, hot, painful patch on the inner left lower leg below the calf muscle/tenderness, pain on affected area; tightness, tenderness, pain on affected area; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN6204), via an unspecified route of administration at the age of 43 years old, administered in arm right on 17Mar2021 19:45 at single dose for covid-19 immunisation. Medical history included diabetes, Hashimoto's, PCOS (Polycystic ovarian syndrome), allergies to medications, food, or other products: contrast dye. The patient's concomitant medications were not reported, the patient had received medications within 2 weeks of vaccination, but the patient did not provide the specified drug. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Thursday morning, 18Mar2021 07:00, after vaccine, pain and redness was present in the lower left calf. This progressed to a large red, hot, painful patch on the inner left lower leg below the calf muscle. This has progressed over the past eight days and the patient had gone to Urgent Care (Sat 20Mar2021) where they were concerned about a clot and sent the patient to the ER. An ultrasound in Mar2021 confirmed there was no clot, but the Dr. did not know what the issue was. The doctor started the patient on an antibiotic. This still progressed and 25Mar2021 it spread bilaterally and could not walk on her left foot. Dr. believed it to be a vascular issue with how it presented at her office 26Mar2021 and was closely monitoring the situation. Left lower leg and foot bluer than right, redness, tightness, tenderness, pain on affected area. Subsides at various points during the day, but always returns at night. The patient was told to keep elevated, try Benadryl, and Advil and keep doctor informed to determine referral vasc Dr. The outcome of the events was not recovered. Date of start of events was reported 18Mar2021 07:00. Events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Case was reported as non-serious by reporter: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
43 2021-04-12 injection site pain I presented to the medical shot clinic event for my second COVID-19 injection on schedule. My inject... Read more
I presented to the medical shot clinic event for my second COVID-19 injection on schedule. My injection was given by a nurse at the Hospital and while I did not watch the needle enter into my shoulder, I quickly developed the symptoms of adhesive capsulitis to my right shoulder within a few hours. Initially I did not realize why I was in such extreme pain but did notice that the injection site and bandage placed over top seemed very high. The next day I could not move my shoulder in any direction without severe pain. Regardless of this I still presented to work as I had no one to cover my shift but wasn't able to continue working due to the amount of pain and inability to use my right arm. My coworker is a family medicine Doctor who reached out to a local orthopedic surgeon and fortunately I was able to get a same day visit with the orthopedist. He diagnosed frozen shoulder on January 26, 2021 citing improper placement of the vaccine and I was prescribed a variety of medications including muscle relaxers and anti-inflammatory medicine. He offered to give me a shoulder joint injection however I was concerned about a corticosteroid affecting the efficacy of the Covid vaccine that I had just received. After only minimal relief with the medications that were prescribed hi was in directed by the orthopedic surgeon to start physical therapy which I did. Physical therapy sessions were only partially helpful, and I was still having limitations with my work duties as well as activities of daily living in my home (Such as being able to trust myself, wash my hair, use a blow dryer, doing light housework with my right arm well-being right hand dominant etc.). Finally, after eight weeks of conservative treatment not helping and daily pain I opted for a right shoulder joint corticosteroid injection at orthopedic office. Just a day after the steroid joint injection in my right shoulder I was significantly improved and for a few weeks I was actually pain-free. Unfortunately, a few days ago my shoulder pain started to recur and I have been advised by my orthopedic surgeon that the next step is an MRI and potentially more invasive treatments. I have no way of knowing the name of the nurse at the Hospital who administered my vaccine, and no reporting channels as I am not an employee of that facility. I was able to get the vaccine without being an employee because of my company's relationship with that facility. I have reported this to my employer however, as well as through the V-safe check ins. I am discouraged and concerned that this may be happening to other patients going through that service for their vaccine.
43 2021-04-15 hives, redness, itchy skin Allergy, red and itchy and hives
43 2021-04-17 redness This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient re... Read more
This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number ER8730, Expiration date: 31Jul2021), via an unspecified route of administration on 30Mar2021 at 10:00 (at the age of 43-years old) as a single dose in the right arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No lab test was performed. Prior Vaccinations (within 4 weeks) and other vaccinations within four weeks prior to the first administration date of the suspect vaccine reported as None. Patient has a few concerns, states that patient and her husband got the first dose of their Pfizer vaccines 3 days ago, on 30Mar2021, states patient is experiencing typical side effects listed like headaches and not feeling well, clarifies she turned beet red in the face right after the vaccine and sore in arm on 30Mar2021, patient had a migraine on one side of her head, felt throw uppy, woke up with a sore throat and was coughing up blood on 02Apr2021. patient states she treated herself this morning with Excedrin migraine and has completely resolved. Patient states her throat is still sore but she is no longer coughing up blood. As per the reporter seriousness criteria for the event (coughing blood) was medically significant. The outcome of the event Sore throat was not recovered, coughing blood was recovered on an unspecified date in 2021, Pain in arm, migraine, vomiting was recovered on 02Apr2021, Face red was recovered on 30Mar201 and unknown for another events. No follow-up attempts are needed. No further information is expected.
43 2021-04-17 hives broke out with hives on her face and hands; Swollen lymph nodes in throat; This is spontaneous repor... Read more
broke out with hives on her face and hands; Swollen lymph nodes in throat; This is spontaneous report received from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in left arm on 25Mar2021 16:30 (Batch/Lot Number: ER8732) (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included benign brain tumor removal, seizures (previous seizures prior to surgery), penicillin (PCN) allergy and sulfa drugs allergy. Concomitant medications included topiramate (TOPAMAX), eletriptan hydrobromide (RELPAX), ergocalciferol (VITAMIN D) and ascorbic acid (VITAMIN C), all were taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient broke out with hives on her face and hands and had swollen lymph nodes in throat on 27Mar2021 08:00. The patient went to emergency room/ department or urgent care due to the events, broke out with hives on her face and hands and swollen lymph nodes in throat. The patient received antihistamine as the treatment for the events, broke out with hives on her face and hands and swollen lymph nodes in throat and the patient was also offered steroid but she declined it. The outcome of events, broke out with hives on her face and hands and swollen lymph nodes in throat, was recovering. No follow-up attempts are needed. No further information is expected.
43 2021-04-21 itchy skin Itchy all over face and body around twenty minutes after injection. Went home and took benadryl whic... Read more
Itchy all over face and body around twenty minutes after injection. Went home and took benadryl which relieved itching for six hours then symptom returned and will take more Benadryl and see how it goes from there.
43 2021-04-30 shingles Oral Shingles Outbreak; This is a spontaneous report from a contactable consumer (patient). A 43-... Read more
Oral Shingles Outbreak; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient (not pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 01Apr2021 12:00; at the age of 43-year-old, (Batch/Lot Number: EP 6955) as SINGLE DOSE for covid-19 immunisation. Historical vaccination included first dose of BNT162B2 (Lot number: EN 5318) on 02Mar2021 02:00 PM. Medical history included, lyme disease from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took hydroquinone and experienced drug hypersensitivity. The patient experienced oral shingles outbreak (herpes zoster) (disability) on 10Apr2021 09:00 with outcome of not recovered. The patient was seen at Physician Office. The patient underwent lab tests and procedures on 16Apr2021 which included blood immunoglobulin G: pending results, blood immunoglobulin M: pending result, Sars-cov-2 test: pending the same day (16Apr2021). Therapeutic measures were taken as a result of oral shingles outbreak includes Valacyclovir HCL 1 gram.
43 2021-04-30 itchy skin problem with her cholesterol; pain on the top of my head and my hands hurt/headache; pain on the top... Read more
problem with her cholesterol; pain on the top of my head and my hands hurt/headache; pain on the top of my head and my hands hurt; Nauseous; my hands and feet started going numb; they itch they burn; feet are painful; uncomfortable; blood clot/a clot or something in her legs; from the knees down I was having a lot pain/leg pain felt like it is really deep in the vein; she thought she was having a stroke; cramps; burning from my calf to my feet; pain in her neck then to her back; pain in her neck then to her back; different temperatures like hot and cold make it bad and irritating; can't sleep well because of her symptoms; Swelling in her Feet; can't think right; This is a spontaneous report from a contactable consumer. A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in the right arm in the morning of 01Apr2021 (Batch/Lot Number: ER8727) as a single dose for COVID-19 immunization. Medical history included ongoing complex regional pain syndrome, ongoing fibromyalgia, ongoing arthritis - all diagnosed 20 years ago. Her mother has lupus and rheumatoid arthritis and she can't have the vaccine, states she doesn't know if something could be genetic. Low potassium in the past and stated that she has a lot of allergies to medications, but she consulted with the pharmacist and he said it would be okay. There were no concomitant medications. No additional vaccine was administered on the same date of BNT162B2 and no prior vaccination within four weeks. The patient was having weird symptoms and she tried looking online and in different groups to find out if anyone has similar symptoms, but she hasn't been able to find anything. She began by saying she has health issues; she has Fibromyalgia and Complex Regional Pain Syndrome. She doesn't know if studies were performed on patients with those disorders that took the vaccine. It's been about 3 weeks since getting the vaccine (Apr2021) and she started having symptoms that she thought could be a blood clot. From the knees down, she was having a lot of pain, cramps, burning from her calf to her feet. She would keep rubbing them and massaging them. It was excruciating pain. She was having symptoms and she did go see her Nurse Practitioner on 14Apr2021 because she thought she was having a stroke or a clot or something in her legs or that she was having a problem with her cholesterol. The nurse thought maybe it was her electrolytes, because she had low potassium in the past, but everything came back normal. Her feet were painful but not as bad in Apr2021. She felt like her condition but it's flaring up like 200% it's like over a 10 on the pain scale. She can't think right, she can't work, and was very uncomfortable in Apr2021. The leg pain felt like it is really deep in the vein, it doesn't feel like it is superficial, and she can feel stuff or liquid flowing. Her pain alternates from her head to her neck to her feet and it is very uncomfortable. Her hands and feet started to go numb, not completely numb but like when they fall asleep from sitting on them and then hit something and it hurts. Her arms were burning like crazy; they itch, they burn in Apr2021. Different temperatures like hot and cold make it painful, bad and irritating, and she can't sleep well because of her symptoms. She doesn't know the exact dates, but it has been about a week, but it is changing. It started with cramps in her legs from her knees down. That is where she had injuries and she thought it was her cholesterol. From her knees down, she has cramps and pain and it is very uncomfortable, she felt a really deep pain. She has pain in her neck then to her back, it started in her lower extremities and it is going up. It has stayed the same and she has to keep taking Tylenol to control the pain. Her symptoms got worse and she started taking Tylenol and that helped and then on 15Apr2021, her hands and feet started going numb and she had a headache and pain on the top portion of her head (reported as brain) and her hands hurt, and she was nauseous. She hasn't heard back from the nurse practitioner, so she decided not to go and get it done because she felt it is from the vaccine. She also has swelling of feet in Apr2021, and now she just woke up an hour ago and she slept somewhat okay, but she had to take Tylenol. Now that she is standing, it felt like her legs are starting to hurt again. Treatment included Tylenol, which helps a little and she has to keep taking it. If she doesn't take Tylenol, she can't even function. The events from the knees down I was having a lot pain/leg pain felt like it is really deep in the vein, cramps, my hands and feet started going numb, they itch they burn, feet are painful, uncomfortable, pain on the top of my head and my hands hurt/headache, swelling in her feet, nauseous, pain in her neck then to her back, different temperatures like hot and cold make it bad and irritating had not resolved, while the event can't sleep well because of her symptoms was resolving, and the outcome rest of the events was unknown.
43 2021-05-03 redness Facial swelling, redness, burning/pain started 24 hours after injection and has not resolved itself ... Read more
Facial swelling, redness, burning/pain started 24 hours after injection and has not resolved itself 9 days later. Other common reactions (nausea, joint pain, chills, fatigue) started at the same time, and have since mostly resolved itself except I'm still experiencing fatigue and tiredness.
43 2021-05-11 rash autoimmune disease; body pains; nausea; rash under both of her breast and upper stomach; Sick; This ... Read more
autoimmune disease; body pains; nausea; rash under both of her breast and upper stomach; Sick; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included psoriatic arthritis. Concomitant medication included guselkumab (TREMFYA) taken for psoriatic arthritis, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date for COVID-19 immunization. With the second shot on Wednesday, she got sick, had body pains, nausea, rash under both of her breast and upper stomach on an unspecified date. She wanted to know if this is from the vaccine or if she should go to the doctor. Stated that she has an autoimmune disease which she does not know if it is the reason why she is having the reaction. She also has psoriatic arthritis and has not taken the injection since 19 Mar - she takes Tremfiya. She wanted to know if others had reported it. The outcome of the events was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained.
44 2020-12-31 redness After 12 hours of receiving the vaccination, my legs felt heavy. The bottom of my right foot felt ... Read more
After 12 hours of receiving the vaccination, my legs felt heavy. The bottom of my right foot felt numb after standing for a little time. The feeling of heaviness continued, but I was able to walk and completed my daily activities. My right arm felt painful similar to receiving a tetanus shot, I took some Tylenol and drank some coffee and felt better. However, the feeling of heaviness in my legs continued. On Sunday, my left leg continued to swell and I noticed that the area under my knee cap and above the upper part of the rim of my socks was visible swollen, red, and painful. I took some Motrin and the swelling improved. Later, I noticed I am having musculoskeletal pain and general body aches that improve with Mortin but returns. I am able to continue with my ADLs
44 2020-12-31 rash Rash from L arm, up to neck and down back, palpitations and dizziness within5 minutes of receiving v... Read more
Rash from L arm, up to neck and down back, palpitations and dizziness within5 minutes of receiving vaccine, elevated Bp. Treated with benadryl25mg oral. Symptoms returned within 45 minutes. Received another 25mg benadryl orally plus 40mg pepcid. Symptoms mostly resolved after that. Rash flared up again 4hours later. 25mg benadryl orally administered at home. Rash was present the next morning but resolved with no treatment.
44 2020-12-31 injection site nodule, rash, itchy skin, injection site warmth, injection site pain, injection site redness itching & rash (both arms & chest) started 10 minutes after injection; treated by paramedics on si... Read more
itching & rash (both arms & chest) started 10 minutes after injection; treated by paramedics on site with benadryl 25 mg po; VS monitored for approx 15 minutes- remained normal, slightly elevated temp, lungs sounds clear, hot flashes throughout afternoon. About 45 minutes after injection took 1000 mg tylenol and 800 mg ibuprofen. additional 50 mg benadryl and 800 ibuprofen at bedtime for continued rash & itching. Next day symptoms still present, but minor. injection site became red, warm, tender to touch with small knot, 8-00mg ibuprofen taken in the morning and then 50 mg benadryl & 800 mg ibuprofen taken at bedtime. Day 3, slight itching, faint rash remains, injection site remains red, warm, tender to touch with small knot,
44 2021-01-01 injection site rash, injection site redness, rash, itchy skin, injection site warmth, injection site pruritus At injection site, at 1202, redness, rash, itchiness, and warmth. Then at 1206 head itchiness. Cold ... Read more
At injection site, at 1202, redness, rash, itchiness, and warmth. Then at 1206 head itchiness. Cold Compress applied to injection site. Later patient reported whole body itchiness and rash that was not raised. Patient is an NP and took prednisone.
44 2021-01-01 hives Within 2 hours of the vaccine, patient had shortness of breath, urticaria, nasal congestion and EKG ... Read more
Within 2 hours of the vaccine, patient had shortness of breath, urticaria, nasal congestion and EKG and CXR were normal in ED and she was given albuterol, decadron, famotodine, and epinephrine and resolved.
44 2021-01-01 injection site bruising, injection site redness, injection site swelling Woke up next day very fatigued, left work after 1/2 day and slept 20hrs Two days after injection ly... Read more
Woke up next day very fatigued, left work after 1/2 day and slept 20hrs Two days after injection lymph nodes very sore and swollen in armpit (pain with applying deodorant) Four days after injection bruising with about 3x3 cm area of redness/swelling present at injection site Daily headaches managed with ibuprofen Not anything too concerning but not comfortable. I have never reacted to a vaccine prior
44 2021-01-01 injection site rash, injection site warmth ocal allergic reaction warmness rash right at site of injection
44 2021-01-02 rash rash to torso, back and arms the next day following the vaccine
44 2021-01-03 injection site pain Arm pain at injection site, fatigue, mild headache, swollen lymph nodes
44 2021-01-03 injection site pain INJECTION SITE TENDERNESS PIXELATED VISION MIGRAINE
44 2021-01-03 skin reaction felt hot, prickly, right arm red. Later felt chest tightness
44 2021-01-04 redness Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushin... Read more
Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushing, throat swelling, heart palpitations, trouble swallowing , feet swelling, light headed, anxiety. Hospitalized from the 12/23/20 to 12/26/2020 . Medications now on Epinephrine, diphenhydramine, cetirizine, famotidine, prednisone, lorazepam, cephalexin. on 1/1/2021 was taken to E.R. by ambulance around 11:00 am left hand was tingle started to go numb traveled up my arm into left side of my face ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins then went away transferred to ambulance enroute to ER blood pressure was high and and started having right ear pain and right side frontal severe headache, arrived to ER and was given diphenhydramine ,ketorolac, metoclopramide HCI, lorazepam. MRI was ordered and Neurologist found two small lesions on right side of frontal brain, following up now with neurologist. added more meds naproxen
44 2021-01-04 injection site inflammation Day 1: (12/23/20) fatigue, mild headache Day 2: (12/24/20) fatigue mild headache Day 3-5 (12/25/20-1... Read more
Day 1: (12/23/20) fatigue, mild headache Day 2: (12/24/20) fatigue mild headache Day 3-5 (12/25/20-12/29/20)- large painful lymph node inflammation approx. size of a baseball. Right axilla.
44 2021-01-04 itchy skin Ee entered observation @ 1630. This nurse asked Ee if she was feeling okay around 1645. Stated she... Read more
Ee entered observation @ 1630. This nurse asked Ee if she was feeling okay around 1645. Stated she felt as if she had a "lump in her throat". Denied any type of SOB or breathing issues. @ 1650, Ee stated she felt an itching, burning, and tingling to her lips and chin. Ee also had mild edema noted to her lips. Also stated that she had onset nasal congestion. Benadryl 25mg given @ 1652. Ee remains @ observation @ present time, 1706. @ 1715 Ee stated that she had mild itching to entire body. Around 1720, stated that the symptoms were easing up. @ 1725, Ee stated that the symptoms were better, but slight itching still remained. Insisted on leaving observation, stated she was okay. Ee left observation @ 1726.
44 2021-01-04 vaccination site pain Pain at injection site; Chills; Fever; Fatigue; Headache; This is a spontaneous report from a contac... Read more
Pain at injection site; Chills; Fever; Fatigue; Headache; This is a spontaneous report from a contactable nurse (patient herself). This 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685), via an unspecified route, on 26Dec2020 (at 02:30 PM) at single dose for COVID-19 immunisation. Vaccine location was right arm. The patient was not pregnant. Relevant medical history included depression, endometriosis, and COVID-19 in Aug2020. The patient did not have relevant concomitant medications. No other vaccine was received in four weeks. No known allergies. No congenital anomaly/birth defect. The patient was vaccinated at hospital, age at vaccination was 44-year-old. On 27Dec2020 (at 02:00 AM) the patient woke up with chills, fever, fatigue, headache and fever 99.5. After taking 2 paracetamol (TYLENOL) (1.5hr after med temp was taken), she felt like it did when she had COVID in Aug2020. She also had pain at injection site as well (onset date not provided). Post-vaccination COVID test was not performed. Therapeutic measures were taken for fever, no treatments were given for chills, fatigue and headache. The patient had not recovered from fever, chills, fatigue and headache while the outcome from pain at injection site was unknown.
44 2021-01-04 redness, itchy skin pain with the turning of the head; enlarged lymph nodes on her neck; severe sore throat; earache; te... Read more
pain with the turning of the head; enlarged lymph nodes on her neck; severe sore throat; earache; teeth hurting; cheeks were flushed and the neck; chin being red/redness on the chin; itching on the face; This is a spontaneous report from a contactable Other HCP (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration in left arm on 18Dec2020 at single dose for covid-19 immunisation. Medical history included lymphoma, hodgkin's disease, inflammation. Concomitant medication included prednisone. She had to finished 2 weeks worth of prednisone, it was for inflammation in her abdomen, she had finished the prednisone either on the 18Dec2020 the following day. The patient got her first dose of the covid vaccine on 18Dec2020. She was schedule for her 2nd dose of the covid vaccine on 08Jan2021. On 18Dec2020 after receiving the vaccine her cheeks were flushed and the neck, it first started with the chin being red, an hour later her cheeks and neck were flushed, but she felt this symptom was normal. She also added that on the day of the vaccine she had itching on the face, and redness on the chin, this was on 18Dec2020 about an hour after receiving the vaccine. The enlarged lymph nodes on her neck were noticed on 23Dec2020, as well as the severe sore throat, earache, and teeth hurting. Her pain with the turning of the head was more so noticed on 24Dec2020. It's painful to turn her head back and forth but she thought this was because of lymph nodes. She stated that she had a history of lymphoma and so swollen lymph nodes did worry her. The doctor gave her an antibiotic for it, and she was actually on a second round because she was not any better. The antibiotic was prescribed on 24Dec2020, and the second round started today 29Dec2020. The first antibiotic she was prescribed was Azithromycin also known as a Z-pak. The second antibiotic she was prescribed was amoxicillin clavulanate (AUGMENTIN). Her lymph nodes were getting better starting today 29Dec2020, today was the first date that she was feeling better overall. The patient underwent lab tests and procedures which included rapid covid test negative on 24Dec2020, strep throat swab negative on 24Dec2020. She has had no positive test for Covid prior the vaccine. She had been tested like 5 times now, all negative. She had no Covid antibody test prior to vaccine. She had no issues with vaccines in the past. The outcome of event cheeks were flushed and the neck was unknown. The outcome of events enlarged lymph nodes on her neck, severe sore throat, earache, teeth hurting was recovering. The outcome of events chin being red/redness on the chin, itching on the face was recovered on 18Dec2020. The outcome of event pain with the turning of the head was recovered on 28Dec2020.
44 2021-01-05 injection site pruritus 15 minutes after the injection, I got some itching on my right shoulder near the injection site. I w... Read more
15 minutes after the injection, I got some itching on my right shoulder near the injection site. I waited around a bit longer and the itching and heat started to grow down my arm and across my chest and back. I was asked to go to the ER as it was not resolving. At about one hour, I started to get some mild chest pain, My BP was 173/101 and around 100+ for heart rate. O2 was 100% . ER staff did an EKG. The ER DR gave me Pepcid, Benadryl and Prednisone and 1 liter of normal saline. I was observed for about 3 hours. I went home and was feeling much better. The next 3 days I had a moderate headache and sore arm. I took Tylenol. I had some hot flushes and mild spikes of temperatures 100-101F, through the next couple of days.
44 2021-01-05 vaccination site pain Nausea; Headache; Fatigue started about 5 hours after injection and seems to be getting worse; Muscl... Read more
Nausea; Headache; Fatigue started about 5 hours after injection and seems to be getting worse; Muscle aches-started about 5 hours after injection and seems to be getting worse; Stiff Arm; Slight pain at injection site; This is a spontaneous report from a contactable nurse, the patient. A 44-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EJ1685), via an unspecified route of administration, in the right arm on 30Dec2020 at 06:45 AM (at the age of 44-year-old) as a single dose for COVID-19 immunization. Medical history included crohn's disease, ankylosing spondylitis, gastroparesis, and sulfa allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Dec2020 at 07:45 AM, about an hour after injection, the patient experience nausea and headache. Fatigue and muscle aches started about 5 hours after injection and seemed to be getting worse. The patient experienced stiff arm 12 hours after injection, and slight pain at injection site after 12 hours. The events were reported as non-serious. The patient did not receive any treatment for the nausea, headache, fatigue, muscle aches, stiff arm, and slight pain at injection site. The clinical outcome of the events nausea, headache, fatigue, muscle aches, stiff arm, and slight pain at injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
44 2021-01-05 itchy skin, hives Pt reported minor itching/hives in her arms and back after 15 minutes of receiving the vaccine. Pt w... Read more
Pt reported minor itching/hives in her arms and back after 15 minutes of receiving the vaccine. Pt was given diphenhydramine IM 25mg Denies SOB, chills, or trouble breathing. Will continue to monitor.
44 2021-01-05 vaccination site redness, vaccination site pain, vaccination site swelling lymphadenopthy; Injection site pain; joint pain; injection site swelling and redness (about the size... Read more
lymphadenopthy; Injection site pain; joint pain; injection site swelling and redness (about the size of a hard dollar); injection site swelling and redness (about the size of a hard dollar); This is a spontaneous report from a contactable other health professional (other HCP) reported for herself. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EK5730) via an unspecified route of administration at left arm on 30Dec2020 at 01:00 PM, at a single dose (dose number: 1) for COVID-19 immunization. Medical history included known allergies to apples, and no other medical history. The patient was not pregnant. Concomitant medications in two weeks included colecalciferol (VITAMIN D). No other vaccine received on same date. No other vaccine in four weeks. Facility where the most recent COVID-19 vaccine was administered was at hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced adverse events injection site pain, joint pain, lymphadenopthy, injection site swelling and redness (about the size of a hard dollar); all with start date on 30Dec2020 at 05:00 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was not recovered.
44 2021-01-06 rash 5d after vaccine I developed a R sided trigeminal neuralgia of branches 1 & 2. By d10 I developed t... Read more
5d after vaccine I developed a R sided trigeminal neuralgia of branches 1 & 2. By d10 I developed the rash consistent with herpes zoster, including ophthalmic involvement of the R eye. I have not previously had shingles, but did have varicella as a child. I went to the ER as it was the middle of the night on the weekend and as a physician I realized the eye involvement required immediate treatment. I have since had to see the ophthalmologist x2. The shingles itself is improving, and the eye has healed with steroids and valtrex. I did still receive my 2nd booster shot on 1/5/21 and thus far have not had any additional effects.
44 2021-01-06 injection site pruritus, injection site redness, injection site swelling ErythemaMultiform swelling at site of injection Narrative: employee experiencing swelling & redness... Read more
ErythemaMultiform swelling at site of injection Narrative: employee experiencing swelling & redness in arm apx 10min post injection. vital signs stable at 133/82 HR 78 O2 97% T 98.4 RR16. no further symptoms after 30min monitoring. returned to clinic at 1430 with increased redness/swelling w/new onset of itching near injection site. VS: 138/83 HR 69 O2 96% T99 RR 16. Admin 50mg IV Benadryl. code team arrived and took to ED for further monitoring.
44 2021-01-06 itchy skin, hives, rash PT DEVELOPED A MILD HIVES RASH AND ITCHY SCALP ROUGHLY 30 MINUTES AFTER VACCINATION. PT WAS GIVEN 5... Read more
PT DEVELOPED A MILD HIVES RASH AND ITCHY SCALP ROUGHLY 30 MINUTES AFTER VACCINATION. PT WAS GIVEN 50MG BENADRYL. PTS HIVES AND ITCHING STARTED TO FADE ROUGHLY 15 MINUTES AFTER BENADRYL WAS ADMINISTERED. PT HAD NO PROBLEMS BREATHING.
44 2021-01-06 itchy skin Patient began experiencing fuzzy tongue and itchiness all over within 15 minutes of receiving vaccin... Read more
Patient began experiencing fuzzy tongue and itchiness all over within 15 minutes of receiving vaccination. Patient was provided 50mg Benadryl and observed for 15-20 minutes at which point they began improving. Patient was checked in on after about an hour and was doing okay.
44 2021-01-06 itchy skin Patient has history of anaphaylyxsis, she pre medicated at home this morning with Zyrtec 20 mg and F... Read more
Patient has history of anaphaylyxsis, she pre medicated at home this morning with Zyrtec 20 mg and Famotadine 40 mg prior to going to F13 clinic for her covid vaccination. Patient stayed an hour after vaccine administration to be monitored. She came to ER for further monitoring and allergic reaction concerns and received 2 doses of 25 mg diphenhydramine. She was reporting itching of her trunk and arms, itchy throat, and hot flashes. She was monitored in ER, she maintained airway and stayed on RA the entire visit.
44 2021-01-06 rash SkinRash Narrative:
44 2021-01-07 rash Beginning at 10:30 pm, I had severe chills and body aches through the night. It felt like the flu bu... Read more
Beginning at 10:30 pm, I had severe chills and body aches through the night. It felt like the flu but no fever. I slept until 1:30 the next day (1/6) I noticed a rash on the outer border of my left shoulder blade around 1:30 on 1/6. I was tired but ok the rest of 1/6. I felt totally normal on 1/7.
44 2021-01-07 vaccination site pain FLUL LIKE SYMPTOMS SINCE 3AM 1/8/2021, CHILLS, SEVERE MUSCLE PAIN BACK NECK AND HEAD, HOT FLASHES, L... Read more
FLUL LIKE SYMPTOMS SINCE 3AM 1/8/2021, CHILLS, SEVERE MUSCLE PAIN BACK NECK AND HEAD, HOT FLASHES, LOSS OF APPETITE , PAIN AT VACCINATION SITE, LEFT AXILLARY PAIN ON ABDUCTION. UNABLE TO GO TO WORK DUE TO SYMPTOMS
44 2021-01-07 vaccination site pain Pain in actual site my shoulder is actually throbbing; Sore throat; This is a spontaneous report fro... Read more
Pain in actual site my shoulder is actually throbbing; Sore throat; This is a spontaneous report from a contactable consumer. A 44Year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 02Jan2021 at single dose for COVID-19 immunization. The patient did not have medical history or concomitant medications. Patient informed she received the vaccine, her first round of dose yesterday at 2'O clock (02Jan2021) and she was experiencing pain in her shoulder, that was actually throbbing. She also noticed it within a couple of hours, she had a sore throat. Treatment received included Aleve. At the time of the reporting event outcome was unknown. Information on lot/ batch number has been requested.
44 2021-01-07 hives Patient was given covid vaccine 1 at 1:10 PM and had face and neck urticaria within 5 min. Denied t... Read more
Patient was given covid vaccine 1 at 1:10 PM and had face and neck urticaria within 5 min. Denied throat tightness, or breathing difficulties. Was taken to ED for observation. PMHX includes anxiety, HTN; Meds: Amlodipine, acyclovir; Allergies to Betadine, Erythromycin, Fentanyl, Minocycline, PCN, Versed, and reactions include dyspnea and Hives
44 2021-01-07 injection site pain Pfizer-BioNTech COVID-19 Vaccine EUA Given at Hospital L upper arm has been achy / painful at inject... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Given at Hospital L upper arm has been achy / painful at injection site and has not gone away, gets worse with some motions, has not been red or swollen Makes dressing, reaching, dishes, laundry, putting on a backpack, working with patients all painful (I am a physical therapist in the hospital) I have an old injury to the long head tendon of my biceps in the L arm and originally thought it just flared that up for some reason, but the pain is also more lateral by the injection site I have been resting it, trying not to aggravate it, using some tylenol as needed for sleeping as positioning is hard lately, and it's been hurting more towards the end of the day It is not getting better, and I feel like may be getting a little worse. I am going to start icing it this weekend too. It is starting to affect how I do my daily activities and my job - I am considering going to the doctor
44 2021-01-07 redness Redness and itching on the left ear lobe and nose, lasted for about 1 hour and symptoms resolved on ... Read more
Redness and itching on the left ear lobe and nose, lasted for about 1 hour and symptoms resolved on its own in 1 hour. Did not need to call physician.
44 2021-01-07 rash, shingles Severe painful shingle like rash , chills,
44 2021-01-07 rash Sxs started 15 minutes post vax, difficulty breathing, rash. Sent to ED. Sxs resolved by 12/29/2020... Read more
Sxs started 15 minutes post vax, difficulty breathing, rash. Sent to ED. Sxs resolved by 12/29/2020.
44 2021-01-08 skin burning sensation 1 hour after receiving the COVID-19 vaccine, I experienced a tingling sensation that started in my l... Read more
1 hour after receiving the COVID-19 vaccine, I experienced a tingling sensation that started in my lips (right side only). This turned into an icy, burning sensation that traveled up my right cheek, ear and scalp and stayed for 2 hours. The feeling returned that night at an unknown time and I felt fine the next day.
44 2021-01-08 itchy rash, rash 1st Dose Vaccine - I had localized itchy rash in my chest area 2nd Dose Vaccine - Right Cheek swelli... Read more
1st Dose Vaccine - I had localized itchy rash in my chest area 2nd Dose Vaccine - Right Cheek swelling, chills and dry mouth
44 2021-01-08 rash, itchy skin Headache, lump in right armpit, pain in right armpit unable to extend without sensation of pulling i... Read more
Headache, lump in right armpit, pain in right armpit unable to extend without sensation of pulling in armpit. Rash on upper chest itchiness of upper coast and left lower leg
44 2021-01-08 redness, rash, shingles, blister I exp pain in my cheek and swelling of my face. On 12/27 I went to urgent care with a rash and di... Read more
I exp pain in my cheek and swelling of my face. On 12/27 I went to urgent care with a rash and diagnosed with Shingles. I had blisters with redness scalping which fell off on 1/8.
44 2021-01-08 injection site pain Injection site and entire arm soreness x 48 hrs Nausea x 3 days Chills x 2 days Sore throat x 2 days... Read more
Injection site and entire arm soreness x 48 hrs Nausea x 3 days Chills x 2 days Sore throat x 2 days Severe headache x 2 days (OTC Ibuprofen 600mg Q6-8 hrs, OTC Acetaminophen 1000mg x 1 dose) Mild headache x 1 day (OTC Ibuprofen 400mg PRN) Dizziness x 2 days (Ensured proper hydration) Body aches x 3 days (OTC Ibuprofen 600mg Q6-8 hrs, OTC Acetaminophen 1000mg x 1 dose) Malaise x 3 days
44 2021-01-09 injection site pain Injection site soreness the following day. That is the only adverse reaction I have experienced thus... Read more
Injection site soreness the following day. That is the only adverse reaction I have experienced thus far
44 2021-01-09 injection site pain Moderate pain in the injection site (upper right arm) followed by severe fatigue, back ache, and a ... Read more
Moderate pain in the injection site (upper right arm) followed by severe fatigue, back ache, and a slight fever (37.8 Celsius). Symptoms started 8 hours after the vaccination. No treatment other than strict rest and ibuprofen taken once (600 mg).
44 2021-01-10 injection site pain 1/7/21 9pm- low grade Fever, chills, sore arm at injection site. 1/8/21 2pm-low grade fever, sore ar... Read more
1/7/21 9pm- low grade Fever, chills, sore arm at injection site. 1/8/21 2pm-low grade fever, sore arm at injection site, left axilla pain and swollen left axillary lymph nodes 1/9 to- present: swollen axillary lymph nodes and tenderness left axilla
44 2021-01-10 skin discolouration Both times I received the injection about 48 hours later I had a headache all over my head and naus... Read more
Both times I received the injection about 48 hours later I had a headache all over my head and nausea. Today I was so nauseous that I vomited about 4 times. I also noticed strangely that my birthmark on my leg which is normally a light pink had turned a very dark purple.
44 2021-01-10 hives, injection site pain, injection site pruritus, injection site redness Day after vaccine - red welt, tender, sore, itchy. Took Benadryl and applied ice to area. Pain subsi... Read more
Day after vaccine - red welt, tender, sore, itchy. Took Benadryl and applied ice to area. Pain subsided after 5 days. 3 weeks after vaccine - large area around site is discolored ( 1 inch bruise in center and redness extends 3 inches around bruise) and itchy.
44 2021-01-10 hives Hives on back and stomach, took a Benadryl on 1/10/2021, but the hives came back on the 11th of Janu... Read more
Hives on back and stomach, took a Benadryl on 1/10/2021, but the hives came back on the 11th of January on my abdomen only.
44 2021-01-10 vaccination site warmth, vaccination site swelling, injection site redness Next Day - Wake up with fever, chills, headache, back pain, joints pain and a little nauseous. Those... Read more
Next Day - Wake up with fever, chills, headache, back pain, joints pain and a little nauseous. Those symptoms last for two days. Area of vaccination was red, hot and swelled for 4 days, with left axilar ganglion and both neck ganglion swelled for 4 days too.
44 2021-01-10 injection site pain, redness Redness, pain injection site, swollen armpit resolved
44 2021-01-10 injection site redness, injection site swelling, injection site pain, injection site hardening, hives, injection site bruising Sat. Jan. 9, 2021 Aches and swelling in left axilla, Sun. Jan 10, 2021 Woke up with left arm pain fr... Read more
Sat. Jan. 9, 2021 Aches and swelling in left axilla, Sun. Jan 10, 2021 Woke up with left arm pain from shoulder to forearm, pain got better with regular daily movement. Enlargement of the injection site welt, increase firmness, redness and diameter, deep centrally located bruise. Shoulder begins to ache consistently worsening with movement or pressure to area. Mon. Jan 11, 2021 More noticeable swelling to left axilla and swelling appears to left upper outer pectoral area and below clavicle. Arm feels heavy and like fluid is traveling down arm and into hands/fingers. Fingers, wrist and forearm have brief periods tingling and pain. Swelling feeling in left extremity feels better when hand is held up over head.
44 2021-01-10 injection site pain Severe pain at injection site for over 4 days. Severe for the first two days. Took 400 mg Ibuprofen... Read more
Severe pain at injection site for over 4 days. Severe for the first two days. Took 400 mg Ibuprofen on day4 morning.
44 2021-01-10 itchy skin, redness about 2 hours after injection I got very itchy, face, arms torso red and itchy lasted for twos even ... Read more
about 2 hours after injection I got very itchy, face, arms torso red and itchy lasted for twos even with Bendryl. End of second day had sore "fiery" throat. Felt like throat was on fire lasted for a week. Nothing made it better.
44 2021-01-10 vaccination site pain difficulty breathing; woke with 102 fever; Body aches; injection site soreness; Fatigue/extreme fati... Read more
difficulty breathing; woke with 102 fever; Body aches; injection site soreness; Fatigue/extreme fatigue; This is a spontaneous report from a contactable healthcare professional. A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), intramuscular in right arm on 30Dec2020 13:00 at single dose for COVID-19 immunization. Medical history included asthma. The patient has no known allergies. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior vaccination. The patient experienced fatigue, injection site soreness day of vaccine, following extreme fatigue on 30Dec2020 16:00. Five days after (04Jan2021), woke with 102 fever, body aches, fatigue, and difficulty breathing. The events resulted in doctor or other healthcare professional office/clinic visit. The events were treated with an unspecified antibiotic. The patient underwent lab test and procedures which included nasal swab and Rapid Saers on 04Jan2021 with negative results. The outcome of the events was not recovered. Information on lot/batch number has been requested.
44 2021-01-11 injection site pain 1/7/21 2nd shot. Pain with injection, tasted in mouth lasted 20 minutes. Sore arm got worse within a... Read more
1/7/21 2nd shot. Pain with injection, tasted in mouth lasted 20 minutes. Sore arm got worse within a couple hours. Took ibuprofen which helped. Low grade fever 99.8, EXTREME weakness and fatigue, body aches devloped evening with profuse watery diarrhea 1/7-1/10, poor appetite (NO nausea, NO vomiting) also had mild symptoms of intermittent runny nose, itchy eyes, mild cough. Symptoms improved 1/11/21 with decr freq diarrhea, improvement energy level. I pushed fluids in home and ate soup. Visit to urgent care 1/11/21 for IV hydration after receiving covid testing req for job d/t symptoms. 1/12/21 feeling improvement in symptoms but not fully recovered at this time-monitoring symptoms in home
44 2021-01-11 vaccination site pain 100.4 low grade fever; chills; arm pain was so bad I could hardly list my arm from the pain; body ac... Read more
100.4 low grade fever; chills; arm pain was so bad I could hardly list my arm from the pain; body aches; Extreme arm pain where the injection was given/Minor aches following the injection; headache; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number not provided), via an unspecified route of administration on 04Jan2021 18:15 at SINGLE DOSE for COVID-19 immunization. Medical history included high cholesterol. The patient's concomitant medications were not reported. It was reported that the patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since vaccination. On 04Jan2021 18:30, the patient immediately had extreme arm pain where the injection was given and a headache. The next day (05Jan2021), the patient's arm pain was so bad on which she could hardly list her arm from the pain (minor aches following the injection). The patient also had extreme Body aches that night. Twenty-four hours after extreme body aches (06Jan2021), the patient had 100.4 low grade fever and chills for 2 to 3 hours. The patient did not receive any treatment for the events. The patient recovered from the events of low grade fever and chills on 06Jan2021 while the remaining events were in Jan2021 Information on the lot/batch number has been requested.
44 2021-01-11 pain of skin 24 hours after vaccine injection I experienced swelling, heat, tenderness and nodules to my chin and... Read more
24 hours after vaccine injection I experienced swelling, heat, tenderness and nodules to my chin and cheeks where I had dermal filler injections in March 2020. This did not resolve with Benadryl 50mg. On 1/10/21 I was given a Rx for prednisone and the tenderness and swelling resolved with 40 mg of Prednisone.
44 2021-01-11 redness Flushing, irregular heart beat, redness on chest
44 2021-01-11 injection site pain Initially pain with injection and taste in mouth. Arm pain worsened but improved w/ibuprofen. Mild f... Read more
Initially pain with injection and taste in mouth. Arm pain worsened but improved w/ibuprofen. Mild fever 99.8. EXTREME weakness and fatigue, profuse diarrhea, poor appetite, feeling morose, intermittent runny nose, itchy eyes, mild congestion and mild rare coughing spells. Please note- shot in first series was not painful- couldn't even feel shot. Only symptom after shot in 1st series was mild arm pain and mild fatigue for 2 days.
44 2021-01-11 itchy skin, redness On 1/8, developed diarrhea, nausea, stomach upset. Called in sick on 1/8. Symptoms improved 1/10. De... Read more
On 1/8, developed diarrhea, nausea, stomach upset. Called in sick on 1/8. Symptoms improved 1/10. Developed pruritus on legs, arms and posterior neck; on 1/10/2020; cannot recall time. w/ scratching becomes red. Took Benadryl last night which caused her to sleep. She reports that she had COVID PCR test performed today through CU, in the bldg. denies other symptoms, SOB, wheeze, rash. recommend that she follow-up w/ her PCP, allergist.
44 2021-01-11 redness On January 6,2021 when I woke up my face was red, swollen and extremely warm. My face was like this ... Read more
On January 6,2021 when I woke up my face was red, swollen and extremely warm. My face was like this for at least 16 hours (very uncomfortable). Also, on January 6, 2021 at 1130pm I had horrible stomach pains, then started vomiting, after I was done vomiting I felt better. I did take 2 Benadryl and aleve to help When I got back injections and had surgeries I had the same reactions happen to me usually after 8-10 hours after I was out of surgery. I was given medicine to help with the discomfort either through IV or Benadryl.
44 2021-01-11 rash, itchy skin, redness Patient complained of itching starting on her legs, which went upwards; Redness on her arms, neck, f... Read more
Patient complained of itching starting on her legs, which went upwards; Redness on her arms, neck, face; Redness on her arms, neck, face; Redness on her arms, neck, face; Itching up to her scalp; Dry cough; Rash; This is a spontaneous report from a contactable nurse (patient). A 44-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, in the left arm, on 26Dec2020, at 09:00 AM, for COVID-19 immunisation. COVID-19 vaccine was administered at hospital. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included asthma, hypertension, hypothyroidism, penicillin allergy, food allergy (melon and pineapple) and latex allergy. Concomitant medications, received within 2 weeks of vaccination, included omalizumab (XOLAIR), levothyroxine sodium (LEVOXYL), levocetirizine dihydrochloride (XYZAL), losartan and formoterol fumarate, mometasone furoate (DULERA). After covid vaccination, the patient was advised to stay 30 minutes for observation. On 26Dec2020 at 09:15, less than 15 minutes later, the patient complained of itching starting on her legs, which went upwards. The patient took 25 mg oral diphenhydramine hydrochloride (BENADRYL). She noted to have redness on her arms, neck, face, itching up to her scalp. By then she started to have a dry cough, removed her mask, nurse who was with her called for a rapid response team. Patient's epi pen was used, they then started IV and pushed emergency meds and transported to ED. Emergency room/department or urgent care was required. Another dose of epinephrine IM and additional meds were given. Placed on oxygen via non-rebreather with albuterol. Epinephrine drip started. Stabilized after 3 hours, stayed in observation for 12 hours then discharged to home. Around the clock 50 mg diphenhydramine hydrochloride (BENADRYL) at home x 2 days, then levocetirizine (ZYXAL) thrice daily x 7 days to control itching and redness/rash. Other treatment included steroids, pepcid. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19 (PCR, Nasal Swab) on 26Dec2020 and the result was negative. Clinical outcome of the adverse events was recovering at time of this report. Information on the lot/batch number has been requested.; Sender's Comments: Based on a close temporal association, a causal relationship between reported events and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
44 2021-01-11 injection site warmth, injection site tingling, injection site numbness Thursday - immediately after receiving the vaccine, I felt a warm sensation down my right arm follow... Read more
Thursday - immediately after receiving the vaccine, I felt a warm sensation down my right arm followed by numbness and tingling (pins and needles), a few minutes later I experienced a dull headache. The arm sensation slowly subsided by the time my fifteen minutes was up. The dull headache lasted through the night Around 9 pm, I experienced chills, that lasted for 2 days with body aches and sore right and left arm. During the night, I had a hard time sleeping experiencing nightmares. Woke up at 2 am took a walk felt a little better. Chills continued throughout the night. Friday- chills continued with body aches and a general feeling of malaise. Temp was 98.7 at highest, bp 122/79, hr 80, and blood sugar 149, I have no hx of diabetes. Saturday- "hungover feeling" - headache that came in waves with a general feeling of malaise. Sunday- Pounding headache, extreme fatigue-slept until 1500 woke up and then went back to bed, body aches-worst I have felt in years. Monday shaky feeling somewhat better still malaise. Tuesday vomited all my breakfast, feeling of phlegm or something stuck in my throat. BP 120/77 hr 64 temp 98.4. Continued body aches.
44 2021-01-11 shingles viral outbreak S1/S2 dermatome, ddx zoster vs. HSV (history of genital HSV). simultaneously had recu... Read more
viral outbreak S1/S2 dermatome, ddx zoster vs. HSV (history of genital HSV). simultaneously had recurrence of genital HSV.
44 2021-01-12 injection site pain 18 hours after second dose I had Temp 99.0, chills, body aches, fatigue, headache not relieved by Ty... Read more
18 hours after second dose I had Temp 99.0, chills, body aches, fatigue, headache not relieved by Tylenol or Advil, injection site pain. The symptoms were so severe that I was unable to go to work this morning. I have a headache, fatigue, feel foggy, and injection site pain still.
44 2021-01-12 rash, redness About 1 hr and half , Developed redness started in my neck spreads to my face and both ears. Rashes ... Read more
About 1 hr and half , Developed redness started in my neck spreads to my face and both ears. Rashes noted in face and felt heart palpitations. Took ibuprofen and Benadryl twice. Redness and rashes dissipated. Generalized Muscle ache started at night lasted for 2 days.
44 2021-01-12 injection site pain About 10min after vaccine given, patient complained of pain to the injection site. Flushed. "I don't... Read more
About 10min after vaccine given, patient complained of pain to the injection site. Flushed. "I don't feel right." No SOB. C/o 7/10 migraine headache. Nausea but no vomiting. Frontal lobe pain. Dizzy. Felt like she was drunk. BP 136/29, HR 79. Became slower to respond to questions and a rapid response was called. Transported to ED for observation where patient received acetaminophen 975mg po x 1 and metoclopramide 10mg po x 1. Patient declined NS 1L bolus. Per ED note, patient presented with likely vasovagal episode after receiving COVID-19 vaccination. Patient's symptoms improved and patient was discharged home.
44 2021-01-12 injection site mass Golf ball sized knot at injection site. Fever
44 2021-01-12 rash, shingles, skin burning sensation Headache and right eye pain started on 01/06/2021. Skin burning sensation started on 01/08/2021. Ras... Read more
Headache and right eye pain started on 01/06/2021. Skin burning sensation started on 01/08/2021. Rashes started on 01/09/2021. I went to the emergency room on 01/10/2021, diagnosed with shingles, started treatment with Valacyclovir.
44 2021-01-12 hives Moderate anaphylaxis reaction per urgent care provider. Developed severe hives and swelling, fever, ... Read more
Moderate anaphylaxis reaction per urgent care provider. Developed severe hives and swelling, fever, severe headache 2 days after vaccination. Was treated with Benadryl, Solumedrol IM, and Prednisone taper at local urgent care center.
44 2021-01-12 rash The night of the vaccine I experienced trouble sleeping and could not go to sleep. The morning after... Read more
The night of the vaccine I experienced trouble sleeping and could not go to sleep. The morning after I had a very bad headache and a rash on my right arm and shoulder where near proximity of where the shot was given. It was red dots, no itching, no discomfort. I felt feverish as the day proceeded but never had a temperature. The second day after the shot I had the headache the rash was 75% resolved.
44 2021-01-12 rash, skin burning sensation, shingles Whole headache and right eye pain started on 01/06/2021, Skin burning sensation started on 06/08/202... Read more
Whole headache and right eye pain started on 01/06/2021, Skin burning sensation started on 06/08/2021. Rashes started on 06/09/2021. On 06/10/2021, I went to the emergency room, diagnosis with Shingles, and the doctor prescribed Valacyclovir.
44 2021-01-12 injection site pain, injection site swelling employee reported mild swelling and tenderness of right armpit area lymph nodes approximately 24 hou... Read more
employee reported mild swelling and tenderness of right armpit area lymph nodes approximately 24 hours post receiving second dose of covid 19 Pfizer vaccine on 1/7/2021 in right arm. When questioned the employee stated she also experienced the same mild swelling and tenderness of the armpit area lymph nodes with first dose of vaccine also. The first dose of vaccine was given 12/18/2020 at approximately 1600 in left arm and lymph node mild swelling and tenderness noted in left armpit the following evening. On both occasions the swelling and tenderness lasted 48-72 hours and occurred in the corresponding armpit of the arm which vaccine was administered
44 2021-01-13 itchy skin 5 minutes later - perfuse sweating, entire body hot, dizzy, elevated pulse and BP 147, heart palpita... Read more
5 minutes later - perfuse sweating, entire body hot, dizzy, elevated pulse and BP 147, heart palpitations; drank a juice & some water 10 minutes later - sweats/chills, still dizzy, BP decreasing 135, agitated 20 minutes later - still sweating,/chills, head clearing, heart palpitations subsiding, Tired, legs/body very heavy. Dizzy when walking, told to rest longer 30 minutes - still sweating/chills, could only walk short distance with heavy legs and dizziness, told to rest longer 40 minutes - massive headache, slight dizziness, continued leg heaviness. nausea, light sensitive, very itchy arm. Did not feel better until 11:30 PM that night Woke in the morning with just a sore arm, runny nose and an over-all fatigue, a little cough
44 2021-01-13 vaccination site pain Chills; 100 temperature; Whole body soreness; Left arm severe pain; Left axilla lymph node swelling;... Read more
Chills; 100 temperature; Whole body soreness; Left arm severe pain; Left axilla lymph node swelling; Headache; the first dose administered on 19Dec2020 10:00 and the second dose administered on 05Jan2021; the first dose administered on 19Dec2020 10:00 and the second dose administered on 05Jan2021; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch EJ1685) via intramuscular on 19Dec2020 10:00 on left arm at a single dose and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch EL0142) via intramuscular on 05Jan2021 07:45 on left arm at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were reported as none. Prior to vaccination, the patient did not diagnose with COVID 19. The patient was not allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive within 2 weeks of vaccination. The patient experienced chills, 100 temperature, Whole body soreness, left arm sever pain, left axilla lymph node swelling and headache on 05Jan2021 19:00. No treatment received for the adverse event. No covid tests post vaccination. The outcome of the events chills, 100 temperature, Whole body soreness, left arm sever pain, left axilla lymph node swelling and headache was recovering.
44 2021-01-13 hives I received my second dose of the Covid vaccine on 1/12 at 11:00am. At 2:00pm I noticed one large hi... Read more
I received my second dose of the Covid vaccine on 1/12 at 11:00am. At 2:00pm I noticed one large hive on my right cheek. I did not have any other symptoms or any other hives that I noted on my body.
44 2021-01-13 injection site bruising, injection site pain, injection site redness Later that evening on the 23rd I began having chills which lasted for about an hour. The next day I ... Read more
Later that evening on the 23rd I began having chills which lasted for about an hour. The next day I lost my sense of smell which lasted about 1.5 week and my arm was sore, heavy and red at the injection site. The soreness and the feeling of heaviness ended the next day but the redness stayed for about 5 days and changed to a bruise which then stayed for about 1 another week. On the 29th I was given a COVID-19 test which came back positive. I noticed when I lay flat I cough alot but when I prop myself up I dont.
44 2021-01-13 injection site swelling, injection site pain THREE DAYS OF SYMPTOMS, DIZZINESS,WEAKNESS,PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN CHILLS,J... Read more
THREE DAYS OF SYMPTOMS, DIZZINESS,WEAKNESS,PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN CHILLS,JOINT PAIN,FEVER,SWELLING ON INJECTION SITE,NAUSEA,INFLAMATION OF NODES.
44 2021-01-14 itchy skin, hives 0845 flush to chest and throat 0850 vitals checked BP: 90/60 0930 Benadryl 50 mg PO taken 1000 hives... Read more
0845 flush to chest and throat 0850 vitals checked BP: 90/60 0930 Benadryl 50 mg PO taken 1000 hives to left side of neck 1005 another 50 mg of Benadryl PO taken and Tylenol 650 mg PO for chills and headache 1200 famotidine PO taken for burning to stomach 1400 diarrhea and weakness. Hives had subsided 1800 another round of Benadryl and Tylenol and famotidine. Saturday at 0200 woke up abruptly itching all over. Took more Benadryl. Saturday all day medicated every six hours with Tylenol, Benadryl and Pepcid. Diarrhea continued with abdominal cramps. Sunday continued same treatment for same symptoms. Hydration was aggressive and added Bentyl. Monday, Tuesday and Wednesday symptoms continued except for the itchiness. Continued Tylenol. Diarrhea persists as well as body aches, weakness and headaches. Friday, it is now a week and I still have diarrhea and chills and weakness.
44 2021-01-14 injection site pain 1/8/2021 soreness/pain at the injection site, fever, muscle ache, malaise, headache. Tylenol 1000mg ... Read more
1/8/2021 soreness/pain at the injection site, fever, muscle ache, malaise, headache. Tylenol 1000mg was taken around the clock every 6 hours. It helps with the fever and also for the headache. 1/9/2021 woke up at 4:00 am with vertigo plus the above side effects. In addition to the Tylenol, I had taken dramamine in the morning and had been taking Meclizine 25-50 mg for the dizziness/vertigo. I also had done epley maneuver to help get rid of the vertigo since I am more dizzy turning on my right side and thinks that it is positional vertigo. 1/13/2021 still dizzy and taking Meclizine because it helps for the dizziness. I don't have anymore fever, the pain at the injection site is now mild, still moderate pain for the headache, some body aches but not as much as before. I had gone to the urgent care at this point to be seen since the vertigo is still there since Saturday 1/9 and it is now Wednesday 1/13. The doctor at the urgent care told me to continue taking Meclizine, hydrate and rest for a total of one week since the onset of the vertigo.
44 2021-01-14 rash I am a doctor. I think the nurse went a little subcutaneous in retrospect (she pinched up on my ski... Read more
I am a doctor. I think the nurse went a little subcutaneous in retrospect (she pinched up on my skin). I developed left supraclavicular lymphadenopathy on 12/25 and that is still present and unchanged. I reported that prior. I developed a rash similar to pityriasis rosea on 1/11. This is progressive and still present. I do currently also have fatigue and possible conjunctivitis.
44 2021-01-14 pain of skin, skin irritation Inflammation and tenderness of dermal filler which was placed in Dec2019.; Inflammation and tenderne... Read more
Inflammation and tenderness of dermal filler which was placed in Dec2019.; Inflammation and tenderness of dermal filler which was placed in Dec2019.; first dose 20Dec2020/second dose 06Jan2021; This is a spontaneous report from a contactable physician (patient) reported that a 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported) on 20Dec2020 11:45 then received the second dose on 06Jan2021 14:30, via an unspecified route of administration on the right arm at single dose for COVID-19 immunization. Medical history included allergic rhinitis, depression and gastrooesophageal reflux disease (GERD); all from unknown dates. On Dec2019, patient was placed with dermal filler. The patient was not pregnant. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN) and omeprazole. On 08Jan2021 07:00, the patient experienced inflammation and tenderness of dermal filler which was placed in Dec2019. No therapeutic measures were taken as a result of the reported events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
44 2021-01-14 hives, itchy skin Itching/hives over head, ears, no breathing difficulty
44 2021-01-14 injection site redness, injection site warmth, injection site hives Large, warm, red hive, size of entire arm directly surrounding injection site.
44 2021-01-14 rash, itchy rash Left supraclavicular lymphadenopathy started Dec 25th and still present, unchanged. Rash started o... Read more
Left supraclavicular lymphadenopathy started Dec 25th and still present, unchanged. Rash started on abdomen Jan 11th and progressive. worsening. Mildly itchy, spreading to back/arm/legs. Blanching. Fix eruption. Looks like pityriasis rosea
44 2021-01-14 itchy skin Pt reported feeling itchy "all over" 19 minutes post vaccination. She denied any other sxs such as S... Read more
Pt reported feeling itchy "all over" 19 minutes post vaccination. She denied any other sxs such as SOB, throat tightness, difficulty swelling, lightheadedness, nausea, vision change. I checked her BP and pulse @ 1117 and again @ 1122. Her BP and pulse remained stable and in normal range. Her lungs were clear, no wheezing. There was no visible rash. I administered 25 mg of benadryl @ 1125. She left the clinic 35 minutes post vaccine in good condition without evidence of significant reaction.
44 2021-01-14 hives, rash, itchy skin Rash/hives, itching, fever, body aches Treating with Motion and Benadryl Fever and body aches resolv... Read more
Rash/hives, itching, fever, body aches Treating with Motion and Benadryl Fever and body aches resolved after 24 hrs Rash/hives and itching continue
44 2021-01-14 injection site redness, injection site mass Redness around the injection site approximately the size of a half dollar. Also, a knot at the injec... Read more
Redness around the injection site approximately the size of a half dollar. Also, a knot at the injection site.
44 2021-01-14 rash macular red blotches on my arms and upper chest; This is a spontaneous report from a non-contactable other h... Read more
red blotches on my arms and upper chest; This is a spontaneous report from a non-contactable other health care professional. A 44-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK9231), via an unspecified route of administration on 06Jan2021 at single dose at arm left for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 08Jan2021, the patient experiencing red blotches on my arms and upper chest. The patient did not receive treatment for the adverse event. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
44 2021-01-15 injection site swelling, injection site redness 2nd shot: Very different experience. Got the shot in my left arm after work like before. I had a hea... Read more
2nd shot: Very different experience. Got the shot in my left arm after work like before. I had a headache and felt tired so took some melatonin, had a hot toddy, and went to bed early. Woke up roughly 18 hours post vaccine with back aches and lower rib pain when I took a breath. Took my temp, it was 100*. By 21 hours I had a temp of 102*. My groin, neck, and left arm pit lymph nodes were enlarged as well. After sleeping most of the day away, it felt like my fever 'broke' at 28 hours, it came down to 101*. Finally I took some Tylenol at 34 hours so I could sleep from the back pain. Woke up the next morning at 45 hours with a stiff back/neck but temp down to 99*. I also had a swollen and reddened entire deltoid where the shot had been given (painless when shot given and no blood after), almost like a cellulitis or allergic reaction. My left armpit lymph node remains enlarged but not as painful. Now almost 72 hours out, the only residual effects are a decreasing but enlarged left armpit lymph node, improving swollen/reddened deltoid, decreased appetite, and decreased energy level.
44 2021-01-15 injection site pain Have pain to site and worsening to the point where I have to use my right arm to move my left one. ... Read more
Have pain to site and worsening to the point where I have to use my right arm to move my left one. Not moving it much since 1/15/21
44 2021-01-16 rash, itchy skin, hives Egan as itchiness, still extreme itchiness with welts and rash over entire body
44 2021-01-17 skin warm 30 minutes after I was given the vaccine I felt my left temple become warm and then numb. 40 minute... Read more
30 minutes after I was given the vaccine I felt my left temple become warm and then numb. 40 minutes after receiving the vaccine my left cheekbone and left jaw felt numb, like I had a Novocain shot from the dentist.
44 2021-01-17 injection site swelling, injection site pain 7 DAYS OF SINSTOMES,PAIN ON IJECTION SITE,SWELLING ON INJECTION SITE PAIN AND SWELLING ON RIGHT ARM ... Read more
7 DAYS OF SINSTOMES,PAIN ON IJECTION SITE,SWELLING ON INJECTION SITE PAIN AND SWELLING ON RIGHT ARM PIT (GANGLIOS INFAMATION )
44 2021-01-17 itchy rash, rash with redness, rash, injection site tingling, injection site rash, injection site swelling Approximately 36 hours after I developed a red itchy painful rash below the injection site down my a... Read more
Approximately 36 hours after I developed a red itchy painful rash below the injection site down my arm. It also had paresthesias on the skin and swelling. It is still present.
44 2021-01-17 skin warm, redness Axilla on right side is swollen with enlarged lymph nodes, redness, warm to touch, and painful.
44 2021-01-17 redness, itchy rash, skin warm Injection given at 10:39 AM. HR increased in 30 minutes, later to 120. At 11:40, she noted pruritis ... Read more
Injection given at 10:39 AM. HR increased in 30 minutes, later to 120. At 11:40, she noted pruritis on arms and rash erupted - fine; erythema, warmth, HR 8, R 18, Pulse ox 97%, lungs clear. At 11:45, she noted tingling of the tongue, but no enlargement. Benadryl 25mg given PO at this time. At 12:00, she noted fingers tingling. At 12:20: HR 98, pulseox 97%. At 12:25: Rash, pruritis on right leg just below knees and behind the left knee.
44 2021-01-17 hives Patient had Pfizer vaccine and came in with Mild urticaria and hives after receiving COVID vaccine M... Read more
Patient had Pfizer vaccine and came in with Mild urticaria and hives after receiving COVID vaccine Mild urticaria and hives after receiving COVID vaccine, with no signs of anaphylaxis or shock and no indication for medication administration (e.g. epinephrine, diphenhydramine). Symptoms spontaneously resolved. Tryptase level was 6.7 ug/l (within normal limit). Patient discharged in stable condition. Further follow up showed that patient is feeling fine after allergic reaction. Plan is underway to schedule for the second vaccine, although they have tentatively told her that she will get her second dose in the allergy clinic. Possible this was due to the vaccine given the proximity of timing and adverse event but since the second dose will be given in allergy clinic, the pt will be monitored closely.
44 2021-01-18 skin discolouration Began with fever at 1030pm and continued with fever over 104 and lower back pain for 29 hours. Fever... Read more
Began with fever at 1030pm and continued with fever over 104 and lower back pain for 29 hours. Fever did not go below 102.9 with both motrin and Tylenol. Fever finally broke completely on 1/14 at 330am. At 300pm I spiked a fever at 104.6 within 5 minutes and had vigorous rigors and horrible lower back pain. I was at work in the hospital and turned blue as per other nurses and doctors. I was evaluated b/p 144/100 HR 130 lactate 4.9. I am 120lb and have never had a b/p higher then 120. After NS Tylenol 2 liters of Lactated ringers my fever was 103.3 and the rigors stopped. I never had elevated wbc and my covid they did in the ER was negative. I went home. For the next 24 hours I continues with intermittent fevers. The next day I began with runny nose and sneezing. Since then I am very congested with headaches all day relieved partially with Motrin but never fully relieved.
44 2021-01-18 injection site pain Day 1: soreness at the site of injection (left arm) Day 2: extreme fatigue, whole body muscle aches,... Read more
Day 1: soreness at the site of injection (left arm) Day 2: extreme fatigue, whole body muscle aches, whole body joint aches, chills, fever (100.3), headache Day 3: none Day 4: headache and nausea Day5: symptoms have resolved
44 2021-01-18 rash, hives Diarrhea; nausea and vomiting; nausea and vomiting; rash on her right arm, like a hive or whelp; Fev... Read more
Diarrhea; nausea and vomiting; nausea and vomiting; rash on her right arm, like a hive or whelp; Fever; Headache; really sore right arm; right arm felt numb; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of BNT162B2 (Pfizer COVD 19 vaccine), lot number: EL0142, via an unspecified route of administration on 07Jan2021 17:00 at single dose in right arm for COVID-19 immunisation. Medical history included blood pressure abnormal, had a cough from having COVID 19 on 16Dec2020, cough was ongoing and unknown for COVID-19. Concomitant medication included amlodipine from an unspecified date (taking for 2 years) and ongoing at 10mg once daily by mouth for blood pressure abnormal. No other vaccines were administered on same date and no prior vaccinations (within 4 weeks). Registered nurse (patient) was calling regarding Pfizer COVID 19 vaccine. Reported she received the first dose last Wednesday 07Jan2021 17:00 in the right arm. Reported she noticed the next day (08Jan2021) fever and a headache. On 08Jan2021, Friday she had a really sore right arm and her right arm felt numb. On 09Jan2021, Saturday, she experienced nausea and vomiting and also noticed a rash on her right arm, like a hive or whelp. On 10Jan2021 Sunday, again with the fever, nausea, vomiting and she had diarrhea. Today she stated she woke up a new woman. She feels felt with no fever and her arm was better. She still had a cough from having COVID 19 on 16Dec2020. Stated she was used to coughing. Added she treated the fever with Tylenol 1000mg. Stated she didn't remember exactly but she took a little everyday starting on Thursday the day after the vaccine. Stated she was unsure if she would have the next dose. The events didn't require a visit to physician office or emergency room. The outcome of fever was recovered on 10Jan2021, of Headache, sore arm, rash on right arm, nausea and vomiting was recovered on 11Jan2021, of arm numb was recovered on 09Jan2021, of diarrhea was recovering. Serious criteria for fever was reported as yes, medical significant, for Headache, sore arm, arm numb and Diarrhea was non-serious, for rash on right arm, nausea and vomiting was unspecified.; Sender's Comments: Based on the compatible time association, the event fever is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
44 2021-01-18 hives I developed itching, throat itching, cough with wheezing and hives on my left arm. Elevated BP 197/... Read more
I developed itching, throat itching, cough with wheezing and hives on my left arm. Elevated BP 197/94 Pulse ox was good.
44 2021-01-18 itchy skin, rash I had moderate reaction to first vaccine where I had to go to the ER, for rash on my arm and chest/b... Read more
I had moderate reaction to first vaccine where I had to go to the ER, for rash on my arm and chest/back, increase blood pressure and chest pain. Pepcid, benadryl and prednisone were given to me in the ER and a liter of fluids. VAERS number Date Form Completed: 01/06/2021 Temporary VAERS E-Report No: 223935 So on the second dose, I premedicated the night before 8pmwith 20mg of prednisone, 10mg of claritin, and 40mg of pepcid. In the morning 9am I took 40 mg of pepcid, 20 mg of predisone and 30 minutes prior to second vaccine around 12pm, I took 25mg of benadryl. After vaccine , I had severe nausea at about 20 minutes (1240p), and increase blood pressure at about 30 to 40 minutes. 156/94 was my highest. I had fewer areas of itching and specks of rash and itching around my back than on the first dose that I took. If I did not premediate, I am sure I would have had a similar or worse reaction since I still had similar reaction but milder.
44 2021-01-18 injection site swelling Immediate swelling to administration site
44 2021-01-18 injection site swelling Immediate swelling to injection site. Patient observed for20 min and then she decided to leave prio... Read more
Immediate swelling to injection site. Patient observed for20 min and then she decided to leave prior to BP taken
44 2021-01-19 rash ACHINESS AND HEADACHE- A LITTLE OVER 24 HRS STARTING THE NIGHT VACCINE WAS RECEIVED. RASH ON NEC, CH... Read more
ACHINESS AND HEADACHE- A LITTLE OVER 24 HRS STARTING THE NIGHT VACCINE WAS RECEIVED. RASH ON NEC, CHEST, UPPER BACK AND STOMACH STARTING 2ND DAY AFTER VACCINE. LASTED A LITTLE LESS THAN 24 HRS. TOOK TYLENOL AND MOTRIN
44 2021-01-19 injection site swelling, injection site pain Fever (as high as 101.8), rigors, joint/muscle aches, headache, lethargy, malaise, injection site pa... Read more
Fever (as high as 101.8), rigors, joint/muscle aches, headache, lethargy, malaise, injection site pain & swelling
44 2021-01-19 injection site warmth, injection site rash, injection site redness, injection site pruritus On Day 4 post injection, I developed a 4 inch vertical by 2 inch across red "splotch" rash at the in... Read more
On Day 4 post injection, I developed a 4 inch vertical by 2 inch across red "splotch" rash at the injection site on my left arm, which was hot to the touch. On Days 5 and 6, it is no longer red, but it itches. This Day 4 "splotch" rash was visible and I took a picture and sent it to my doctor and she told me to report it to you. It was no longer visible when I woke up yesterday on Day 5 post injection. I am going to keep monitoring it and see if I have any symptoms that get worse, because I have had adverse reactions to flu shots twice in past.
44 2021-01-19 hives Patient received first Pfizer SAR COVID vaccine dose at 18:16 pm. Patient advised vaccination team ... Read more
Patient received first Pfizer SAR COVID vaccine dose at 18:16 pm. Patient advised vaccination team of previous allergic reactions to H1N1 vaccine (anaphlyxis - swelling of mouth, lips and tongue) and flu vaccine (head to toe hives). Patient was counseled by lead pharmacist regarding risk and and data related to vaccine. Patient agreed to receive vaccine. Informed patient that we would monitor for potential reaction for 30 minutes, patient agreed to stay. Patient was observed by nursing. At approximately, 1850 patient reported that she felt her lips swelling, and noted to have difficulty in her speech. She has administered 50mg Benadryl suspension. Vital signs taken: 1900: 147/92; 82; 97% room air 1905: 132/101; 84; 97% room air 1910: 145/104; 84; 97% room air. 1915: 147/104; 81; 97% room air RN observer called vaccine physician on call at 1915 regarding patient status. Patient was then observed to have hives around her neck, upper chest and arms. RN then called again at 1924. Was advised to send patient to the ED. RN called ambulance and was advised to administer epinephrine. Pharmacist pulled up 0.3mL of epinephrine. Administered injection in right thigh at 1934. Ambulance called and arrived on site at 1936. Patient was assessed, IV access secured and transferred to ED for further observation. Observed for 4 hours with improvement in symptoms. sent home with prednisone. Patient contacted the next day and reported hives on arms, face, back, hands as well as swollen lips and fever to 101.6. Contacted again the following day and symptoms were resolving. Patient is tracking symptoms in VSAFE
44 2021-01-20 hives Day 7 post vaccine developed hives and angioedema on face chin and forehead
44 2021-01-20 itchy skin Itching was given Benadryl 25mg oral and Pepcid 40mg oral monitored for 30 minutes and sent home.
44 2021-01-20 vaccination site swelling, vaccination site itchiness Swelling and itching at injection site; Swelling and itching at injection site; This is a spontaneou... Read more
Swelling and itching at injection site; Swelling and itching at injection site; This is a spontaneous report from a contactable pharmacist (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number:EL1284) via an unspecified route of administration into the left arm on 03Jan2021 12:45 at a single dose for covid-19 immunisation. Medical history included hypothyroidism and hyper cholesterol. The patient's concomitant medications were not reported. The patient experienced swelling and itching at injection site on 11Jan2021 20:00. The patient did not receive treatment and was not pregnant. Outcome of events was not recovered.
44 2021-01-20 sensitive skin body pain; rapid onset of fever (within 30 min 101.7); skin sensitivity; cough; itchy throat; violen... Read more
body pain; rapid onset of fever (within 30 min 101.7); skin sensitivity; cough; itchy throat; violent episodes of shaking and chills for 36 hours; violent episodes of shaking and chills for 36 hours; increased urination/diuresis; This is a spontaneous report received from a contactable nurse (who is also the patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), intramuscular in left arm, on 09Jan2021 07:30, at single dose, for COVID-19 immunization, in the hospital. The patient medical history was not reported. The patient is not pregnant. The patient had no other medications in two weeks. The patient did not have COVID-19 prior to vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), intramuscular in right arm, on 22Dec2020 12:00, at single dose, for COVID-19 immunization. The patient experienced body pain, rapid onset of fever (within 30 min. 101.7, as reported), skin sensitivity, cough, itchy throat, violent episodes of shaking and chills for 36 hours and increased urination/diuresis all on 09Jan2021 at 22:15. No treatment was received for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events body pain, rapid onset of fever (within 30 min 101.7), skin sensitivity, cough, itchy throat and increased urination/diuresis was recovered on unspecified dates; and the outcome of violent episodes of shaking and chills for 36 hours was recovered on 11Jan2021 at 08:15. Information on the lot/batch number has been requested.
44 2021-01-20 hair loss near syncope; Sinus Tachycardia; Hypothyroidism; tested positive for Covid 19; tested positive for C... Read more
near syncope; Sinus Tachycardia; Hypothyroidism; tested positive for Covid 19; tested positive for Covid 19; lost weight; No sense of taste or smell; No sense of taste or smell; losing hair; heart rate started increasing; high blood pressure; Increased cough; Sleepy; tired; Headache; This is a spontaneous report from a contactable other healthcare professional (patient) through the Medical Information Team and Pfizer-sponsored program Pfizer First Connect. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscularly on the arm on 19Dec2020 11:15 at a single dose for COVID-19 immunization. Medical history included tachycardia and stroke from 2019 and diabetes mellitus diagnosed in summer of 2020 and ongoing. Family medical history included father had type 2 diabetes. Concomitant medication included metformin hydrochloride, sitagliptin (JANUMET) for diabetes. The patient previously took regular flu shot and had body aches; it did not happen at the year of report but in years past she did have it. The patient took the COVID vaccine for precaution as she was a healthcare worker/paramedic and stated there was no prescriber. She received the vaccination at a health department facility, not a military facility. She had no previous immunizations and no additional vaccines were administered on the same date as COVID-19 vaccine. The patient received her first dose of COVID-19 vaccine on 19Dec2020 and after nine days, she tested positive for COVID-19 on 30Dec2020 and had an inpatient hospital stay. She mentioned she was so happy that she did not have any symptoms for those days. She stated that she got the shot on the 19th and later that evening was when she started having symptoms. She tried to sleep and it woke her up, she felt sleepy, tired and experienced headache on 19Dec2020 20:00 to 21:00. On 28Dec2020 23:00, she had an increased cough. She initially had increased cough from wearing mask and was having post nasal drip, then she got wet cough and that was when she decided to get tested. She went back and forth on dates; stated she was confused with the dates because of being in the hospital, it had been a while and the dates were all meshing in together. Her specimen was collected and they did the test on 29Dec2020 then found out that she tested positive for COVID virus with a COVID test nasal swab on 30Dec2020 17:30. She mentioned she lost weight after she got COVID, had no sense of taste or smell on unspecified dates. She did not know if it was related to her thyroid but she started losing hair and her heart rate started increasing on Monday, so they took her off all her meds and said the COVID was doing crazy things to the body. She had to go on Carvedilol for the sinus tachycardia and had high blood pressure now. This was all new after she tested positive. She has had bouts of tachycardia before and did have a heart monitor as she had a stroke last year. So those have never been persistent or symptomatic. If she did have a high heart rate, it always went down. This one was symptomatic. She did fine the whole week after the shot, just had that little bit of sleepiness, was tired, and had a headache. The patient reported near syncope with sinus tachycardia due to COVID-19 and hypothyroidism on 08Jan2021 14:30 to 15:00, which required hospitalization from 08Jan2021 to 10Jan2021 (2 days). ER or physician's office was required. She never went to the ER for the vaccination, it was just for the near syncope with sinus tachycardia due to COVID-19 and hypothyroidism that she went and was then admitted to hospital. She just got out of the hospital the day before report (10Jan2021), was there for two days and was still recovering. She was supposed to receive her second vaccination on the day of report however her doctor did not know if she should get the second dose due to double antibodies. She did not ask if she still had the virus or it went away. She has not been to work in two weeks. Outcome of the events tested positive for COVID virus was not recovered; near syncope with sinus tachycardia due to COVID-19 and hypothyroidism was recovered with sequel; sleepy, tired and headache was recovering; while the remaining events was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
44 2021-01-21 hives, injection site pain 48 hours after vaccine, at 3 pm, I developed an allergic response. I had diarrhea, hives, itchy eyes... Read more
48 hours after vaccine, at 3 pm, I developed an allergic response. I had diarrhea, hives, itchy eyes, mouth, and throat, coughing, and slight constriction in my lungs. Within 30 minutes of taking Benadryl the symptoms began to subside. After the allergic reaction, I developed the normal symptoms of the vaccine with chills, fever, body aches and a headache. Injection site had increased soreness for the rest of the day.
44 2021-01-21 injection site pain AT 530PM ON 1/19/21, DEVELOPED BODY ACHES, FEVER, CHILLS, FATIGUE, EXCRUTIATING ARM PAIN AT INJECTIO... Read more
AT 530PM ON 1/19/21, DEVELOPED BODY ACHES, FEVER, CHILLS, FATIGUE, EXCRUTIATING ARM PAIN AT INJECTION SITE
44 2021-01-21 itchy skin COVID-19 Vaccine EUA; Difficulty breathing, swelling of my face and throat, fast heartbeat, itchines... Read more
COVID-19 Vaccine EUA; Difficulty breathing, swelling of my face and throat, fast heartbeat, itchiness all over, dizziness and weakness.
44 2021-01-21 skin warm, injection site pain woke up with left sided chest pain and thought she may be having an MI; Injection received in left a... Read more
woke up with left sided chest pain and thought she may be having an MI; Injection received in left arm, resulting in extreme left side pain and soreness; woke up with left sided chest pain and thought she may be having an MI; Left upper body continues to be sore, not only at injection site but also left axillary area; Left arm is still warm although vaccine was received 72 hours ago; This is a spontaneous report from a contactable pharmacist (patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284), via an unspecified route of administration in the left arm on 08Jan2021 07:45 AM at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient has no known allergies. Patient was not pregnant. Patient has no COVID-19 prior to vaccination. No other vaccines was given in four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685) given in the left arm on 21Dec2020 at 02:00PM for COVID-19 immunization. On 09Jan2021 at 03:00 PM, the patient experienced injection received in left arm, resulting in extreme left side pain and soreness. She woke up with left sided chest pain and thought she may be having an MI. Left upper body continues to be sore, not only at injection site but also left axillary area. This pain was not noted with her first vaccination. Left arm was still warm although vaccine was received 72 hours ago. This was not noted with her first vaccination. No treatment was given for the reported events. Patient was not tested for Covid post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the event myocardial infarction with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
44 2021-01-22 itchy skin About 10 min after injection I began to feel dizzy, then had 1 faint wheeze at the base of my chest,... Read more
About 10 min after injection I began to feel dizzy, then had 1 faint wheeze at the base of my chest, I became nauseous, then developed rapid palpitations. I BP was checked about 10 min later and I was hypertensive SBP 180s. By the HR was down to about 90 bpm and I felt the palpitations begin to decrease. I was feeling better by about 10 min later and went home. I also had itchiness of the L hand for about 1 hr afterwards.
44 2021-01-22 hives Hives on face/chin, self-limited, resolved without treatment
44 2021-01-24 bruising A few days after receiving the first Pfizer Covid 19 vaccine I have an insidious mark running down m... Read more
A few days after receiving the first Pfizer Covid 19 vaccine I have an insidious mark running down my right forearm. I initially thought it was a bruise but don't recall hitting my arm in such a violent way to create this big purple mark on my arm. After weeks-the mark is still there and is not fading. I've also been getting short flashes of headaches that I don't recall experiencing in the past.
44 2021-01-24 sensitive skin Fever, chills, sweats, headache, tooth pain, skin sensitivity, finger locking in left arm (short dur... Read more
Fever, chills, sweats, headache, tooth pain, skin sensitivity, finger locking in left arm (short duration), slight lymph node enlargement in neck, tiredness, aches and discomfort, "flu-like" lasted approx. 30 hours
44 2021-01-24 itchy skin itching of all over body, started on arms and head the day following the vaccination. The second day... Read more
itching of all over body, started on arms and head the day following the vaccination. The second day following the vaccination I woke up with a swollen face and later on in the day my hands started swelling a lot. On the third day in my feet swell very little compared to my hands. I took benadryl which seemed to help. I have an appointment with my pcp tomorrow to get checked out. Today is day 5 and my hands are still swollen but the severity has lessened over the day today. I am very itchy all over my body.
44 2021-01-24 rash pt started to have rash right flank area- likely shingles vaccine
44 2021-01-25 hives Cough, vomiting, hives, pain to neck and back and left wrist
44 2021-01-25 rash Noticed a rash on my neck while taking my shower on Friday 22nd... last Covid shot was Tuesday 19th
44 2021-01-25 rash Rapid heart rate approximately 12 hours after dose. Continued throughout the day. Rate approximatel... Read more
Rapid heart rate approximately 12 hours after dose. Continued throughout the day. Rate approximately 160-170s. Then about 40 hours after vaccination a rash developed. Previous history of viral rashes. Rash covered front and back of trunk took benadryl but lasted approximately 2 days. Lastly, on 1.25.2021, had a CT with contrast for another medical concern (not related) ended up having an allergic response to the contrast. Has had multiple CT over the years (greater than 10) has never had a reaction.
44 2021-01-25 rash Rash / Headache / Fatigue / Muscle weakness
44 2021-01-25 hives Several hives on face and trunk of body about 15 to 20 minutes after receiving the vaccine without s... Read more
Several hives on face and trunk of body about 15 to 20 minutes after receiving the vaccine without shortness of breath or other discomfort. Patient brought benadryl with her and took 50mg upon noticing the hives. The symptoms completely resolved after about 10 minutes of taking the benadryl. Patient left with her husband upon resolution of the hives, stating that she will contact her personal physician for advice and possible further medical treatment (such as prednisone to prevent recurrence of symptoms). I advised patient to speak with her physician & allergist regarding wheather she could take the second dose of the covid 19 vaccine, given that she has a reaction which might be caused by the first dose of the vaccine.
44 2021-01-25 vaccination site pain joint pain; chills; headache; severe injection arm pain; Fever; This is a spontaneous report from a ... Read more
joint pain; chills; headache; severe injection arm pain; Fever; This is a spontaneous report from a contactable nurse. A 44-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in arm right, on 13Jan2021 14:15 at single dose for covid-19 immunisation. The patient previously received the first dose of BNT162B2, intramuscular in arm right, on 23Dec2020 13:15 at single dose for covid-19 immunisation. The vaccine was administered at Physician Office. No other vaccine was administered in four weeks. COVID was not tested post vaccination. No known allergies. Medical history included migraines from an unknown date and unknown if ongoing. The patient had COVID prior vaccination. The patient's concomitant medications included butalbital, caffeine, paracetamol (FIORICET). On 13Jan2021 the patient experienced joint pain, chills, headache, severe injection arm pain, fever. The patient was treated for the events with OTC fever and pain reducer and IBUPROFEN. The outcome of the events was resolving. Information on the lot/batch number has been requested.
44 2021-01-26 redness, skin burning sensation Diarrhea, nauseated, headache, fever, arm pain, body aches, chills, joint pain, skin burning, facial... Read more
Diarrhea, nauseated, headache, fever, arm pain, body aches, chills, joint pain, skin burning, facial redness, left chest wall swelling and tenderness. Seen Dr today
44 2021-01-26 cellulitis High fever, tiredness, headache, cellulitis and nodes
44 2021-01-26 itchy skin, hives Itching, Hives to neck and back; Itching, Hives to neck and back; This is a spontaneous report from ... Read more
Itching, Hives to neck and back; Itching, Hives to neck and back; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EK9231), via an unspecified route of administration on right arm at 08:45AM on 12Jan2021 at single dose for COVID-19 immunization. Medical history included hashimotos thyroid, mild exercise and allergy induced asthma, Allergies: Penicillin, Allergies: mold, Allergies: ragweed, Allergies: coconut, citrus. Concomitant medication included thyroid (ARMOUR THYROID), colecalciferol (VITAMIN D), vitamin c [ascorbic acid]. The patient previously received her first dose of bnt162b2 (Lot number=EK5730) at 09:00 AM on 22Dec2020 on right arm for COVID-19 immunization, PABA and experienced drug hypersensitivity. The patient experienced itching, hives to neck and back noted 25-30min after receiving vaccine at 09:15AM on 12Jan2021. Observed in vaccine clinic, vitals stable. Took Claritin 40min after vaccine. Hives resolving, no new symptoms at 90min post vaccine. Hives did return the next day when Claritin dose wore off; took another dose with Hives resolving within 2hours. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovering.
44 2021-01-26 injection site discomfort Patient described feeling flushed and hot all over, some tightness in the chest, anxiety and ringing... Read more
Patient described feeling flushed and hot all over, some tightness in the chest, anxiety and ringing in her ears, tension in her neck and arm in the left side where she received the vaccine. Took her pulse and lay her on a cot, gave her water. After about 20 minutes of rest, she felt well enough to drive home.
44 2021-01-26 hives, itchy skin Received Pfizer COVID 19 vaccination (Dose 1) at 10:07a.m. Itching - 10 minutes post vaccination Vis... Read more
Received Pfizer COVID 19 vaccination (Dose 1) at 10:07a.m. Itching - 10 minutes post vaccination Visible hives, shortness of breath, and rapid heart beat- 25 minutes post vaccination Decreased BP, followed by increased BP - 30 minutes post vaccination Given 50 mg chewable children's Benadryl at facility: 35 minutes post vaccination EMS called: approximately 40 minutes post vaccination EMS placed IV, pushed epinephrine and solumedrol, and transported me to Hospital. Emergency Department: pushed another dose of epinephrine, Benadryl, and Pepcid. I also received an EKG. Discharged from ED at 4pm Relapse in symptoms (Shortness of breath, nausea, rapid heart rate, and hives): 7p.m. Return to ED at 9pm and discharged at 1 a.m. 1/16/2021
44 2021-01-26 itchy skin Received allergy immunotherapy on 1/21/21 and had itching, difficulty breathing, tightness in throat... Read more
Received allergy immunotherapy on 1/21/21 and had itching, difficulty breathing, tightness in throat/chest, flushed skin and tachycardia after. Received Antihistamines, Albuterol treatment and steroid for treatment.
44 2021-01-26 injection site pruritus, injection site redness, injection site hardening Small lump and redness and itching at injection site
44 2021-01-26 rash Systemic: Rash (other than injection site)-Mild
44 2021-01-26 vaccination site pain arthralgia; fatigue; insomnia; soreness at site of injection; swollen lymph nodes on left anterior c... Read more
arthralgia; fatigue; insomnia; soreness at site of injection; swollen lymph nodes on left anterior clavicular region; Fever (99.9 at highest); chills; first dose was received on 27Dec2020/2nd dose on 13Jan2021; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302 and expiry date:May2021), via an unspecified route of administration on the left arm on 13Jan2021 13:30 at single dose for covid-19 immunisation. The first dose was received on 27Dec2020 13:30 on the left arm, Medical history included hypertension, anxiety, GERD (gastrooesophageal reflux disease) and insomnia. Concomitant medication included atenolol, omeprazole (PRILOSEC), hydroxyzine hydrochloride (VISTARIL) and unspecified multivitamins. The patient previously took neomycine and experienced drug hypersensitivity. The patient experienced fever (99.9 at highest), chills, arthralgia, fatigue, insomnia, soreness at site of injection, swollen lymph nodes on left anterior clavicular region on 14Jan2021 05:45. No treatment was given for the events. Outcome of the events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The reporter considered the events non-serious.
44 2021-01-26 vaccination site pain headache, lightheadedness, fatigue, joint pain, diarrhea, normal vaccine site tenderness, chills
44 2021-01-26 hives, blister, rash, rash vesicular surface blisters, like deep blisters all over her body/blistering rash all over; Hives; Itchy tongue... Read more
surface blisters, like deep blisters all over her body/blistering rash all over; Hives; Itchy tongue; Headache; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK4176 and expiry date: unknown), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After receiving the vaccine, patient had hives and an itchy tongue on an unspecified date in Jan2021. Patient received some Benadryl at site. She spoke for about two hours and it seemed to ease a little bit. Patient came home and slept a quite a bit. As soon as she woke up, patient had the itchy tongue and hives again, so she took another the Benadryl. She woke up and then had a blistering rash all over on Jan2021. But the blisters were like surface blisters, like deep blisters all over her body. She went to the urgent care and received some IM steroid and Benadryl as treatment. Patient also had the headache on Jan2021. Outcome of the events was unknown. Patient was asking if she should get her second dose as back in the emergency room, they said they would not suggest to get the second dose.; Sender's Comments: Based on the time association, the blistery rash is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
44 2021-01-26 rash, shingles was not ill prior to vaccine. 3 days later started getting rash on neck. went to doctor was told it ... Read more
was not ill prior to vaccine. 3 days later started getting rash on neck. went to doctor was told it was shingles. never had any warning signs of shingles. I had just had a complete health check a couple months prior and everything was OK.
44 2021-01-27 hives, itchy skin 1/15/21 had itching on the scalp 1/16/21 @8pmdeveloped hives around the neck with the upper lip swel... Read more
1/15/21 had itching on the scalp 1/16/21 @8pmdeveloped hives around the neck with the upper lip swelling. Took Tab.Benadryl and Tab.Pepcid .Tab Benadryl continued 3 times. 1/17/21 @9.30pm developed more hives on thighs and lower lip swelling. Centracare was closed. continued Tab.Benadryl and Pepcid. The following day while woke up in morning@8.30am, noted all my face swollen with hives all over the body more on the trunk. seen by PCP. Inj.Solumedrol 125mg IM given, and a Medrol pack given. symptoms started to subside by the following day and took almost 4 days for the complete recovery. Took a call off from work.
44 2021-01-27 injection site warmth Arm neuropathy and tingling, warmth in the injection site
44 2021-01-27 skin warm, rash I have rash that got progressively worse started at left side of my neck and to front then to right ... Read more
I have rash that got progressively worse started at left side of my neck and to front then to right side going up my chin. It?s hot to touch and painful fever also with this. Nothing has been done different just the last vaccination.
44 2021-01-27 injection site pain her eye is still swollen with chills; low grade fever; chills; muscle cramps; general muscle ache; T... Read more
her eye is still swollen with chills; low grade fever; chills; muscle cramps; general muscle ache; Tiredness; scratchy throat which got worse with time; tenderness around the injection site; it felt really bad almost like a flu; it felt really bad almost like a flu; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date: 30Apr2021, NDC number: 59267100001), intramuscular in the left deltoid, on 08Jan2021, at 0.3 mL, single, for COVID-19 immunization. There were no medical history and concomitant medications. The patient reported she had side effects after receiving the first dose (Jan2021). She had a scratchy throat which got worse with time. She had a general muscle ache, tenderness around the injection site. The muscle ache increased with chills and low grade fever. She said it felt really bad almost like a flu. She reported her eye is still swollen with chills and low grade fever. She further clarified that she was given the vaccine on 08Jan2021, Friday afternoon. On 09Jan2021, Saturday, she had muscle aches, tiredness, and by Saturday night she had a scratchy throat. On 10Jan2021, Sunday, she experienced tiredness and muscle cramps. She worked half day on 11Jan2021, Monday, and by the afternoon she had chills and low grade fever. On 12Jan2021, Tuesday morning, she woke up and her eyes were swollen. She noticed the swelling has decreased a little bit. She didn't have any symptoms such as difficulty breathing. The reporter asked what have caused these side effects and why did her immune response react this way after receiving the vaccine. She mentioned that her second dose is set up for the end of January and asked if she will be able to get the second dose since she had a reaction and she was wondering if had an illness when she got the vaccine could that have caused her to have a hyper response in her immune system to the vaccine. The outcome of the events scratchy throat which got worse with time, general muscle ache, tiredness, muscle cramps, eye swelling and low grade fever was recovering; chills was not recovered; and the outcome of the remaining events was unknown.
44 2021-01-28 rash, hives 1/26--diarrhea, 1/27--hives on face and eyes, diarrhea has worsened, 1/28--itchy throat, SOB, rash o... Read more
1/26--diarrhea, 1/27--hives on face and eyes, diarrhea has worsened, 1/28--itchy throat, SOB, rash on face, watery stools, 1/29--rash has resolved with benadryl, still severe diarrhea
44 2021-01-28 itchy skin During monitoring period post Pfizer COVID-19 vaccine, pt experienced throat tightness and left arm ... Read more
During monitoring period post Pfizer COVID-19 vaccine, pt experienced throat tightness and left arm itching. Patient reported she had a slight headache prior to administration of Covid vaccine. Patient denied allergic reaction symptoms prior to leaving the COVID vaccine clinic.
44 2021-01-28 rash Headache, dizziness, burning tingling lips, nausea, rash on chest, drop in blood pressure
44 2021-01-28 hives Hives, chills, hypertensive, bradycardia, pallor, felt like she was going to pass out
44 2021-01-28 skin peeling, vaccination site pain, vaccination site rash I developed a painful burning rash below the injection site; I developed a painful burning rash belo... Read more
I developed a painful burning rash below the injection site; I developed a painful burning rash below the injection site; I developed a painful burning rash below the injection site; It appears my skin is beginning to peel as well. It remains painful to touch; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3246), via an unspecified route of administration in the left arm on 15Jan2021 at 2:30 PM (at the age of 44-year-old) as a single dose for COVID-19 immunization. Medical history included unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), intramuscular, left arm on 29Dec2020 for COVID-19 immunization. On 17Jan2021, approximately 48 hours after, the patient developed a painful burning rash below the injection site. It appears her skin is beginning to peel as well, it remains painful to touch. Treatment with over the counter (OTC) medicine was taken as a result of patient developed a painful burning rash below the injection site, it appears her skin is beginning to peel as well, it remains painful to touch. The clinical outcome of the events patient developed a painful burning rash below the injection site, it appears her skin is beginning to peel as well, it remains painful to touch was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
44 2021-01-28 skin warm, redness My face was bright red and very hot and swollen cheeks I felt nauseous Very bad headache Very thi... Read more
My face was bright red and very hot and swollen cheeks I felt nauseous Very bad headache Very thirsty
44 2021-01-28 hives, itchy skin No initial reaction. About 9 hours later she woke up from sleep with wheezing and itching of the thr... Read more
No initial reaction. About 9 hours later she woke up from sleep with wheezing and itching of the throat, ears, and armpits. She developed three hives on her abdomen. She took diphenhydramine and Claritin then was able to go back to bed. She did not use the EpiPen but had it available. When she woke up in the morning she had swelling of the eyelids and face.
44 2021-01-28 itchy skin, rash macular Right after the shot I had itching, tingling, and red spots all down my arm, then my throat swelled ... Read more
Right after the shot I had itching, tingling, and red spots all down my arm, then my throat swelled a bit and I became sweaty. Nurse checked my blood pressure and it was very high for me (144/83) usually 117/78. Nurse administered one Benadryl tablet and I felt better within about 15 minutes. Now I just feel very tired.
44 2021-01-28 skin burning sensation The 2nd injection was done much lower in the arm than the first one. Extreme pain started within hou... Read more
The 2nd injection was done much lower in the arm than the first one. Extreme pain started within hours of injection, could not touch my arm. The pain radiates from the shoulder to finger tips with sharp shooting, stabbing pains at times. A lot of pressure. There is a burning feeling from my shoulder to finger tips. By the end of day on 01/18/2021, I had decreased range of motion in my arm, it is difficult and very painful to try and extend my arm out to the side, which continues to today 01/29/2021.. My entire arm is still tender and sore, tricep, bicep, and shoulder. It is difficult to sleep and work due to the pain.
44 2021-01-28 injection site pain This is a spontaneous report from a contactable pharmacist (patient). A 44-year-old female patient r... Read more
This is a spontaneous report from a contactable pharmacist (patient). A 44-year-old female patient received first dose of bnt162b2 ( COVID-19 VACCINE; lot EK9231, expiration date unspecified), via an unspecified route of administration on 08Jan2021 at single dose (left arm) for COVID-19 immunization. Medical history included mild sleep apnea. The patient had no known allergies. The patient was not pregnant. There were no concomitant medications. On 09Jan2021, the patient experienced injection site pain and arm soreness on day 1 and day 2, patient was also very tired on day 1. Patient also had occasional sneezing and mild headache since day 1. On day 2, energy level was back to normal. However, on 11Jan2021, on day 3, the patient started to develop occasional shortness of breath and continued today, day 7. The shortness of breath comes and goes. On 14Jan2021, on day 6, the patient experienced occasional coughing and continued today, day 7. Since the patient was working in a pharmacy, she cannot rule out if symptoms were from vaccine or Covid exposure, so patient decided to get Covid test done today, day 7. The patient had no treatment received for the events. The patient had no other vaccine in 4 weeks and no other medications in 2 weeks. Patient had no Covid prior vaccination and was Covid tested post vaccination. The patient underwent lab tests and procedures which included nasal swab with pending results on 14Jan2021. Outcome of events was not recovered.
44 2021-01-29 itchy rash, rash maculo-papular, rash 12/20/2020 had the 1st covid19 Pfizer vaccine, left arm. no rash on the area of the injection site. ... Read more
12/20/2020 had the 1st covid19 Pfizer vaccine, left arm. no rash on the area of the injection site. Abdominal rash started, which was maculopapular and itchy. continued on abdomen but slightly had improved over the month, so went ahead and got covid19 second vaccine, 1/20/2021. Later rash within 1-2 days, then spreading to chest and to thigh area, and recurring on abdomen. Eventually went to allergist, had increased zyrtec to 40mg po daily, however, persistent rash of which they were not sure if related to vaccine as it is Pfizer and not Moderna, and symptomatic treatment with steroid cream and continue Zyrtec. but site of injection, left deltoid remains rash free. still having issues with the rash, 1/30/2021.
44 2021-01-29 itchy skin, rash Rash on forearms developed 24hrs after shot. On the third day developed intense itching in various a... Read more
Rash on forearms developed 24hrs after shot. On the third day developed intense itching in various area around my body. Comes and goes through the day. Stronger at night. Rash has subsided but itching continues.
44 2021-01-30 bruising Fever, painful swelling redness and bruising since 5 hours after administering vaccine.
44 2021-01-30 hives Hives reported within 1 hour of vaccination, Patient did not report reaction to administrator until ... Read more
Hives reported within 1 hour of vaccination, Patient did not report reaction to administrator until clinic 3 weeks later, did not receive second shot.
44 2021-01-30 shingles Shingles on left side of upper torso
44 2021-01-31 injection site pain Debilitating lethargy and body aches for 72 hours. Severe arm pain at sight and down arm for 48-72 h... Read more
Debilitating lethargy and body aches for 72 hours. Severe arm pain at sight and down arm for 48-72 hours. Moderate dizziness for 72 hours
44 2021-01-31 injection site pain Patient described arm pain at the site of injection soon after injection. Began to develop difficult... Read more
Patient described arm pain at the site of injection soon after injection. Began to develop difficulty swallowing, which the patient described as her tongue feeling heavy and her throat feeling tight. Adult EpiPen was administered at 10:33 AM with PO diphenhydramine 25 mg immediately after. Symptoms resolved. Patient was tachycardic (~100) and hypertensive 140/100. EMS arrived and brought patient to emergency department for additional testing/monitoring.
44 2021-01-31 itchy skin Patient with throat tightness during monitoring period and left arm itching. Patient denied allergic... Read more
Patient with throat tightness during monitoring period and left arm itching. Patient denied allergic reaction symptoms prior to leaving the COVID vaccine clinic.
44 2021-01-31 injection site pain Severe lethargy for about 12 hours, severe abdominal cramping for about 72 hours Moderate-severe arm... Read more
Severe lethargy for about 12 hours, severe abdominal cramping for about 72 hours Moderate-severe arm pain at injection site and all down arm for about 24 hours
44 2021-01-31 injection site swelling, injection site pain Soreness at injection site within 1 hour. Swelling at injection site within 1 hour pain and swelling... Read more
Soreness at injection site within 1 hour. Swelling at injection site within 1 hour pain and swelling continued until Thursday (4 days later). Feeling ?off? or unwell without any other symptoms -3 hours after injection and lasted until 5:00pm next day when symptoms increased. Starting 5:45pm Lethargy, shaking all over, feeling of ?freezing ?, upset stomach, fever of 101- continued into the evening. Fever resolved with Advil and rest. Shaking and upset stomach stopped sometime overnight. Feeling very tired next day.
44 2021-01-31 pain of skin Temp max of 103.5, remained elevated from 12 hours post vaccine until 36 hours post vaccine. Remaine... Read more
Temp max of 103.5, remained elevated from 12 hours post vaccine until 36 hours post vaccine. Remained 100.5; headache; muscle aches; skin tenderness; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231), via an unspecified route of administration on the left arm on 13Jan2021 07:00 at a single dose COVID-19 immunization. Medical history included none. The patient is not pregnant. The patient's concomitant medication includes an unspecified birth control pill. On 13Jan2021 19:00, the patient experienced a temp max of 103.5, remained elevated from 12 hours post vaccine until 36 hours post vaccine. Remained 100.5 with ibuprofen 800 mg and Tylenol 1000mg. The patient also experienced headache, muscle aches and skin tenderness x 48 hours. The patient was given treatment for the events. The outcome of the events was recovered on an unspecified date.
44 2021-02-01 skin warm, redness, rash I go the vaccine A couple days later I had redness on my arm that went away 5 days later, a week lat... Read more
I go the vaccine A couple days later I had redness on my arm that went away 5 days later, a week later my arm rash was more severe and hot to the touch, from shoulder down to my elbow, I contacted the Dr which thought it was a sterile abcess and prescribed ibuprofen and went away after another week
44 2021-02-01 injection site pain Moderate injection site pain - at least 2 days Fatigue - at least one day Low-grade fever (100.3) -... Read more
Moderate injection site pain - at least 2 days Fatigue - at least one day Low-grade fever (100.3) - at least one day Headache - at least one day
44 2021-02-01 vaccination site swelling, vaccination site pain chills with shaking; chills with shaking; joint pain; muscle pain; fatigue; swelling at injection si... Read more
chills with shaking; chills with shaking; joint pain; muscle pain; fatigue; swelling at injection site; pain at injection site; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EA9899, via an unspecified route of administration on Arm Left from 19Jan2021 08:15 to 19Jan2021 08:15 as single dose for COVID-19 immunisation. The patient took first dose of the BNT162B2 vaccine on an unspecified date. Medical history included asthma, penicillin (PCN) allergy, environmental allergies, and major depression. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast sodium (SINGULAIR), fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN), and lamotrigine (LAMICTAL). On 19Jan2021 20:00, the patient experienced chills with shaking, joint pain, muscle pain, fatigue, swelling at injection site, and pain at injection site. The outcome of the events was recovering. Prior to vaccination and since the vaccination, was the patient was not diagnosed with COVID-19. No treatment was received for the events.
44 2021-02-01 injection site pain right after the vaccine my whole arm got hot and traveled to the top half of body. I felt hot right... Read more
right after the vaccine my whole arm got hot and traveled to the top half of body. I felt hot right away , during the day I felt my left eye a bit droppy and pain to the injection site by the end of that day I had chills, next day chills , nauseated, tired, slight cough and still felt my left eye droppy , next day slight sorethroat and by the next day I was good.
44 2021-02-02 injection site swelling, itchy skin, injection site pain, injection site hives, injection site redness Left arm sore directly after injection at 730am, around 9am right upper arm started to itch. Aroun... Read more
Left arm sore directly after injection at 730am, around 9am right upper arm started to itch. Around lunch time started getting a headache, by the time work was over around 5pm arm was becoming more sore and itching became more intense. Went home took ibuprofen around 6pm for headache, checked injection site and discovered it was red and swollen, looked at inside of upper right arm and noticed about 4 or 5 red bumps (hives). Went to bed around 9pm Woke up Tuesday 2/2 felt nauseous both right and left arm itching found red bumps on left arm including one on top of my injection site, headache becoming a little more intense, called Dr?s office and spoke to on call RN and directed to take an antihistamine. Took 2 Benadryl and headed to work, while at work started to get chills, body aches and when the Benadryl wore off intense itching. Came home and took 2 more Benadryl around 545pm not able eat not hungry, took 2 more Benadryl at 930pm and went to bed. Today 2/3 felt better itching not as bad, headache gone but still feeling tired, still have hives but they have not spread.
44 2021-02-02 hives Patient developed hives after receiving vaccine. Presented to Emergency Department for evaluation. N... Read more
Patient developed hives after receiving vaccine. Presented to Emergency Department for evaluation. No shortness of breath. Diffuse erythemetous circular raised rash noted to bilateral upper extremities. Patient reports itchiness but no pain. Patient treated with dexamethasone, diphenhydramine and famotidine. Discharged from emergency department to home.
44 2021-02-02 itchy skin Patient received initial dose of Covid-19 vaccine. During observation period, patient reported progr... Read more
Patient received initial dose of Covid-19 vaccine. During observation period, patient reported progressive pruritus in left arm. While evaluating patient, pruritus progressed to right arm. At that time, patient reported significant reaction previously to influenza vaccine with similar initial presentation. At no point did patient report SOB, increased heart rate, or chest tightness. While waiting for transport to ER, patient reported progressive burning while continuing to have pruritus
44 2021-02-03 injection site pain Light headache & injection area soreness at 2pm 10pm started to notice some aches. Midnight (14 ho... Read more
Light headache & injection area soreness at 2pm 10pm started to notice some aches. Midnight (14 hours post injection) awakened by intense headache, severe body aches, sweating, hot and cold. Extreme fatigue. In bed & slept all day. 8:30pm still have headache, fatigue & light body aches.
44 2021-02-03 hives, redness Noticed red welts to bilateral cheeks.
44 2021-02-04 injection site pain Chills at 9pm (10 hours after vaccine). Chills continued for 2 days. Muscle and body aches, nausea, ... Read more
Chills at 9pm (10 hours after vaccine). Chills continued for 2 days. Muscle and body aches, nausea, dizziness, tiredness, very sore at injection site, started at 8am the next day and continued for 3 more days. Vomited twice on day 3
44 2021-02-04 rash with redness, vaccination site itchiness, itchy skin Immediate itching at site which spread to generalized body; Immediate itching at site which spread t... Read more
Immediate itching at site which spread to generalized body; Immediate itching at site which spread to generalized body; Red rash and warmth to entire upper arm; Red rash and warmth to entire upper arm; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1284), via an unspecified route of administration on 02Jan2021 07:00 AM at single dose on left arm for COVID-19 immunization. COVID-19 vaccine was administered in the hospital. Patient is not pregnant. Medical history included hypothyroid. No other vaccines within 4 weeks prior to COVID vaccine. Concomitant medications (received within 2 weeks of vaccination) included thyroid (ARMOUR THYROID), prednisone, famotidine (PEPCID) and fexofenadine hydrochloride (ALLEGRA). The patient previously took influenza vaccine, azithromycin and monistat, and experienced allergies to all. Patient was not diagnosed with COVID-19 prior vaccination. The patient experienced immediate itching at site which spread to generalized body. Patient also experienced red rash and warmth to entire upper arm. All events occurred on 02Jan2021 07:15 AM. No treatment was given for the events. Events were assessed as non-serious. Outcome of the events was recovered in Jan2021. The patient has not been tested for COVID-19 since the vaccination.
44 2021-02-04 injection site pain Nausea immediately after injection, joint and muscle pain, sharp back spasms shortly , site soreness... Read more
Nausea immediately after injection, joint and muscle pain, sharp back spasms shortly , site soreness, mild headache
44 2021-02-04 itchy skin Stayed home with fever and body aches first day. Second day radiating pain in arm, back, left should... Read more
Stayed home with fever and body aches first day. Second day radiating pain in arm, back, left shoulder, arm pit and under rib cage. Itching and could not sleep. Can touch, turn or sleep on her left side.
44 2021-02-04 vaccination site pain low blood pressure; pale and diaphoretic; pale and diaphoretic; Pain injection site; nausea and feel... Read more
low blood pressure; pale and diaphoretic; pale and diaphoretic; Pain injection site; nausea and feeling faint; nausea and feeling faint; This is a spontaneous report from a contactable nurse and a contactable consumer. A 44-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3247, Expiration Date: 31May2021), via an unspecified route of administration on 19Jan2021 at 14:00 at 0.3 mL, single on deltoid left for covid-19 immunisation. Medical history included panic attack. There were no concomitant medications. Patient received the vaccine on 19Jan2021 at around 14:00 in her left deltoid. Pain at injection site started at 14:10 on day of injection, patient came to observation area with pain at injection site, nausea and feeling faint. After that, the nurse in observation area took blood pressure (BP) at 14:12 and blood pressure was 88/60 and pulse was 78 and O2 sat 88 on room air, pale and diaphoretic at this time. Treatment: patient legs elevated, offered juice and water. Patient was able to swallow. Nurse in observation placed call to 911 at this time. 14:17 BP rechecked 118/82 and pulse was 78 and Sat 98% and starting to feel better. 14:20, blood pressure was taken again 120/84 pulse 80 and O2 Sat 98%, patient was returned to upright position and stated they felt so much better, cancelled EMS (Emergency Medical Services). Patient stated at this time that she had a history of panic attacks and she felt that she worked herself thinking about the vaccine. Did call doctor in charge of clinic and checked out the patient. Checked on patient the following day and stated that she was fine and going back to work. Outcome of the events was resolved.
44 2021-02-05 injection site pain, injection site hardening, injection site bruising I had typical injection site pain, for 2 days following the shot, and was then fine. I had no other ... Read more
I had typical injection site pain, for 2 days following the shot, and was then fine. I had no other symptoms. Today, 13 days later, I developed moderate pain at the injection site, and throughout the day, have since developed a golf ball sized, hard hematoma-like mass at the site. It is sore and painful, and feels like a very tender bruise. No itching or redness is present.
44 2021-02-06 redness, skin warm, itchy skin, rash Arm swollen, red and hot and very itchy. Developed rash all the way down to elbow.
44 2021-02-07 itchy skin Feeling ichy/unwell within 2-3 minutes post vaccination. Feeling dizzy and weak, flushed skin, overw... Read more
Feeling ichy/unwell within 2-3 minutes post vaccination. Feeling dizzy and weak, flushed skin, overwhelming fatigue, out of it. Administered lactated ringer and famotidine Potential vasovagal response. Felt improved within 2.5 hours 48 hours later began abdominal pain (7/10) and diarrhea lasting 36 hours, with diminishing severity of pain and volume of diarrhea; mild nausea without vomiting. Treatment includes Allegra every 12 hours and Naproxen Sodium.
44 2021-02-07 itchy skin Itching and swelling in hands and feet.
44 2021-02-07 itchy skin Itching and swelling on hands and feet.
44 2021-02-07 vaccination site rash, vaccination site swelling Rash (pruritic) and swelling distal and medial to the vaccination site that continued to migrate dis... Read more
Rash (pruritic) and swelling distal and medial to the vaccination site that continued to migrate distally over the course of a week. Treated at home with topical antihistamine cream and oral antihistamines. Incremental resolution each day after the first two days, 95% resolved by day 6. Adverse event did not prevent any ADLs.
44 2021-02-07 injection site pruritus She received the first dose of the Pfizer Covid Vaccine in the left deltoid. She has reported aller... Read more
She received the first dose of the Pfizer Covid Vaccine in the left deltoid. She has reported allergies to oxycodone, codeine sulfate, and penicillins which she reports as experiencing hives. 1220 she reported itching at the injection site. 1224 she reported that her throat felt like it was itching, and she was assessed, O2 100%, BP 115/83 in the left arm. 126 she reported that she felt as though her throat was closing up ans she was given Benadryl IM 25mg in the right deltoid. 1228 she utilized her personal albuterol inhaler. 1233 EMS called to the building. 1235 she received EpiPen injection in left thigh. 1250 she was transported off the property by EMS.
44 2021-02-08 injection site swelling, injection site pain Events lasting approximately 48 hours (onset 18 hours after vaccine): Allodynia (whole body) Muscle... Read more
Events lasting approximately 48 hours (onset 18 hours after vaccine): Allodynia (whole body) Muscle aches (whole body) Debilitating headache Pain and swelling at injection site (right arm) Painful joints *Safe dose range of OTC Tylenol ineffective Ongoing effects (onset approximately 24 hours after first vaccine): Painful lump right breast/armpit
44 2021-02-08 skin infection at injection site cellulitis from Right shoulder to Right elbow within 48 hours of shot, necessitating antibiotic ther... Read more
cellulitis from Right shoulder to Right elbow within 48 hours of shot, necessitating antibiotic therapy for cellulitis.; Fevers to 102 F; chills x 48 hours; severe Right arm swelling; This is a spontaneous report from a contactable physician (patient). A 44-year-old female patient received first dose of bnt162b2 (BNT162B2, lot number 4121 EL 1283) , via an unspecified route of administration from 19Jan2021 13:15 at single dose on right arm for covid-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient experienced cellulitis from right shoulder to right elbow within 48 hours of shot, necessitating antibiotic therapy for cellulitis. The patient experienced fevers to 102 f, chills x 48 hours, severe right arm swelling on 20Jan2021 02:00. The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit on 20Jan2021. Therapeutic measures taken as a result of the events included Keflex times 10 days. No covid prior vaccination, no covid tested post vaccination, no other vaccine in four weeks. The outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be completely excluded for reported events cellulitis, fever, chills and swelling arm. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
44 2021-02-09 redness, itchy skin chills; headache; feeling sore in her arm; tiredness; she was also breastfeeding; she was also breas... Read more
chills; headache; feeling sore in her arm; tiredness; she was also breastfeeding; she was also breastfeeding; itching/itching was worse on her chest and back/allergy like a reddish thing, an itching thing was on her body, on her chest area, her breast area; was breastfeeding; it was full of milk that also hurts very bad; allergy like a reddish thing, an itching thing was on her body, on her chest area, her breast area; on her back as well; allergy like a reddish thing, an itching thing was on her body, on her chest area, her breast area; on her back as well; feeling unwell; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and baby. This is the maternal report. A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration on 21Jan2021 (lot number and expiry date unknown) at single dose for Covid-19 immunization. The patient stated "just to protect myself". Medical history included blood pressure high, lost weight because she was breastfeeding now (ongoing). Concomitant medication included labetalol from unspecified date for blood pressure high, and blood pressure medicine. Historical vaccine included first dose of BNT162B2 on 31Dec2020 for Covid-19 immunization and experienced allergy. The patient informed that she already reported to a pharmacist. The female patient received the second dose of the COVID vaccine on Thursday (21Jan2021). The patient informed that she was fine the same day she received the vaccine and had some itching (21Jan2021), but the next day (22Jan2021) she had a headache and was feeling sore in her arm. The patient experienced a little bit sore in her arm, bad sore on her arm; after she had the first one maybe after a day, but it was not that bad. The patient informed that she received the covid vaccine on Thursday (21Jan2021) and has been feeling unwell ever since (Jan2021). The first day it was okay, she meant a little bit sore in her arm, her sore arm. On Friday (22Jan2021), she started like having tiredness, headache, and sore like bad sore on her arm. Then now she has seen, she said it was okay then she knew because there was a side effect so she tried to take rest and drink water. What happened was, now (Jan2021) on her body it looked like some kind of allergy like a reddish thing, an itching thing was on her body, on her chest area, her breast area and she was a breastfeeding mom and on her back as well. The patient informed that after 3rd day (Jan2021) it got like especially on her breast area and her chest area got like itchy. Today (24Jan2021), the headache came back, and she was experiencing chills and her itching was worse on her chest and back. The patient informed that she was also breastfeeding. The patient wanted to know what she was supposed to do. The patient informed that she has headache, the headache was back today, now when she woke up, she has headache. The patient was asking for guidance if she was breastfeeding and has received the second dose of the COVID vaccine. The patient informed that she was to feed her son, because she didn't feed him yesterday, so it was full of milk that also hurts very bad. The patient was scared, because it was itchy area on her breast, so she was scared to breastfeed her son. The patient informed that it was like back and forth, but now this morning (Jan2021) the patient has headache, yesterday (Jan2021) she was okay. The patient informed that about her treatment, she didn't take even a painkiller; she just only took her blood pressure medicine. The outcome of the event headache was not recovered, while itching/itching was worse on her chest and back/allergy like a reddish thing, an itching thing was on her body, on her chest area, her breast area, feeling sore in her arm, feeling unwell, tiredness, allergy like a reddish thing, an itching thing was on her body, on her chest area, her breast area; on her back as well, chills, was breastfeeding; it was full of milk that also hurts very bad was unknown. Follow-up activities are possible, information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092765 baby case
44 2021-02-09 vaccination site pain sever body aches; severe under arm pain; Chills; severe injection site pain; This is a spontaneous r... Read more
sever body aches; severe under arm pain; Chills; severe injection site pain; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the second dose BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EJ1686) in the hospital, via an unspecified route of administration on 19Jan2021 at 08:30 at a single dose on the right arm for COVID-19 immunization. The patient had no medical history nor any concomitant medications. The patient did not have any allergies. The patient did not have COVID-19 prior to vaccination. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine and did not receive other medications within two weeks prior to the COVID vaccine. The patient received the first dose (lot number unknown) of BNT162B2 on 28Dec2020 (age at vaccination: 43 years) on the right arm for COVID-19 immunization. The patient experienced sever body aches, severe under arm pain, chills and severe injection site pain on 20Jan2021 at 02:00 AM. The patient did not receive any treatment for the events. The outcome of the events was recovered. The patient has not been tested for COVID-19 post vaccination.
44 2021-02-10 shingles Developed shingles aboit 1 week after first vaccination.
44 2021-02-10 redness On 2/3, 2 hours after vaccine, I experienced extreme heat to my face. (The feeling I get when I?m g... Read more
On 2/3, 2 hours after vaccine, I experienced extreme heat to my face. (The feeling I get when I?m going into anaphylaxis) but anaphylaxis never came. It dissipated after a couple of minutes, but red face and ears all day. On the 7th, I started noticing partial paralysis on the right hand side of my face. It is still there. I have not been around anyone outside of my home since March 2019 nor have those who live with me. The only exception has been when I got my two vaccine doses.
44 2021-02-10 hair loss Symptoms came on suddenly around 3:00 am on 02/09/2021 with migraine headache, shaking chills, extre... Read more
Symptoms came on suddenly around 3:00 am on 02/09/2021 with migraine headache, shaking chills, extreme body aches, fever as high as 102, nausea, abdominal cramps, and exhaustion lasting about 48 hrs. Then lesser symptoms and a lower temp another 12 hrs., with a normal temperature by 7:00 pm on 02/11/2021. Also, I'm not sure if this is related at all but thought it was worth mentioning, while washing my hair on 02/11/2021,a lot more hair than usual came out.
44 2021-02-10 injection site pain fever, chills, muscle aches, pain at injection site., headache
44 2021-02-11 injection site pain ASMA TARQUICARDIA,PAIN ON INJECTION SITE,HEADACHE,CHILLS,FEVER,SICKNESS,ALERGIC ACTIVE PAIN ON CHEST... Read more
ASMA TARQUICARDIA,PAIN ON INJECTION SITE,HEADACHE,CHILLS,FEVER,SICKNESS,ALERGIC ACTIVE PAIN ON CHEST AND REFLUX 2 DAYS OF SINTOMES.
44 2021-02-11 itchy skin PATIENTS TIME IS UP FOR 15 MIN OBSERVATION TIME AND STATES FELLS ITCHY WITH DRY IRRITATION TO MOUTH.... Read more
PATIENTS TIME IS UP FOR 15 MIN OBSERVATION TIME AND STATES FELLS ITCHY WITH DRY IRRITATION TO MOUTH. PATIENT STATES SAME REACTION LIKE WHEN SHE HAS PEANUTS. PATIENT TOOK 25 MG OF HER BENADRYL AND STATES IS GOING TO MED CENTER NORTH FOR FURTHER TREATMENT. PATIENT DID NOT WANT ANY FURTHER TREATMENT FOR SYMPTOMS HERE AT THIS TIME.
44 2021-02-11 rash Patient received 1st dose of Pfizer Covid19 vaccine today at approx 10:45 AM; pfizer lot number EN53... Read more
Patient received 1st dose of Pfizer Covid19 vaccine today at approx 10:45 AM; pfizer lot number EN5318. Patient has history of severe head to toe rash within minutes of receiving Vancomycin/Gent IV. Order obtained from APRN to give dose and monitor for 30 min. Patient alerted monitoring nurse at 10:59AM that she was experiencing a "scratchy" throat and difficulty swallowing. BP 130/88 O2 99% room air, P84. Epi 0.5mg 0.5ml (Lot 339384) administered LD IM at 11:02 AM. Patient hesitant with receiving Benadryl, does not respond well, has to take allegra instead; Benadryl not given. EMS arrived at 11:08AM and assumed care of patient. Patient transported to Hospital. Attempted phone call on 2/11/2021 with no answer.
44 2021-02-11 itchy skin Received 2nd dose of Pfizer vaccine on 1/29/2021. The day after the vaccine patient started experien... Read more
Received 2nd dose of Pfizer vaccine on 1/29/2021. The day after the vaccine patient started experiencing bilateral itchy eyes. She went to urgent care and they gave her eye drops (unknown medication) but they made her sleepy so she discontinued. Patient presented to employee health and was recommended to take 10 days of oral anti-histamine without improvement. Re-presented to employee health 2/9/21 reports of increased eye itching and that itching was migrating down to her neck. She denied itchiness of the throat, rash, or redness. Employee health sent patient to urgent care.
44 2021-02-11 vaccination site swelling Redness to vaccine site raised edges-has moved down left arm.
44 2021-02-14 vaccination site pain Body aches; Joints aches; Head Aches; Injection site pain; neck pain; Swelling of arm; pit of inject... Read more
Body aches; Joints aches; Head Aches; Injection site pain; neck pain; Swelling of arm; pit of injection side; severe fatigue, tiredness; chills; This is a spontaneous report from a contactable (patient). A 44-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm on 26Jan2021 at 01:30 PM as a single dose for COVID-19 immunisation, lot number: EL 1283. Medical history included quinolone antibiotics allergy. Patient received first vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Jan2021, 08:00 AM via an unspecified route of administration in Left arm for COVID-19 immunisation, lot number: EL1685. Concomitant medications in two weeks prior to the vaccination included ibuprofen, Tramadol, Meloxicam. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On 26Jan2021 at 06:00 pm patient experienced body aches, joints aches, head aches, injection site pain, neck pain, swelling of arm, pit of injection side, severe fatigue, chills and tiredness. No treatment received for the events. Since the vaccination patient had not been tested for COVID-19. Patient was recovering from the events, at the time of the report.
44 2021-02-14 redness, skin warm Pt began to feel "hot, warm, and tingling through her mid section chest / stomach area, skin and che... Read more
Pt began to feel "hot, warm, and tingling through her mid section chest / stomach area, skin and chest and arms red and flushed. VS @1222 BP 176/80, HR 86, O2 99%. @ 1232, feels better, Vitals recheck @ 1238 BP 140/78, HR 92, O2 99%.
44 2021-02-14 injection site pruritus, injection site swelling, injection site warmth, injection site redness Red, raised, itchy area about 3-4 inches in diameter around site of injection. Warm to touch. Lasted... Read more
Red, raised, itchy area about 3-4 inches in diameter around site of injection. Warm to touch. Lasted about 1 week. Started approximately 12 days after injection.
44 2021-02-15 shingles Unsure of onset of VZV rash, but first noticed it about a week after receiving first dose of COVID v... Read more
Unsure of onset of VZV rash, but first noticed it about a week after receiving first dose of COVID vax. Rash was under left armpit, was associated with mild pain/irritation. When rash did not resolve, ultimately saw dermatologist on 1/8/2021. PCR of scraping from rash confirmed VZV. Was prescribed Valtrex for rash on 1/8/2021, but did not take it due to receipt of 2nd dose of covid vax on 1/8/2021 and wanted to avoid taking meds concomitantly. Rash resolved slowly on its own.
44 2021-02-16 itchy skin, rash within 15 minutes of Pfizer vaccine had itchy arms and facial twitching. She was observed for an hou... Read more
within 15 minutes of Pfizer vaccine had itchy arms and facial twitching. She was observed for an hour and was told to take benadryl as needed after leaving. Noticed facial rash later that night. The next day patient was itchy in both arms and has some facial swelling, does not have any trouble breathing. was taking benadryl every 4 hours, seen by allergist next day for telemedicine visit and was advised to switch to cetirizine, max 2 tab bid.
44 2021-02-17 skin burning sensation, hives Arm burning, swelling of throat, facial numbness, dizziness, hives
44 2021-02-18 injection site swelling Aches Exhaustion Sore throat Loss of appetite Loss of taste/smell Headache Diarrhea Stomach p... Read more
Aches Exhaustion Sore throat Loss of appetite Loss of taste/smell Headache Diarrhea Stomach pain Chills Fever Extreme swelling on left arm / injection site
44 2021-02-21 rash 1/27/21-About 2 hours after injection; developed facial, neck and chest rash, and itchy throat. ... Read more
1/27/21-About 2 hours after injection; developed facial, neck and chest rash, and itchy throat. 75mg Benadryl taken orally. - 1 hour later dizziness, heart rate 44, lost voice, face looked swollen. - 5 hours after vaccine administered went to outpatient clinic, heart rate 48 there. - After 1 hour, heart rate 120, sweaty, dyspnea and went to Emergency Room. 1/27/21-Amitted to Hospital -Given Solumedrol, Benadryl and Pepcid. Slowly improved. 1/29/21-Discharged Home on Pepcid 20mg BID x15 Days and PRN Benadryl. 2/8/21-Returned to work, but still has to take Benadryl daily for rash and uses Albuterol inhaler intermittently for "tightness" in throat.
44 2021-02-21 injection site pain About an hour after my vaccine I felt like my tongue had been burned with hot liquid. It stayed that... Read more
About an hour after my vaccine I felt like my tongue had been burned with hot liquid. It stayed that way for several hours. 2 days later my arm felt like someone was hitting it over and over with a needle. I had numbing pain in my shoulder and back. I felt nauseated. It has been over a week and I still have pain at the injection site and have body aches. I am unsure who to contact and am not sure what I should do.
44 2021-02-21 injection site pain Day 1 - pain in arm where shot was administered. Day 2 - 4 - pain down arm concentrated in left arm... Read more
Day 1 - pain in arm where shot was administered. Day 2 - 4 - pain down arm concentrated in left arm-pit, area surrounding arm-pit and left wrist and top of hand.
44 2021-02-21 rash Intermittent Loss of taste, rash, body aches, muscle aches, sore throat, tiredness, weakness, migrai... Read more
Intermittent Loss of taste, rash, body aches, muscle aches, sore throat, tiredness, weakness, migraine, shortness of breath, ear pain
44 2021-02-21 shingles, rash Shingles developed on the right upper back 3 weeks after the rash
44 2021-02-21 pain of skin Shot 2-Nausea; vomiting; couldn't eat or drink; headache; skin pain; This is a spontaneous report fr... Read more
Shot 2-Nausea; vomiting; couldn't eat or drink; headache; skin pain; This is a spontaneous report from a contactable other HCP. A 44-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 22Jan2021 18:00 (at the age of 44 years old) at single dose for covid-19 immunisation. Medical history included vestibular problems, allergies Cipro, migraines, concussion, all from an unknown date and unknown if ongoing. Concomitant medication included budesonide (BUDES), levocetirizine dihydrochloride (XYZAL), montelukast sodium (SINGULAIR), nortriptyline, olopatadine. The patient previously took cipro [ciprofloxacin] and experienced allergies. Patient also had BNT162B2 dose 1 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) lot unknown, on 02Jan2021 at 11:45 AM on left arm. The patient did not have any other vaccines in four weeks. The patient has not had covid-19 prior to vaccination. The patient experienced " Shot 2-Nausea, vomiting, headache, skin pain, couldn't eat or drink" on 23Jan2021 09:00 with outcome of recovering. The events resulted patient in Emergency room/department or urgent care. Patient was also received IV fluids, nausea medication, 2 pain medications for headache. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 25Jan2021. Therapeutic measures were taken as a result of the events. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Nausea, Vomiting, and Eating disorder cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
44 2021-02-21 rash Stye developed on 2/1/2021 to left eye, consulted PMD. NO tx resolved after 4 days later. Then 5 da... Read more
Stye developed on 2/1/2021 to left eye, consulted PMD. NO tx resolved after 4 days later. Then 5 days later developed rash to bialteral arms and gluteal region, resolved at the end of day.
44 2021-02-22 injection site pain Sore arm at injection site and fatigue
44 2021-02-22 redness Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Swelling and ... Read more
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Swelling and redness in cheeks. Patient described feeling swelling in lips but no swelling was visible. She was given 25mg Benadryl and monitored for approximately an hour with no additional swelling seen and was driven home by a relative.
44 2021-02-22 itchy skin, rash patient had itching of hands My symptoms were were primarily mild itching in the palms and throat an... Read more
patient had itching of hands My symptoms were were primarily mild itching in the palms and throat and a rash on my chest and hands (was wearing a jacket and mask). On an itching scale of 1 to 10, I told them 2 to 3. According to my nurse, the rash on my chest and hands seemed to peak around 15-20 minutes after (not crimson) and when I finally got to go to the bathroom at the one hour mark and check myself in the mirror
44 2021-02-23 injection site pain Low grade fever, muscle aches, headache, dizziness, extreme soreness at injection site, and general ... Read more
Low grade fever, muscle aches, headache, dizziness, extreme soreness at injection site, and general malaise / extreme fatigue at 5-6 hours post vaccination
44 2021-02-24 itchy skin Had reaction with first dose. Given Benadryl 50 mg oral at 17:00 just prior to vaccine administratio... Read more
Had reaction with first dose. Given Benadryl 50 mg oral at 17:00 just prior to vaccine administration. Within 10 minutes of vaccine administration she developed scratchy throat, felt like lump in throat, then progressed to itching all over body, no visible rash, became nauseated and dizziness. Denied any SOB or tongue swelling. About an hour after vaccine given began to vomit. Patient then transported to ED for further evaluation and treatment. Admitted to ED at 18:25 where she received Decadron 10mg IV, Pepcid 20mg IV and Zofran 4mg IV. Vomiting resolved as well as chest tightness, dizziness, headache, throat itching resolved. She was dismissed from ED at 20:03.
44 2021-02-24 skin discolouration Initial symptoms numbeness and tingleness in mouth anf face; hour after vaccine both hands dark blue
44 2021-02-24 itchy skin Woke up at 1 am with irritation in throat causing me to cough until I sat up . Throat just kept feel... Read more
Woke up at 1 am with irritation in throat causing me to cough until I sat up . Throat just kept feeling very scratchy and irritated and like something was ? stuck ? in the back of my throat . Tried drinking some water and continued trying to clear throat . Eventually took Benadryl 50 mg orally And if it didn?t improve was contemplating going to ER. Was able to fall asleep about an hour and a half later . When I woke up throat was still sore and scratchy feeling but didn?t feel like there was anything ?stuck ? anymore . Also had some mild itching on face especially my eyelids .
44 2021-02-25 vaccination site redness BCG vaccine site/mark became red on 14Feb2021 after 2nd dose.; This is a spontaneous report from a c... Read more
BCG vaccine site/mark became red on 14Feb2021 after 2nd dose.; This is a spontaneous report from a contactable other hcp (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL9265), via an unspecified route of administration on 12Feb2021 16:45 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of vaccine on 21Jan2021 05:00 PM at left arm at age of 44 years old with lot number EL1283. Patient is not pregnant at the time of vaccination. The facility type vaccine was Doctor's office/urgent care. The patient medical history was not reported. No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included omeprazole, levothyroxine, montelukast sodium (SINGULAIR). The patient experienced BCG vaccine site/mark became red on 14Feb2021 after 2nd dose. No itching as of now. Did not happen after 1st dose. It's been red for few hours now. There was no treatment received for the adverse event. The outcome of event was unknown. The event was reported as non-serious.
44 2021-02-25 shingles Development of herpes zoster in T1 dermatome, migraine headache
44 2021-02-28 rash with redness I woke up this morning with my hands swollen and bumpy with a red, rough rash. They do not itch.
44 2021-02-28 injection site pain, rash with redness, injection site bruising, injection site reaction Left Arm started with pronounced soreness, pain & bruising, which did not occur with 1st Covid shot ... Read more
Left Arm started with pronounced soreness, pain & bruising, which did not occur with 1st Covid shot or any other previous & numerous vaccinations in the past. Over the last 36 hours, it has developed into a more pronounced red rash that has extended from the side of the arm around to the rear of the arm with a burning sensation. It not only itches, but burns and the appearance of the rash continues to spread.
44 2021-02-28 redness, hives, rash, itchy skin, injection site hives, injection site rash, injection site pruritus, injection site redness Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itchin... Read more
Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itching, rash and hives. Pt PE upon arrival stated that she was in acute distress. Itching,rash,hives,swelling and redness present on pt's back, chest and left arm. Progression: worsening. Moderate severity. Pt had taken lisinopril 10 mg with no improvement. Pt was treated with steroids, H1 and H2 blockers with good response. 02.01.2021 Pt presented to ED with BP of 200/140. Pt reports BP has been elevated since receiving her COVID vaccine on 01.29.2021. Pt exam positive for tinnitis. BP @ 1253 144/98, 1152 170/107, 1130 185/112, 1126 190/124. Pt BP came down with self administered hydralazine. 02.04.21 Pt presents to Ed with elevated BP of 161/111 and chest pressure. Pt has not had relief with dose of clonidine and hydralazine. She also took a dose of steroid. Pt ROS pos for chest tightness, chest pain and leg swelling. BP improved with anxiolysis.
44 2021-02-28 injection site reaction Severe body aches started at 4:00am, could not get comfortable. Only thing that helped aches was the... Read more
Severe body aches started at 4:00am, could not get comfortable. Only thing that helped aches was the bath tub. Didn?t take temperature until 9:00am 100.9. Husband gave me Advil & Tylenol. Stomach ache/nausea came next, didn?t feel like eating. Very painful back ache shortly after that. Temperature kept fluctuating all day (due to Tylenol use). The next day (today 3-1-2021), I felt better, so I went to work. I noticed all day I getting the cold sweats. I was clammy most of the day, but didn?t feel tired. Took temperature after someone noticed I looked pale at work. My temp was 99.7. At around 4:30 I noticed my left armpit was hurting. Went home at 5:30 and relaxed. I told my husband my armpit was hurting around 10:30pm, I decided to Take my temp at 11:15pm and it was 97.6. I will see if the adverse side affects go away after today.
44 2021-02-28 rash macular, rash Tongue and lips tingling 10-15 mins after vaccine, the nurse on site took pulse/ox, blood pressure,... Read more
Tongue and lips tingling 10-15 mins after vaccine, the nurse on site took pulse/ox, blood pressure, blood sugar, and looked at my face and neck to see if she could see a reaction from the outside. These symptoms stopped 1 hr after vaccine. Then, very slight rash on neck and chest the next day (2/28) red spots (no itching), no treatment. Today (3/1) the rash is lighter and many spots are gone.
44 2021-02-28 vaccination site swelling, vaccination site pain, vaccination site redness injection site pain; tiredness; headache; muscle pain; chills; joint pain; Eye pain; fever =(on Tyle... Read more
injection site pain; tiredness; headache; muscle pain; chills; joint pain; Eye pain; fever =(on Tylenol); feel febrile and woke up with the sweats at 2:am; injection site swelling; injection site redness; nausea; feeling unwell; This is a spontaneous report from a contactable nurse (patient). This 44-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL3249) intramuscularly in the right arm on 26Jan2021 (at the age of 44-years-old) at 11:00 as a single dose for COVID-19 immunization. Medical history included allergy to bee stings. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously took thimerosal on an unknown date for an unknown indication and experienced drug allergy. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL0140) on 05Jan2021 at 10:30 intramuscularly in her right arm. On 27Jan2021 at 02:00 the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, eye pain, "fever = (on TYLENOL) feel febrile and woke up with the sweats at 2:am," injection site swelling, injection site redness, nausea, and feeling unwell. No treatment was provided for the events. Therapeutic measures were taken as a result of fever and included paracetamol. The clinical outcomes of injection site pain, tiredness, headache, muscle pain, chills, joint pain, eye pain, "fever = (on TYLENOL) feel febrile and woke up with the sweats at 2:am," injection site swelling, injection site redness, nausea, and feeling unwell were unknown. It was also reported the patient was not COVID tested post-vaccination.
44 2021-03-01 rash Within 12 hours had fevers, chills, sweat, myalgia, HA, and axillary LN (size of golf ball). These s... Read more
Within 12 hours had fevers, chills, sweat, myalgia, HA, and axillary LN (size of golf ball). These sx eventually improved. 72 hours latter diffuse macularpapular rash on trunk, inguinal region, back.
44 2021-03-02 hives, rash 2/25/21 11:36 AM Patient states that her symptoms (swollen around left eye to her throat, right side... Read more
2/25/21 11:36 AM Patient states that her symptoms (swollen around left eye to her throat, right side of her face feels fine, tight through, light bumpy rash on her chin) increased over the last hour and now do not seem to be getting worse. She is able to breathe without difficulty. She will take 50 mg Benadryl and if symptoms progress she will go to the ER for further treatment and evaluation of an allergic reaction to COVID vaccine. She will call Dr. back later and may need note for work. 2/26 11:30 AM Received text message from patient. "I woke up with trouble breathing, hives on my neck and jaw and swollen face. Nausea and diarrhea. Trouble swallowing so I took Benadryl. Swelling went down on face but still tight in throat. . Dr. "instructed her to go to ER if symptoms worsen and told her I would check on her on Monday. I asked her if her symptoms were not changed, worse, or improved. She answered: "They got worse this am from 5 to 10 and feeling better now. As far as swelling and breathing feels better. 3/1 10:21 AM Dr. Spoke with patient 10:21 am. She states that she is feeling much better and no longer has difficulty breathing or feeling of throat tightness. She does still have nausea, with occasional vomiting, and diarrhea. She felt well enough to return to work today. 3/3 11:09 AM Dr. spoke with patient. She stated that she is finally feeling "back to normal". We discussed severity of side effects and recommendation to defer 2nd Pfizer vaccination. She stated that at one point she was "close to going to the ER".
44 2021-03-02 shingles, rash Back and right hip pain and small rashes on right side, ended up diagnosticated with shingles.
44 2021-03-02 itchy skin First felt itching on inner forearms; moved to neck and stomach; throat itching.
44 2021-03-02 injection site pain Numbness in left leg, pain in the administered area, difficulty to lift the leg, dizziness, double v... Read more
Numbness in left leg, pain in the administered area, difficulty to lift the leg, dizziness, double vision.
44 2021-03-02 hives Symptoms were: general allergic reaction with hives followed by a seizure and spontaneous recovery. ... Read more
Symptoms were: general allergic reaction with hives followed by a seizure and spontaneous recovery. Pt relates Seizure was consistent with her normal seizures but slightly worse. She had a seizure 1 week ago and has seizures in clusters, this was consistent with the waning period of the current cluster. Vital signs were (abnormal with tachycardia and hypertension on arrival to the ED). Exam was notable for neck pain. Patient was treated with Benadryl on scene and with Toradol and fluids in the ED and symptoms recovered but multiple shaking episodes characterized by patient as seizure. Patient was observed in the emergency department for an extended period.
44 2021-03-02 rash Within minutes, Xavier felt burning sensation but did not report it while she was in the observation... Read more
Within minutes, Xavier felt burning sensation but did not report it while she was in the observation room because she thought it will go away just like it did with first dose. She then started to have rashes, low grade fever, and felt weak same day, and went on the following day. On 2/21/21 she had generalized swelling and rashes, difficulty breathing and went to the hospital.
44 2021-03-03 itchy skin, hives, redness itching, hives, redness. Transported to Emergency Room/department or urgent care.
44 2021-03-04 injection site pruritus, injection site redness, injection site swelling Injection site/upper arm swollen, red and itchy.
44 2021-03-04 pain of skin, blister Report blister filled lesions in clusters right side of face and forehead that is painful to touch. ... Read more
Report blister filled lesions in clusters right side of face and forehead that is painful to touch. Treatment: None Outcome: Recommend EE be seen by PCP to rule out shingles. Does not interfere with ADLs.
44 2021-03-04 injection site pain Soreness at site of injection. About 12 hours after the shot I had body aches, chills, headache. I t... Read more
Soreness at site of injection. About 12 hours after the shot I had body aches, chills, headache. I took some Advil to help with aches. I felt better in the morning (24 hrs after shot) but still had a headache and some fatigue.
44 2021-03-06 injection site pain Fever, body aches, arm pain (at injection site); bilateral eyelid swelling, lip numbness/swelling
44 2021-03-06 rash, rash with redness First dose, no reaction except arm pain for about 2 days. Second dose (which I am reporting here bec... Read more
First dose, no reaction except arm pain for about 2 days. Second dose (which I am reporting here because I think it is unusual) was followed one day afterwards resulted in fever and joint pain; 2 weeks later (Mar 6) I had sudden knee pain and then the palms of my hands broke into a red, lacy rash. I became nauseous. One day after that (Mar 7), the palms of my hands are bumpy, but the red, lacy rash is gone. My right knee has a red, prickly rash on it that resembles Fifth disease. I have not had any contact with people without an N95 mask following my second shot, except my husband, who is also isolated.
44 2021-03-06 itchy skin, hives Instant hives and itchy prickly feeling going on 24 hours. Is managed with Benedryl and Claritin
44 2021-03-06 rash Nausea, Weakness, Overheated, Lightheaded, Body Aches, Fever, Rash, Dizziness
44 2021-03-07 vaccination site pain generalized aches and pains; fatigue; head fog; hot and cold flashes; Nausea; vomiting; insomnia; Si... Read more
generalized aches and pains; fatigue; head fog; hot and cold flashes; Nausea; vomiting; insomnia; Site pain persisted; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9265 and expiry date: unknown), via an unspecified route of administration on the right arm, 04Feb2021 16:00 at a single dose for COVID-19 immunization. Medical history included HTN and Asthma. Patient was not pregnant at the time of administration. Concomitant medication included Olmesartan, bupropion hydrochloride (WELLBUTRIN), loratadine and vitamins. The patient previously took sulfur and morphine and experienced allergies. Events began with insomnia the night of injection on 04Feb2021 23:00. The following morning of 05Feb2021, patient woke with generalized aches and pains, fatigue, head fog, and hot & cold flashes. She had nausea and vomiting midday. Symptoms resolved by second day on 05Feb2021 but site pain persisted on Feb2021. TYLENOL and ibuprofen were given as treatments for the events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested post-vaccination.
44 2021-03-07 rash rash over both arms and neck/chest area as well as sides of my face. small bumps from arms to finger... Read more
rash over both arms and neck/chest area as well as sides of my face. small bumps from arms to fingers and most prevalent across necka nd chest
44 2021-03-08 skin spots, rash 1/7/21-1/9/21: fevers consistent >39.5 x 36hrs 1/7/21- 1/8/21 extreme nausea and vomiting--nausea ... Read more
1/7/21-1/9/21: fevers consistent >39.5 x 36hrs 1/7/21- 1/8/21 extreme nausea and vomiting--nausea has continued daily, vomiting is decreased to 2-3 days/week. Zofran 8mg has been used as needed 2/8/21 ALT164, AST 156 (increased from post vaccine January '21) Aldolase 10.2, CK 199, Alk Phos and Bilirubin normal, WBC and neutrophil sudden decrease. UA 4+ bacteria epith cells and protein... worsening but negative culture 1/2021palpitations and chest pain intermittent but no respiratory distress Other Items: petechial rash to lower flank and extremities, facial rash, peripepheral edema, rash, and pain consistent with vascular inflammation. Right temporal lobe painful to touch. Neck pain. Throat pain and difficulty swallowing
44 2021-03-08 rash, redness Felt an immediate flush on face, face reddened across cheeks and nose. Later, after work, noted rash... Read more
Felt an immediate flush on face, face reddened across cheeks and nose. Later, after work, noted rash on arms, back was dark with lighter rash on stomach and chest
44 2021-03-08 hives Hives, took Benadryl they went away. Fever, chills then really hot, super achy. This happened on Sat... Read more
Hives, took Benadryl they went away. Fever, chills then really hot, super achy. This happened on Saturdat around 515 then Sunday super achy, very tired, couldnt function or move. Monday still very achy still had fever. Tuesday felt better
44 2021-03-08 itchy skin Itching of neck, face, head, and some itching of trunk and arms. 24+ hours after dose, itching of t... Read more
Itching of neck, face, head, and some itching of trunk and arms. 24+ hours after dose, itching of the face/neck has continued, and increased around the 24 hour mark. Took over the counter benadryl for the itching and motrin for other expected/listed side effects (sore throat, headache, chills)
44 2021-03-09 itchy skin Body aches; itching eyes & body; itching eyes & body; chills; headache; This is a spontaneous report... Read more
Body aches; itching eyes & body; itching eyes & body; chills; headache; This is a spontaneous report from a contactable other health professional (Patient). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EM9810), via an unspecified route of administration, Right arm on 05Feb2021 at single dose for covid-19 immunisation (Age at vaccination 44 years) at hospital. Patient was not pregnant at the time of vaccination. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't received other medications received within 2 weeks of vaccination. Medical history included ehlers-danlos syndrome (EDS), mast cell activation syndrome (MCAS), postural orthostatic tachycardia syndrome (POTS). Allergies to medications, food, or other products included Latex allergy. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (COVID 19, Pfizer, PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249), via an unspecified route of administration, Right arm on 15Jan2021 at single dose for covid-19 immunization (Age at vaccination 44 years). On 06Feb2021, the patient experienced body aches, chills, headache, itching eyes & body. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. No treatment was received for the events. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.
44 2021-03-09 rash, hives Flushed; over heated; rash/hives on chest; rash/hives on chest; dry mouth; swollen tongue; rapid hea... Read more
Flushed; over heated; rash/hives on chest; rash/hives on chest; dry mouth; swollen tongue; rapid heart rate; nausea; headache; weakness; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261), via an unspecified route of administration on 21Jan2021 at 16:00 at a single dose in the left arm for COVID-19 immunization. Medical history included seasonal allergies, some environmental allergies, some heart issues specified as SVT, slight asthma, and lung damage. Prior to vaccination, the patient was diagnosed with COVID-19 on 26Dec2020 (also reported as possibly had COVID in Mar2020, however no tests were available; patient was told to quarantine). On 31Dec2020, COVID-19 test showed a positive result. The patient recovered on 09Jan2021, two weeks from onset of symptoms. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not pregnant at the time of vaccination. On 21Jan2021 at 16:15, the patient experienced the following adverse events: flushed, over heated, rash/hives on chest, dry mouth, swollen tongue, rapid heart rate, nausea, headache, and weakness. The events resulted to emergency room visit and doctor office visit. The patient received two epi shots, allergy and anti-nausea medications as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date.
44 2021-03-09 injection site pain Moderate headache for two days following, then a full blown migraine in the early evening on second ... Read more
Moderate headache for two days following, then a full blown migraine in the early evening on second day after vaccination. Sore arm muscle at vaccination site for a day and half.
44 2021-03-09 vaccination site pain lymph node under my left arm, close to my left breast is swollen; it is sore; felt chills; injection... Read more
lymph node under my left arm, close to my left breast is swollen; it is sore; felt chills; injections site pain; tiredness; This is a spontaneous report from a contactable consumer reporting for herself. A 44-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 11:15 (Lot number: EN5318) via an unspecified route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization. The patient's medical history included high blood pressure from an unknown and unknown if ongoing. Concomitant medications included lisinopril, amlodipine, metoprolol and levocabastine hydrochloride (Zyrtec). The patient had no allergies to medications, food or other products. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated that the lymph node under his left arm, close to his left breast was swollen. The patient also felt chills, injections site pain, and tiredness on 27Jan2021 04:00. The events assessed as non-serious by the reporter. It was unknown if the patient received treatment. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
44 2021-03-10 rash macular Headache; general weakness, in her legs especially; No energy; No appetite; Diarrhea; Green colored ... Read more
Headache; general weakness, in her legs especially; No energy; No appetite; Diarrhea; Green colored stools; Very faint/thought she was going to pass out; Eyes were watering; blotches on her neck and chest; tingly experience on her tongue and lips; Severely shaking; Overwhelming chills; Extreme nausea; This is a spontaneous report from a contactable consumer (patient). This 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: E19266) via intramuscular at single dose on 20Feb2021 09:30 for COVID-19 immunization. The first dose was on 30Jan2021 in left arm. Medical history included splenectomy from Feb2017; pancreatic surgery from Feb2017, they removed her spleen as part of that; soy allergy; poultry allergy. Patient confirmed she had splenectomy. The surgery was sort of emergency based so knowing most likely they were taking her spleen out; she was given 4 vaccinations. In the hospital, she did break out in what appeared to be like a chicken pox type rash. The rash lasted a month and then it started to fade. She did not have any breathing sort of symptoms. The doctors did attribute the rash to one of the vaccinations, she was not clear on what vaccine caused the reaction. Ideally, she was supposed to have 2 weeks prior to the surgery so her body had time to reabsorb but she did not have that kind of time, but she had nothing internally going on. She confirmed she had no names, NDC, Lot number or expiration dates for the vaccines she received at that point in time. Having the splenectomy was the biggest thing. In the past, she did not have any allergies to medications, but did have allergies to soy and poultry. She did break out from certain food and her skin develops those blotches. She did have an extra work up in Feb2020, where they tested a bunch of food sensitivities and allergies, and nothing came back. This was right before COVID hit so she did not really follow back up after that, but she was tested for all major foods and household things and nothing came up. In her late 20's, she definitely tested for a soy allergy and allergy to poultry. She did check off yes, she had a reaction previously when she was filling out the form at the COVID-19 vaccine site knowing that she had this prior experience. She was held 30 minutes each time for that reason. Concomitant medication was none. Prior vaccinations (within 4 weeks) was no. On 20Feb2021, patient was very faint, thought she was going to pass out, eyes were watering, blotches on her neck and chest, tingly experience on her tongue and lips, severely shaking, overwhelming chills, extreme nausea. On an unspecified date, patient experienced headache, general weakness, in her legs especially, no energy, no appetite, chills that come and go, diarrhea and green colored stools. Patient received her second shot of Pfizer's vaccine on 20Feb2021. She had had symptoms ever since. She had a reaction on site at the vaccine center. She eventually had to go to the Emergency Room by ambulance. Her symptoms were still going on and tomorrow would mark a week since she received the second dose. The symptoms she experienced on site were different than what she was currently experiencing. She felt like she had a true reaction at the vaccine facility site. Within 6 minutes of receiving the second vaccine, she became very faint, her eyes were watering. She thought she was going to pass out for a bit. She was told she had blotches on her neck and chest. She had a tingly experience on her tongue and lips. She was severely shaking and had overwhelming chills. She stated this happened for a couple of hours. Basically, there were 3 waves of these symptoms kind of happening. The third wave happened probably a couple hours after receiving the vaccine. At that point, she had been given two pills of diphenhydramine hydrochloride (BENADRYL), taken orally. With the third wave, she thought she was going to pass out, which she thought multiple times before, but then with this particular wave, she experienced extreme nausea which was kind of a new symptom. The doctor on site said to the EMT that he wanted her to go to the Emergency Room. Patient confirmed she was taken to the ER via ambulance the day she received the vaccine, 20Feb2021. She was never admitted into the hospital; she was only seen in the Emergency Room for a couple of hours. She was given IV fluids, she had blood work done. She didn't have a copy of her labs but she was told they were okay. She was injected with diphenhydramine hydrochloride (BENADRYL) via IV before she was released. A lot more symptoms came after she was released from the hospital (ER). She came home and she had just a crazy headache that she really woke up with every single day until this morning. She had been taking a lot of caffeine/paracetamol (EXCEDRIN, Lot#: H044G, Expiry Date: Jun2022) for her headaches. She experienced extreme weakness, nausea. She clarified she had weakness in her legs. She had this exhaustion, and she felt this general weakness sort of in her legs especially. She was still taking stuff for a headache, and she was taking nausea pills. She had been out of work all week. She had no energy, no appetite really. She had chills that come and go. She had diarrhea. She clarified she had more diarrhea in the beginning days after receiving the vaccine, but it was always been a green colored stool as well. The ER called and checked in and were very surprised she had been having the symptoms still so severely. They wanted her to go get an actual COVID test. She went to the Urgent Care to get COVID tested on 23Feb2021 and had a rapid and PCR test. The rapid test came back negative. She had not received the results for the PCR test yet. She was taking diphenhydramine hydrochloride but she stopped taking that. The hospital directed her stop taking the diphenhydramine hydrochloride earlier in the week. She clarified she was taking a generic version (Lot#: P113966, Expiry Date: Feb2021), coated mini tablets. She clarified the nausea pills she had been taking was the generic for ZOFRAN, ondansetron 4 mg tablet, by mouth, every 8 hours. She confirmed this product was dispensed in a pharmacy bottle with no NDC, Lot number or expiry date on it. She clarified she also had been taking the generic version of TYLENOL EXTRA STRENGTH, it was the Up and Up Brand acetaminophen (Lot#: P122699, Expiry Date: Nov2022) gel caps, 500mg. COVID-19 rapid test was negative on 23Feb2021; COVID-19 PCR test on 23Feb2021 was unknown results. Patient asked if there was a hotline she can call or an information number where she can talk to somebody about her symptoms. She also reported this to her doctor but the doctor made it clear since it was a private practice, they had limited information. The doctor did take down similar information, she just did not know if there was any further information or a hotline she could call. The outcome of events was unknown.
44 2021-03-10 itchy skin Reports itching "all over". Patient reports Pepcid & diphenhydramine 25mg at 0930. Patient began t... Read more
Reports itching "all over". Patient reports Pepcid & diphenhydramine 25mg at 0930. Patient began to clear throat during monitoring. Administered additional 25 mg diphenhydramine at 1117. 1/24/21 patient reports that she went to ED for treatment. As given "shot of prednisone" and discharged.
44 2021-03-10 injection site pain Within 4 hours on date of second dose (3/8/21) only felt tired and site injection soreness. 27 hours... Read more
Within 4 hours on date of second dose (3/8/21) only felt tired and site injection soreness. 27 hours after vaccine (3/9/21) I felt "unwell", out of sorts, very tired. at 31 hours I had body aches throughout my body, no energy, light headed, could not be up and about for more than a few seconds, no appetite. Slept for about 3 hours then went to bed officially from 8pm to 6am and felt 100% normal.
44 2021-03-11 dry skin, injection site pain Fatigue, tingling in lips, face, neck, hands. Dryness in lips and hands. Soreness at injection site.... Read more
Fatigue, tingling in lips, face, neck, hands. Dryness in lips and hands. Soreness at injection site. Temperature 99.8
44 2021-03-11 hives dizziness on the verge of passing out; welts all over midsection from upper legs through hips and on... Read more
dizziness on the verge of passing out; welts all over midsection from upper legs through hips and onto torso lasting for weeks; Intense headache; dizziness on the verge of passing out; flushed face and ears; This is a spontaneous report from a non-contactable other healthcare professional. This 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1283), dose 1, single dose via an intramuscular route of administration in the left arm on 10Feb2021 at 10:30 AM (at the age of 44- years-old) for COVID-19 vaccination. Medical history included complete thyroidectomy with neck dissection (removed lymph) for papillary thyroid cancer with neck dissection (removed lymph) for papillary thyroid cancer- otherwise healthy and penicillin allergy. The patient was tested for COVID-19 on 14Aug2020 by nasal swab and was negative. The patient was not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 10Feb2021 at 10:30 AM, the patient experienced intense headache within 5 minutes, dizziness on the verge of passing out (waited in the lobby for 1 hour before leaving), flushed face and ears, headache for several days, welts all over midsection from upper legs through hips and onto torso lasting for weeks. The clinical outcome of headache, dizziness on the verge of passing out, flushed face and ears, headache and welts was unknown. No follow-up attempts are possible. No further information is expected.
44 2021-03-11 skin warm, redness elevated heart rate pounding heart beat (could hear it) Pounding headache Turned red like a cherry w... Read more
elevated heart rate pounding heart beat (could hear it) Pounding headache Turned red like a cherry warm
44 2021-03-12 rash Mild Skin Rash on chest and neck, developed less than 24 hours after injection.
44 2021-03-12 itchy skin SOB, throat tightness 5 minutes after vaccination 4 mg decadron, epi and benadryl given IM on scene ... Read more
SOB, throat tightness 5 minutes after vaccination 4 mg decadron, epi and benadryl given IM on scene transferred to Emergency room via ambulance C/) SOB, itching and swelling at the back of her throat and in her neck. No hives. No syncope. Described as moderate and later mild. No radiation, no vomiting, no wheezing. Patient discharged from ED at 09:30 am
44 2021-03-12 rash, shingles, blister Shingles outbreak. Muscle pain, then rash on right side of the torse, blisters. Contacted Doctor on... Read more
Shingles outbreak. Muscle pain, then rash on right side of the torse, blisters. Contacted Doctor on 03/09/2021 via online portal, described symptoms and sent images of the rash. Doctor prescribed Valacyclovir. The illness is still going on (03/12)
44 2021-03-12 rash rash, lightheaded. Evaluated by EMS-Cleared
44 2021-03-13 injection site hives, hives Hives at injection site and across chest and neck, shortness of breath, minor swelling of face and t... Read more
Hives at injection site and across chest and neck, shortness of breath, minor swelling of face and throat as symptoms progressed.
44 2021-03-13 injection site pruritus Immediate intense deep itching at injection site. Itchy throat and mild swelling of mouth. Treated ... Read more
Immediate intense deep itching at injection site. Itchy throat and mild swelling of mouth. Treated with Benadryl
44 2021-03-13 itchy skin, hives Received covid shot #2 on 3/11/21 around 430 pm. Major hives and welts and extreme itching around 1... Read more
Received covid shot #2 on 3/11/21 around 430 pm. Major hives and welts and extreme itching around 1 pm on 3/14/21. Thinking back to the first shot on 2/18/21, I had a rash on my stomach an hour after injection that was slightly itchy but went away after an hour. Hives and itching were reduced after taking Benadryl and steroids.
44 2021-03-14 shingles, rash 5 days after my 2nd dose of the Pfizer covid vaccine, I broke out with a rash on the right side of m... Read more
5 days after my 2nd dose of the Pfizer covid vaccine, I broke out with a rash on the right side of my neck. I recieved the shot in my left arm. The doctor put me on a 7 day dose of Valtrex. I had to also use Terrasil over the counter lotion. The shingles were gone by March 1, 2021.
44 2021-03-14 injection site bruising I got sick the next day BUT my main concern is the horrible bruising that started the next day where... Read more
I got sick the next day BUT my main concern is the horrible bruising that started the next day where the shot was given. As the days passed it continued to get worse. I have pictures of my bruises. My 2nd dose is this Thursday 3/18 and I'm concerned I shouldn't be getting it due to what has been reported recently in other countries with blood clotting Issues which has never been an issue for me in the past. Again I have pictures.
44 2021-03-14 shingles Shingles developed on right occiptal scalp 36 hours after injection
44 2021-03-15 rash with redness, itchy rash, itchy skin 6 hours in - very sore arm. 12 hours in - sore arm that required tylenol. 12-24 hours headaches, fat... Read more
6 hours in - very sore arm. 12 hours in - sore arm that required tylenol. 12-24 hours headaches, fatigue. 24 hours later - itchy throat/roof of mouth (took benadryl). 36-48 hours itchy throat/roof of mouth continued but became itchy on arms and legs. 2-4 days post vaccine it progressed to itchy spots on my entire body. No hives - but a rash and redness. Feels like pin and needles.
44 2021-03-15 skin peeling, hives After receiving my first dose I experienced the following adverse side effects: -Fatigue -Extreme so... Read more
After receiving my first dose I experienced the following adverse side effects: -Fatigue -Extreme soreness in my arm -The lymph nodes under my arm pit was swollen and tender -I broke out in hives on my hands and face -I had a rash on my tongue -A knot on the bottom of my right foot [in the area of the arch] -The skin on both of my hands have been peeling extremely bad
44 2021-03-15 itchy skin Itching / Soreness of right breast. Started about 1 hour after vaccination and continued for approxi... Read more
Itching / Soreness of right breast. Started about 1 hour after vaccination and continued for approximately 48 hours.
44 2021-03-15 rash, redness Swelling of lips, redness. Rash on wrist of lower arm
44 2021-03-16 injection site pain Pain at the injection site that lasted about 24 hours
44 2021-03-17 redness Bell's palsy on right hand side of my face; extreme heat in my face; Red face and ears all day; Red ... Read more
Bell's palsy on right hand side of my face; extreme heat in my face; Red face and ears all day; Red face and ears all day; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female consumer received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Feb2021 at single dose in right arm for covid-19 immunisation at the age of 44-year-old. Lot number was Ez9264. Medical history included asthma, interstitial cystitis, allergy to peanuts. The patient experienced anaphylactic reaction with GADAVIST. Concomitant medications were unknown. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Jan2021 at 04:30 in right arm at the age of 44-year-old for Covid-19 immunisation (lot number was Gl3249). The patient was not pregnant. On 03Feb2021 at 07:15, the patient experienced extreme heat in face that lasted 2 minutes. Red face and ears all day but no more extreme heat. On 06Feb2021, Bell's palsy on right hand side of face occurred. The patient was not treated for the events. The patient did not recover from the events. Patient was not covid tested post vaccination; patient did not have covid prior vaccination.
44 2021-03-17 hives Right side of face, neck and chest broke out in hives. I had numbing in my lips and tingling on the ... Read more
Right side of face, neck and chest broke out in hives. I had numbing in my lips and tingling on the right side of my body.
44 2021-03-17 injection site pain Sore arm at the injection site which was very painful for 2 days. patient also complained of runny ... Read more
Sore arm at the injection site which was very painful for 2 days. patient also complained of runny nose on 3/4 which lasted for about 4 hours.
44 2021-03-18 hives, itchy skin Arm pain immediately following vaccination. 2 hours later, became extremely itchy all over body (no ... Read more
Arm pain immediately following vaccination. 2 hours later, became extremely itchy all over body (no rash.) One raised hive popped up on my stomach. I took Benadryl to reduce itchiness so I could sleep. Today I am dealing with a mild headache and bad diarrhea immediately after eating.
44 2021-03-18 rash with redness, hives, rash papular, itchy rash Hives. Itchy, raised red bumps on arms, neck, face, and thighs. First appeared several days ago and... Read more
Hives. Itchy, raised red bumps on arms, neck, face, and thighs. First appeared several days ago and has been getting progressively worse. The first welts appeared on my face. The arm where I received the vaccine is more affected than the other arm. Because onset was so long after the jab, I'm not sure the vaccine is the cause. But I have barely left the house, not eaten anything new, not changed any soap or perfume or anything and have no history of hives. Prednisone prescribed.
44 2021-03-18 hives, rash Hives/rash developed on chest and side of neck, as well as facial flushing, about 15/20 minutes afte... Read more
Hives/rash developed on chest and side of neck, as well as facial flushing, about 15/20 minutes after the injection. Blood pressure was taken repeatedly and high 150/100.
44 2021-03-18 vaccination site pain Low grade fever (100.1F); Achy joints; headache; sore arm, especially at injection site; sore arm, e... Read more
Low grade fever (100.1F); Achy joints; headache; sore arm, especially at injection site; sore arm, especially at injection site; muscle aches; This is a spontaneous report from a contactable healthcare professional (the patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), via an unspecified route of administration in the left arm on 12Feb2021 10:45 (at the age of 44-years-old) as a single dose for COVID-19 immunization. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included: vitamin C and ibuprofen (ADVIL), both taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), via an unspecified route of administration in the left arm on 22Jan2021 13:45 (at the age of 44-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Feb2021 06:00, the patient experienced low grade fever (100.1F), achy joints, headache, sore arm, especially at injection site, and muscle aches. The clinical course was as follows: Low grade fever (100.1 F), achy joints, headache and sore arm, especially at injection site, at 06:00 on 13Feb2021. Low grade fever lasted for about 10 hours, took ADVIL, which brought temperature to normal level (98.8 F). Slight headache still remained on 14Feb2021, but ADVIL relieved that. Fever and muscle aches dissipated by morning of 14Feb2021. No treatment was received for achy joints, sore arm, especially at injection site, and muscle aches. The clinical outcome of the events fever and muscle aches was recovered on 14Feb2021, and for other events was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
44 2021-03-19 hives, itchy skin Hives, itchy, throat tightness. Given epinephrine and Benadryl by EMS at scene and transported to ho... Read more
Hives, itchy, throat tightness. Given epinephrine and Benadryl by EMS at scene and transported to hospital for evaluation.
44 2021-03-19 itchy skin Patient experienced swelling of lips and itching sensation in her throat 20 minutes after receiving ... Read more
Patient experienced swelling of lips and itching sensation in her throat 20 minutes after receiving her 2nd dose. Called EMS to her vehicle. Transport ambulance was called to bring patient to ER. Benadryl 50mg IM given by onsite EMS prior to transport.
44 2021-03-19 rash pt experienced a small rash on the right side of neck. No other reaction was reported
44 2021-03-20 rash Muscle weakness , diarrhea, and fatigue lasting 48 hours. Developed rash on face, both arms, and b... Read more
Muscle weakness , diarrhea, and fatigue lasting 48 hours. Developed rash on face, both arms, and both legs 24 hrs following vaccination. The rash is still present on day four, even with two days worth of Benadryl and Tylenol consumed.
44 2021-03-21 itchy skin, skin burning sensation Approximately 6 hours after injection I began to feel as if my skin was burning and itching. Had cr... Read more
Approximately 6 hours after injection I began to feel as if my skin was burning and itching. Had crawling sensation throughout body and throat felt a little tight/dry. The burning, itching and crawling feeling continued for a couple weeks. Had to take Allegra and Benadryl and currently am still taking it to ward of symptoms.
44 2021-03-21 itchy skin Patient had a metallic taste in her mouth. Her entire left arm felt itchy. She was also dizzy. Ga... Read more
Patient had a metallic taste in her mouth. Her entire left arm felt itchy. She was also dizzy. Gave patient one Cetirizine 10mg tablet. Patient refused benadryl and said that she was allergic.
44 2021-03-21 hives, itchy skin, skin warm Symptoms started on 03.15.3022. Swelling on right arm at crook, nothing at injection site. Poc mar... Read more
Symptoms started on 03.15.3022. Swelling on right arm at crook, nothing at injection site. Poc marks developed as well where swelling was, armpits, shoulder blade and legs all right side. Swelling increased became very red and hot to touch, itching all where marks were. I was taking Benadryl and applying cortisone cream. On Friday went to walk in, advised not much they can do stop taking Benadryl. On 0321.2021 hives broke out all on right arm started Benadryl again. Still have them now over a week later.
44 2021-03-21 injection site pain Upper left arm soreness around site of injection was distinct and noticeable after I woke up on 3/21... Read more
Upper left arm soreness around site of injection was distinct and noticeable after I woke up on 3/21; Soreness lasted all day but was gone upon waking on 3/22
44 2021-03-21 hives, itchy skin hives and itching
44 2021-03-22 injection site rash, injection site pain About 3-4 days later developing a rash at the injection site. Otherwise no major initial symptoms af... Read more
About 3-4 days later developing a rash at the injection site. Otherwise no major initial symptoms after receiving the dose, other than a mildly sore arm for first two days and some fatigue.
44 2021-03-22 injection site tingling After approximately 5 minutes my arm was tingling from the injection site to my fingers, I became n... Read more
After approximately 5 minutes my arm was tingling from the injection site to my fingers, I became nauseous and went to the brink of passing out. An ambulance was called and my blood pressure had dropped to 100/60. My blood sugar also dropped.
44 2021-03-22 itchy skin Itchy throat, arms and legs.
44 2021-03-23 hives After receiving 2nd dose of pfizer covid vaccine patient waited her 15 minutes and went to car to le... Read more
After receiving 2nd dose of pfizer covid vaccine patient waited her 15 minutes and went to car to leave but noted she was developing hives on her chest and flushing of face. She had no difficulty breathing. She waited in car for 5-10 minutes but it was not subsiding so she re-entered the facility and sought out EMS for evaluation. At that time she was noted to have confluent hives on chest and flushing of cheeks but no angioedema, throat or tongue swelling, sob, wheezing, difficulty breathing, or difficulty speaking. Hives remained localized to chest and flushing to cheeks. Vitals were stable and remained stable. She was observed x 20 minutes with no further progression of symptoms. She was offered benadryl but refused as she has a 1.5 hour drive home and has no one here with her. She was offered decadron but refused. She opted to drive to nearest gas station to get non drowsy antihistamine. She carries her own epi pen due to bee sting reactions and is well versed in how to use it. She was instructed to call 911 if getting worse or if she needs to use epi pen.
44 2021-03-23 injection site pain Felt flushed/hot about 30-60 minutes after shot. Muscle pain at site of injection and throughout upp... Read more
Felt flushed/hot about 30-60 minutes after shot. Muscle pain at site of injection and throughout upper arm - painful throughout the night. Pain dissipated somewhat 26-28 hours out from shot. Ran low-grade fever about 29 hours out from shot. Nausea, just general malaise throughout the day.
44 2021-03-23 hives Hives on the neck and face and anxiety. BP 166/110 HR 78 Sp02 98%. Benadryl 50mg po given and monito... Read more
Hives on the neck and face and anxiety. BP 166/110 HR 78 Sp02 98%. Benadryl 50mg po given and monitored for 30 min
44 2021-03-23 rash macular, hives I believe I had a purple dotted rash on belly on 3/14. Broke out in hives on 3/18 on arms, legs, tr... Read more
I believe I had a purple dotted rash on belly on 3/14. Broke out in hives on 3/18 on arms, legs, trunk,.
44 2021-03-23 hives, itchy skin, rash, rash papular I felt fine for the fors 24 hours. Limited arm soreness, no other symptoms. At 11:00Am Sunday I bega... Read more
I felt fine for the fors 24 hours. Limited arm soreness, no other symptoms. At 11:00Am Sunday I began to get achy at my joints. I was out on a 5 mile hike and unable to turn around. When I got home took Tylenol and rested. At 11Pm Sunday night I started feeling itchy and discovered a full body rash. They were raised patches and if i scratched myself the area would swell up like a hive. Took Benadryl and it was mostly gone by morning. At 11:00pm Tuesday night I started feeling itchy again and discovered the rash had returned again. Again took Benadryl and it was mostly gone by morning.
44 2021-03-23 itchy skin Patient came in to get her second COVID shot. informed me that she had reactions to the first (lymph... Read more
Patient came in to get her second COVID shot. informed me that she had reactions to the first (lymph node swelling, hives, bells palsy symptoms, and nausea). Her doctors and specialists discussed it with her and agreed they wanted her to have the second dose. She had pneumonia twice, had covid and has residual effects from it, and had mono. They were unsure if the symptoms were directly from the immunization or the fact that she had mono/pneumonia when she got it and didn't know. I Gave her the immunization and she said she felt warm after it. I sat with her for 30 minutes and she said she felt flushed and itchy, she was given 10 ml of Benadryl 12.5mg/5ml. She had no visible hives or swelling at the injection site or on her chest or arms. She felt nauseous and took her own phenergan. After sitting for 45 minutes together she said she wanted to go home. She went shopping for a few things and checked in before she left. I told her if there was any swelling at all in her throat/face or if she felt like she couldn't breathe to call 911 or get to the hospital immediately. She said she would and I will call tomorrow to follow up with how she is feeling.
44 2021-03-23 rash Per pt she applied Hydrocortisone cream that she was currently using for another rash. Rash subsided... Read more
Per pt she applied Hydrocortisone cream that she was currently using for another rash. Rash subsided after 2 days.
44 2021-03-23 vaccination site pain, vaccination site redness numerous Herpes Type 1 sores on my vulva; severe myalgia; chills; 103 degree fever; headache; nausea... Read more
numerous Herpes Type 1 sores on my vulva; severe myalgia; chills; 103 degree fever; headache; nausea; gastrointestinal pain; extreme fatigue; pain at injection site; large red rash around the injection site; This is a spontaneous report from a contactable 44-year-old female Other HCP reported for himself that she received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 19Feb2021 (Batch/Lot Number: Lot EN6200) as SINGLE DOSE for covid-19 immunisation. Medical history included hyperthyroidism from an unknown date and unknown if ongoing Hyperthyroidism, controlled with medication. Concomitant medication included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. The patient previously took hydrocodone and experienced drug hypersensitivity, hydrocodone and experienced pruritus, bnt162b2 for covid-19 immunisation. The patient experienced Within 8 hours of receiving the second dose, I developed chills, 103degree fever, headache, severe myalgia, nausea, gastrointestinal pain, extreme fatigue, pain at injection site. These symptoms mostly subsided as of Sunday February 21 by 7 PM. At 10 PM on Sunday February 21 I developed a large red rash around the injection site. I also developed numerous Herpes Type 1 sores on my vulva. I know they are Type 1 as I was tested for all STDs and this is the only one I have. The sores appeared once before following an illness I had in December 2019 that was accompanied by a high fever. I was tested for Covid19 antibodies in April of 2020 and was negative. When the sores were cultured in December of 2019, they were Herpes 1 type appearing in the genital region. The patient underwent lab tests and procedures which included body temperature: 103 on 21Feb2021 degree, sars-cov-2 antibody test: negative on Apr2020. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the event was reported as not recovered.
44 2021-03-24 rash Pt returned for her second dose and reported Bilateral rash to hands within an hour of vaccine.
44 2021-03-24 injection site pain R arm: tenderness after vaccine. Over the course of 3 months, worsening rotator cuff signs and symp... Read more
R arm: tenderness after vaccine. Over the course of 3 months, worsening rotator cuff signs and symptoms including decrease range of motion Physical exam suggests supraspinatus tendinopathy Planning to start PT
44 2021-03-24 itchy skin itching in the arm that was injected, itching belly. some chills and shortness of breath x 1 week.
44 2021-03-25 injection site mass, shingles, injection site rash After the first vaccine I got swelling and a hard lump at the site of injection. I couldn?t even lif... Read more
After the first vaccine I got swelling and a hard lump at the site of injection. I couldn?t even lift my arm for more than 24 hours and then the lump lasted over a week. Then after second dose I also got sore arm and a lump but developed a rash on my arm too. (Same day). Next day I had low grade fever and body aches and chills. 2 days after the vaccine I woke up with a migraine and still didn?t feel well but no more fever. I also had small blister like rash on my inner thigh that developed about 10 days after the first vaccine but thought they were unrelated. Today I saw a dermatologist and she said the rash on my leg was Shingles and was also caused from the vaccine.
44 2021-03-25 itchy skin Anaphylaxis: Shortness of breath, chest tightness, itching, muscle spasm
44 2021-03-25 pain of skin I had long term Covid symptoms from early February 2020 to late February 2021 including, intense con... Read more
I had long term Covid symptoms from early February 2020 to late February 2021 including, intense concussion like brain fog for months, coughing for months, problems with my fingers seizing up and twitching uncontrollably, and extreme exhaustion for months. I had finally started to feel Covid free, except for some problems with my left hand, by end of February 2021. I got the first dose and about 45 minutes or so later the exhaustion came back suddenly - like someone removed all my batteries - and I started having trouble talking, thinking, remembering. Reading and writing work, but talking is difficult. My hands feel swollen and lacking dexterity and strength. I had an odd headache in the middle of the night (on day 2) with some sharp pain that kind of seeped around my scalp. I thought at first I had been stung by a bee and it went away as quickly as it came. But then the pain would suddenly appear on another part of my scalp. There was a tingling/seeping/spreading out feeling just before it would disappear. I woke up the next morning with a more normal headache, took IBU and CBD gummies, ate breakfast and it?s gone. I feel like all I can do is lay in bed and stare at the wall. This is exactly as I felt when I had Covid (though without finger seizures and coughing). I find myself coming to tears with a fear that it won?t ever go away or I?ve brought it on again by getting the vaccine.
44 2021-03-25 dry skin, itchy skin Kidney pain, Fatigue, Swollen eye lids, Severe dry skin, Itchy skin.
44 2021-03-25 rash Patient developed a rash on both arms about 32 hours after shot
44 2021-03-25 injection site warmth, injection site redness pt noticeably antsy, asked if she was ok. she stated that she was trying to power through but couldn... Read more
pt noticeably antsy, asked if she was ok. she stated that she was trying to power through but couldn't. Nurse asked her to see the injection site. When she took off her sweatshirt, stating she felt on fire, the site and her arms were extremely red. She was asked to remove her mask and we discovered her lips and area around her nose was starting to swell. At that time she stated that her tongue felt "weird". Assessing the situation, the nurse administered an Epi-pen while I dialed 911 and gave information. Epi-pen very helpful, to the point she "wished we hadn't called the ambulance" . Once the EMTs arrived, they assessed her and after some time, had her sign a release form since she declined attention. Pt was informed that she would not be allowed to finish her shift and was asked if someone could come get her. The daughter was on her way. The nurse and I sat with her, watching to make sure she didn't have a rebound reaction which she did not in the hour + we were with her. Daughter arrived, took instruction from the nurse and took her home.
44 2021-03-25 vaccination site pain right sided facial twitching; severe soreness in the vaccine site; fatigue; body aches; gastrointest... Read more
right sided facial twitching; severe soreness in the vaccine site; fatigue; body aches; gastrointestinal pain; dizziness; heart palpitations; This is a spontaneous report from a contactable Other HCP (the patient). This non-pregnant 44-year-old female patient received her second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318 ), via an unspecified route of administration, in left arm on 20Feb2021 at 11:15 AM (at the age of 44-year-old) as a single dose for COVID-19 immunization. Medical history included Grave's disease (treated with an ablation resulting in hypothyroidism). The patient had known allergies to raw egg whites, red food dye, and penicillin's. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included levothyroxine sodium (TIROSINT). The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot # EN5318, on 30Jan2021, in the left arm COVID-19 immunization. On 20Feb2021, within 4 hours of receiving the vaccine at 4:15 PM, the patient experienced severe soreness in the vaccine site, fatigue, body aches, gastrointestinal pain. Starting at 48 hours after the vaccine she experienced dizziness, heart palpitations, and right sided facial twitching, No treatment was received. The clinical outcome of right sided facial twitching, severe soreness in the vaccine site, fatigue, body aches, gastrointestinal pain, dizziness, heart palpitations was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
44 2021-03-26 injection site redness, injection site swelling Awoken during sleep (around 12 am the next day) with chills and elevated temperature. Did not sleep ... Read more
Awoken during sleep (around 12 am the next day) with chills and elevated temperature. Did not sleep rest of night/early morning. Developed all over body aches, chills subsided by noon on same day they began. Injection site swelled, and was very red. Swelling spread to underarm/lymph node area. Headache began in early morning on day after shot as well, and nausea set in as well. Slept most of day, ran fever, was nauseous, and achy. The second day after the vaccine was improved - no headache, appetite returned, fever was better. Arm and underarm was still red, swollen and sore, and had overall tiredness and still achy. The only lasting side effect was the red, swollen, and sore arm, which is now almost back to normal. There is still some soreness in the arm and underarm, but the redness and swelling is gone as of 3/22.
44 2021-03-26 skin warm My arm became very hot later in the night and then my face got really hot and when I woke up my face... Read more
My arm became very hot later in the night and then my face got really hot and when I woke up my face was swollen like I had a mild reaction
44 2021-03-26 injection site pain Pain at injection site, fatigue lasting several days and intermittent nausea, mild sore throat and s... Read more
Pain at injection site, fatigue lasting several days and intermittent nausea, mild sore throat and some dry coughing. The pain in arm is 90% reduced. Fatigue was moderate 1-3 days after injection but still persists and is currently mild.
44 2021-03-26 injection site pain Site: Pain at Injection Site-Medium, Error: Wrong Dose of Vaccine - Too High
44 2021-03-26 rash chest warmth, rash
44 2021-03-27 injection site pain Injection site pain tiredness headache muscle pain chills joint pain nausea feeling unwell
44 2021-03-28 skin burning sensation 3/25/2021-pt states that about 10-15 minutes after taking the covid vax her throat was tight and she... Read more
3/25/2021-pt states that about 10-15 minutes after taking the covid vax her throat was tight and she was wasn't feeling right. About an one hour and ten minutes she went into anaphylaxis shock. Paramedics were called. Pt had a seizure while in transport to the Hospital ER. She was given an EKG in ambulance w/ abnormal results that showed tachycardia and abnormal ECG. Vent rate was 48 beats faster per minute, no spectral infarct detected. When came to she was having seizure like muscle spasms all her entire body. In the ER she was given meds and monitored for 4 hours before being released to home. 3/26/2021- Next day her skin, her eyes, and the inside of her body felt like it was boiling. She went back to the same ER. She was given another EKG which show possible left atrial enlargement and spectral infarct age undetermined - Abnormal ECG when compared to the ECG on 3/25/201. She blood work and Chest Ray. She was given more meds and told to FU w/ PCP. Her appt w/ PCP is on 3/29/21 and will be determined if she needs to see Cardiologist.
44 2021-03-28 rash Within the first hour after receiving the vaccine, I experienced a flushing warm sensation in my ski... Read more
Within the first hour after receiving the vaccine, I experienced a flushing warm sensation in my skin on my face and neck area. About 2-3 hours after receiving the vaccine, I broke out in a skin rash on my face, neck, and upper body. About 2 days later, the rash began to diminish. Now (6 days later) it has continued to recede (although it is still somewhat visible).
44 2021-04-01 rash Purplish red spots on bottom of feet, lasted >day; headaches, fatigue, confusion, numbness in hands/... Read more
Purplish red spots on bottom of feet, lasted >day; headaches, fatigue, confusion, numbness in hands/ arms and feet. All but spots continue today. Nausea for 3 days, 3/29-3/31. Diminished sense of smell and taste, still.
44 2021-04-06 vaccination site warmth, hives 3-4 hot welts on left arm near injection; 3-4 hot welts on left arm near injection; This is a sponta... Read more
3-4 hot welts on left arm near injection; 3-4 hot welts on left arm near injection; This is a spontaneous report from a contactable consumer (patient). A 44-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 20Mar2021 09:15 (Batch/Lot Number: Ep7534) as SINGLE DOSE for covid-19 immunisation.The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received bnt162b2 (BNT162B2) dose 1 via an unspecified route of administration, administered in Arm Left on 27Feb2021 10:30 AM (Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination The patient experienced 3-4 hot welts on left arm near injection on 22Mar2021 at 08:00 AM. No treatment was received for the events. The events were assessed as non-serious by the reporter. Outcome of the events were not recovered.
44 2021-04-08 itchy rash, rash, injection site pruritus, injection site rash Itching and "rash" in the arm area of the vaccination, but then spread to other parts of the body
44 2021-04-17 itchy skin Itching all over, coughing, asthma, anaphylaxis; Itching all over, coughing, asthma, anaphylaxis; It... Read more
Itching all over, coughing, asthma, anaphylaxis; Itching all over, coughing, asthma, anaphylaxis; Itching all over, coughing, asthma, anaphylaxis; Itching all over, coughing, asthma, anaphylaxis; This is a spontaneous report from a contactable consumer (reporting for herself). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 20Mar2021 (Batch/Lot Number: Ep-7534) as single dose for COVID-19 immunization. Medical history included seasonal allergy, asthma, and known allergies: penicillin. Concomitant medication included fexofenadine hydrochloride (ALLEGRA); montelukast sodium (SINGULAIR); amlodipine. all taken for an unspecified indication, start and stop date were not reported. The patient previously took grastek for immunomodulatory therapy and experienced drug allergy; bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En-6198) on 27Feb2021 for COVID-19 immunization. On unspecified date the patient experienced itching all over, coughing, asthma, anaphylaxis. The patient received 2 doses of epinephrine, 100 ml benedryl, and h1h2 bloc. The outcome of the events was recovering. The patient was not tested post vaccination and did not has COVID prior to vaccination.
44 2021-04-20 itchy skin, hives Immediate left side (injection side) headache.; Intense headache, neck, facial and cranial pain; Int... Read more
Immediate left side (injection side) headache.; Intense headache, neck, facial and cranial pain; Intense headache, neck, facial and cranial pain; Extreme vertigo within 1 hour; loose stool; Nausea; vomiting; Swollen; itchy hives; itchy hives; Swollen left eye; This is a spontaneous report from a contactable HCP and a consumer (the patient). A 44-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Apr2021 11:30 (Batch/Lot Number: EW0150) as single dose for covid-19 immunisation . Medical history included migraine, demyelination , post-traumatic stress disorder. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced immediate left side (injection side) headache. on 03Apr2021 11:45 with outcome of not recovered , intense headache, neck, facial and cranial pain on 03Apr2021 11:45 with outcome of not recovered , extreme vertigo within 1 hour on 03Apr2021 11:45 with outcome of not recovered , loose stool on 03Apr2021 11:45 with outcome of not recovered , nausea on 03Apr2021 11:45 with outcome of not recovered , vomiting on 03Apr2021 11:45 with outcome of not recovered , swollen on 03Apr2021 11:45 with outcome of not recovered , itchy hives on 03Apr2021 11:45 with outcome of not recovered , swollen left eye on 03Apr2021 11:45 with outcome of not recovered. All the reported events were considered Important Medical Events. Course of the event: Immediate left side (injection side) headache. Spread to entire head within 30 minutes. Intense headache, neck, facial and cranial pain persists at hour 53. Extreme vertigo within 1 hour, persisting now at hour 53. Nausea, vomiting and loose stool within 6 hours. Vomiting ceased at 48 hours post 1st shot vaccination. Nausea and diarrhea persists at hour 53. Swollen, itchy hives, injection side within 40 hours, spread to neck and face. Swollen left eye, within 24 hours, waning at hour 53. No follow-up attempts are needed. No further information is expected.
44 2021-04-24 vaccination site pain PMS symptoms; nipples became very hard and sore.; swollen breast tissue; Menses late and hasn't star... Read more
PMS symptoms; nipples became very hard and sore.; swollen breast tissue; Menses late and hasn't started; symmetrical lumps on the distal sides of my breasts; faint; slight injection site soreness; intense tingly whole body sensations; Sense of pressure and tingling on eyeballs; Increased sensitivity to touch; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 30Mar2021 16:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Mild/moderate TBI in Oct1999 with herniated disk in lower lumbar region from auto accident (patient was a pedestrian and a car ran into her); fractured tibia/fibula from occurrence; low blood pressure which she had occasionally fainted from at blood draws (started after being active athletically during recovery from 1999 injury). Patient was not pregnant. There were no concomitant medications (no vaccine in 4 weeks and no other medication in two weeks). Patient did faint 15 minutes after receiving Pfizer Covid vaccine on 30Mar2021. Medical people at vaccination site made a vasovagal note on record. Patient reported that there were no body aches or fatigue or fever, only slight injection site soreness for a couple of days which was hard to notice through intense tingly whole body sensations that started after receiving vaccine on 30Mar2021 16:15. Still continuing to feel a week and a half later. It was very uncomfortable but not painful. Patient also experienced sense of pressure and tingling on eyeballs and increased sensitivity to touch. Menses were due one week after vaccination but 4.5 days after vaccination on 03Apr2021, nipples became very hard and sore. After a few days on nipples slightly sore still but mostly swollen breast tissue with soreness on Apr2021. Patient had not had this as PMS symptom since becoming pregnant almost 9 years ago and it never lasted 7.5 days with it still ongoing as of time of report. Her menses was late on Apr2021 and hasn't started but she was not pregnant. Patient's usual PMS symptoms have kind of started yesterday on 09Apr2021. It quickly formed bilaterally symmetrical lumps on the distal sides of her breasts which was also unusual on Apr2021. No treatment was received and events results in doctor's clinic visit. Outcome of the events was not recovered. Patient was not diagnosed with covid prior to vaccination and had not been tested post vaccination. Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event syncope and the suspect suspect vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
44 2021-04-26 vaccination site itchiness, vaccination site redness, vaccination site swelling larger red and swollen itching injection spot; patient had larger red and swollen itching injection ... Read more
larger red and swollen itching injection spot; patient had larger red and swollen itching injection spot; patient had larger red and swollen itching injection spot; tired; sore arm; nausea tired; Earache; headache; This is a spontaneous report from a contactable consumer (Patient) reported for himself. A 44-years-old female (Non-Pregnant) patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6203, Expiration date: unknown), via an unspecified route of administration in left arm on 24Feb2021 at 11:30 AM (at age of 44years) at single dose for COVID-19 immunization. Patient medical history included which was acid reflux. Patient had Known allergies to gluten, food sensitivity to dairy and tomatoes. Patient concomitant medications included esomeprazole (20mg) two times in daily, vitamin B12 (5000mcg). Patient did not receive any vaccine in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 24Feb2021 at 12:00 the patient experienced headache, nausea, earache and on 25Feb2021 second day patient had sore arm headache and tired, on 26Feb2021 (day 3) the patient had red, swollen, and itching at vaccination site also, tired, nausea. and on 27Feb2021 (day 4) the patient had larger red and swollen itching at vaccination spot nausea tired. Patient didn't take treatment for the events. The outcome of the events was recovering. No follow up attempts are possible. No further information is expected.
44 2021-05-04 hair loss Migraine; extreme body aches; shaking chills; nausea; lower abdominal cramps; fever as high as 102; ... Read more
Migraine; extreme body aches; shaking chills; nausea; lower abdominal cramps; fever as high as 102; General malaise; when washing my hair much more than usual has come out since receiving vaccine; This is a spontaneous report from a contactable other HCP (Patient). A 44-year-old female patient received second dose of BNT162B2 (Pfizer Covid-19 Vaccine, Solution for injection, Lot# EN5318), via an unspecified route of administration, administered in left arm on 08Feb2021 at 15:00 (at the age of 44-years) as single dose, dose 1 administered in left arm on 18Jan2021 at 02:45 (Lot# EL3246) as single dose for COVID-19 immunisation. Medical history included Lyme disease from 2017, treated with doxycycline. Patient had no known allergies. The patient concomitant medications were not reported. On 09Feb2021 at 03.00 (one day after vaccination), patient experienced migraine, extreme body aches, shaking chills, nausea, lower abdominal cramps, and fever as high as 102 lasting about 48hrs. Then lessening of symptoms over the next 12hrs and normal temp achieved by 60hrs, general malaise and when she was washing her hair much more than usual has come out since receiving vaccine. The patient underwent lab tests which included body temperature as 102 on 09Feb2021, and SARS-CoV-2 test, Nasal Swab: Negative on 09Feb2021 and pending on 12Feb2021. The patient did not receive any vaccine in four weeks nor received other medications in two weeks prior vaccination. The outcome of the events was recovering.
44 2021-05-04 rash Patient developed adverse reaction like fever, flu like symptoms and rashes on the first day post va... Read more
Patient developed adverse reaction like fever, flu like symptoms and rashes on the first day post vaccine second dose (05/01/2021) and then she went to ER morning of 05/04/2021 at about 1 am due to chest pain and SOB
44 2021-05-04 hives, rash Rash and hives on face; Rash and hives on face; throat itchiness; swollen face around eyes; This is ... Read more
Rash and hives on face; Rash and hives on face; throat itchiness; swollen face around eyes; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old non pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number EL9262, expiry date: unknown) via an unspecified route of administration in left arm on 15Feb2021 at 09:15 (at the age of 44-year-old) as a single dose for Covid-19 immunization in Hospital. The patient had known allergies: sulfa, penicillin, latex. The patient did not had any other medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications (in two weeks) included melatonin, magnesium, cetirizine hydrochloride (ZYRTEC), and azelastine hydrochloride, fluticasone propionate (DYMISTA). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number EL9262, expiry date: unknown) via an unspecified route of administration in left arm on 25Jan2021 at 08:15 as a single dose for Covid-19 immunization. On 20Feb2021 at 7:30, the patient experienced rash and hives on face, throat itchiness, and swollen face around eyes. Patient received treatment with Oratidine, Benadryl, and Prednisone for the events. The outcome of the events of rash and hives on face, throat itchiness, and swollen face around eyes was recovering. No follow-up attempts are possible. No further information is expected.
44 2021-05-07 rash macular, itchy skin almost passed out; Dizzy; heart started racing; Dry mouth; metal taste; hard to swallow; itchy on ar... Read more
almost passed out; Dizzy; heart started racing; Dry mouth; metal taste; hard to swallow; itchy on arm it is little bit blotchy; itchy on arm it is little bit blotchy; Migraine; This is a spontaneous report from a contactable consumer. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180), dose 1 via an unspecified route of administration, administered in left arm on 05Apr2021 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient had unspecified concomitant medications; unspecified allergy medicine and unspecified vitamins. On 05Apr2021, the patient experienced the following events: almost passed out, dizzy, heart started racing, dry mouth, metal taste, hard to swallow, itchy on arm it is little bit blotchy, migraine. Details were as follows: patient had a reaction after the vaccination. She got really dizzy, almost passed out. Then her heart started racing. It took about 10 minutes to go normal and then she got like a super dry mouth and a metal taste after that, elaborated as like she had penny or something in her mouth like metal. After that, it was little more hard to swallow and just started to get itchy on arm, it is little bit blotchy. Therapeutic measures were taken as a result of migraine, and included treatment with sumatriptan (MANUFACTURER UNKNOWN), at 100 mg ( take half every time). The outcome of events, almost passed out, dizzy, heart started racing, dry mouth, metal taste, hard to swallow, itchy on arm it is little bit blotchy, migraine was unknown.
44 2021-05-11 redness, hives, itchy skin blisters in her mouth; exhausted and winded; exhausted and winded; Metallic taste, hives on face and... Read more
blisters in her mouth; exhausted and winded; exhausted and winded; Metallic taste, hives on face and neck, shortness of breath walking; Metallic taste, hives on face and neck, shortness of breath walking; Metallic taste, hives on face and neck, shortness of breath walking; cold sore; super red and itchy; super red and itchy; tongue started to get itchy; the lymph nodes in her neck were really swollen; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0153, first dose, expiration date 31Jul2021) solution for injection intramuscular in the left arm on 16Apr2021 at 15:45 (at the age of 44-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included acid reflux, latex (allergy), sulfa based medicine (allergy), and pineapple (allergy). Concomitant medications included ongoing lansoprazole (PREVACID) for acid reflux, ongoing montelukast sodium (SINGULAIR) for seasonal allergy, ongoing fluticasone propionate (FLONASE) for seasonal allergy. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 16Apr2021, the patient experienced metallic taste (5 seconds after vaccination), hives on face and neck (45 minutes after), shortness of breath walking resulting on doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care which included treatment with steroid shot and BENADRYL shot. On 17Apr2021, the patient experienced exhausted and winded. In Apr2021, the patient experienced cold sore, was super red and itchy, tongue started to get itchy, the lymph nodes in her neck were really swollen that included unspecified treatment. On 24Apr2021, the patient experienced blisters in her mouth and used hydrogen peroxide 3% to clean. The outcome of the events metallic taste, hives on face and neck, shortness of breath walking was recovering. The outcome of the events cold sore, super red and itchy, exhausted and winded, tongue started to get itchy, the lymph nodes in her neck were really swollen was unknown. The outcome of the event blisters in her mouth was not recovered. Since the vaccination, the patient has not been tested for COVID-19. Information on Lot/Batch number was available. Additional information has been requested.
44 2021-05-11 hives blisters inside and outside the mouth; hives; metallic taste; This is a spontaneous report received ... Read more
blisters inside and outside the mouth; hives; metallic taste; This is a spontaneous report received from a contactable consumer, the patient. A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as a single dose (at the age of 44 years-old) for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced blisters inside and outside the mouth, hives, metallic taste all on an unspecified dates. Therapeutic measures were taken as a result of hives and included the patient received a steroid shot. The outcome of the events blisters inside and outside the mouth, hives, and metallic taste was unknown. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
45 2020-12-31 injection site pruritus, injection site bruising, injection site warmth, injection site redness 12/28 Urgent Care HPI - patient is a 45 year old who works for facility. she got a covid vaccine 8 d... Read more
12/28 Urgent Care HPI - patient is a 45 year old who works for facility. she got a covid vaccine 8 days ago. The site on her left deltoid where she got the shot is warm and read. It also itches. No pain into the rest of left arm. no numbness of tingling at site or distally. no trouble breathing or tingling around mouth/throat. 01/01 - EE notes that her arm was very sore and she had a bad headache. As the days went on, it got redder, hotter, and more swollen. On 12/20, she began to feel bad. On 12/28 while at work, she heard that her supervisor was COVID (+). Throughout the day she felt worse and worse. Was seen at urgent care and COVID was negative. Prescribed Cephalxin and predinose 01/01 -- arm is much better today. Today it is still bruised. She thinks it was bruised previously but that the bruise could not be seen under the redness and swelling
45 2020-12-31 redness Anaphylaxis, allergic reaction: Throat swelling, facial and ear numbness on left side. Ear redness a... Read more
Anaphylaxis, allergic reaction: Throat swelling, facial and ear numbness on left side. Ear redness and swelling. Went to ER, treated with IV Benadryl, Epinephrine, Famotidine, Solumedrol, Klorcon M.
45 2021-01-01 redness Less than one hour after receiving COVID-19 vaccine, patient arrived at the ER stating her face felt... Read more
Less than one hour after receiving COVID-19 vaccine, patient arrived at the ER stating her face felt hot, lips tingling/swollen and chest red. Denies any issues with breathing.
45 2021-01-03 itchy skin, redness 2 Red Area-, itching, burning-the size of a golf ball, the other the size of a quarter- Located at t... Read more
2 Red Area-, itching, burning-the size of a golf ball, the other the size of a quarter- Located at the front of my neck I had vaccine on 12/30/20 at 1:30 pm, and woke up on 01/01/21 at 7am with the red areas.
45 2021-01-03 injection site pain Around 6pm I started with a slight headache and by 8pm i had trouble keeping my eyes open. (headach... Read more
Around 6pm I started with a slight headache and by 8pm i had trouble keeping my eyes open. (headache is not uncommon for me but the extreme drowsiness is). I slept solid through the night (unusual) and the puppy woke me around 5am. (ususal) I felt that i had a heavy? head. My thoughts seemed clear but my head had a fullness to it. Its difficult to describe. I was not stuffy. I had trouble staying awake, to the point I was nodding off at times I should have been able to stay awake. I did not feel safe to work and felt obligated to call in. I slept solidly for the next 5 hours. Later in the day, my affected arm began to have pain radiate from the injection site to my wrist. (probably not unusual). 600mg of Ibuprofen did not seem to help much. By the time I went to bed last night (24+ hrs after receiving the vaccine) I noticed my axillary nymph nodes were extremely tender to the touch and remain so this morning. The pain in my arm still continues to radiate to my wrist but not as intense.
45 2021-01-03 itchy skin itching both thighs, mild h/a, sinus pressure
45 2021-01-04 redness, cellulitis Full arm became swollen, red, warm to the touch, mimicking a cellulitis-looking infection. Redness ... Read more
Full arm became swollen, red, warm to the touch, mimicking a cellulitis-looking infection. Redness was spreading to left lateral neck and across upper chest. Took 50mg chewable Benadryl and 600mg motrin. All symptoms subsided approximately an hour later.
45 2021-01-04 redness, skin warm Notice yesterday, a large round red circle about 2 inches across, raised and swollen, hot to the tou... Read more
Notice yesterday, a large round red circle about 2 inches across, raised and swollen, hot to the touch, soreness and tender.
45 2021-01-04 itchy skin, rash itchy flushed skin with a rash; itchy flushed skin with a rash; itchy flushed skin with a rash; This... Read more
itchy flushed skin with a rash; itchy flushed skin with a rash; itchy flushed skin with a rash; This is a spontaneous report from a contactable healthcare professional. A 45-year-old female patient received bnt162b2 (BNT162B2; reported as Pfizer-Bio-Tech COVID-19 Vaccine; lot number: EH9899; expiration date: unknown), intramuscular left arm on 16Dec2020 10:45 (also reported as 10:50 AM) at single dose for Covid-19 vaccination. The patient's medical history and concomitant medications were not reported. It was unknown if the patient has allergies to medications, food, or other products. It was reported that the patient was given vaccine at 10:50 am and 10 minutes after receiving the vaccine individual developed itchy flushed skin with a rash. She was given Benadryl 50 mg IM (intramuscular) in Right arm at 11:00 am. 11:37 am the itchy skin was less intensified, and vitals were stable. The patient went home with her husband. The event was considered as non-serious, was not life-threatening, did not caused/prolonged hospitalization, did not cause congenital anomaly/birth defect and did not resulted to death. The patient received the COVID-19 vaccine in the Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patent had any other medications the patient received within 2 weeks of vaccination. It was unknown if the patient diagnosed with COVID-19 prior to vaccination and if the patient been tested for COVID-19 since the vaccination. The outcome of the event itchy skin was recovering while the outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.
45 2021-01-05 itchy skin ABOUT 1020 25 MINUTES AFTER VACCINE ADMINISTRATION PATIENT FELT ITCHY ALL OVER BODY. PATIENT DESCRI... Read more
ABOUT 1020 25 MINUTES AFTER VACCINE ADMINISTRATION PATIENT FELT ITCHY ALL OVER BODY. PATIENT DESCRIBES ITCHING AS MODERATE. NO RASH NOTED. NO ANGIOEDEMA. PATIENT NO IN RESPIRATORY DISTRESS. 1028 VITALS: BP: 172/93 P: 62 SAO2: 99%. BENADRYL 50MG ORAL GIVEN AT THIS TIME. 1038 VITALS: BP: 155/99 P: 64 SAO2: 99% PATIENT DESCIBES ITCHING AS THE SAME, MODERATE. NO REDNESS AT SITE, NO RASH, NO RESPIRATORY DISTRESS. 1048 VITALS: BP: 164/108 P: 63 SAO2: 99% PATIENT TAKEN TO ER
45 2021-01-05 itchy skin Patient stated she started having symptoms < 5 minutes after receiving the vaccine (while waiting), ... Read more
Patient stated she started having symptoms < 5 minutes after receiving the vaccine (while waiting), she initially had significant headache (which has now resolved), full-body itching, some throat irritation, and lacrimation. Patient also noticed swelling in her bottom lip. Patient states she's only allergic to pineapple, has never reacted to vaccines before, and states she's never had anaphylaxis before this. She does not carry an Epi pen with her regularly." Patient also had chest tightness, sore-throat/neck muscles. Patient was given Epi, benadryl IV, decadron IV, and bolus fluid. She was monitored for 4 hours and discharged once stable.
45 2021-01-05 injection site pain, injection site redness [1] Lightheadedness: started 1 minute after vaccine, lasted 1-2 minutes. Relieved with meditative br... Read more
[1] Lightheadedness: started 1 minute after vaccine, lasted 1-2 minutes. Relieved with meditative breathing; believed it to be anxiety related until seeing CDC produced list of symptoms from vaccine. [2] Mild soreness, mild redness at injection site: started 4 hours after vaccine, lasted 24-36 hours. [3] Felt feverish and flushed, arthralgia: started approximately 18 hours after vaccine (12/31/2020). "Fever" initially managed with Tylenol 650 mg. Later that evening took naproxen 440 mg to address arthralgia, which lasted about 2 days. No medication taken on 1/1/2021.
45 2021-01-06 rash with redness, rash Allergic reaction to vaccine, tingling to upper lip and face, red rash on bilateral forearms, starte... Read more
Allergic reaction to vaccine, tingling to upper lip and face, red rash on bilateral forearms, started approximately 10 minutes after receiving vaccine. Reaction resolved with no treatment. Patient developed Bell?s Palsy 2-3 days after vaccine. Currently being treated with high dose steroids and acyclovir.
45 2021-01-06 hives DIffues hives over chest, abdomen, back, arm
45 2021-01-06 injection site mass Patient called, stating swelling of arm and lymph nodes within 24 hrs of injection and lump at sit... Read more
Patient called, stating swelling of arm and lymph nodes within 24 hrs of injection and lump at site. Applied ice and heat. States it is getting better but if "ball" does not get any better would like to be seen. Agreed with aptient
45 2021-01-06 rash, itchy skin Rash Narrative: Employee received Covid 19 vaccine (Pfizer) at 2:30 pm, developed rash 4:30pm, pres... Read more
Rash Narrative: Employee received Covid 19 vaccine (Pfizer) at 2:30 pm, developed rash 4:30pm, presented to clinic on 12/30/2020 rash still present with some itching. Seen by MD advised Benadryl and to seek medical attention for any increase in symptoms such as SOB.
45 2021-01-06 rash, rash macular SkinRash chills Narrative: macular rash over the trunk anterior chest, abdomen, back and both arms
45 2021-01-06 injection site pain Woke up in night sweats, nausea, severe headache with neck and back pain. right shoulder pain and ti... Read more
Woke up in night sweats, nausea, severe headache with neck and back pain. right shoulder pain and tingling right hand.
45 2021-01-07 rash, injection site redness, injection site warmth, itchy skin, itchy rash 11 hours after vaccination (12 midnight), I noticed a small redness on the injection site. Right aft... Read more
11 hours after vaccination (12 midnight), I noticed a small redness on the injection site. Right after I saw that, I took a shower and minutes after a shower I developed red itchy rash all over my arms and legs. Then my abdomen and back started to itch as well. Immediately I took 50 mg of Benadryl and went to sleep. Itch continued while I was trying to fall asleep. In the morning there was no rash on my body except for a small redness on my injection site. By the way, with the first shot that I had on December 19, 2020, Pfizer Lot # EH9899 in the same facility , I developed red, hot to touch, not raised rash all over my deltoid muscle of the left arm 2 days after the shot was administered and it lasted for 3 days with no change. Benadryl and Allegra did not help with shot # 1.
45 2021-01-07 redness Approximately 3 days later noticed facial swelling at the site of prior facial filler injection - a... Read more
Approximately 3 days later noticed facial swelling at the site of prior facial filler injection - around nasolabial folds and tear trough areas/minimal erythema and tenderness only on palpation; Approximately 3 days later noticed facial swelling at the site of prior facial filler injection - around nasolabial folds and tear trough areas/minimal erythema and tenderness only on palpation; Approximately 3 days later noticed facial swelling at the site of prior facial filler injection - around nasolabial folds and tear trough areas/minimal erythema and tenderness only on palpation; This is a spontaneous report from a contactable physician (patient herself). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration (arm left), on 19Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received facial filler Restylane, which was injected in Sep2019. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within two to four weeks prior to COVID vaccination. On 22Dec2020, approximately 3 days after vaccination, patient noticed facial swelling at the site of prior facial filler injection - around nasolabial folds and tear trough areas. There was minimal erythema and tenderness only on palpation. The events resolved approximately 3-4 days later (unspecified date in Dec2020). The events did not require intervention/treatment. Outcome of the events was recovered. Information on the lot/batch number has been requested.
45 2021-01-07 injection site pain Headache, Myalgia, NauseaVomiting, lethargy; injection site soreness, loss of appetite Narrative: V... Read more
Headache, Myalgia, NauseaVomiting, lethargy; injection site soreness, loss of appetite Narrative: Vaccine 12/17 @6:00 pm. On 12/18/2020 - woke up with a headache and "tight" muscles. Progressively that day she felt lethargic. She also had soreness in her arm at the site of the vaccine. Within 24 hours she developed nausea and lost her appetite. She took alleve and went back to sleep. 12/20 - slept all day. 12/21 - woke up feeling much better with a mild headache. 12/22 felt back to normal.
45 2021-01-07 rash with redness, shingles I got the vaccine on 12/18/20 on my left arm and on 12/28/20, 10 days after I started to have pain o... Read more
I got the vaccine on 12/18/20 on my left arm and on 12/28/20, 10 days after I started to have pain on my upper left arm and the next day the pain went to my armpit, back and forth from my upper left arm to my armpit and this went on for at least 5 days. On 01/02/21, 15 days after I notice red bumps on my upper left arm and as days went on red bumps show in my armpit, left back, and chest. The pain went from sharp to burning. On 01/06/21 I got the 2nd dose of the vaccine and I told the injection person about the red bumps. I told him that they look like hives. He spoke with the medical doctor about it and doctor said it was ok for me to get the 2nd dose of the vaccine. They think it was a delayed reaction. They have me monitored for 30 mins after the 2nd dose of the injection before I leave the site. I still have pain and red bumps so I went to see my primary doctor on 01/07/21. The doctor said that I have shingles. I told him that I never had shingles before and he said maybe the vaccine trigger it. He prescribed me some medications for the shingles. I don?t know if the vaccine trigger the shingles or just coincidence but I want to report this maybe someone might have the same experience. Thank you.
45 2021-01-07 vaccination site pain My arm where I received the shot is now hurting more and I can't lift my arm up out in front of me a... Read more
My arm where I received the shot is now hurting more and I can't lift my arm up out in front of me are straight up in the air.; My arm where I received the shot is now hurting more and I can't lift my arm up out in front of me are straight up in the air.; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685; expiry date: unknown) via an unspecified route of administration (right arm), on 18Dec2020 at 06:15 a.m., at single dose, for COVID-19 immunization. The patient has no relevant medical history. Concomitant medications included vitamins and calcium chews (one a day) and cetirizine hydrochloride (ZYRTEC). The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccine four weeks prior vaccination. The vaccine was administered in the hospital. On 01Jan2021, the arm where patient received the shot was now hurting more. Patient can't lift her arm up out in front of her and straight up in the air. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since vaccination.
45 2021-01-07 rash Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse All COVI... Read more
Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/7/2021   Date: 1/7/2021   Subjective Patient is a 45 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination.   She denied any history of previous adverse reactions to vaccines.   She was given the Pfizer vaccination in the left deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience throat tightness and sinus drainage. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, skin changes, tongue swelling and vomiting. Pt took allegra this am for allergies.   ALLERGY REVIEW OF SYSTEMS: All other systems negative     Previous Reactions: She states with first shot a few hours after her shot she had a rash on her mid back. and and lower extremities. Pt also had a head ache. Symptoms lasted 5 days.     Objective   Vitals Vitals:   01/07/21 1248 01/07/21 1303 01/07/21 1321 01/07/21 1334 BP: (!) 150/87 130/71 137/87 123/73 Pulse: 94 86 75 76 SpO2: 97% 99% 98% 99%         Physical Exam Vitals signs and nursing note reviewed. Constitutional: Appearance: Normal appearance. She is well-developed. HENT: Head: Normocephalic. Jaw: There is normal jaw occlusion. Right Ear: External ear normal. Left Ear: External ear normal. Nose: Nose normal. Mouth/Throat: Mouth: Mucous membranes are moist. Eyes: Pupils: Pupils are equal, round, and reactive to light. Neck: Musculoskeletal: Normal range of motion. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Abdominal: General: Abdomen is flat. Musculoskeletal: Normal range of motion. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Findings: Rash (on chest) present. Rash is macular. Comments: Flushing over the cheeks and bridge of the nose. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Behavior is cooperative. Thought Content: Thought content normal. Judgment: Judgment normal.       Assessment/Plan Treatment included: antihistamines. Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP.Pt told if symptoms worsen or changed she is to be seen in the ER.   Diphenhydramine 25 mg oral given at 12:55pm.   Pt okay to go home with dad driving at 14:22 pm.     Electronically Signed 1/7/2021 2:03 PM      
45 2021-01-07 itchy skin Patient was at work and felt nauseous at around 0800 and took a Zofran. Then around 1030 she started... Read more
Patient was at work and felt nauseous at around 0800 and took a Zofran. Then around 1030 she started to have lower chest (near the lower ribs) pain 9/10 pain and she was diaphoretic. We called 911 as we were concerned about an MI. She was transported via EMS to the hospital. They ran various tests and determined it wasn't cardiac or lung issues and was likely side effects from the COVID vaccine. On 1/8/21, Patient reports that she feels dizzy and is "itching all over." She took antihistamine and that helped the itching symptom.
45 2021-01-07 itchy skin Pfizer-BioNTech COVID-19 Vaccine EUA, Itching that started about 3 minutes
45 2021-01-07 rash Rash present at the top of the neck that appeared 30 minutes after vaccination
45 2021-01-07 redness Redness on face, neck, and arms, Tachycardia, HTN
45 2021-01-07 injection site pain dizziness, congestion, cough, heart rate elevated, fatigue, injection site pain, chest heaviness neg... Read more
dizziness, congestion, cough, heart rate elevated, fatigue, injection site pain, chest heaviness negative Covid test
45 2021-01-07 injection site pain dizziness, congestion, cough, heart rate elevated, fatigue, injection site pain, chest heaviness y n... Read more
dizziness, congestion, cough, heart rate elevated, fatigue, injection site pain, chest heaviness y negative Covid test
45 2021-01-07 vaccination site pain typical flu body aches; also had terrible fatigue. I couldn't do normal activity; my arm was getting... Read more
typical flu body aches; also had terrible fatigue. I couldn't do normal activity; my arm was getting so sore I couldn't lift it; Within a few hrs I lost the ability to move it at all for a few hrs; overwhelmed with fatigue; Every bone hurt and my ribs were so sore I couldn't take deep breaths; Every bone hurt and my ribs were so sore I couldn't take deep breaths; Every bone hurt and my ribs were so sore I couldn't take deep breaths; nauseous; dizzy; No fever but I felt hot & flushed.; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: Ek9231), via an unspecified route of administration on the right arm on 31Dec2020 09:00 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included lupus.The patient also had allergies to penicillin (PCN). It was also mentioned that the patient COVID twice (Mar2020 until 2020&Nov2020 until 2020). Concomitant medications included lisdexamfetamine mesilate (VYVANSE) and bupropion hydrochloride (WELLBUTRIN). It was reported that the patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient reported that she had a very slight reaction after administration & took diphenhydramine (BENADRYL). She described that approximately at the 11-hour mark (31Dec2020 20:00), her arm was getting so sore and she couldn't lift it. Within a few hours, she lost the ability to move it at all. Also, she was getting overwhelmed with fatigue & she had a feeling that can best be described as the feeling of death entering my bones. Every bone hurt and her ribs were so sore she couldn't take deep breaths. The patient would wake up crying in pain & her pain tolerance was very high. She felt nauseous & dizzy and was the worst night of her life. She took acetaminophen (APAP) 1000mg & meloxicam 15mg that night with no relief. She narrated that she had COVID twice (Mar & Nov) & that night that she experienced; she would rather have COVID 1000 more times than ever have this pain she was in. It was also mentioned that she had no fever, but she felt hot & flushed. At the 23hour mark (01Jan2020 20:00), her symptoms became typical flu body aches which was 100% manageable & was a relief after what she had. It was mentioned that she still had terrible fatigue and couldn't do normal activity (in Jan2021). The patient was not sure if she will take the 2nd shot after this. Outcome of the event of fatigue was not recovered; unknown for "couldn't do normal activity" and recovering for the remaining events.
45 2021-01-08 hives Hives 14 days post injections
45 2021-01-08 itchy skin I waited 30 minutes after the vaccine. No issues and went back to work. At 70 minutes after shot adm... Read more
I waited 30 minutes after the vaccine. No issues and went back to work. At 70 minutes after shot administration, felt itchy on limbs, then trunk and neck, then ears, eyes and into scalp. Symptoms progressed over the next 2 hours (flushed neck and then lips felt tingly and numb). At 7:30 my soft palate started to feel numb and I started to have some difficulty swallowing. Went to ER. Symptoms continued. After IV meds given swallowing difficulty continued to worsen so I was given a low dose shot of Epi. Swallowing improved (not to normal but not as severe) over the next hour but itchiness returned. It is now 8:00pm on 1/9/2021 and I continue to have itchiness, my tongue and soft palate are still numb but I am able to swallow fairly well and my entire face has decreased sensation to touch.
45 2021-01-08 rash, skin irritation, redness, itchy skin SkinRash c/o itchiness of the lower back with redness noted on lower back and the forehead (between ... Read more
SkinRash c/o itchiness of the lower back with redness noted on lower back and the forehead (between the eyebrows). Hx. seasonal and alcohol allergies that present with rash Narrative: c/o itchiness of the lower back. redness noted on the lower back and the forehead (between the eyebrows). No sob. states hx/seasonal and alcohol allergies that present with rashes. Benadryl given @ 1650: 156/86, 86, 95%O2sat. @ 1700: 163/89, 81, 97%O2sat; @1720: 163/89, 91, 98% O2sat. 1720 redness diminishing, redness to forehead almost gone. In good spirits and denies sob. D'c'd stable to home with friend to escort. Going home, husband home, per pt.
45 2021-01-08 injection site pain Sore Arm where injection was given, Temp of 100.2, Hiccups for 2 hours on the morning of 01/09/2021 ... Read more
Sore Arm where injection was given, Temp of 100.2, Hiccups for 2 hours on the morning of 01/09/2021 (hiccups are not something that I normally get, if I do I only hiccup 3-4 times on average
45 2021-01-09 injection site rash, injection site pain 18 hours after injection developed maculopapular rash at injection site, muscle pain at sight of inj... Read more
18 hours after injection developed maculopapular rash at injection site, muscle pain at sight of injection and neck. Subsequently developed flu-like symptoms: headache, fever(101F), chills, myalgias, arthaligias, fatigue that continued daily for several weeks.
45 2021-01-09 hives No side effects with dose 1. After dose 2 at about 55 hours post injection, I woke up covered in hiv... Read more
No side effects with dose 1. After dose 2 at about 55 hours post injection, I woke up covered in hives head to toe. I took pictures if you need them.
45 2021-01-09 hives, rash on day of injection approx 13 mins after injection RN was called to her car. She reported throat tig... Read more
on day of injection approx 13 mins after injection RN was called to her car. She reported throat tightness, and dizziness 911 was called and pt was monitored until symptoms improved. Was not transported to ED. 2 days later developed a hive like rash and was seen at walk in clinic was treated with prednisone.
45 2021-01-10 injection site pain, injection site pruritus, injection site redness, injection site swelling HA muscle aches, nausea and dizziness improved. Swelling, pain, itchiness and redness at the injecti... Read more
HA muscle aches, nausea and dizziness improved. Swelling, pain, itchiness and redness at the injection no treatment no improvement.
45 2021-01-10 injection site pruritus, itchy skin, injection site warmth, injection site swelling Itching from shoulder to elbow within a few minutes of vaccine, took Benadryl within the hour. Swel... Read more
Itching from shoulder to elbow within a few minutes of vaccine, took Benadryl within the hour. Swelling and itching continued to get worse. Site was hot. Stared taking Zyrtec twice a day. Within 48 hours site was so swollen visible through clothes, like a plum under the skin and was hot, itching. 99.5 temp Added Pepcid on Sunday, Swelling started going down, better Monday morning.
45 2021-01-10 hives, itchy skin Left nostril stopped up; Sinus pressure in head; Pressure in head; Burning sensation in both arms an... Read more
Left nostril stopped up; Sinus pressure in head; Pressure in head; Burning sensation in both arms and in her left knee/both of her thighs swollen, burning and itching on both knees; Hives on both arms and left knee; both of her thighs swollen, burning and itching on both knees; Burning and itching on both knees; neck feels like someone is sitting on the back of it/Left side neck pressure and throbbing; Left side neck pressure and throbbing; Lower back spasms; This is a spontaneous report received from a contactable consumer. A 45-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, in Dec2020, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the vaccine in Dec2020 (reported as "Thursday"). She began experiencing symptoms on Friday (as reported). Her left nostril stopped up and had sinus pressure in her head. On Saturday and Sunday (as reported), her left nostril was not stopped up but still had pressure in her head. On Monday (as reported), she began to feel burning sensation in both arms and in her left knee. When the patient was de-gowning PPE while at work, she found hives on both arms and left knee. She took BENADRYL and applied cold compress to site. Later Monday (as reported), she woke up to both of her thighs swollen, burning and itching on both knees. Her neck feels like someone is sitting on the back of it. She experienced left side neck pressure and throbbing and lower back spasms. The patient would like to know if these symptoms have been reported and what should she do. The outcome of the event "left nostril stopped up" was recovered on an unspecified date; "sinus pressure in head" and "pressure in head" was not recovered; and the outcome of the remaining events was unknown. Information on lot/batch number for the product has been requested.
45 2021-01-10 injection site pain, injection site redness, injection site warmth Pain, redness and streaking, warmth at injection site, seen in ED and prescribed doxycycline.
45 2021-01-10 itchy skin, redness Patient starting experiencing full body itching and redness at approximately 20 minutes post-vaccina... Read more
Patient starting experiencing full body itching and redness at approximately 20 minutes post-vaccination. Patient reports having taken Benadryl 25 mg PO on her own approximately 1 hr before receiving the vaccine. Another Benadryl 25 mg PO x1 dose adminstered at 9:05am. BP 162/80 HR 64 O2=96% at 09:20am. Lip numbness being reported at 9:20am. Itching subsiding at 9:30am. Patient clinically stable. Patient released from clinic at 9:30am. Patient also reports itching and redness with 1st dose of Pfizer COVID-19 vaccine. Patient also reports having Bell's Palsy after receiving the 1st dose of Pfizer vaccine (with photographic evidence) that was noticed approximately 11 hours after 1st dose of vaccine administration. Patient realized she was having Bell's Palsy after she began noticing having slurred speech and facial drop. Took muscle relaxant (Robaxin) and prednisone (5 days) prescribed by her physician. Bell's Palsy resolved in approximately 6 hours.
45 2021-01-10 injection site swelling, injection site pain Pfizer-BioNTech COVID-19 Vaccine EUA Onset of chills x 7 hours, significant injection site pain 8/10... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Onset of chills x 7 hours, significant injection site pain 8/10, injection site swelling
45 2021-01-10 redness Redness, warmth and swelling 2 days post injection. Seen in ED and prescribed doxycycline and improv... Read more
Redness, warmth and swelling 2 days post injection. Seen in ED and prescribed doxycycline and improving.
45 2021-01-10 redness Severe diaphoresis following the immunization. Occurred in waves, about 5 times throughout the day a... Read more
Severe diaphoresis following the immunization. Occurred in waves, about 5 times throughout the day at work. Face turned red, needed to change her clothes the sweating was so bad.
45 2021-01-10 hives Swollen lips and face hives on face
45 2021-01-10 skin peeling Woke up at 7am at 8:15am both of my eyes swelled almost shut instantly. Both were swollen above my ... Read more
Woke up at 7am at 8:15am both of my eyes swelled almost shut instantly. Both were swollen above my eyebrow. Whites of eyes were still white. They didn't itch or hurt. Went to Urgent care and they recommended cold compresses, Loratadine, Vaseline. About 6 hours later the swelling went down, but not completely. Woke up Sunday morning and my eyelids were dry and scaly.
45 2021-01-10 injection site redness, injection site pain redness, pain on arm resolved
45 2021-01-11 itchy skin, rash macular, redness A few hours after the vaccine I got hot. About 2 hours later I got really cold. At night when I was ... Read more
A few hours after the vaccine I got hot. About 2 hours later I got really cold. At night when I was sleeping I had very vivid dreams. I was cold all night. When I woke up my arm was sore to touch , to move and both ankles hurt to walk and I started itching on my face. Started Saturday in the evening( chin, nose) Eyelid and underneath was red and I also had a headache. I had blotches on my cheek. Next day I woke up and no change but I was extremely fatigued.. Monday 10am it started going away. By evening majority of pain was gone. About 98% recovered. I still have some itching and chills.
45 2021-01-11 rash macular Face,neck and arms had blotches all over them and lips were swollen. Injection was at 1:15pm after ... Read more
Face,neck and arms had blotches all over them and lips were swollen. Injection was at 1:15pm after I had waited my 15 minutes I left and it happened in the car and notified the person that gave me the injection and was told to go to Emergency Room. Was told by Emergency Room that I should not have had the injection being allergic to bee stings. Was given IV with Steroid. Discharge papers said Allergic reaction to drug.
45 2021-01-11 redness Got very hot and clammy but at the same time had the goosebumps; Got very hot and clammy but at the ... Read more
Got very hot and clammy but at the same time had the goosebumps; Got very hot and clammy but at the same time had the goosebumps; Got very hot and clammy but at the same time had the goosebumps; My whole body was as if I was sun burnt; My heart started to race; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2, (Pfizer COVID Vaccine, lot number: EK9231, expiry date: Apr2021) intramuscular on an unspecified date at single dose on right arm for COVID-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing. Concomitant medication included nortriptyline for migraine, botulinum toxin type a (BOTOX) for migraine and birth control medication. The patient stated that, "I was wondering if this was a reaction to the vaccination I had today. So I ended up 3 hours after I received the vaccine, I got very hot and clammy but at the same time had the goosebumps and then my whole body was as if I was sun burnt and my heart started to race. And then my whole body was red as if I had a sunburn. Actually I went to the ER today and they just did lab work because of the way I was feeling. All they gave me in the emergency room is IV fluids." Therapeutic measures taken as a result of the events included IV fluids. The outcome of the events was unknown.
45 2021-01-11 vaccination site pain, vaccination site swelling, vaccination site itchiness Had problems with arm mobility and soreness to the touch in the arm; Had problems with arm mobility ... Read more
Had problems with arm mobility and soreness to the touch in the arm; Had problems with arm mobility and soreness to the touch in the arm; Eyes were really heavy; Headache; Chills; Muscle pain; Injection pain; Injection site swelling; Injection site itchiness; Sensation on my face like when eating spicy food. It is a tingling sensation; Tiredness; This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 31Dec2020 (15:20) at a single dose on the left arm for COVID-19 immunization. Medical history included ongoing rosacea. There were no concomitant medications. On 31Dec2020, the patient had injection pain; injection site swelling; injection site itchiness; had sensation on the face like when eating spicy food further clarified as a tingling sensation; had tiredness. On 03Jan2021, the patient had chills and muscle pain. On 05Jan2021, the patient had headache, and eyes were really heavy. On an unspecified date, the patient had problems with arm mobility and soreness to the touch in the arm. The patient had received treatment for all the reported events. The outcome of the events was recovered on 31Dec2020 for 'injection pain', 'tiredness'; was recovered on an unspecified date for 'injection site swelling' and 'injection site itchiness', 'problems with arm mobility and soreness to the touch in the arm' and 'problems with arm mobility and soreness to the touch in the arm'; was recovered on 03Jan2021 for 'chills' and 'muscle pain'; was not recovered for 'headache'; and was unknown for 'sensation on the face like when eating spicy food further clarified as a tingling sensation'.
45 2021-01-11 itchy skin, rash, redness, injection site pain Right after shot my eyes were feeling dry and my head was slowly hurting (headache). In the afterno... Read more
Right after shot my eyes were feeling dry and my head was slowly hurting (headache). In the afternoon around 4 or 5 got really hot and then in the evening around 9 got really cold and face started to itch. chin was bumpy and face was itching, eyes were still hurting with slight headache. I did have vivid dreams at night and slept not well. in the am my face was itchy red eyelids and under eye, patch like rash on face and itch . Ankles hurt to walk (joints hurt) and arm site was painful and hurt. was cold on and off during day and monday it was hard to wake up, v ery drosy and exhausted. Later that day the face cleared up and i could walk fine and headache was gone . I did feel a little cold monday night. Tuesday everything gone except a slight itch here and there on my face. I feel fine and arm pain is gone as well.
45 2021-01-12 redness, skin warm 12/22/2021-tingling in left arm/fingers, shoulder pain 12/23-12/25/2021-burning pain between elbow a... Read more
12/22/2021-tingling in left arm/fingers, shoulder pain 12/23-12/25/2021-burning pain between elbow and shoulder intermittently 12/26/2021-vomiting and constant severe burning pain in left arm. Applied ice pack 12/27/2021-went to ER for the constant severe pain. Given prescriptions for prednisone 60mg orally x two days and norco. Later that night left arm between elbow and shoulder was bright red and hot to the touch. Took Benadryl liquid and the redness/heat went away in 4 hours. Shoulder, tricep, and bicep have continued to hurt with tingling in fingers. Have seen primary care physician at clinic and Dr. with another facility. Have orders for an MRI and follow up with the other facility
45 2021-01-12 injection site swelling, injection site redness, injection site pruritus Chills, joint pain, redness/swelling/itching at injection site
45 2021-01-12 blister, hardening, redness HOT, HARD RED AREA, BLISTERING, PAINFUL
45 2021-01-12 hives, rash Hives covering most of body; began 2-3 hours after injection; bloody diarrhea.
45 2021-01-12 injection site warmth, injection site hardening, injection site redness Left arm at injection site is red (size of an apple), hard and warm. My provider drew a circle arou... Read more
Left arm at injection site is red (size of an apple), hard and warm. My provider drew a circle around the redness to see if it gets bigger 01/13/21
45 2021-01-12 rash Patient developed a rash from the neck up.
45 2021-01-12 itchy skin Pt received vaccine on left deltoid at 8:56am. Checked on pt at 9:05 pt stated she had itchiness on ... Read more
Pt received vaccine on left deltoid at 8:56am. Checked on pt at 9:05 pt stated she had itchiness on her back, heart palpitations and right handed numbness, and felt flushed. Provider made aware at 09:05. Vitals taken at 9:15 temp 98.8, heart rate 83, blood pressure 150/91, and oxygen saturation 96% on room air, at 9:26 BP 151/88, heart rate 73, and oxygen saturation 99% on room air, blood pressure rechecked at 9:32 and was 151/88. Vitals rechecked at 09:56 BP 164/89, heart rate 72, oxygen saturation 100% on room air, temperature 97.7, vitals checked again at 10:00 BP 158/95, heart rate 75, oxygen saturation 100% on room air, and temp 97.7. Heart palpitations resolved. Provider prescribed Diphenhydramine 25mg x2capsules to be taken at home. Provider referred patient to urgent care and follow up with PCP.
45 2021-01-12 itchy skin Pt received vaccine on left deltoid at 8:56am. Checked on pt at 9:05 pt stated she had itchiness on ... Read more
Pt received vaccine on left deltoid at 8:56am. Checked on pt at 9:05 pt stated she had itchiness on her back, heart palpitations and right handed numbness, and felt flushed. Provider notified at9:05. Vitals taken at 9:15 temp 98.8, heart rate 83, blood pressure 150/91, and oxygen saturation 96% on room air, at 9:26 bp 151/88, heart rate 73, and oxygen saturation 99% on room air, blood pressure rechecked at 9:32 and was 151/88. Vitals rechecked at 9:56am temp 97.7, BP 164/89, HR 72, oxygen sat 100% on room air. Vitals at 10:00am BP 158/95, HR 75, oxygen sat 100% on room air, temp 97.7. Provider prescribed Diphenhydramine 25mg x2 capsules to be taken at home, and referred patient to urgent care and follow up with primary care provider.
45 2021-01-12 blister, rash Rash all over body with swelling and blisters
45 2021-01-12 injection site pain, injection site redness, injection site swelling, injection site pruritus Swelling, redness, itching and burning radiating out from injection site starting two days after, in... Read more
Swelling, redness, itching and burning radiating out from injection site starting two days after, increasing in severity over time, got to the size of an orange, went to urgent care, treated with steroids and antihistamines. All localized, no other symptoms. Medication started 1/13/2021 but the initial antihistamine helped with discomfort.
45 2021-01-12 injection site rash Systemic: Rash (other than injection site)-Mild
45 2021-01-12 injection site nodule, redness The day after the injection I had a itchy red knot appear at the injection site. Starting 27 hours a... Read more
The day after the injection I had a itchy red knot appear at the injection site. Starting 27 hours after injection I had chills, anxiety, slight shortness of breath, headaches, body aches. Today I have had nausea that comes and goes, the red knot is still present on my right arm and the redness has increased a small amount from the marking placed last night. The injection is not in my deltoid muscle or even close and I am wondering if that is at the least what created the redness and the knot.
45 2021-01-13 rash with redness, rash Allergic reaction to vaccine; tingling to upper lip and face; tingling to upper lip and face; red ra... Read more
Allergic reaction to vaccine; tingling to upper lip and face; tingling to upper lip and face; red rash on bilateral forearms; Patient developed Bell's Palsy 2-3 days later; This is a spontaneous report from a contactable consumer. A 45-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284), via an unspecified route of administration on 23Dec2020 at 14:30 at single dose in left arm for covid-19 immunization. Medical history included mitral valve prolapse from an unknown date, and allergies: Cephalosporins and nut (peanut derived). Concomitant medication included epinephrine (EPIPEN) 0.3MG/0.3ML, fluticasone propionate 50MCG/ACT nasal spray. On 23Dec2020 at 14:45, the patient experienced allergic reaction to vaccine, tingling to upper lip and face, red rash on bilateral forearms. Reactions resolved with no treatment. The patient developed Bell's Palsy 2-3 days later in Dec2020. Currently being treated with high dose steroids and acyclovir. All events required emergency room visit and physician office visit. All events were reported as non-serious by reporter. The outcome of event Bell's Palsy was not resolved, outcome of other events was resolved on an unspecified date. The patient was not diagnosed with COVID-19 prior to vaccination, and it was unknown if the patient has been tested for COVID-19 since the vaccination.
45 2021-01-13 rash Associate reported to Employee Health on 01/13/2021 that she experienced a rash on her arms and legs... Read more
Associate reported to Employee Health on 01/13/2021 that she experienced a rash on her arms and legs on 01/08/2021. Patient reported that the rash was present after her first vaccination on 12/18/2020, but she did not report her reaction to Employee Health. After her second dose of COVID19 vaccine the rash re-appeared and spread from her legs to her arms. Employee Health encouraged her to follow up with her medical provider. Rash was still present as of 01-13-21.
45 2021-01-13 rash, itchy rash Bumpy itchy rash the began with a few bumps on right thigh 4 days ago and has progressed to bumpy it... Read more
Bumpy itchy rash the began with a few bumps on right thigh 4 days ago and has progressed to bumpy itchy rash covering entire leg hip to ankle bilaterally
45 2021-01-13 injection site swelling, injection site pain FIVE DAYS OF SYMPTOMS, PAIN INJECTION SITE, TIRED, MUSCULAR PAIN, CHILLS, JOINT PAIN, SWELLING INJEC... Read more
FIVE DAYS OF SYMPTOMS, PAIN INJECTION SITE, TIRED, MUSCULAR PAIN, CHILLS, JOINT PAIN, SWELLING INJECTION SITE, FEELING BAD.
45 2021-01-13 hives Hives occured 15 mins after vaccination Patient took diphenhydramine 25 mg
45 2021-01-13 itchy skin Itching; This is a spontaneous report from a contactable pharmacist. A 45-year-old female patient re... Read more
Itching; This is a spontaneous report from a contactable pharmacist. A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EK9231, intramuscularly in the right arm on 08Jan2021 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included allergies to peanuts and shellfish, COVID-19 on an unspecified date (reported as a COVID-19 diagnosis prior to vaccination). The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 08Jan2021 (reported as 3 minutes after receiving the vaccine), the patient experienced itching. The patient was treated with diphenhydramine (BENADRYL) 50 mg for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of "itching" was not resolved.
45 2021-01-13 injection site pruritus, injection site pruritus Recieved the vaccine at 4:30pm; at 4:40, injection site became very itchy; Associate was advised to ... Read more
Recieved the vaccine at 4:30pm; at 4:40, injection site became very itchy; Associate was advised to take Benedryl p.o.; discharged home. No signs of visible distress following administration and prior to discharge
45 2021-01-13 skin burning sensation shortness of breath, cough, sore throat, chest pain, myalgia, arm soreness, sweats, hot flashes, nau... Read more
shortness of breath, cough, sore throat, chest pain, myalgia, arm soreness, sweats, hot flashes, nausea, skin burning sensation, facial swelling
45 2021-01-14 injection site swelling, injection site pain Approx 10-12 hours after dose: injection site pain, swelling, headache, fever (temp max 99.5)
45 2021-01-14 redness, itchy skin, rash, rash papular Erythema, raise, pruritic, rash on upper thigh, and arms. Presented to urgent care for steroid admi... Read more
Erythema, raise, pruritic, rash on upper thigh, and arms. Presented to urgent care for steroid administration.
45 2021-01-14 vaccination site pain Headache, pain at injection site, nasal congestion, nasal pain.; Headache, pain at injection site, n... Read more
Headache, pain at injection site, nasal congestion, nasal pain.; Headache, pain at injection site, nasal congestion, nasal pain.; Headache, pain at injection site, nasal congestion, nasal pain.; Headache, pain at injection site, nasal congestion, nasal pain.; This is a spontaneous report from a contactable other health care professional. A 45-year-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose (lot number: EH9899); via an unspecified route of administration on 17Dec2020 14:00 at single dose at arm left; second dose (lot number: EK9231) via an unspecified route of administration on 08Jan2021 00:45 at SINGLE DOSE for COVID-19 immunization. Medical history included asthma, chronic back pain, Allergies to medications, food, or other products: Avocado. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), celecoxib (CELEBREX), pregabalin (LYRICA), triamcinolone acetonide (NASACORT), omeprazole. On 08Jan2021 09:00, the patient experienced Headache, pain at injection site, nasal congestion, nasal pain. The events were assessed as non-serious. There was no treatment received for the events. The outcome of the events was recovering.
45 2021-01-14 vaccination site pain Increase bowel movements; fever; body ache; injection site pain; intermittent moderate headache; fat... Read more
Increase bowel movements; fever; body ache; injection site pain; intermittent moderate headache; fatigue; weakness; feeling unwell; This is a spontaneous report from a contactable other HCP (patient). A 45-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 15:00 at single dose on arm left for covid-19 immunisation. Medical history reported as none. Pregnant at the time of vaccination: No. Unknown if COVID prior vaccination. No other vaccine in four weeks. The patient's concomitant medications were not reported. The patient experienced Increase bowel movements, fever, body ache, injection site pain, intermittent moderate headache, extreme fatigue, mild weakness, feeling unwell, all reported from 01Jan2021 07:00 PM (pending clarification). Treatment received for all the events included OTC ibuprofen. Outcome of events was recovering. No COVID tested post vaccination. Information on the lot/batch number has been requested.
45 2021-01-14 rash, injection site pain Nausea, diarrhea, dizziness, rash on hand, muscle soreness in arms, arm pain at site of administrati... Read more
Nausea, diarrhea, dizziness, rash on hand, muscle soreness in arms, arm pain at site of administration, and blurry vision. Still having blurry vision and diarrhea after 3 days
45 2021-01-14 redness Numbness & tingling of left arm. Loss of sensation to arm and fingertips. Redness to left palm and f... Read more
Numbness & tingling of left arm. Loss of sensation to arm and fingertips. Redness to left palm and fingertips.
45 2021-01-14 vaccination site pain Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after inject... Read more
Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection; Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection; Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection; Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection; This is a spontaneous report form a contactable physician. A 45-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number: EL0142, expiry date: not reported) intramuscular, on 07Jan2021 07:30 AM on Arm Left at a single dose for COVID-19 immunization. COVID-19 vaccine was administered at a hospital. Medical history was not reported. It was unknown if patient was pregnant at the time of vaccination. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. On 08Jan2021 07:30 AM, the patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection. Treatment was not received for the adverse events. Outcome of the events was unknown.
45 2021-01-14 rash papular, itchy rash Severe pruritic papular rash
45 2021-01-15 injection site pain Bounding heart rate in 150's dizziness confusion/ hallucinations chills body aches fatigue injection... Read more
Bounding heart rate in 150's dizziness confusion/ hallucinations chills body aches fatigue injection site pain
45 2021-01-16 injection site swelling 2hr post shot - left arm pain, severe headache- lay flat was moderate- sit up felt like my head woul... Read more
2hr post shot - left arm pain, severe headache- lay flat was moderate- sit up felt like my head would explode- severe left eye pain like my eyeball was going to Pop out 4 hrs post shot- chills no fever temp 97.1 fatigue- took a nap. 12 hrs post shot - severe headache, moderate arm pain and mild swelling at site. SEVERE joint pained tiny joints in ties feet, finger, wrists, neck jaw. Knees were the worst. 16 hours later the joint pain is unbearable . Muscle aching and headache continues at the same time as joint pain. 24 hours post Injection. Chills,moderate painful stomach aching from the inside. Nausea. No vomiting, no energy. Could not work, had to leave. 29 hours post shot- now all symptoms at the same time chills, headache, severe joint pain, stomach pain, nausea, felt like I couldn?t drive home or walk to my car. Got home. Called dr. Went to bed. Slept 14 hours. 48 hours post shot- symptoms decreasing. Headache mild joint pain is the worst. Tired and very cold feeling 72 hours- feeling much better.
45 2021-01-16 injection site pain, sensitive skin Fever as high as 103.1 (after Motrin) Injection site pain Joint pain Headache Chills Skin sensitivi... Read more
Fever as high as 103.1 (after Motrin) Injection site pain Joint pain Headache Chills Skin sensitivity All over feeling unwell Increased heart rate (as high as 135)
45 2021-01-17 skin warm, redness, skin swelling, injection site pain FRIDAY, SAT, SUN - BAD HEADACHES; BODY ACHES SUNDAY - MONDAY - BAD PAIN INJECTION SITE; RED SWOLLEN,... Read more
FRIDAY, SAT, SUN - BAD HEADACHES; BODY ACHES SUNDAY - MONDAY - BAD PAIN INJECTION SITE; RED SWOLLEN, HOT TOOK TYLENOL AND IBUPROFEN.
45 2021-01-17 redness, injection site pain, hives, rash papular I received the second dose of Pfizer-Bioteck Covid19 vaccine on Jan 14th. The next day, I had soren... Read more
I received the second dose of Pfizer-Bioteck Covid19 vaccine on Jan 14th. The next day, I had soreness at the vaccine site, headache and fatigue all day. Then, the following day, when I woke up I started itching all over my body and I had hives. I have chronic uticaria(hives) for over 40 years and it has got better as I age. The hives I got this time is different from my chronic hives in that scratched area stayed red for hours and did not go away. The part I scratched hard kept raised and itchyness came back for several times. This hive almost lasted for 2 days and I took benadryl for 3-4 times. I did not see any doctor for this hives. My chronic hives usually last short period of time..itchy spots last for 10-15 mins, it become red and raised. But my skin usually turns normal after 15-20 mins. So this hives are different from my chronic hives and I considered it's from the COVID vaccine.
45 2021-01-17 hives, rash, itchy skin Itching, rash, hives, difficulty breathing, difficulty swallowing, anaphylactic response. Treatment... Read more
Itching, rash, hives, difficulty breathing, difficulty swallowing, anaphylactic response. Treatment: epipen, IM Benedryl shot x2, ambulance transport to ER at Hospital for monitoring Outcome- deduced symptoms and eventual absence of symptoms 24 hours later
45 2021-01-17 itchy skin Patient received Pfizer COVID19 vaccine at 1650 and was directed to remain in observation for thirty... Read more
Patient received Pfizer COVID19 vaccine at 1650 and was directed to remain in observation for thirty (30) minutes. At 1719, patient complained of itchy throat and itchiness on trunk, no shortness of breath, no difficulty breathing. Patient reported a history of anaphylaxis to amoxicillin and that she carries her own Epipen but had never used it prior. PHN activated emergency action plan, patient was moved to treatment room, and on-site manager contacted emergency medical services at 1724. Vital signs at 1726: pulse 72, respiratory rate 24, pulse ox 99%. Patient with wheezing and occasional cough. At 1728 PHN administered 0.3mg of epinephrine via Epipen auto-injector (cont)
45 2021-01-17 pain of skin nausea, lump/swelling under left arm/breast, headache severe, body aches at the slightest touch, pai... Read more
nausea, lump/swelling under left arm/breast, headache severe, body aches at the slightest touch, painful eyes from 1/15-1/17 w/ headache severe, loss of appetite, nausea lasting from 1/15-present day.
45 2021-01-18 pain of skin Body Aches , Chills, 100.9 Temp , Fatigue , nausea , Skin hurt
45 2021-01-18 injection site bruising, injection site pain, injection site redness Flu-like symptoms starting 12 hours after vaccine: myalgias, chills, headache, fatigue--severe first... Read more
Flu-like symptoms starting 12 hours after vaccine: myalgias, chills, headache, fatigue--severe first 24 hours, then about 50% better the next 24 hours; continued aching and headaches through the rest of the week--not back to baseline until day January 16, 2021--vaccine given 1/8/2021; also had severe bruise at site with surrounding erythema extending out to the outline of the deltoid muscle and slightly more distally down the arm with skin tenderness extending into this area of redness
45 2021-01-18 redness, itchy skin, cellulitis Night of 2nd dose had chills/body aches. Developed diarrhea next day. Arm became swollen and sore,... Read more
Night of 2nd dose had chills/body aches. Developed diarrhea next day. Arm became swollen and sore, red and itchy. Continued to get progressively more red, sore, itchy and swollen. On day 5 post vaccination, seeing by primary care doctor and diagnosed with cellulitis. Placed on antibiotics.
45 2021-01-18 skin warm Patient felt flushed, hot, faint occurring approximately 30 minutes after receiving vaccine. "Feels... Read more
Patient felt flushed, hot, faint occurring approximately 30 minutes after receiving vaccine. "Feels wierd." Feeling anxious. At 3:10pm, BP 165/74 HR=78 O2 sat=99%. At:3:30pm, BP=155/72. Symptoms improving. Patient released from clinic at 3:32pm.
45 2021-01-18 skin spots, itchy skin, vaccination site pain Sleepiness; pain at site for >24hrs less than 48hrs; itching on arm below injection site; headache; ... Read more
Sleepiness; pain at site for >24hrs less than 48hrs; itching on arm below injection site; headache; petichiae on site arm below injection site; sneezing; vivid dreams; swelling in legs; lower appetite; thirsty; more frequently urination with larger amounts; more frequently urination with larger amounts; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 04Jan2021 at 15:45 on arm at single dose for COVID-19 immunization. Medical history included Chronic sinusitis and had known allergies with Gluten and Sulfa. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications reported as none. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took tizanidine hydrochloride (TANIN, reported as tanins) and had known allergy. The patient experienced sleepiness, pain at site for more than 24hours less than 48hours, itching on arm below injection site, headache, petichiae on site arm below injection site, sneezing, vivid dreams, swelling in legs, lower appetite, thirsty, more frequently urination with larger amounts on 04Jan2021 at 19:00. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovering. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No. Information on the lot/batch number has been requested.
45 2021-01-18 rash, shingles on Jan 13, 2021 I developed a rash on my back. It was a little tender. Then on 1/14th I developed a... Read more
on Jan 13, 2021 I developed a rash on my back. It was a little tender. Then on 1/14th I developed a little more rash on my left side and under my left breast. The rash is painful. Diagnosed with Shingles!!
45 2021-01-19 itchy skin, hives 1/15 starting with burning tingling hands that become itchy and tingling, burning, hives, and itchin... Read more
1/15 starting with burning tingling hands that become itchy and tingling, burning, hives, and itching all through body that comes and goes. Could this be delayed reaction to vaccine? highly concerned about getting 2nd vaccine.
45 2021-01-19 hives Hives around the waist, weakness/ tired at 0500 1/20
45 2021-01-19 rash, redness I developed a red rash on my torso area that I call a viral rash 48 hours after administration of fi... Read more
I developed a red rash on my torso area that I call a viral rash 48 hours after administration of first vaccine. The rash was not painful or itchy and resolved within 48 hours.
45 2021-01-19 injection site pain Muscle soreness at site, headache, severe body aches, joint pain, chills and fever up to 100.5 lasti... Read more
Muscle soreness at site, headache, severe body aches, joint pain, chills and fever up to 100.5 lasting less than 12 hours.
45 2021-01-19 injection site pain Neck pain Head pressure Dizzy Nauseous Very Fatigue Very sore site (R) arm
45 2021-01-19 rash Rash, dizziness, flushed face, numbness to left side. Occurred approximately 3-5 minutes after the ... Read more
Rash, dizziness, flushed face, numbness to left side. Occurred approximately 3-5 minutes after the dose. Symptoms completely resolved after diphenhydramine within 75 minutes. Patient signed out against medical advice.
45 2021-01-19 itchy skin pt started experiencing tachycardia, dizziness, and itchiness within 2 minutes of receiving vaccine.... Read more
pt started experiencing tachycardia, dizziness, and itchiness within 2 minutes of receiving vaccine. pt reported symptoms 2 hours after receiving vaccine and was given 25 mg of diphenhydramine. pt was monitored every 60 minutes for changes.
45 2021-01-19 hives, itchy skin swelling of left eye on Friday 1/15/21 took Benadryl and came down by next morning. Sunday 1/17/21 ... Read more
swelling of left eye on Friday 1/15/21 took Benadryl and came down by next morning. Sunday 1/17/21 swelling of upper lip took Benadryl and it went away on its own a few hours later. Random hives all over body all weekend From 1/15/21 to 1/18/21. Generalized itchy feeling of skin.
45 2021-01-20 itchy skin, rash 1/20 staff member reported to employee health that she was advised by her own PCP to not get the sec... Read more
1/20 staff member reported to employee health that she was advised by her own PCP to not get the second Covid vaccination. She reports she developed an all over body rash and itching 2 weeks after her Covid vaccination and contacted her PCP - they advised Benydryl and that she should not receive her second vaccination In speaking with her - she is open to speaking to VAERS staff to relay her experience She reports she did not experience any issues immediately post vaccination
45 2021-01-20 rash Body aches, tingling in lip/tongue, tongue swelling, fever, tingling in left arm above the elbow, di... Read more
Body aches, tingling in lip/tongue, tongue swelling, fever, tingling in left arm above the elbow, diarrhea, rash, sore throat, headache
45 2021-01-20 hives Hives, shortness of breath, dizziness, chest pain, numbness of lip and face, felt like throat was cl... Read more
Hives, shortness of breath, dizziness, chest pain, numbness of lip and face, felt like throat was closing. Was rushed to the hospital.
45 2021-01-20 vaccination site pain I had severe nerve pain in the arm I received the injection in/the pain is intermittent and severe a... Read more
I had severe nerve pain in the arm I received the injection in/the pain is intermittent and severe and starts from upper arm to my fingers; This is a spontaneous report from a contactable nurse. A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL0142), via an unspecified route of administration on 07Jan2021 10:30 at single dose at left arm for COVID-19 immunization. Medical history included seizure, meningioma, and asthma. Known allergies: Latex, reglan, and Bactrim. Concomitant medications included lamotrigine (LAMICTAL), mirabegron (MYRBETRIQ). The patient previously took reglan [metoclopramide], and bactrim and experienced allergies. On day 2, 09Jan2021 21:00 post vaccine the patient reported "I had severe nerve pain in the arm I received the injection in. the pain is intermittent and severe and starts from upper arm to my fingers." It was unknown if the patient received treatment for the event. The patient underwent lab tests and procedures which included Nasal Swab: negative, and PCR: negative covid test name post vaccination PCR; both on 04Jan2021. The outcome of the event was not recovered.
45 2021-01-20 itchy skin Numbness, tingling, itching of left arm, whereas vaccine was administered to the right arm
45 2021-01-20 skin spots Since the 1/14/2021 Pfizer COVID vaccine, I had L 2nd MTP and R 3rd MTP burning sensation on 1/15/20... Read more
Since the 1/14/2021 Pfizer COVID vaccine, I had L 2nd MTP and R 3rd MTP burning sensation on 1/15/2021 (like I had foot blister or stubbed a toe). Then, I had petechiae with discoloration on 1/16/2021 and 1/17/2021. With my preexisting Raynaud, I believe the COVID toes again (pictures attached) are a COVID vaccine immunogenic response rather than COVID infection itself given my serial negative COVID PCR, absence of other symptoms, and only home/work social bubbles for > 7 days. I have reported to Pfizer for vaccine adverse events.
45 2021-01-20 hives, itchy skin itching and covered in hives/ all over her entire body; itching and covered in hives/ all over her e... Read more
itching and covered in hives/ all over her entire body; itching and covered in hives/ all over her entire body; This is a spontaneous report from a contactable other health professional. A 45-year-old female patient (non-pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELI284), via intramuscular on 07Jan2021 17:45 in right arm at single dose for covid-19 immunization. Medical history included hypothyroidism. Known allergies was none. The patient's concomitant medications were not reported. The patient previously took the first does of BNT162B2 via intramuscular from on 17Dec2020 04:30 PM in right arm at single dose for covid-19 immunization. The patient had no COVID prior vaccination and was not tested COVID post vaccination. No problems at all on day 1 or 2 post injection. On day 3 (10Jan2021 12:00 am), patient woke up in the night itching and covered in hives. not just in her right arm, but all over my entire body. Outcome of events was recovering. The patient took diphenhydramine hydrochloride (BENADRYL) for events.
45 2021-01-21 rash I had a rash,like small little dots from mid thigh all the way up to my arm pits.
45 2021-01-21 injection site pain Injection site pain, muscle aches, chills
45 2021-01-21 redness, hardening Large baseball sized, painful, hard, reddened, lump on arm day one decreased to golf ball size 4 da... Read more
Large baseball sized, painful, hard, reddened, lump on arm day one decreased to golf ball size 4 days later. I had moderate chills progressed to severe chills, stomach pain, and muscle/joint pain. Unable to work following day. I reported. It advised someone would be calling me. No one ever did. Chills, stomach and joint pain resolved. Still fatigued with painful lump on arm.
45 2021-01-21 injection site pain Swollen and sore arm (same arm injection given in) swollen lymph nodes in neck (both sides) and R ar... Read more
Swollen and sore arm (same arm injection given in) swollen lymph nodes in neck (both sides) and R armpit
45 2021-01-21 injection site pain Vaccine received around 8am, 1/18/21. Normal day, no events, developed a little soreness at injectio... Read more
Vaccine received around 8am, 1/18/21. Normal day, no events, developed a little soreness at injection site. Woke up around 1:30am on 1/19/21 and could not go back to sleep with overall malaise and pain in my right axilla (ipsilateral to vaccine); upon palpation of this area, I could feel enlarged lymph nodes, very sensitive to the touch (never had this from a vaccine, and I take usual flu shots and others occasionally recommended). Malaise slowly went away during the day, pain in right axilla persisted, although not as bothersome for about 2 days. On 1/19/21, I also had myalgia, which were still present on 1/20/19, but slowly subsided. Today 1/22 the enlarged right axillary adenopathy is still palpable, mild to no pain.. No additional symptoms.
45 2021-01-21 injection site swelling, injection site pain severe pain at injection site as well as swelling and severe pain in axillary lymph nodes of the le... Read more
severe pain at injection site as well as swelling and severe pain in axillary lymph nodes of the left arm where the injection was received.
45 2021-01-22 rash, injection site rash Day 0-headache Day 1- fever, chills, headache, joint pain Day 3- diffuse rash over trunk and over i... Read more
Day 0-headache Day 1- fever, chills, headache, joint pain Day 3- diffuse rash over trunk and over injection site on left arm
45 2021-01-22 itchy skin, hives Hives and itchiness all over body, occurring the day after 1st vaccine Dec 21 through Jan 22. Took B... Read more
Hives and itchiness all over body, occurring the day after 1st vaccine Dec 21 through Jan 22. Took Benadryl, Hydroxyzine, Loratidine, Pepcid and Prednisone steroid dose pack. Got 2nd vaccine on Jan 7. After I completed Prednisone, hives returned. I was just prescribed a 2nd round, this time high dose Prednisone pack x 5 days and Atarax. Thankfully, I'm feeling much better just after 1 dose of Prednisone and Atarax.
45 2021-01-23 hives, redness, rash My right arm broke out in hives a few hours following the injection, and then my left arm a few hour... Read more
My right arm broke out in hives a few hours following the injection, and then my left arm a few hours later. The next morning my right ear swelled , was red and covered in hives and very painful. It continued to swell over next few days, very painful. I was feeling drained and had gastrointestinal symptoms for days and this morning woke up with my face swollen and another rash and hives on my face. I had a little trouble breathing as well and went to an Urgent Care. The doctor believes I had an allergic reaction to the vaccine and administered a steroid injection and prescribed steroids and antihistamines.
45 2021-01-23 injection site swelling Swelling at site. temp 100.2, headaches, chills and body aches
45 2021-01-24 skin warm, redness, skin discolouration, hives About 25 min after receiving the vaccine, I noticed a little tingling on my lips and my cheeks and m... Read more
About 25 min after receiving the vaccine, I noticed a little tingling on my lips and my cheeks and my face felt heavy. I looked myself in the mirror, my face, cheeks and neck became very red like beet red and warm to the touch. I returned to the vaccine site and they observed me but the symptoms worsened, my eyes started getting puffy/ my cheeks started getting purple instead of red, and they sent me to the ER. At the ER they continued to monitor me and gave me IV Benadryl and IV Pepcid and IV steroids and said I had a delayed case of hives. Once I had all the IV medication the swelling went down and the hives on my arms and my back went away, the redness in my face and neck stayed until next day and I noticed after taking a warm shower the next day the redness returned on other parts of my body. I took a Benadryl. About after 2 days it was all resolved.
45 2021-01-24 injection site redness, injection site swelling Redness and swelling on site and armpit
45 2021-01-25 rash Immediately after 2nd injection, mouth tingling, felt cold like she might pass out. Never passed out... Read more
Immediately after 2nd injection, mouth tingling, felt cold like she might pass out. Never passed out. Felt better minutes later. Reports rash to body 2 weeks after 1st injection.
45 2021-01-25 rash, itchy skin Rash / Pruritus / Muscle Weakness
45 2021-01-26 injection site bleeding, injection site pain Injection was given firmly and arm bled. Arm was hurting immediately. Two days after injection, pain... Read more
Injection was given firmly and arm bled. Arm was hurting immediately. Two days after injection, pain at injection site was gone but left pectoral muscle and anterior left rotator cuff began to ache. Six days post injection pain intensified and burning sensation began in left pectoral muscle, left clavicle, and left anterior rotator cuff. Arm was placed in a sling to reduce movement and anti-inflammatory meds and Tylenol were taken for the pain. Twelve days post injection pain subsided and I was able to stop using sling and meds. Currently only tenderness remains with certain movements.
45 2021-01-26 injection site pain, injection site bleeding Injection was given with some force, arm bleed at injection site, arm started hurting immediately an... Read more
Injection was given with some force, arm bleed at injection site, arm started hurting immediately and continued for 2 day. Two days after injection left pectoral muscle and left anterior rotator cuff became achy. Six days post injection moderate to severe pain with burning sensation occurred in left pectoral muscle, around left clavicle, and left anterior rotator cuff. Pain continued for 5 days. I placed arm in sling to reduce movement and took anti-inflammatory meds with Tylenol for the pain. 13 days post injection, pain subsided. I am currently able to move arm without pain, only tenderness around anterior rotator cuff remains. No accidents occurred.
45 2021-01-26 rash Mouth and tongue tingling progressed to increased heart rate and flushing within 10 minutes of recei... Read more
Mouth and tongue tingling progressed to increased heart rate and flushing within 10 minutes of receiving vaccine. Transported to ER. Still has rash as of 1/27/2021 face, behind knees, and torso.
45 2021-01-27 skin swelling, dry skin, skin peeling 1/6/21 Received Pfizer COVID vaccine part 2. 1/12/21 ... Read more
1/6/21 Received Pfizer COVID vaccine part 2. 1/12/21 Went to urgent care for mild swelling and numbness on left side of face, scalp, ear. Also very dry flaky skin. Given desnoide cream, and instructed to take Claritin 1/13/21-1/15/21 Took Claritin, and all symptoms resolved except for dry skin 1/16/21-1/17/21 Did NOT take Claritin 1/18/21 Mild facial numbness, on left. Took Zyrtec-D, symptoms improved 1/19/21 No apparent numbness. Took Claritin 1/20/21 Possibly hint of numbness. Extremely dry skin and scalp. Took Claritin. Used desonide. Only skin around eyes slightly swollen. 1/21/21 Mild-mod numbness on left side of face. Extremely dry skin and scalp. Face feels warm. Took Claritin
45 2021-01-27 itchy skin, rash with redness, sensitive skin Pruritus whole body on day 8 followed by erythematous rash and patches, Pruritus lasted 4 weeks with... Read more
Pruritus whole body on day 8 followed by erythematous rash and patches, Pruritus lasted 4 weeks with hypersensitivity of skin
45 2021-01-27 hives Received the second vaccine yesterday 1/27/2021 around 11am. About an hour later started to get hive... Read more
Received the second vaccine yesterday 1/27/2021 around 11am. About an hour later started to get hives and took a Claritin. Was at home later in the evening around 5pm and started to have lip/jaw swelling and throat tightening. Called an ambulance and they gave her EPI pen and took over treatment. Ended up getting discharged around 11-12pm last night and told to take prednisone and Benadryl. Around 5am today 1/28 had swelling in tongue and bottom lip swelling. Went back to emergency room and they did similar treatment. Is planning to follow up with her doctor and will be on her prescribed medications for a few days.
45 2021-01-28 injection site pain 26th January 2021-after the injection-she became foggy funny headed for about an hour-her words 27th... Read more
26th January 2021-after the injection-she became foggy funny headed for about an hour-her words 27th January 2021-Chills, nauseated 28th January 2021-Body aches, left deltoid area extra tender, nauseated, HA, she has a history of migraines 29th January 2921-A lot better today she took Tylenol for her symptoms-told to go to the ER if her symptoms get worse, PCM if she needs to
45 2021-01-28 vaccination site pain Fever (as high as 103.1 after Motrin); Headache; Chills; Joint pain; Inj site pain; Skin sentivity; ... Read more
Fever (as high as 103.1 after Motrin); Headache; Chills; Joint pain; Inj site pain; Skin sentivity; General feeling unwell; This is a spontaneous report from a contactable nurse (patient). A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3249) via an unspecified route of administration in right arm on 15Jan2021 14:00 at single dose for COVID-19 immunisation. Medical history included hypertension, vertigo. The patient's concomitant medications were not reported. The patient was allergic to PCN, Sulfa, Keflex, Solodyn (Tetracycline). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Jan2021 04:30 AM, the patient experienced fever (as high as 103.1 after Motrin), headache, chills, joint pain, injection site pain, skin sensitivity, general feeling unwell. No treatment was received for other adverse events. The patient did not pregnant at the time of vaccination. Events outcome was recovered.
45 2021-01-28 rash Pt arrived at 1247 reported "tonsil swelling" which progressed to tongue feeling thick. Benadryl 25 ... Read more
Pt arrived at 1247 reported "tonsil swelling" which progressed to tongue feeling thick. Benadryl 25 mg IM given at 1252 without relief. Pt still reporting feeling of tongue swelling. Rash developed on neck and arms. Per protocol second dose of Benadryl 25 mg administered with slight relief at 1315. Epinephrine 0.3 ml administered at 1315 with no relief. Symptoms still persist. Second epinephrine dose administered at 1322. EMS notified and arrived at 1329 to transport pt to Northwestern Hospital.
45 2021-01-28 skin warm, rash, redness Rashes face like chemical peel and red on fire, eyes itchy, red line waistline and bra line, neck an... Read more
Rashes face like chemical peel and red on fire, eyes itchy, red line waistline and bra line, neck and chest are red. Pt. had Covid in Oct. 2020, blood drawn showed no anti-bodies 3 weeks prior the vaccine.
45 2021-01-28 vaccination site pain, vaccination site swelling injection site pain & swelling; injection site pain & swelling; Fever (99.5 max); chills; headache; ... Read more
injection site pain & swelling; injection site pain & swelling; Fever (99.5 max); chills; headache; This is a spontaneous report from a contactable nurse (patient herself). A 45-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 11:30 in right arm at single dose for covid-19 immunization. The patient was known allergies: wheat. Other medications in two weeks included multivitamin and calcium. The patient previously took Influenza vaccine, norethisterone (NORETHINDRONE) and experienced known allergies. No other vaccine in four weeks were taken. Facility type vaccine was workplace clinic. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The patient experienced injection site pain & swelling, fever (99.5 max), chills, headache on 12Jan2021 21:00. Outcome of events were recovered on Jan2021. No treatment was received for the events. Information on the lot/batch number has been requested.
45 2021-01-28 blister, skin discolouration, skin spots petechiae with discoloration; petechiae with discoloration; L 2nd MTP and R 3rd MTP burning sensatio... Read more
petechiae with discoloration; petechiae with discoloration; L 2nd MTP and R 3rd MTP burning sensation; foot blister; stubbed a toe; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1284) at Left arm, intramuscular on 14Jan2021 16:45 at single dose for covid-19 immunisation. Medical history included Sjogren's, Raynaud, s/p Total abdominal hysterectomy (TAH)/Bilateral salpingo-oophorectomy (BSO) sex cord sclerosing stromal tumor, and known allergies: Sulfa. Patient did not have Covid prior vaccination. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL), leflunomide, ciclosporin (RESTASIS), pilocarpine, colecalciferol (VITAMIN D), fish oil (OMEGA 3). Since the 14Jan2021 Pfizer COVID vaccine, the patient had left (L) 2nd Metatarsophalangeal (MTP) and right (R) 3rd MTP burning sensation on 15Jan2021 10:00 (like she had foot blister or stubbed a toe). Then, she had petechiae with discoloration on 16Jan2021 and 17Jan2021. No treatment was received for the events. The patient lab data included Covid PCR Test (Nasal Swab): negative on 15Jan2021. The outcome of events was recovering.
45 2021-01-29 rash macular, itchy skin 15 minutes after receiving shot, I started feeling itchy in many places. My face flushed red and my ... Read more
15 minutes after receiving shot, I started feeling itchy in many places. My face flushed red and my skin has red splotches on my upper chest. I had just been released from the vaccination observation area, and I returned for additional guidance. They told me since I drove out of observation, they could not do anything and I had to go to an urgent care center. I phoned my regular doctor and the triage nurse in the office instructed me to take 2 Benadryl immediately. I drive to a pharmacy and took the Benadryl. The Benadryl relieved the symptoms for about 2.5 hours and then they returned. I took 2 Benadryl every 4 hours until the itchiness stopped approximately 12 hours after receiving the shot.
45 2021-01-29 itchy skin Itching all over my body
45 2021-01-29 rash Patient reported tonsil swelling which progressed to tongue feeling thick and slight rash. Benadryl... Read more
Patient reported tonsil swelling which progressed to tongue feeling thick and slight rash. Benadryl given 25mg IM per protocol, patient thought felt slightly better. Tongue swelling reduced per patient. Patient rested, appeared comfortable. Vital signs improved. Tongue swelling appeared to be large, epi given x2, Throat still uncomfortmatble. Tongue appeared swelling. EMS activated 1:23pm. EpI 1.23mg IM repeated, rash bilateral now, patient able to swallow. Benadry .5mg IM given for a total of 50mg.
45 2021-01-29 redness, itchy skin, rash Pretreatment with prednisone 50 mg q6 x 3 doses starting 13 hours prior plus Benadryl 50mg po 1 hour... Read more
Pretreatment with prednisone 50 mg q6 x 3 doses starting 13 hours prior plus Benadryl 50mg po 1 hour prior. 20-25 minutes after injection began itching, rash on upper body, redness to body, lightheaded when stood up. Sought treatment from nurse & paramedic on site. Vital signs about 30 minutes after injection 187/107, hr 135, sats 98%. Given Benadryl 25 mg IM . Over next 30 minutes symptoms improved & bp came down to 145/80 and hr around 100. That evening whole body was red & rash on upper body- took Benadryl 50 mg. A week out remain with mild rash on chest, arms, neck & itching that comes & goes. Have been treating with Claritin during the day & Benadryl at night for 6 nights. Days 2& 3 after injection feet felt very cold, but face felt very hot when wearing a mask.
45 2021-01-30 skin warm 11:32, RRT called to assess 46 y/o female in post vaccine area with c/o difficulty swallowing and fe... Read more
11:32, RRT called to assess 46 y/o female in post vaccine area with c/o difficulty swallowing and feeling of warmth to bilateral upper arms and bilateral lower extremities, shin area. Husband was present/driver of the vehicle. Pfizer vaccine had been given at 11:09 A.M. and symptoms began at 11:30 A.M. Patient w/no prior medical hx or chronic conditions and does not take any routine medication. PHN assessment revealed: awake, alert and oriented x3, able to participate in assessment interview w/ease, no visual oral swelling/discoloration of mucus membranes, moving all extremities freely/warm to touch, no s/s of SOB, or change in sensorium. Vitals signs WNL. Monitored for an additional 10 in post vaccine area, all symptoms resolved, stable, discharged at 11:50 without further incident.
45 2021-01-30 hives Developed hives over chest and neck 2 days after vaccine.
45 2021-01-31 injection site pain, injection site hardening 100.6 fever, diarrhea, very sore and hard injection site. called in sick to work.
45 2021-01-31 injection site warmth, injection site pain, injection site swelling, injection site redness Covid 19 arm- redness, pain, swelling, heat at injection site ,
45 2021-01-31 shingles, rash Received vaccine on 1/15 and developed rash c/w shingles (herpes Zoster) on 1/28.
45 2021-01-31 hives, itchy skin Second COVID-19 vaccine given 1/28/2021 at 4:00pm. Woke up next morning at 0500 with widespread int... Read more
Second COVID-19 vaccine given 1/28/2021 at 4:00pm. Woke up next morning at 0500 with widespread intense itching and increased sinus congestions, hives develop about 11:00am with increased shortness of breath and wheezing. All signs and symptoms continued through today. Improve with increased Zyrtec dose to 2 - 10 mg, Benadryl 50 mg Q4, and Albuterol inhaler 2 puffs Q4-Q6. Improvement with medication regime.
45 2021-01-31 itchy skin, hives about 18 hours after the vaccination which she received on the 23rd the patient started getting hive... Read more
about 18 hours after the vaccination which she received on the 23rd the patient started getting hives on her arm each lesion would last about 1 or 2 hours but then her whole body became itchy often there are itchy areas with no visible rash but often there are hives as well sometimes the hives when scratched turned into papular lesions, which are visible on her chest and upper arms. Symptoms may have slightly improved but are still very bothersome 3 weeks after onset, taking 2 Xyzal twice a day was also taking Pepcid not sure any of these interventions are making much difference although she does note some slight sedation.
45 2021-02-01 blister, itchy skin Following dose #2, had body aches and fever on day two (T 102.7) and felt better next day. Per fami... Read more
Following dose #2, had body aches and fever on day two (T 102.7) and felt better next day. Per family report starting complaining about L ear pain on Friday 1/29, On Sunday 1/31, started to experience dizziness and some L ear discomfort, Had cellulitis last summer after "new earrings" in left ear and assumed this might have been it, had NP check ear on Monday at work, some fluid on R ear. Monday evening pain increased, heaviness and muffled sound increased, pain increased, started to "burn" and "itch". Tuesday AM contacted three MDs, concerns of shingles. Diagnosis later that day, vesicles in L outer ear, started on antiviral and antibiotics. Pain and dizziness at work Tuesday morning however its only Tuesday night. Pain/burning still very intense.
45 2021-02-01 rash, redness, itchy skin I have red itchy patches that come and go. It first started on my stomach now I have rhem on my fore... Read more
I have red itchy patches that come and go. It first started on my stomach now I have rhem on my forearm, chest and knee. Started getting rhis after the 2 vaccine. I became sick rhat night then these patches appeared. I will have to see an allergist or dermatologist.
45 2021-02-01 rash, rash papular, rash macular, redness Patient received COVID vaccine Pfizer first dose in vaccine clinic. Her symptoms started 5 min afte... Read more
Patient received COVID vaccine Pfizer first dose in vaccine clinic. Her symptoms started 5 min after injection, lasted 10-15 min and resolved. She started feeling tingly in her arms, then noticed a red, raised, blotchy rash on her arms. She felt hot and a little weak in the legs. No oral swelling, throat tightening, shortness of breath, nausea, vomiting, diarrhea. Symptoms onset 5 min after vaccine, symptoms resolved spontaneously within 15 min. Patient transferred to ED. No symptoms in ED. Patient given Benadryl in ED. Observed, no further symptoms. Dc home with Epi pen
45 2021-02-02 injection site reaction After receiving vaccination, patient unable to lift L arm. Was evaluated by MD and diagnosed with L ... Read more
After receiving vaccination, patient unable to lift L arm. Was evaluated by MD and diagnosed with L deltoid myositis after injection. Patient reports she was prescribed antibiotic, anti-inflammatory and physical therapy.
45 2021-02-02 redness Extreme swelling, redness, and soreness in left arm, can barely lift.
45 2021-02-02 skin laceration Following day was hypotensive with blood pressure 70/65 and had syncope with fall and laceration to ... Read more
Following day was hypotensive with blood pressure 70/65 and had syncope with fall and laceration to face. Received CT scans, IV fluids in ER . Had another episode of syncope in ER. On days 2 severe pain abdomen with bloating, myalgia and fatigue that lasted fir 2-3 days.
45 2021-02-02 injection site pain Injection Site Pain, Congestion, Fatigue, Swollen Lymph nodes, Nausea, & Headache
45 2021-02-02 itchy skin Itching all over-even her girl part-she says Told to go to the ER, call her PCM-as the day has progr... Read more
Itching all over-even her girl part-she says Told to go to the ER, call her PCM-as the day has progressed her itching has gotten worse
45 2021-02-02 rash macular, redness Mild allergic reaction (tingling in mouth, splotchy red chest, itchy eyes) approximately 5-10 minute... Read more
Mild allergic reaction (tingling in mouth, splotchy red chest, itchy eyes) approximately 5-10 minutes after receiving the vaccine; itchy eyes and puffiness in face on and off from time of vaccine to present (7 days later); vaccine and/or subsequent mild allergic reaction triggered Functional Neurological Disorder symptoms (involuntary muscle activations in legs, face and neck, dystonic posturing of feet)
45 2021-02-02 blister, itchy skin, rash symptoms started Saturday, Jan 9th after my vaccine on Friday Jan 8th. Had terrible fatigue and te... Read more
symptoms started Saturday, Jan 9th after my vaccine on Friday Jan 8th. Had terrible fatigue and terrible headaches, very mild nasal congestion, chills, and a rash on my chest. On Monday, 1/11/21 I was tested for COVID and positive as I was still not feeling well and lost my taste and smell. I can?t recall if I lost taste and smell on the 10th or the 11th. Those first few days I slept most all day and the days run together a little bit. I think maybe mid week, I started with tinnitus. About Wednesday, Jan 13th, I started with what looked like chicken pox mostly on my legs and back- these were itchy and fluid filled. Symptoms were starting to improve on Thursday Jan 21st in regards to my ?pox? as I think it was that day where I did not have any new ones that developed. My fatigue and headaches started to improve that day or the Friday after as well. I still notice some fogginess or mild memory issues, tinnitus is better but not fully gone, taste and smell are returning, fatigue continues to improve, headaches are intermittent.
45 2021-02-03 skin warm Left arm remained sore and warm to touch for several days. On 1/31/21 started having extreme pain wi... Read more
Left arm remained sore and warm to touch for several days. On 1/31/21 started having extreme pain with ROM of left should. Went for evaluation on 2/1/21, was diagnosed with left shoulder deltoid myositis after injection.
45 2021-02-03 skin warm Patient immediately started feeling hot and lightheaded post immunization.
45 2021-02-03 injection site inflammation Profound inflammation of vascular structure originating at injection site and radiating out, vascula... Read more
Profound inflammation of vascular structure originating at injection site and radiating out, vascular structure highly visible through skin. No treatment only observation. After 3 days vascular structures beginning to fade and return to baseline, however, veins are still highly visible and very pronounced.
45 2021-02-03 hives, redness, itchy skin Skin redness/hands were red/red patches; hands were red and itchy; hands were red and itchy, burning... Read more
Skin redness/hands were red/red patches; hands were red and itchy; hands were red and itchy, burning.; extensive hives starting over dorsal hand surface, then wrists,eventually covering entire arms and patches over knees and lower legs; This is a spontaneous report from a contactable nurse (patient). This 45-year-old female patient received the fist dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284 and expiry date unknown), via an unspecified route of administration on 19Jan2021 09:15 at a single dose on the left arm for COVID-19 immunization. Medical history included COVID-19 and allergies: PCN. Concomitant medication included colecalciferol (VITAMIN D). The patient received no other vaccine in four weeks. Patient is not pregnant. On 20Jan2021 08:30, the patient developed skin redness, her hands were red, itchy, and burning. This was followed by extensive hives starting over dorsal hand surface, then wrists, and eventually covering entire arms. The patient also had patches over knees and lower legs. The events resolved with 20 mg prednisone and Allegra after a couple hours, except for the flat red patches which remained over the knees and surrounding skin. The patient has not been tested for COVID-19 post-vaccination. Outcome of the event "skin redness/hands were red/red patches" was not recovered and of the other events was recovered on an unspecified date.
45 2021-02-03 injection site reaction all may veins show from site of injection across chest arms neck and sides of face! has not gone awa... Read more
all may veins show from site of injection across chest arms neck and sides of face! has not gone away I am deformed now and it has effected my emotional well being!!!!!!!
45 2021-02-03 vaccination site pain first dose was administered on 03Jan2021 and second dose was administered on 15Jan2021; pain at inje... Read more
first dose was administered on 03Jan2021 and second dose was administered on 15Jan2021; pain at injection site; Muscle pain; joint pain; nausea; This is a spontaneous report from a non-contactable other health professional. A 45-year-old female patient received second dose oBNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (batch/lot number and expiry not available), via an unspecified route of administration, in the left arm, on 15Jan2021 13:00 at a SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. Patient was not pregnant during vaccination. Historical vaccine included BNT162B2 on 03Jan2021 at 02:00 PM, in the Left arm (1st dose) for COVID-19 immunization. Concomitant medications included Birth control (unspecified) and sertraline hydrochloride (ZOLOFT). The first dose was administered on 03Jan2021 and second dose was administered on 15Jan2021. On 15Jan2021, the patient experienced muscle pain, joint pain, nausea and pain at injection site. The patient underwent lab tests and procedures which included covid test via nasal swab post vaccination (on 15Jan2021) with unknown result. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number cannot be obtained.
45 2021-02-04 shingles, rash, itchy rash Developed an itchy rash on left side of neck that spread up neck onto scalp. Three days later it was... Read more
Developed an itchy rash on left side of neck that spread up neck onto scalp. Three days later it was excruciatingly painful. Diagnosed as shingles. As of today it is improving but still present
45 2021-02-04 itchy skin Left-arm numbness, tingling, itching (vaccine administered on right-arm).; Left-arm numbness, tingli... Read more
Left-arm numbness, tingling, itching (vaccine administered on right-arm).; Left-arm numbness, tingling, itching (vaccine administered on right-arm).; Left-arm numbness, tingling, itching (vaccine administered on right-arm).; This is a spontaneous report from a contactable Pharmacist. A 45-years-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249), intramuscular on 17Jan2021 at single dose for covid-19 immunisation . Medical history reported as none. The patient's concomitant medications were not reported. The patient experienced left-arm numbness, tingling, itching on 17Jan2021. vaccine administered on right-arm. The outcome of events was recovering.
45 2021-02-04 rash, injection site redness, injection site swelling My arm at the injection site got very swollen and red and I had red streaks across my back. Symptoms... Read more
My arm at the injection site got very swollen and red and I had red streaks across my back. Symptoms began 14 hours after injection. I had the normal fever, nausea, chills, body aches, also had severe ear pain in my left ear same as when I had Covid. Dizziness began 14 hours after but increasingly got worse. My blood pressure went up to 200/118 with my HR 131 with the dizziness. I have NEVER had high blood pressure!! I still have some dizziness. Not completely resolved. BP is better but still high at times. I have been monitoring it closely. I did go to the ER where my BP continued to be high.
45 2021-02-06 redness, itchy skin 1640 Red palms, flushed, arms itch hx sensitive skin feels throat full. denies, dysphagia or dyspnea... Read more
1640 Red palms, flushed, arms itch hx sensitive skin feels throat full. denies, dysphagia or dyspnea. Benadryl 25mg po. 1645 Vital signs 160/100,97%,76. 1655 D/C amb. without problems.
45 2021-02-07 rash 1/29/2021 at apx 5:00am patient stated to have an upset stomach. Later in the day at apx. 12:00pm pa... Read more
1/29/2021 at apx 5:00am patient stated to have an upset stomach. Later in the day at apx. 12:00pm patient stated to have a fever of 102.0 F and beginning of a rash throughout her body. Symptoms continued through the following day. 1/31/2021 at apx 5:00am patient stated to have swelling of her throat and went to the emergency room. Patient given IV and gastrointestinal cocktail. Patient sent home steroid and diphenhydramine prescription.
45 2021-02-07 hives Fatigue began 02/04/21 and lasted approximately 24 hours. Hives began 02/05/21 and continue as of 02... Read more
Fatigue began 02/04/21 and lasted approximately 24 hours. Hives began 02/05/21 and continue as of 02/08/2021, currently using Benedryl, Cholecystitis began 02/07/2021 with bloated feeling and abdominal pain behind belly button and off to the right side of abdomen pain is beginning to ease off as of 02/08/2021.
45 2021-02-07 injection site pain Pfizer-BioNTech COVID19 Vaccine Severe symptoms following day: injection site pain, fatigue, headac... Read more
Pfizer-BioNTech COVID19 Vaccine Severe symptoms following day: injection site pain, fatigue, headache, whole body muscle pain, chills, nausea, malaise. 2nd and 3rd day symptoms: left underarm swollen lymph nodes, injection site pain, headache, tiredness, slight nausea, slight muscle pain. Missed work 1 day, unable to drive 2 days.
45 2021-02-07 vaccination site pain fatigue; chills; fever (about 99-100F); the site of injection is sore; a moving painful lump near le... Read more
fatigue; chills; fever (about 99-100F); the site of injection is sore; a moving painful lump near left shoulder blade (may be supraclavicular lymph nodes), which is warm to touch!; a moving painful lump near left shoulder blade (may be supraclavicular lymph nodes), which is warm to touch!; a moving painful lump near left shoulder blade (may be supraclavicular lymph nodes), which is warm to touch!; This is a spontaneous report from a contactable other health professional reported for herself. This 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9031) via an unspecified route of administration on 19Jan2021 at 09:15 AM at single dose in left arm for COVID-19 immunization. The patient is not pregnant. Medical history and concomitant medications were reported as none. Allergies to medications, food, or other products was reported as none. The patient previously received the first dose of BNT162B2 (Lot number EH9899) on 30Dec2020 at 11:15 AM at single dose in left arm for COVID-19 immunisation and had no symptoms; Influenza vaccine on 10Dec2020 for immunization. The patient experienced fatigue, chills followed by fever (about 99-100F) lasted for about one and half days. The site of injection is sore even after 3 days. The patient observed a moving painful lump near left shoulder blade (may be supraclavicular lymph nodes), which is warm to touch. The events onset date was reported as 21Jan2021. The events were reported as non-serious. The patient was not diagnosed with COVID-19 Prior to vaccination and not tested for COVID-19 since the vaccination. The patient received no treatment. The outcome of the events was not resolved.
45 2021-02-07 vaccination site pain swelling on the left side of her jaw and throat began to swell/swelling on left side of face and thr... Read more
swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat; Tingling; swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat/whelping up on the left side of jaw; felt a funny sensation in her throat and face/still not feeling herself; soreness; left arm was sore; throat still feels funny; feels scratchy; feeling fatigued; This is a spontaneous report from a contactable consumer reporting for herself. A 45-years-old female patient started to receive bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (lot# EH9899, exp date 31Mar2021), via an unspecified route of administration in the left arm, on 15Jan2021 at 14:30, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. The patient experienced left arm was sore on 16Jan2021 with outcome of recovered, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat on 18Jan2021 with outcome of recovering, tingling on 18Jan2021 with outcome of recovering, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat/whelping up on the left side of jaw on 18Jan2021 with outcome of recovering, felt a funny sensation in her throat and face/still not feeling herself on 18Jan2021 with outcome of not recovered, feeling fatigued in Jan2021 with outcome of not recovered, soreness on 16Jan2021 with outcome of recovering, throat still feels funny; feels scratchy on Jan2021 with outcome of not recovered. The patient visited the emergency room for left arm was sore, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat, tingling, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat/whelping up on the left side of jaw. The patient was treated in the emergency room with prednisone, Benadryl and acid medicine for her stomach.
45 2021-02-09 itchy skin Itchy runny nose; Itchy runny nose; cough; fatigue; headache; This is a spontaneous report from a co... Read more
Itchy runny nose; Itchy runny nose; cough; fatigue; headache; This is a spontaneous report from a contactable healthcare professional. A 45-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on her left arm on 23Jan2021 09:15 at a single dose for COVID-19 immunization. Medical history included Covid-19 at an unspecified date. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient experienced Itchy runny nose, cough, fatigue, headache; all on 24Jan2021 07:00 AM. No treatment was received for the events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
45 2021-02-09 rash fever; chills; weakness; rash all over the body; sob; This is a spontaneous report from a contactabl... Read more
fever; chills; weakness; rash all over the body; sob; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in arm left on 04Jan2021 08:45 at single dose for COVID-19 immunization. The patient was not pregnant at time of vaccination. Medical history included asthma, obesity. Concomitant medication included ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), macrogol 3350 (MIRALAX), montelukast sodium (SINGULAIR). The patient previously took cefalexin (KEFLEX) and experienced Known allergies: Keflex. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 01:30 PM Intramuscular in right arm for COVID-19 immunization. The patient experienced fever, chills, weakness, rash all over the body, sob all on 04Jan2021 12:00 with outcome of recovered in Jan2021. No treatment was received. Information on the Batch/Lot number has been requested.
45 2021-02-09 rash tremors temp of 104.9 rash pain all over and little zings weak shaking immune system issues
45 2021-02-10 injection site pain Mental fog; Soreness at injection site; Fatigue; Fever ( low grade: 1-2 degrees over basal); This is... Read more
Mental fog; Soreness at injection site; Fatigue; Fever ( low grade: 1-2 degrees over basal); This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN 5318), via an unspecified route of administration on the left arm on 27Jan2021 09:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient is not pregnant. Concomitant medication included esomeprazole magnesium (NEXIUM), ibuprofen (ADVIL), beclometasone dipropionate (QNASL), diphenhydramine hydrochloride (BENADRYL) and doxylamine succinate (UNISOM). The patient previously took naproxen (ANAPROX) and experienced allergy. The patient experienced mental fog, soreness at injection site, fatigue and fever ( low grade: 1-2 degrees over basal) on 27Jan2021 18:00. No treatment and hospitalization was caused by the events. The outcome of the events was not recovered.
45 2021-02-10 injection site pain Pain at injection site, muscle/body aches, chills, prickly skin, headache, nausea & fatigue.
45 2021-02-11 redness Red, Swollen Arm. Muscle aches, flu like symptoms, joint pain. Has a scar on her arm that is typical... Read more
Red, Swollen Arm. Muscle aches, flu like symptoms, joint pain. Has a scar on her arm that is typically flat, but is raised as a result of inflammation
45 2021-02-11 rash rash over entire body except face. fever, loose stools, headache and chills. fatigue.
45 2021-02-14 injection site inflammation, injection site redness, cellulitis Nothing happened until about 7 days later. The site was pink, red and inflamed. It ended up being ce... Read more
Nothing happened until about 7 days later. The site was pink, red and inflamed. It ended up being cellulitis. I started on antibiotics and it seemed to start clearing up within 1 days. I took Cephalexin 500mg for 7 days. It was cleared within 48 hours.
45 2021-02-14 injection site redness, injection site inflammation, injection site pain The site was inflamed, pink/red and tender. Had fever of 104. Given same antibiotic , Cephalexin 50... Read more
The site was inflamed, pink/red and tender. Had fever of 104. Given same antibiotic , Cephalexin 500 mg. Same healing time, but sicker than I was with first dose.
45 2021-02-15 injection site redness, injection site swelling, injection site pain, cellulitis I have a large, swollen, painful area under my left arm, in the armpit, that has been diagnosed as c... Read more
I have a large, swollen, painful area under my left arm, in the armpit, that has been diagnosed as cellulitis. I am on a 10 day course of antibiotics. My left arm, where the dose was given, is red, slightly swollen, and sore to the touch. My doctor has advised to continue to take ibuprofen and to treat with ice packs. I would expect it to resolve in ten days when the antibiotics are completed.
45 2021-02-15 rash, itchy skin, shingles Shingles: rash on left back, itching, fatigue
45 2021-02-16 injection site pain After receiving the vaccine, I experienced moderate arm pain at the site of injection within 2 minut... Read more
After receiving the vaccine, I experienced moderate arm pain at the site of injection within 2 minutes. Almost 7 hours later and the pain has increased to the surrounding area in an approximate 2" radius around the site of injection. I am also experiencing a lymphatic response, mostly felt in my neck, and also have some muscle soreness in my neck. I also experienced a few PVCs...I was diagnosed 4 years ago with heart arrhythmia that was mitigated through reduction of stress and caffeine. So, I don't consider it to be a "chronic" condition and it is not something I normally experience, but I have felt a few PVCs happen since being vaccinated today along with some very mild heart pain that is just beginning. For treatment of muscle soreness at injection site, I am just applying a bit of ice. For lymph nodes, I've been doing some lymphatic exercises and trying to not to sit too much. I also have a little bit of headache that is just developing. These symptoms are mildly uncomfortable over all. The arm tenderness does give me a general feeling of discomfort and limits my desire for movement, but does not seem to impede my ability to move. For headache, I would normally take a 400 mg of ibuprofen, but I'm not going to take any kind of NSAID at this time. I will monitor my heart but am not concerned. I cannot be certain the vaccine is the cause of any of these symptoms, except for the arm tenderness and probably the lymphatic response as well. Headache and PVCs can be caused by a lack of sleep and possible dehydration, and I've had a bit more caffeine than I normally might.
45 2021-02-16 injection site pain, injection site reaction, rash with redness, rash, itchy rash Suspect delayed hypersensitivity reaction. Patient felt some malaise and pain over injection site fo... Read more
Suspect delayed hypersensitivity reaction. Patient felt some malaise and pain over injection site for 2-3 days following 2nd SARS-COV-2 vaccine, however developed large targetoid erythematous, pruritic rash over injection site and much of this arm 3-4 days following vaccination.
45 2021-02-16 itchy rash, rash, injection site rash Throat and mouth "feels funny" following injection of Covid vaccine approx 1717. Slight chest burnin... Read more
Throat and mouth "feels funny" following injection of Covid vaccine approx 1717. Slight chest burning. Patient ambulated. Drinking water without diffuculty. Patient states tongue "feels funny" after getting covid vaccine. Patient states within minutes after the injection her tongue began to feel funny. She denies oral/lip swelling, numbness/tingling, difficulty swallowing, drooling, headache, nausea/vomiting, chest pain, shortness of breath. She also states her chest was burning just after receiving the vaccination however that has since resolved. No palpitations or syncope. No recent illness. No history of adverse reaction to vaccines. No known food/medication allergies. Patient is sitting comfortably on the exam table drinking water without difficulty. Patient states at this time her mouth feels better but "does not feel normal." Patient states she has a history of mitochondrial myopathy and has some esophageal motilty issues at baseline. 1808: patient was given diphenhyramine 25 mg PO x 1. She reports mild improvement in symptoms. No headache, dizziness, nausea, oral edema, difficulty swallowing, chest pain, shortness of breath. 1830: patient states symptoms have resolved. She is sitting comfortably in the chair. No signs of distress. She states she thinks she got too anxious. No headache, dizziness, nausea, oral edema, difficulty swallowing, chest pain, shortness of breath. Patient states she feels comfortable leaving at this time. Discussed ED precautions. Patient verbalized understanding. Advised patient to follow up with her PCP to discuss second dose of covid vaccine. 1/15/21: Pt received 2nd dose of vaccine. About 10 minutes after, pt developed a rash at injeciton side. Rash spread up chest and onto back. Pt was taken to convenient care for further evaluation. At convenient care, pt stated she had no difficulty breathing but that something just didn't feel right. Rash spread to right arm and started to itch. Pt endorsed experiencing throat/tongue swelling but did not think it was closing off or actualy swelling. Pt received epinephrine 0.3 mg IM x 1 and diphenhydramine 25 mg IM x 1. After treatment and about 1.25 hours of monitoring, pt felt well enough to go home. Pt was prescribed epinephrine 0.3 mg IM 2-pak kit. 1/15/21: Pt received 2nd dose of COVID vaccine and develped rash. Pt received epinephrine 0.3 mg IM x 1 and diphenhydramine 25 mg IM x 1. Discharged to home after treatment and monitoring with prescription for epinephrine 0.3 mg IM 2-pak kit.
45 2021-02-16 vaccination site pain injection site pain; chest discomfort (fluttering, thud feeling, tightness); chest discomfort (flutt... Read more
injection site pain; chest discomfort (fluttering, thud feeling, tightness); chest discomfort (fluttering, thud feeling, tightness); chest discomfort (fluttering, thud feeling, tightness); shortness of breath; fatigue; This is a spontaneous report from a contactable consumer reporting for herself. This 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL3247 and expiry date unknown) on 16Jan2021 at 11:00 via an unspecified route of administration into right arm at a single dose for COVID-19 immunization. The patient had known allergies to penicillin, erythromycin, garlic. Other medical history included asthma. She was not pregnant. The patient had not had COVID prior to the vaccination. Nasal Swab (for COVID) tested on 19Jan2021 was negative. Concomitant medications in two weeks included venlafaxine and ceirizine hydrochloride (ZYRTEC). No other vaccine received in four weeks. The patient experienced chest discomfort (fluttering, thud feeling, tightness), shortness of breath, fatigue since 17Jan2021 11:00, and injection site pain since 01Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received prednisone and formoterol fumarate;mometasone furoate (DULERA) as treatment for the adverse events. The patient had not recovered from the events.
45 2021-02-17 itchy skin, vaccination site itchiness Abdominal pain; severe nausea; headache; numbness in hand; itching on body on the side on injection;... Read more
Abdominal pain; severe nausea; headache; numbness in hand; itching on body on the side on injection; itching on body on the side on injection; dizziness; insomnia; night sweats; low grade fever; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient started to received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: unknown, unable to locate or read details), via an unspecified route of administration on 23Jan2021 16:15 (04:15 PM) at single dose on right arm for COVID-19 immunization. Patient was not pregnant at the time of report. The patient medical history was not reported. Patient was not diagnosed with COVID-19 prior vaccination. Concomitant medications included fluticasone, salmeterol, montelukast and paracetamol (TYLENOL). Patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The most recent COVID-19 vaccine was administered in School or Student Health Clinic The patient experienced abdominal pain, severe nausea, headache, numbness in hand, itching on body on the side on injection, dizziness, insomnia, night sweats, low grade fever, all on 24Jan2021 02:00. No treatment was received for the events. The events were assessed as non-serious. Outcome of the events was recovering. Patient has not been tested with COVID-19 since the vaccination. Information on the lot/batch number has been requested.
45 2021-02-17 rash, hives First dose administration on 19Dec2020 and second dose administration on 12Jan2021; Dyspnea; Rash; U... Read more
First dose administration on 19Dec2020 and second dose administration on 12Jan2021; Dyspnea; Rash; Urticaria and folliculitis with near resolution. Severe exacerbation after both vaccinations 2 and 1; Urticaria and folliculitis with near resolution. Severe exacerbation after both vaccinations 2 and 1; Urticaria and folliculitis with near resolution. Severe exacerbation after both vaccinations 2 and 1; This is a spontaneous report from a contactable healthcare professional (the patient). A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El1283, expiration date not reported), via an unspecified route of administration (left arm) on 12Jan2021 at a single dose, for COVID-19 immunization. Medical history was not reported. Concomitant medication included cefalexin monohydrate (KEFLEX), cefdinir, fexofenadine hydrochloride (ALLEGRA), cetirizine hydrochloride (ZYRTEC ALLERGY), and triamcinolone. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5760, on right arm, on 19Dec2020, and experienced urticaria and folliculitis with severe exacerbation after both vaccination. It was reported that on Jan2021, the patient was under successful treatment for urticaria and folliculitis with near resolution. Severe exacerbation after both vaccinations 2 and 1; experience of rash and dyspnea on Jan2021 required steroids and epipen. Treatment included Prednisone course, epipen, and H2 blockers. The adverse event resulted in a doctor or healthcare professional office/clinic visit. The patient's labs on an unknown date was negative for autoimmune disease. It was also reported that the patient had first dose administration on 19Dec2020 and second dose administration on 12Jan2021. The patient was recovering from all events, except for "First dose administration on 19Dec2020 and second dose administration on 12Jan2021" with outcome of unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
45 2021-02-17 redness, itchy skin My ankles were bright red, extremely itchy, and swollen with a eczema like rash formed around them.;... Read more
My ankles were bright red, extremely itchy, and swollen with a eczema like rash formed around them.; My ankles were bright red, extremely itchy, and swollen with a eczema like rash formed around them.; My ankles were bright red, extremely itchy, and swollen with a eczema like rash formed around them.; My ankles were bright red, extremely itchy, and swollen with a eczema like rash formed around them.; This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL1283), at age 45 years, intramuscular on the right arm, on 29Jan2021 09:00 at single dose, for COVID-19 immunisation. Medical history included allergy to red wasp bee stings. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient's concomitant medications were not reported. On 30Jan2021 01:00, patient's ankles were bright red, extremely itchy, and swollen with a eczema like rash formed around them. Patient soaked her ankles and took some diphenhydramine (BENADRYL) and ibuprofen (MOTRIN). She also applied triamcinolone acetonide cream usp. and oatmeal (EUCERIN ECZEMA RELIEF BODY CREAM). She mentioned that it is not resolved by Tuesday, she will visit urgent care. Facility where the most recent COVID-19 vaccine was administered was at a hospital. Since the vaccination, the patient has not been tested for COVID-19. The adverse event resulted in emergency room/department or urgent care. The outcome of the events was not recovered. Case was reported as non-serious.
45 2021-02-18 skin discolouration Daughter rec'd vaccine on 2/17 and she lost her voice and was unable to speak, she's had an underlyi... Read more
Daughter rec'd vaccine on 2/17 and she lost her voice and was unable to speak, she's had an underlying issue. She stayed for 30-45 minutes and started coughing and then lost her voice, her throat started itching and she could not speak she was very hoarse, her skin turned real dark and she went to the hospital, they gave her an EPI pen, Prednisone 40mg for 4 days, Albuteral was given, Solumedrol and Peptin, and benedryl, Ivciartin, She continues to have a deep hoarseness.
45 2021-02-18 rash Fever, chills, loss of appetite, lethargy, headache, body ache, swollen lymph nodes (right underarm)... Read more
Fever, chills, loss of appetite, lethargy, headache, body ache, swollen lymph nodes (right underarm), loss of appetite, rash
45 2021-02-18 blister Onset of blistering to arms a few days after receipt of vaccination, did not realize it was related ... Read more
Onset of blistering to arms a few days after receipt of vaccination, did not realize it was related until the same occured after receiving 2nd dose.
45 2021-02-18 bruising Wednesday, day of vaccine, soreness in arm, started out feeling bruised then progressed to stiffness... Read more
Wednesday, day of vaccine, soreness in arm, started out feeling bruised then progressed to stiffness and pain in my shoulder joint. Thursday my whole body ached, especially my knees and hips, I felt feverish. Thursday night a severe headache developed and persisted through Saturday morning. ibuprophen and acetemetiphine did nothing to relieve any of the symptoms.
45 2021-02-21 injection site pain Elevated temperature, feeling as though I was outside of my body during fever (quasi-dissociative), ... Read more
Elevated temperature, feeling as though I was outside of my body during fever (quasi-dissociative), sweating and heat episodes (heat feels like it's emanating from from my neck/shoulder area). Additional SE's: pain at injection site, fatigue. Quasi-dissociative feeling resolved after fever stopped. At this writing, still having sweating episodes, pain diminished considerably, fatigue waxing and waning.
45 2021-02-23 hives, redness, itchy rash Tingling sensation in extremities followed by an itchy rash, redness, and hives in arms, neck, face,... Read more
Tingling sensation in extremities followed by an itchy rash, redness, and hives in arms, neck, face, and chest.
45 2021-02-23 rash, hives dyspnea; rash; severe exacerbation (of urticaria and folliculitis) was observed after injection (bot... Read more
dyspnea; rash; severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); This is a spontaneous report from a contactable other health professional (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: Ek5760, via an unspecified route of administration in the right arm, on 19Dec2020 17:00 at SINGLE DOSE for covid-19 immunization. The patient's medical history included urticaria and folliculitis: patient was under successful treatment for urticaria and folliculitis with near resolution. Concomitant medication included cefalexin (KEFLEX), cefdinir, fexofenadine hydrochloride (ALLEGRA), cetirizine hydrochloride (ZYRTEC) and triamcinolone. The patient received BNT162B2 on 19Dec2020. Then on 29Dec2020, 12:00, severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); experienced rash and dyspnea requiring steroids and epipen. The adverse event resulted in a doctor or healthcare professional office/clinic visit. The patient's labs on an unknown date was negative for autoimmune disease. The patient was recovering from all events. Treatment for the events included Prednisone course, epipen, and H2 blockers. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.; Sender's Comments: Based on the temporal relationship and known safety profile of BNT162B2, the reasonable possibility of an association between rash, dyspnea and suspect product cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
45 2021-02-24 redness Employee reports redness and swelling to bilateral toes. Reported symptoms started approximately 3 w... Read more
Employee reports redness and swelling to bilateral toes. Reported symptoms started approximately 3 weeks following second dose of vaccine. Employee has officially reported symptoms. Referred employee for COVID testing.
45 2021-02-24 redness, itchy skin Patient noted small area of itching and erythema on neck approximately 10-15 minutes after her first... Read more
Patient noted small area of itching and erythema on neck approximately 10-15 minutes after her first COVID vaccination. No SOB, facial swelling or difficulty swallowing. Vitals at 1:50 BP 152/95, Pulse 60 and O2 sats 100% She received 25 mg oral benedryl and water and observed another 15 minutes. No progression of rash but continued itching on neck and chin,no facial swelling SOB or trouble swallowing. Stable vitals, she took second dose of benedryl 25 mg and will head home to rest. Will monitor for any change in symptoms- does have epi available at home (due to children with severe allergies). She was educated that current CDC recommendations are that with any allergic reaction within first 4 hrs, that the individual not go on to receive second vaccination. She was disappointed by will follow CDC for updates. She did enroll in vsafe. She was agreeable to me checking in on her later. Will submit VAERS for thoroughness tomorrow with update. I confirmed with patient on 2/25/21 that when she awoke today, she noted complete resolution of her itching and rash she experienced on 2/24/21 after vaccination. I invited her to visit with her PCP if she wanted to discuss further the safety of proceeding with second vaccination. She was appreciative.
45 2021-02-25 hives Hive about an hour and a half later and on and off for a few days
45 2021-02-25 injection site pain Other than mild pain at the injection site on the night of 2/19/21, things were fine until Tuesday, ... Read more
Other than mild pain at the injection site on the night of 2/19/21, things were fine until Tuesday, 2/22/21 when my tongue began twitching. It is now 2/26/21 and it continues to twitch. I can eat and drink and swallow fine.
45 2021-02-25 injection site pain pain on vaccination site , unable to move arm, body aches, fever, weakness for 48 hours
45 2021-02-26 injection site pain 1st dose pain in injection site lasting 2-3 days 2nd dose pain in injection site lasting 2-3 days, f... Read more
1st dose pain in injection site lasting 2-3 days 2nd dose pain in injection site lasting 2-3 days, fatigue and muscle stiffness lasting 2 days
45 2021-02-26 redness, itchy skin, rash macular Red, swollen, itchy blotch about an 1in (so far) sore to touch
45 2021-02-26 redness pt with dizziness and painful left arm, redness to nose and face. Benadryl 50 mg given
45 2021-02-28 rash macular, rash Constricted throat. I was given Zyrtec. Observed for an hour. Got discharged. Throat constriction di... Read more
Constricted throat. I was given Zyrtec. Observed for an hour. Got discharged. Throat constriction didn't go away until 2 hours afterwards. Puffy, itchy eyes (both eyes) with rash came and lasted about two weeks. Monday or Tuesday, I noticed a rash all over my body - red and blotchy. That went away in a day. I got chills, fever, weakness, nausea, vomiting, diarrhea and that lasted 48 hours (16th in pm-17th and got better evening of 18th). When I had the rash was all over the body, I took a Zyrtec. The weekend I was really sick I didn't take any medication. Phone visit with Doctor - January 15th - allergist - I followed up with him about the throat constriction. He just was monitoring symptoms. After the weekend that I was really sick, I told him and he ordered bloodwork.
45 2021-02-28 itchy skin, rash macular Diffuse red macular rash over arms legs trunk and chest. Neck also. Face and hands and feet spared; ... Read more
Diffuse red macular rash over arms legs trunk and chest. Neck also. Face and hands and feet spared; Extremely itchy; This is a spontaneous report from a contactable other health professional. A 45-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on 23Jan2021 at 10:30 at a single dose on left arm for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included modafinil. On 24Jan2021 at 12:00, the patient experienced diffuse red macular rash over arms legs trunk and chest. Neck also. Face and hands and feet spared. Started next day. So far lasting for 4 days. Extremely itchy. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
45 2021-02-28 injection site swelling, injection site pain, injection site warmth, injection site redness pain and swelling at the site, low fever, chills for several days, tiredness, constant headache. To... Read more
pain and swelling at the site, low fever, chills for several days, tiredness, constant headache. Tonight, end of day 3, injection site is warm/hot, raised, red and swollen. feelings of nausea intermittently today.
45 2021-03-01 injection site redness, injection site pruritus, injection site pain A few days after the same ecema type rash appeared again over both eyelids but was severly worse thi... Read more
A few days after the same ecema type rash appeared again over both eyelids but was severly worse this time. I also had itchiness, redness and soreness at the injection site which lasted about a week after and I was administed the steroid cream again which made the rash disappear after about a week
45 2021-03-01 injection site hives, injection site redness Asthma flair - 6 hr till 36 hrs after shot. Fever 101.1 24 hrs after vaccine Body Aches Site of ... Read more
Asthma flair - 6 hr till 36 hrs after shot. Fever 101.1 24 hrs after vaccine Body Aches Site of injection Red, welt, hot Itchy. Took Asthma medication,, Tylenol
45 2021-03-01 hives Hives only on same side As shot . Neck back under arms
45 2021-03-01 hives Hives for 3 days. No relief with anihistamines.
45 2021-03-02 skin discolouration Patient DOB 9/21/75 sustained witnessed tonic/clonic seizure like activity with loss of consciousnes... Read more
Patient DOB 9/21/75 sustained witnessed tonic/clonic seizure like activity with loss of consciousness lasting <15 seconds with eyes "rolling back" and skin color change from normal for age/race to pale followed by bilateral upper extremity convulsions. Witnessed by monitoring area Registered Nurse. Hx: Seizures, last seizure secondary to codeine ingestion >1 y ago. Anxiety related to injections. Timeline: 1759- Vaccinated with Pfizer Lot # EN6199 1st dose 1805- adverse reaction occurred 1806- mental status: slow to respond, skin: pale/diaphoretic, VS: HR 51 (regular at the radial site), BP 80/palp, RR: 12, T: 36.8, Spo2 100% on RA 1807- 911 activated, placed in position of comfort. 1815- EMS arrived, EKG consistent with sinus bradycardia, HR 58, BP 150/130, RR 15, Spo2 100% on RA 1820- EMS placed patient on gurney. 1825- Departed via EMS gurney
45 2021-03-02 rash with redness Red rash on chest, back, neck, and arms (does not appear to be hives and does not itch); Two sudden,... Read more
Red rash on chest, back, neck, and arms (does not appear to be hives and does not itch); Two sudden, swollen nodules under my chin. Located in the center, almost directly under the center of my tongue. Very tender locally, externally; This is a spontaneous report from a contactable consumer, the patient. A 45-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number:EN5318), via an unspecified route of administration in the left arm on 15Feb2021 at 09:00 (at the age of 45-years-old) as a single dose, for COVID-19 vaccination. Facility where the most recent COVID-19 vaccine was administered was a workplace clinic. Medical history included known Drug Allergy to: Sulfa and Cipro antibiotics.. Concomitant medication included buspirone (BUSPIRONE), bupropion (BUPROPION), vitamin c [ascorbic acid] (VITAMIN C), vitamin d vitamin d [nos] (VITAMIN D), vitamin b complex (VITAMIN B). Historical Vaccine BNT162B2 received on 25Jan2021 at 09:00 Dose 1, Lot Number EN5318 in Left arm. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 17Feb2021 at 07:00 The patient experienced red rash on chest, back, neck, and arms (does not appear to be hives, two sudden, swollen nodules under my chin, located in the center, almost directly under the center of my tongue, very tender locally, externally. The events were considered non serious. No treatment was given for the event. The clinical outcome of the event Red Rash and Lymph nodes cervical swollen was not recovered.
45 2021-03-02 redness increased swelling and redness and neck tenderness and pain
45 2021-03-03 injection site rash fever, rash and swollen around the shot area, dizziness, fast heart beat a few minutes after receivi... Read more
fever, rash and swollen around the shot area, dizziness, fast heart beat a few minutes after receiving the second shot.
45 2021-03-04 rash, shingles rash; Shingles; intense burning; intense dizziness; body aches; fever of 102.7; left ear pain; This ... Read more
rash; Shingles; intense burning; intense dizziness; body aches; fever of 102.7; left ear pain; This is a spontaneous report from a contactable other health professional (patient). A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3249), via an unspecified route of administration in the left arm, on 25Jan2021 at 15:30 (at the age of 45-years-old) at a single dose for COVID-19 immunization. Medical history included atrial fibrillation (AFib), tachycardia, and allergy to proton pump inhibitors. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications, taken within two weeks of vaccination, included metoprolol tartrate (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231) on 04Jan2021 at 11:00 (at the age of 45-years-old) in the left arm for COVID-19 immunization. The patient experienced body aches and fever of 102.7 on 26Jan2021, left ear pain in Jan2021, intense burning and intense dizziness on 01Feb2021, and rash and shingles on 02Feb2021. The events were reported as non-serious. The clinical course was reported as follows: The day after the vaccination, 26Jan2021, the patient had body aches intermittently (reported as: not bad) and then spiked a fever of 102.7 the evening of 26Jan2021. The pain (per family recollection: complains of left ear pain) started about 28Jan2021 or 29Jan2021, but intense burning, pain, and intense dizziness started on 01Feb2021 with diagnosis of rash and shingles on 02Feb2021. Therapeutic measures were taken as a result of all of the events, which included valacyclovir (MANUFACTURER UNKNOWN) and prednisone (MANUFACTURER UNKNOWN). The clinical outcome of body aches, fever, left ear pain, intense burning, intense dizziness, rash, and shingles was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
45 2021-03-05 injection site warmth, injection site pruritus ?COVID arm? (according to the CDC a website): a large circle appeared on the right upper arm at the ... Read more
?COVID arm? (according to the CDC a website): a large circle appeared on the right upper arm at the injection site and was first noticed seven days after injection. Circle was approximately 6cm in diameter with darker red outline around slightly purple interior. Area was itchy and warm to the touch, but not raised. Ring was outlined when first noticed and did get slightly larger over 24 hours, but had almost completely disappeared approximately 36 hours after first being noticed.
45 2021-03-05 itchy skin Itching upper back, upper chest and mid torso.
45 2021-03-05 injection site swelling, injection site redness, injection site pain Redness, pain and swelling at injection site Fatigue Joint pain Muscles weakness
45 2021-03-05 itchy skin Significantly itchy nose and face. No hives.
45 2021-03-06 hives Approximately 3 - 5 minutes after the vaccine I got a very hot feeling in my chest. I then started... Read more
Approximately 3 - 5 minutes after the vaccine I got a very hot feeling in my chest. I then started to feel lightheaded and just weird. I was taken to lay down. My blood pressure was taken and it was elevated. I don't recall the exact numbers. I then began to develop hives on my chest and neck and a few minutes later I began coughing. An ambulance was already on site. They took me in the ambulance and gave me 25 mg of Benadryl and a dose of epi. The coughing subsided for about 10 minutes then began again. I was given another 25 mg of Benadryl. At the hospital I was observed. At approximately 5:30 I began to cough again. It was decided that I needed steroids and was given steroids in my IV. Once I stopped coughing I was discharged and sent home with a prescription for steroids and an Epi-pen
45 2021-03-07 bruising, redness redness, pain and swelling began 7 day post injection. I also have unexplained bruising on my leg an... Read more
redness, pain and swelling began 7 day post injection. I also have unexplained bruising on my leg and thigh
45 2021-03-07 skin discolouration thought she was going to die/She could have died; she couldn't speak/unable to speak very clearly; S... Read more
thought she was going to die/She could have died; she couldn't speak/unable to speak very clearly; She lost her voice completely; coughing; itchy throat; very hoarse voice/her voice goes and comes; she got very dark in her face; She had an allergic reaction from the Pfizer COVID vaccine; This is a spontaneous report from a contactable consumer (patient's mother). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration on the right arm on 17Feb2021 10:46 at a single dose for covid-19 immunization. The patient medical history included renal failure which she has had since 17Feb2020 and she was on dialysis which started on 04Dec2020. She had had a prior renal transplant before which was on 12Aug2004. Concomitant medications included prednisone, nifedipine (PROCARDIA [NIFEDIPINE]), clonidine, sevelamer, tacrolimus, carvedilol and repaglinide; all were taken from an unspecified date for an unspecified indication. She was on current medication for that for the renal failure. However, at the time of the vaccine her regular medication was on hold, she did not take it because she wanted to do the vaccine. The patient's mother reported that on 17Feb2021 her daughter has been having a lot of difficulty, she couldn't speak, she can't speak properly, unable to speak very clearly. She lost her voice completely/loss of voice, coughing, itchy throat, very hoarse voice, her voice goes and comes, and she got very dark in her face. The patient's mother thought that her daughter was having a stroke. The patient's mother also thought that the patient was going to die. She added that her daughter went to the ER and she still has problems and she could have died. She had an allergic reaction from the Pfizer COVID vaccine. She took the Pfizer vaccine at 10:46 AM. She can't speak now if she does it strains her voice then she was more hoarse. She said after the vaccine this occurred about 30 or 45 minutes. The patient was terrified, she was frightened because she wasn't able to speak. She had coughing, itchy throat, unable to speak clearly. The patient stated that she was dying. They had to get her to the hospital and she stayed over night for observation. She was discharged the next day, she stayed over night because they gave her medications they had to watch and take her vitals and blood work and they came back normal it was just the hoarseness but she had a bad allergic reaction. They gave her a lot of medications to go home on. She said that on 17Feb2021 she went to the hospital and she was discharged home 18 Feb2021. They were doing an EKG, a chest Xray, blood work, those test were being done to make sure her respiratory was okay. She had no swelling, no enlargement or they would have admitted her but all of that was normal and she was discharged home on 18Feb2021 on Solumedrol, Albuterol, Pepcid, Benadryl, Claritin. She had a terrible allergy. She said she was not admitted to the hospital they kept her for observation and she stayed in the emergency room for observation. They gave her an EpiPen. They discharged her home with an EpiPen and Prednisone 40 mg for 4 days. She said that the doctor said if you have an allergy, go to the nearest hospital and that was all being done. She asked what happens now because the patient was supposed to get a second dose but the patient's mother doesn't think so since the patient was terrified. The patient's mother said the vaccine was causing a lot of big allergies up there. She confirmed that it was her daughter experienced. Coughing itchy throat, loss of voice, unable to speak very clearly, and her face was very dark. She said hopefully someone will get back to her. She said the loss of voice after so many days, it has been 7 days now and her voice that way frightens the patient's mother. The outcome of the events was unknown.
45 2021-03-08 injection site pain On March 8th, I started my period 11 days early. I have 94 cycles tracked on my tracking application... Read more
On March 8th, I started my period 11 days early. I have 94 cycles tracked on my tracking application and my cycle does not deviate from 27-29 days. I had cramps and pain the 9th. the symptoms that started on 2/28 were normal: site of injection soreness, fatigue, some face flushing and flashes of hot and cold.
45 2021-03-08 rash macular Two large red blotches on upper arm. One on bicep and one on back of arm. Both sore to the touch.
45 2021-03-10 itchy skin Itching x 6 days after vaccine, ongoing myalgias, headache
45 2021-03-10 injection site swelling, injection site warmth, injection site redness, injection site pain Pain , Swelling at injection site Redness & warm to touch
45 2021-03-11 rash A few days after the vaccine I developed a rash on my torso including my stomach and back. It has b... Read more
A few days after the vaccine I developed a rash on my torso including my stomach and back. It has been approximately 4 weeks and I am still experiencing the rash. Dermatologist suggested it might be due to the vaccine.
45 2021-03-11 itchy skin, rash About an hour after the vaccine, I developed a rash on my neck and a slight itchy feeling. It's been... Read more
About an hour after the vaccine, I developed a rash on my neck and a slight itchy feeling. It's been about 5 hrs and it's gone down a lot but still feels tight, stingy. About 3 hours after the vaccine I developed 1 mouth ulcer on my lower lip.
45 2021-03-11 injection site pain Extreme soreness at injection site when moving muscle, joint pain, extreme aches, tiredness, fever
45 2021-03-11 hives Hives with facial flushing. No airway concerns. Received Benadryl, observed for 30 min and was disch... Read more
Hives with facial flushing. No airway concerns. Received Benadryl, observed for 30 min and was discharged home in a stable condition. BP 139/91, O2 sat 97 % RA, HR 68.
45 2021-03-11 itchy skin pt reported feeling itchy, elevated heartrate, nauseous, drowsy, tightness in chest. Pt informed vac... Read more
pt reported feeling itchy, elevated heartrate, nauseous, drowsy, tightness in chest. Pt informed vaccinator before injection that these side effects are common when she gets vaccinated. She took a dye free benadryl at home before her appt. She was checked on 15 minutes after the injection and she reported the above reaction. She wanted to go home but was convinced to remain in the waiting area and given 25mg gelcap of dye free benadryl. After waiting for a little while she decided to go home with the person she came to her appt with. She did not want to wait any longer. She said this reaction was not abnormal and she just wanted to lie down. She was told we will call soon to check on her.
45 2021-03-12 injection site pain On 3/8/21 around 4:45 pm I got the first dose of Pfizer COVID vaccine. In the evening around 11 pm,... Read more
On 3/8/21 around 4:45 pm I got the first dose of Pfizer COVID vaccine. In the evening around 11 pm, I experienced difficulty in breathing and had a slow heart rate. In addition to muscle pain on my left arm where I got the shot, whenever I almost felt into sleep I was startled and woke up from short of breath. I wore a watch to check on my heart rate. On the low end it went into 53 ~ 54 especially when I felt short of breath. On the high end it was around 67 ~ 70 which is my normal heat beat when at rest.
45 2021-03-12 bruising Sore left arm, bruise. Very sore, swollen lymph node. Sore upper left arm. No fewer and no other co... Read more
Sore left arm, bruise. Very sore, swollen lymph node. Sore upper left arm. No fewer and no other concerns. As of 3/13/21 still slight soreness.
45 2021-03-14 hives Body covered in hives; This is a spontaneous report from a contactable Other-HCP. A 45-years-old non... Read more
Body covered in hives; This is a spontaneous report from a contactable Other-HCP. A 45-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: 3246, dose number:2) via an unspecified route of administration on 03Feb2021 at single dose for Covid-19 immunization. Medical history included hypothyroid, subcutaneous lupus and allergic to sulfa, penicillin, phenergen from an unknown date and unknown if ongoing. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: Ek9231, dose number:1) via an unspecified route of administration on 12Jan2021 02:30 PM at single dose for Covid-19 immunization. Concomitant medications included levothyroxine sodium (SYNTHROID) and celecoxib (CELEBREX). On 05Feb2021 at 09:00 AM, the patient's body covered in hives. Then she took oral Benadryl as a treatment. The outcome of event was recovered. No follow-up attempts are possible. No further information is expected.
45 2021-03-14 injection site pain Day 1 soreness in sight injection and arm Day 2-3 soreness in arm and underarm area Day 4 sore throu... Read more
Day 1 soreness in sight injection and arm Day 2-3 soreness in arm and underarm area Day 4 sore throught, painful to swallow
45 2021-03-14 shingles, hives diagnosed with Shingles. March 4th, thought I had a pulled muscle, over the next few days, decided ... Read more
diagnosed with Shingles. March 4th, thought I had a pulled muscle, over the next few days, decided it was nerve pain and started looking into massage therapy for sciatica. A few days later hive developed and considered if it could be shingles. The next day I consulted a doctor and shingles was confirmed.
45 2021-03-15 injection site pain Exactly one week after shot, I experienced pain at the injection site. Pain spread from injection si... Read more
Exactly one week after shot, I experienced pain at the injection site. Pain spread from injection site to middle of arm. Left index finger joint pain. Friday, the joint was just sore. Saturday it was swollen and very painful. Attempted compression and heat therapy unsuccessfully. Sunday pain reduced to soreness. Today pain and soreness from arm and joint have ceased. Index finger joint affected is the one above palm of hand.
45 2021-03-15 hives Fever reaching 102.6 and hives treated with OTC antihistamine
45 2021-03-15 itchy skin Pt felt itching Benadryl 25mg given PO. Pt had her own and reported taking Benadryl 25mg before va... Read more
Pt felt itching Benadryl 25mg given PO. Pt had her own and reported taking Benadryl 25mg before vaccine as well.
45 2021-03-15 rash Rash on arms, neck, ears, and back
45 2021-03-16 hives Woke up with hives covering most of my entire body
45 2021-03-17 itchy skin, skin reaction, hives Approximatey 1hr after the vaccination, c/o of feeling internal itching all over but under the skin ... Read more
Approximatey 1hr after the vaccination, c/o of feeling internal itching all over but under the skin at 4:30. An hr later c/o "flu like symptoms e.g. aches and pains, then had to take a nap. Woke up the next morning c/o soarness, itching, and self-administred Zyrtec 1 po in a.m then again in the p.m. Felt some relief but a little achey just flu-like. Most of Sunday felt the same but Sunday approx 6p broken out into red whelts on the chest and back, throat felt like it was starting to close in and I went to the ER at approximately 8 p.m. Was given Prednasone 10 day pack, and Benadryl both p.o. Did receive somewhat relief from the Rx. Nothing was done to airway. Continues to c/o itching underneath the skin
45 2021-03-17 redness Face was bright red and flushed off and on fir a few hours.
45 2021-03-17 itchy skin Itching all over body. BP 141/99 (pulse 93), O2 sat 99%. Given Benadryl 25 mg PO.
45 2021-03-17 rash body rash; tachycardic; near syncope; This is a spontaneous report from a contactable other health c... Read more
body rash; tachycardic; near syncope; This is a spontaneous report from a contactable other health care professional (patient). A 45-year old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown) via an unspecified route of administration on the left arm on 05Jan2021 at a single dose for COVID-19 immunisation at the hospital. Medical history included asthma, clotting disorder and allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. However, it was reported that the patient had other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID019 prior to vaccination. The patient experienced body rash, tachycardia, near syncope on 20Jan2021. As a result, the patient went to the doctor office; clinic visit and emergency room/ department or urgent care. The patient received Cortisone injections, oral steroids and antihistamine in response to the events. The events were considered as non-serious by the reporter. The outcome of event recovering. Since the vaccination, the patient has not been tested for COVID-19. The patient received the second dose of bnt162b2 (lot number: el3246, expiration date unknown) on 26Jan2021 at 9:30 AM via an unspecified route of administration on the left arm at a single dose for covid-19 immunization. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Based on the information received, the reported serious events of Generalized rash, Tachycardia and Pre-syncope were plausibly consequent to single dose for COVID-19 immunisation. The impact of this report on the benefit/risk of profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
45 2021-03-18 injection site redness, injection site discomfort, injection site swelling, injection site hardening Burning almost immediately after injection while waiting during the 15 minute observation. No immedi... Read more
Burning almost immediately after injection while waiting during the 15 minute observation. No immediate swelling. Pinching sensation at site of injection throughout evening. Due to lack of visual change within an hour or two of injection, area not further observed. Next morning, observed injection site. It was/is swollen and with a small raised, white area at the immediate injection site. Red area surrounding pinpoint injection is approximately 2 inches in diameter and the area is firm with the firmness additionally extending beyond the red area. Would not describe this as a rash. Reporting due to lack of information reported about "Covid arm" relating to Pfizer as compared to Moderna reports of same reaction.
45 2021-03-18 itchy skin I waited at the clinic for 30 minutes, but when I left I realized that I was a bit dizzy, itchy (wit... Read more
I waited at the clinic for 30 minutes, but when I left I realized that I was a bit dizzy, itchy (without hives), and flushed. I took 50mg of Benadryl and waited in my car until I felt safe to drive again (about ten minutes). By evening, I felt like I had been punched in the left bicep. I also had some minor flu-like symptoms (muscle and join pain) that resolved with Tylenol. Today is two days after receiving the vaccine and I feel perfectly fine.
45 2021-03-18 injection site pain Swollen under arm lymph node (same side of the arm as injection site)-Did not go away until 3-4 days... Read more
Swollen under arm lymph node (same side of the arm as injection site)-Did not go away until 3-4 days after shot. Fatigue Injection site soreness Mild headache
45 2021-03-19 pain of skin, itchy skin 1. Hair follicle pain - started a few hours after injection, still having 2 days later 2. Itching al... Read more
1. Hair follicle pain - started a few hours after injection, still having 2 days later 2. Itching all over body - started 32 hours after injection, still itchy the next day
45 2021-03-19 cellulitis, injection site warmth, injection site swelling, injection site pruritus, injection site pain, injection site redness, redness Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection ... Read more
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: cellulitis, growing erythema, swelling, heat. Given ATB-Medium, Additional Details: Pt given ATB for increased swelling, erythema, heat. Pt has daily tracked progression. Site circled, currently 14 cm today in L detoid. Lot number of COVID-19 immunization not available to NP in Clinic.
45 2021-03-21 hives 2 hours after vaccine patient developed hives on legs. 24 hours after vaccine patient developed hiv... Read more
2 hours after vaccine patient developed hives on legs. 24 hours after vaccine patient developed hives on hands.
45 2021-03-21 injection site hardening, injection site swelling, injection site redness About 20 hours after first dose, I experienced extreme under eye puffiness. Also at injection site, ... Read more
About 20 hours after first dose, I experienced extreme under eye puffiness. Also at injection site, firm, swollen and red.
45 2021-03-21 injection site swelling Inflammation, swollen neck and underarm of the side the vaccine was given. Fatigue sensation and hea... Read more
Inflammation, swollen neck and underarm of the side the vaccine was given. Fatigue sensation and headache
45 2021-03-21 itchy skin Itching starting 10 minutes after vaccine to next day Severe headache on the 19th and 20th Severe ... Read more
Itching starting 10 minutes after vaccine to next day Severe headache on the 19th and 20th Severe fatigue on 19th
45 2021-03-21 rash Rash on torso and back: currently ongoing for 36 hours since a few hours after vaccine
45 2021-03-21 rash, itchy skin Rash, Severe itching. Can not take Benedryl
45 2021-03-21 skin warm, pain of skin Within 8 hours, felt very fatigued and had chills. Within 24 hours, lymph node under my left arm swe... Read more
Within 8 hours, felt very fatigued and had chills. Within 24 hours, lymph node under my left arm swelled to the size of a kiwi. Swelling gradually reduced over 2 days to the size of a large grape. Very hot and painful. I have never had such an extreme reaction to a vaccine.
45 2021-03-21 rash macular Within minutes of the COVID injection my heart was racing and fluttering with flushing and warmth in... Read more
Within minutes of the COVID injection my heart was racing and fluttering with flushing and warmth in my face. Resting heart rate was as high as 140 (measured by my Apple watch) prior to seeking medical assistance. After sitting in the waiting area for 20 minutes my pulse had slowed down to 100 (my resting heart rate is typically lower-mid 60s); however, my pulse was still high and I did not feel well and had started clearing my throat with mild tightness in my throat and chest. A doctor took my blood pressure reading was 140/78, typically my blood pressure is 105/65. My throat was not visibly swollen. At about 40min the EMT hooked me up to monitor my blood pressure, oxygen, pulse. At the same time I was being hooked to the monitor, my lower lip began itching and visibly showing minor swelling as well as minor swelling and red splotches in my cheeks and forehead. My heart was initially showing PVC but returned to normal. After being monitored for about 30 minutes my adverse reactions had slowed and stabilized to be released to go home. I took antihistamines and ibuprofen.
45 2021-03-21 redness after 10 min I started a headache, then felt lightheaded getting worse as time pass, then my lips st... Read more
after 10 min I started a headache, then felt lightheaded getting worse as time pass, then my lips started to tingling, then my cheeks, then my tongue. My cheeks started to get red and a bit swollen, then my breathing was getting weird, my blood pressure rise. At that moment I agreed to go in the rescue.
45 2021-03-21 injection site pain soreness at injection site, massive headache that subsequently turned into a migraine and lasted for... Read more
soreness at injection site, massive headache that subsequently turned into a migraine and lasted for 3 days, extreme fatigue that lasted for 3 days, sore throat, facial tingling and sensitivity.
45 2021-03-22 itchy skin 1335 Contact made with pt in observation as she came into the area. pt stated she was having itchin... Read more
1335 Contact made with pt in observation as she came into the area. pt stated she was having itching on her face and neck, also having an asthma attack. She was coughing, audible wheezing. Took 4 puffs from her own Proair inhaler and took 2- 25 mg Benedryl tab that she had with her. 1340 EMT at car. Pulse Ox 93% HR 107 they placed a O2 mask.1400 Alberturol Tx given by EMT and 50 mg Benedryl IM given. 1425 Pt feeling better and asked to be released. Released by EMT with ER warnings. Pt denied to administering nurse that she had a previous reaction with the Pfizer vaccine.
45 2021-03-22 redness 48 hours later moderate to severe facial swelling, erethema, worsening over 2 more days slowly subs... Read more
48 hours later moderate to severe facial swelling, erethema, worsening over 2 more days slowly subsiding after day 3 of benadryl
45 2021-03-22 skin warm 5 minutes after vaccine patient felt anxiety attack in chest, bottom of throat/ chest felt tight, he... Read more
5 minutes after vaccine patient felt anxiety attack in chest, bottom of throat/ chest felt tight, heart raced, shaking and sweating, hands trembled, light headed, felt both hot and cold at same time. Patient alerted pharmacist and sat down in chair. 23 minutes after vaccine patient not 100% but better, feel fuzzy in head, shaky and feel sweaty but not sweating, carpet looks weird (patient states has hallucinations from other drugs). 25 minutes after vaccine patient light headed, vision not perfect. 28 minutes after vaccine patient's body feels warmer 32 minutes after vaccine patient feels unbalanced, body warm, legs heavy. 36 minutes after vaccine patient's feet feel heavy, feel more normal, temperature difference, sweating stopped, feel more like herself. 39 minutes after vaccine patient's feet feel smidge heavy, feel like herself. 41 minutes after vaccine patient left observation.
45 2021-03-22 itchy skin, redness 5 minutes post injection, client c/o of itching every where; redness noted on upper chest, extending... Read more
5 minutes post injection, client c/o of itching every where; redness noted on upper chest, extending to face - just below the eyes and redness noted on upper back. Client denied respiratory symptoms at this time. Epinephrine 1:1000 0.5mg given IM @ 9:55AM. EMS contacted. Client transported to ER.
45 2021-03-22 itchy rash, rash with redness Approximately 15 minutes after receiving second COVID vaccine dose I developed a red somewhat itchy ... Read more
Approximately 15 minutes after receiving second COVID vaccine dose I developed a red somewhat itchy rash to chest, abdomen, back and bilateral arms. I was wheelchaired over to the Urgent care section of the building with a Dr following along. By the time I reached the Urgent Care room I was feeling the same strange feeling in my mouth tongue and throat that I had felt with the first vaccine. I felt as if my tongue and possibly lips may be swelling a little though I don?t think they were. It was hard to swallow but I have a mitochondrial disorder which causes trouble swallowing at times too so it may have been a little worse than what I usually feel with that. I seemed to be having trouble pronouncing words as my tongue seemed to be in the way and my voice weaker. By blood pressure was elevated as it was after the first vaccine. I was given a subcutaneous shot of epinephrine and the symptoms started to improve within approximately 15-20 minutes though I was very shaky and anxious from the epi. I was then given an IM injection of Benadryl. After possibly an hour and a half I was sent home with my husband an epi pen and a script for prednisone. I continued to have a strange feeling in my mouth and throat on and off for a couple of days but less severe and I did not use the epi pen for
45 2021-03-22 injection site redness, injection site pain Chills, muscle aches, fatigue, headache, redness and soreness at injection site- this occurred begin... Read more
Chills, muscle aches, fatigue, headache, redness and soreness at injection site- this occurred beginning 3 days later)
45 2021-03-22 rash with redness, hives, rash macular Pfizer-BioNTech COVID-19 Vaccine EUA: patient has a mild urticarial, erythematous, macular rash on f... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: patient has a mild urticarial, erythematous, macular rash on face, neck, and exposed area of chest that started four days after receiving vaccine. Lymph nodes are also swollen. Denies chest pain, shortness of breath, flu-like symptoms, fever, itching, or swelling at injection site. Patient has experienced urticarial symptomns with upper repiratory infections in the past. Provider recommended diphenhydramine and home management.
45 2021-03-22 injection site warmth, injection site swelling, injection site redness, injection site rash Rash below injection site. Red, hot, and swollen.
45 2021-03-22 hives approximately 3 days after vaccination developed full body hives, no respiratory or GI involvement, ... Read more
approximately 3 days after vaccination developed full body hives, no respiratory or GI involvement, no other plausible antecedent known. no h/o type 1 hypersensitivity reactions.
45 2021-03-22 injection site pain lethargy, low fever. swollen neck(both sides), painful arm and breast on same side of injection. sor... Read more
lethargy, low fever. swollen neck(both sides), painful arm and breast on same side of injection. sore throat
45 2021-03-22 rash with redness red rash face, neck, upper abdomen patient took Benadryl 25mg/10ml , symptoms resolved with in 3 ho... Read more
red rash face, neck, upper abdomen patient took Benadryl 25mg/10ml , symptoms resolved with in 3 hours
45 2021-03-22 injection site pain, injection site tingling severe Left shoulder pain, weakness, paresthesia's, changes in temperature, skin sensitivity consist... Read more
severe Left shoulder pain, weakness, paresthesia's, changes in temperature, skin sensitivity consistent with brachial neuritis
45 2021-03-23 injection site pain I woke up with severe chills from 4am-10am and then had fever of 103 plus that afternoon, could bare... Read more
I woke up with severe chills from 4am-10am and then had fever of 103 plus that afternoon, could barely get up out of bed, nausea, weakness, dizziness. Aches all over my body and joints especially, intense headache, pain at injection site. The next night, same thing, woke up at 5am with chills and fever of 103 plus and all the other symptoms the second day. I was in so much pain I considered going to the doctor but could barely move. Tylenol did not touch it. I was delirious. The third night/day the fever finally had broken but I was still super weak and tired. The next day I was better. Anyway, if I had the option I would not take the vaccine again because of these side effects.
45 2021-03-23 redness, injection site pain, itchy skin Redness/Flush Face within minutes, Minor itching Migraine headache within hours including Jaw pain M... Read more
Redness/Flush Face within minutes, Minor itching Migraine headache within hours including Jaw pain Muscle tightness in neck and shoulders Soreness at injection site
45 2021-03-23 injection site redness, injection site reaction, injection site pain, skin warm, injection site swelling Swollen, red area at injection site. Painful and hot to the touch. Worsening each day over past 2 ... Read more
Swollen, red area at injection site. Painful and hot to the touch. Worsening each day over past 2 days
45 2021-03-23 vaccination site pain exhaustion; headache; nausea; vomiting; chills; Low grade fever; general feeling of unwell; soreness... Read more
exhaustion; headache; nausea; vomiting; chills; Low grade fever; general feeling of unwell; soreness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6201,), intramuscularly, on 18Feb2021 at 15:00 (at the age of 45-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history was reported as "None." She is allergic to sulfa drugs and penicillin. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9264) on 28Jan2021 at 13:30 as a single dose in the left arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The vaccination was administered to the patient at a Public Health Clinic. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN) and vitamin D (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Feb2021 at 07:00, the patient experienced fatigue, chills, headache, nausea, vomiting, low grade fever, exhaustion, general feeling of unwell, soreness at injection site. The patient did not receive any treatment for the events. The clinical outcomes of the events fatigue, chills, headache, nausea, vomiting, low grade fever, exhaustion, general feeling of unwell, and vaccination site pain were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
45 2021-03-24 pain of skin 1. Felt arm soreness after shot and tried to move around around a lot and flex muscle to reduce sor... Read more
1. Felt arm soreness after shot and tried to move around around a lot and flex muscle to reduce soreness. 2. Started feeling chills, muscle aches, headache and nausea around 9:00PM. 3. Began vomiting around 11:00PM, with other symptoms remaining. Vomited about 3 separate times that evening. 4. The following day, felt chills, muscle ache, joint ache, skin pain, nausea, headache and arm pain, along with sore throat (probably caused by previous night's vomiting). I had very low energy and did not want to eat or drink anything. I began taking Tylenol every 6-8 hours and taking Pepto Bismol as needed to address the nausea. 5. The symptoms continued, but lessened each day over the course of the next 5 days. I anticipate symptoms will continue to reduce over the next 1-2 days, and no treatment will be needed.
45 2021-03-24 itchy skin 5 minutes post administration: Throat tightness, facial tightness, itching to throat, chest, and upp... Read more
5 minutes post administration: Throat tightness, facial tightness, itching to throat, chest, and upper extremities. Treated in ER: EPINEPHrine 1mg/mL injection 0.3mg IM, diphenhydramine 50mg IV, Solu-Medrol 125mg IV, d/c to home with Rx for prednisone 50mg 1 tablet by mouth daily x5 days. Pt kept in observation for 4 hours post Epinephrine/diphenhydramine/solumedrol with marked improvement. D/c to home for continued care with PCP in community.
45 2021-03-24 bruising Bruising on right side of body from broken blood vessel near carotid artery
45 2021-03-24 vaccination site hardening, vaccination site redness, vaccination site warmth Coughing; Dizziness; Vaccine site became red, hot, hard; Vaccine site became red, hot, hard; Vaccine... Read more
Coughing; Dizziness; Vaccine site became red, hot, hard; Vaccine site became red, hot, hard; Vaccine site became red, hot, hard; Fever; Body aches; She felt like she was going to die; feels awful; Constipation; Couldn't keep her eyes open; Chills; Sore arm; Tired; couldn't keep her eyes open; Nauseousness; Lightheaded; it felt like someone was playing with my head and controlling her memories; sugar levels going up; This is a spontaneous report from a contactable consumer (patient). This 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN6205 and expiration date 30Jun2021 received on 03Mar2021 as a single dose (at the age of 45 years), unspecified route in left arm for COVID-19 immunisation. History included thyroid removed in 2014 and diabetes in 2019 (diagnosed about a year and a half ago), Cirrhosis liver, fatty liver. Concomitant medications include metformin for diabetes, glyburide for diabetes, levothyroxine sodium (TIROSINT) for thyroid disorder, cetirizine hydrochloride (ZYRTEC), omeprazole, ascorbic acid (VITAMIN C), zinc, ergocalciferol (VITAMIN D), bifidobacterium lactis (PROBIOTIC), fluticasone propionate (FLONASE), albuterol (SALBUTAMOL), and budesonide, formoterol fumarate (SYMBICORT). Following the vaccination on 03Mar2021, she came home at night with sore arm and started getting chills. She felt very nauseous. She could not open her eyes anymore. She went to sleep and woke up in the middle of the night. She felt like someone was controlling her memories. It felt like someone is taking away memories (Mar2021) and she was trying to hold on. Like something was messed up in her head. The next day she woke up with a sore arm and felt fine. She had a little nauseousness but it was controlled. On Friday (04Mar2021), the vaccine site became red, hot, hard, and had a white ring around it. The more red it became the more fever, nauseousness, and constipation she had. She couldn't keep her eyes open. She started coughing. She had to use her inhalers even more. Her inhalers are Albuterol and Symbicort and she doesn't have a lot number to provide for her inhalers. All day she felt that way. She felt like she was going to die, has body aches. It was awful. She also had dizziness at nighttime she took the ice pack and froze her arm because she couldn't take it anymore. Saturday, 05Mar2021 she woke and still had dizziness and couldn't go to the bathroom. She feels nauseous. She can't keep her eyes open. Sunday (06Mar2021) it was better (unspecified events), but she is not herself. Ever since then she feels like she is always tired. Today it has been a week after and she is so tired. She called the number and one of the representatives said she wouldn't do the second dose. The doctor said it is side effect. She also reported that she is lightheaded. She said her sugar numbers have been sky high. She told the nurse that it didn't hurt like the flu shot. She did not have NDC, lot, and expiry to provide for flu shot. Lab information in Mar2021 included Sugar levels were up and weight: 203 to 205 pounds. Outcome of events was unknown.
45 2021-03-24 injection site pain Fever, chills, body aches, soreness at injection site
45 2021-03-24 rash, redness Instant Lupus flare; Instant extremely high blood pressure and pulse rate; Instant extremely high bl... Read more
Instant Lupus flare; Instant extremely high blood pressure and pulse rate; Instant extremely high blood pressure and pulse rate; Instant red face; tightness in chest/Instant hot fire feeling in stomach and chest.; Instant hot fire feeling in stomach and chest; Shortness of breath; Sore throat; diarrhea; upper back pain; Tiredness; rash on arm; chills; insomnia; This is a spontaneous report from a contactable consumer. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 18Mar2021 08:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included lupus, high blood pressure, asthma, anemia. No pregnant. No covid prior vaccination. No known allergies. No other vaccine in four weeks. Other medications in two weeks. The patient's concomitant medications were not reported. The patient experienced instant lupus flare, instant extremely high blood pressure and pulse rate, instant hot fire feeling in stomach and chest, instant red face, shortness of breath, tightness in chest, sore throat, diarrhea, upper back pain, tiredness, rash on arm, chills, insomnia on 18Mar2021 08:15 with outcome of recovered. The patient underwent lab tests and procedures which included heart rate: instant extremely high, blood pressure measurement: instant extremely high, sars-cov-2 test(Nasal Swab): negative on 07Jul2020, on 11Nov2020, on 15Dec2020, on 01Feb2021. Treatment received as Emergency care and needed extra bp and Lupus meds. The patient experienced Emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). Information on the Lot/Batch number has been requested.
45 2021-03-24 redness, skin warm, itchy skin Patient stated her face was feeling itching and was hot. Patients face was red and warm to touch. Pa... Read more
Patient stated her face was feeling itching and was hot. Patients face was red and warm to touch. Patient was given 10mg of oral cetirizine. Patient observed for 30 minutes in observation area. Patient went home with spouse, stated she was feeling better. Redness in face resolved.
45 2021-03-24 itchy skin Pt received 1st COVID vaccine on 2/23/21. Returned to clinic on 3/17/21 for 2nd dsoe. Reports "being... Read more
Pt received 1st COVID vaccine on 2/23/21. Returned to clinic on 3/17/21 for 2nd dsoe. Reports "being itchy without any rash on various parts of the body" about a week after injection. Also reported no appetite and a dry mouth along with being weak and tired. Denied any dyspnea, rash, or other s/s allergic reaction or anaphylaxis. States s/s resolved after 1-1.5 weeks. Did not seek medical care. States "she thinks it may have been pre- or post- menstrual issues and/or supplements". Also states she had had rash in December 2020 of unknown cause. Reports she used "allergy cream then and was sick to her stomach" and was resolved before first dose.
45 2021-03-24 rash Soreness in arm; Rash covering neck, chin, scalp, ears, arm (non-shot arm)
45 2021-03-25 injection site pain, injection site swelling Next day fever up to 100.8 with Tylenol, joint aches and pain, fatigue, injection site pain radiatin... Read more
Next day fever up to 100.8 with Tylenol, joint aches and pain, fatigue, injection site pain radiating 2 inches out in radius. At 48 hours woke with tenderness and swelling of underarm on injection side (lymphadenopathy).
45 2021-03-25 redness, rash with redness, itchy skin, hives, rash Really sore arm the day after. Developed a full body rash anout 36 hours after the shot. 48 hours la... Read more
Really sore arm the day after. Developed a full body rash anout 36 hours after the shot. 48 hours later developed a bright red. burning and painful rash on my face. On day 3 I went to work and underneath my right eye started to swell up and a red streak from the inner corner of my eyelid went down my face. On day 4 I woke up with both eyes swollen. I started on benedryl. 2x a day. The redness, welts and hives traveled down my face, onto my neck, then up my forehead and onto my earlobes. On March 22, day 5, I woke with even more swelling on my face and both eyes. The rash was very bad. I called my primary care physician and made an appointment to see him on Tuesday. I went for that appointment and dr. gave me antihistamines, took pictures and reported it to CDC. I started the antihistamines, but on Day 7, I woke up with the worst of it. Hives all down my neck, lips swollen, bruising and swollen eyes and itchy red rash everywhere. I called the dr back and started prednizone steriods. Today, March 26, it is starting to calm down.
45 2021-03-25 rash, itchy skin Symptoms felt at 8p on day of vaccination (6 hours after dose): Pain Swelling Symptoms beginning T... Read more
Symptoms felt at 8p on day of vaccination (6 hours after dose): Pain Swelling Symptoms beginning Tuesday, 3/23/2021, one day after dose: Rash Symptoms beginning Thursday, 3/25/2021: Itching
45 2021-03-25 hives, itchy skin c/o itching that started 15mins after vaccine, pt completed observation period then advised RN of it... Read more
c/o itching that started 15mins after vaccine, pt completed observation period then advised RN of itching. Red diffuse hives obs. on pts abd, hands, and chest Vitals: @526 BP 144/99, HR 70, RR 14, O2SAT 98% @534P BP 130/92 HR 68, RR 14, O2SAT 98% @540 BP 11/96, HR 67, RR 14, O2SAT 97% @545 BP 132/94 HR 64, RR 14, O2SAT 99% pt declined benadryl po, did not have anyone to drive her home. Pt. observed until itching and hives resolved. Spontaneous resolution of Itching. Pt discharged to self, alert oriented. Recommended, follow up with primary care provider.
45 2021-03-25 injection site pruritus patient got pruritus and itching around injection site
45 2021-03-26 hives Whole body inflammation, tingling and pain from neck to fingers down right arm. Also, hives from rig... Read more
Whole body inflammation, tingling and pain from neck to fingers down right arm. Also, hives from right forearm to elbow.
45 2021-03-27 injection site pruritus, injection site redness, injection site hardening, injection site warmth, injection site pain ?COVID ARM?: red circle, tender, hard and warm to the touch, itchy below the injection site. Adverse... Read more
?COVID ARM?: red circle, tender, hard and warm to the touch, itchy below the injection site. Adverse reaction noticed on the 8th day after first dose was given. 1st dose given on 3/19/2021. Delayed adverse reaction on right arm noticed on 3/27/2021.
45 2021-04-01 rash Tachycardia; Rash; This is a spontaneous report from a contactable healthcare professional. This is ... Read more
Tachycardia; Rash; This is a spontaneous report from a contactable healthcare professional. This is the second of two reports for the same patient with reoccurring events separated in time. A 45-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose (Batch/Lot Number: UNKNOWN) via an unspecified route of administration on 26Jan2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The vaccination was received at the hospital. Medical history included asthma, clotting disorder and allergies. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included unspecified medications. It was reported that the patient had received other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 on 05Jan2021 for COVID-19 immunisation and experienced tachycardia, rash and presyncope. The patient developed tachycardia and rash which started approximately 2 weeks after the first vaccine and worsened after the second vaccine on 26Jan2021. The tachycardia and rash required a visit to the Emergency Room and Physician Office. Treatment included steroid injections, oral steroids and Diphenhydramine (BENADRYL). The patient was not admitted to the hospital. The outcome of event tachycardia was recovered on an unknown date. The outcome of event rash was recovering. The healthcare professional reported casual effect of the events tachycardia and rash to the vaccine. The lot number for the vaccine was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of tachycardia and rash due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021092876 same patient/reporter, different vaccine dose and event.
45 2021-04-08 rash, itchy rash Headache, stomach pain, chills, tiredness, general body ache. Rash on the skin (the itch lasted more... Read more
Headache, stomach pain, chills, tiredness, general body ache. Rash on the skin (the itch lasted more than a week). Since the vaccine I have felt inflammations in the body in general.
45 2021-04-15 skin warm, redness I had my first dose of Covid vaccine, Pfizer 30ug at 3:40pm on 4/8/21. 1 day after my first dose I s... Read more
I had my first dose of Covid vaccine, Pfizer 30ug at 3:40pm on 4/8/21. 1 day after my first dose I started have low fever(98.8-99.2f). 2 days after my first dose of Covid vaccine my left breast start being painful and start whole body ache. 4 days after first dose my left breast start having an half egg size painful touchable lump with red, warm and swelling. I started taking Acetaminophen 10 mg bid. 4 days on 4/11 till today after first dose for both pain control and reducing body temperature. I used to have granulomatous mastitis on my right breast which is self limited and I had not have this problem for one year. Although the mechanism is still unclear but some theory of this disease is more like an autoimmune problem. I doubt somehow this vaccine has too strong immunogenicity, or at least which is too strong for me. I was getting Pfizer which is 30ug I think. Possibility: 1 Too large dose for my body size (120 lb) 2 Some adjuvant in this Pfizer vaccine induces too strong cellular immune response which may initiate or help for some none Covid specific antibody production, unfortunately for some patients who have autoimmune disease are triggered by this vaccine then they may start producing autoimmune antibody which start self attacking.
45 2021-04-20 shingles immune system was low; shingles; heart attack; This is a spontaneous report from a contactable consu... Read more
immune system was low; shingles; heart attack; This is a spontaneous report from a contactable consumer (patient) via Medical Information, also received via Pfizer-sponsored program. A 45-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Mar2021 as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Within 5 hours after receiving the dose, she developed shingles on 23Mar2021. She stated the pain was so bad she thought she was having a heart attack on an unspecified date in 2021. Her medical doctor (MD) told her that she should get the second dose of the vaccine and that the shingles was dormant in her system and because her "immune system was low" she developed the shingles outbreak. The patient further stated that she developed shingles 4 hours later after receiving the first dose. She stated that the eruptions have stopped but it was still painful. She was asking if she should get the second covax or wait. The patient had not yet recovered from shingles while outcome of the rest of the events was unknown. Follow-up attempts are needed. Further information on the lot/batch number has been requested.
45 2021-04-21 shingles Shingles outbreak on face.
45 2021-04-21 redness arm felt tingly when shot went in and immediately started to hurt on forearm between elbow an wrist.... Read more
arm felt tingly when shot went in and immediately started to hurt on forearm between elbow an wrist. immediately that area swelled up and turned red. today (4/22) it is still significantly swollen, though swelling has decreased. also immediately felt "spacey" and feet and forehead felt tingly. within 30 minutes it felt odd to walk because legs/feet felt a bit numb. the spacey feeling stayed for 6 full days during which i felt exactly the same as i had when i had a concussion about 6 years ago. i could think but i couldn't multi-task, communicate well, focus well, speak normally. it's hard to explain but it felt like i had a concussion and it was really scary. i tried to drive at day 6 and realized i could not do it. by day 7, my head started to clear up and i felt better mentally.
45 2021-04-27 injection site pain I started to get muscle twitching in my left arm, it moved to my breast bone and around to the upper... Read more
I started to get muscle twitching in my left arm, it moved to my breast bone and around to the upper portion of my rib cage. I also experienced quite a bit of deep muscle pain around the injection site and extreme tiredness. I spoke to my doctor and he prescribed cyclobenzaprine for the twitching
45 2021-04-29 injection site pain, injection site mass Within seconds/ less than a minute of receiving the vaccine, I felt heat rush up through left side o... Read more
Within seconds/ less than a minute of receiving the vaccine, I felt heat rush up through left side of neck... Then underneath my eye / crawl / felt strange like swelling. Then within 5-10 min my skin on left side of head crawl .... But ok within an hour. Only on left side. Also, no pain at all didn't even feel needle go in but had lump at injection site and painful when touched until Day 12.
45 2021-04-30 vaccination site pain, itchy skin Arm weakness/leg weakness; Little irritation at the injection site; Minor headache off and on; Leg p... Read more
Arm weakness/leg weakness; Little irritation at the injection site; Minor headache off and on; Leg pain/really bad arm pain in the left arm with lifting and movement/arm pain; Itching on chest and arms; Tenderness in injection site; Neuropathy; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6955; Expiration date was not reported) on the left arm on 27Mar2021 (19:55) as a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital (not a military facility). The patient had no relevant medical history. Concomitant medications included cetirizine hydrochloride (ZYRTEC). On an unspecified date in 2021, the patient had neuropathy. On 27Mar2021, the patient had minor headache that was off and on; leg pain and really bad arm pain (left arm) with lifting and movement; itching on the chest and arms; and a little irritation at the injection site. On 28Mar2021, the patient had arm and leg weakness. In Mar2021, the patient had tenderness at the injection site. The patient had received diphenhydramine (BENADRYL) as treatment for the itching on the chest and arms. The patient's x-ray was normal on an unspecified date in 2021. The outcome of the events was not recovered for 'arm and leg weakness'; recovered on 27Mar2021 for 'itching on the chest and arms'; and was unknown for all the other events. The patient was scheduled to receive the second dose of vaccination, but did not want to risk having the same effects in the right arm.
45 2021-05-04 rash, itchy skin, blister Bells Palsy on right side of face; Severe rash on hands, trunk, neck; large blister like bumps on ha... Read more
Bells Palsy on right side of face; Severe rash on hands, trunk, neck; large blister like bumps on hands, trunk and head: itching; itching; facial swelling/ swelling in face; hand swelling/ swelling in hands; tingling in lips; some mild difficulty swallowing; throat swelling; mild difficulty breathing; numbness; swelling in mouth; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 06Apr2021, this case now contains serious adverse reaction. Information processed together. This is a spontaneous report from a contactable healthcare professional (HCP) (patient). A 45-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose on 05Feb2021 15:00 (lot: EN6201) and second dose on 25Feb2021 15:00 (lot: EN6205); both via an unspecified route of administration in left arm (at the age of 45-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was a public health department. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient have not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to bnt162b2. Medical history included known allergies Sulfa, bee stings, shellfish and Ceclor. Concomitant medications included armodafinil; clonazepam; vortioxetine hydrobromide (TRINTELLIX), also Tooo Max and an unspecified vit. The patient experienced Bells Palsy on right side of face; throat swelling; itching; mild difficulty breathing; severe rash on hands, trunk, neck; numbness; swelling in mouth; large blister like bumps on hands, trunk and head: itching; facial swelling/ swelling in face; hand swelling/swelling in hands; tingling in lips; some mild difficulty swallowing on 02Mar2021 at 15:00. The patient considered the case as non-serious, did not result in death, non-life threatening, did not cause/prolong hospitalization, non-disabling/incapacitating and non-congenital anomaly/birth defect. The events resulted doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received prednisone, cetirizine hydrochloride (ZYRTEC), omeprazole (PRILOSEC), methylprednisolone sodium succinate (SOLU-MEDRO) IV at ER as treatment. The outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
45 2021-05-07 itchy skin, hives Severe allergic reaction; Fainting; Hives; Itching; Burning; Shortage of breath; This is a spontaneo... Read more
Severe allergic reaction; Fainting; Hives; Itching; Burning; Shortage of breath; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 09Apr2021 08:45 as single dose for COVID-19 immunization in an hospital. Medical history included known allergy from an unknown date. There were no concomitant medications. No other vaccines taken in four weeks. No COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. On 10Apr2021 13:00, the patient experienced severe allergic reaction - hives, itching, burning, shortage of breath, fainting. She was unable to stand or sit, and had to call ambulance and go to emergency. The events resulted in emergency and physician's office visit and required hospitalization. The patient was given a steroid and unspecified allergy medications as treatment. The outcome of the events was reported as recovered. Information on the lot/batch number has been requested.
46 2020-12-31 rash, redness Pt endorses onset of 2.5 hours ago. Endorses associated rash, numbness, palpitations, and elevated b... Read more
Pt endorses onset of 2.5 hours ago. Endorses associated rash, numbness, palpitations, and elevated blood pressure. She reports getting the COVID-19 vaccine this morning, and after having been given the vaccine developed elevated blood pressure, palpitations described as "her heart feels hot", shortness of breath, a diffuse rash, and some generalized numbness. Patient called EMS after her symptoms did not resolve on their own, who gave her 50mg of IV Benadryl and transported her to the ED. Received solumedrol and famotidine IV in ED. Erythema noted on neck  
46 2021-01-02 rash, rash macular, hives, itchy skin 4 days after vaccine I got a blotchy rash on lower back, itchy hives. On day 5 I had blotchy itchy h... Read more
4 days after vaccine I got a blotchy rash on lower back, itchy hives. On day 5 I had blotchy itchy hives on neck, part of face, upper and lower back, a spot on buttock cheek. Also have some itchy spots in under arm area. I took a Loratidine 10mg 24 hour tab to help with itchy hives.
46 2021-01-02 itchy skin, rash Rash spreading both arms. Itching all over.
46 2021-01-02 redness, itchy skin Started to lose voice and clearing throat- took benedryl as suggested , stayed an extra hour for obs... Read more
Started to lose voice and clearing throat- took benedryl as suggested , stayed an extra hour for observation, left on my own. Noticed face was swollen and red after showering- took photo. Cough and clearing throat like when I eat something I?m allergic to. Took another benedryl four hours later as well as Tylenol for headache. Ate dinner went back to sleep notice arm hurts a bit. Next morning 9 am face no longer swollen but arm hurting to the slightest touch. 4:30 pm still resting arm very painful . Headache and facial swelling under control. At no time did I have trouble breathing, slight itching
46 2021-01-03 injection site pain, injection site redness, injection site mass On day two I noticed a golf ball sized lump at injection site. It was there until day 4 or 5 when it... Read more
On day two I noticed a golf ball sized lump at injection site. It was there until day 4 or 5 when it started to go away, but never went away completely. It was sore, but not very painful. On day 10, I noticed it was more sore and now there is a lot of redness over injection site. The lump is a little bigger, but not as big as it was originally.
46 2021-01-03 injection site warmth, injection site redness, injection site pain, injection site mass Patient states she was advised by nurse that because it was intermuscular (triceps), it may be becau... Read more
Patient states she was advised by nurse that because it was intermuscular (triceps), it may be because she is experiencing a headache that lasted 36 hours, also fatigue for 5 days, also joint stiffness for 7 days and she states she felt very sore and stiff and had a hard time walking up and down stairs without feeling shortness of breath. Said she felt "run down". On day 8 (12/31) she felt a lump like a mosquito bite. Day 9 the injection site became red and became very hot to touch. No fever reported. She was advised to see a nurse and was advised it could be hypersensitivity and to report this. This happened on 01/02/2021
46 2021-01-03 hives Throat swelling, urticaria
46 2021-01-03 itchy skin, redness, hives Triage for COVID 19 SEVERE post Vaccine Reaction VAERS reportable Your concerns: Vaccine at noon wi... Read more
Triage for COVID 19 SEVERE post Vaccine Reaction VAERS reportable Your concerns: Vaccine at noon without immediate effect. Driving home at 1400 developed itching and redness at scalp, face, neck, chest, back, arms and sides. Reports that she did not feel warm but looked like she had a sunburn. It appeared to fade over the next two hours but re-occurred at 1700 with all previous symptoms. She took 50mg of Benadryl and went to sleep. She woke at 0200 the re-occurrence of all symptoms, she did not take any Benadryl as that would make her too sleepy to come to work. The symptoms subsided and when we spoke at 1050 she had only small bumps/hive like spots on her fore arms and cleavage. They do not itch or burn at this time. Discussed with PA and Dr. after which I spoke with patient again regarding pending plan. She will call the clinic if she has any further symptomatic episodes in the near future. We will investigate moving her second dose ahead 2 days from 1/12/2021 (day off) to 1/14/2021 this way she will be here at work should it happen again, she works 0630-1900. Med provider will consult with allergy to determine if further steps are needed for dose #2. Dept: Respiratory Therapy Have you missed work? #shifts: none Did you seek emergency care? none Date and Time of Vaccine: 12/22/2020 at 1200 Age at time of vaccination, 46 years 6 months Sex: female Was the vaccine received at facility? yes Site of vaccine (LD or RD): RD Type of Vaccine Pfizer (X ) Moderna ( ) Other _______________ 1st or 2nd dose: first When did your symptoms start? 12/22/2020 at 1400 Please note reported symptoms yes or no, these symptoms are considered mild to moderate and are NOT VAERS reportable Injection site pain no Tiredness no Headache no Muscle Pain no Chills no Joint Pain no Fever (note temp if known) no Injection Site Swelling no Injection Site Redness no Nausea no Feeling Unwell no Swollen Lymph Nodes (lymphadenopathy) no Other: no Employee reports THE FOLLOWING SEVERE post vaccine ADVERSE reactions (reportable): Difficulty breathing no Swelling of your face and throat no A fast heartbeat no A bad rash all over your body yes, see above Dizziness and weakness no If COVID-19 symptoms persist and/or worsen beyond 48 hours consider COVID-19 testing Treatment/Advise: see above Plan: see above If employee was vaccinated at another facility, they need to contact that facility , it is an expectation that the facility that gave the vaccine complete the VAERS report. N/A Employee verbalizes understanding and agreement with plan. yes VAERS report is completed electronically vaccine given at facility. Pending further review. 12/24/2020 01:51pm Follow up to VAER 12/23/2020 Patient called this morning to update regarding vaccine reaction. Yesterday she went home and did some shoveling. Later, around 1900, she developed a itchy, red rash that started on her chest and the right side of her neck which later covered her entire body. The skin on her face was bright red and very hot to the touch, there were small raised hives on her face which were likened to 'petechia if they were raised'. She took pictures of the raised/red areas. She took 50mg of Benadryl and went to sleep, when she woke at 0230 she was asymptomatic. Regarding the bumps on her forearms and cleavage, she has residual mottling on her arms. Updated providers.
46 2021-01-03 redness Turned red and flushed within 5 minutes of vaccine administration. Lasted for about 60 minutes. N... Read more
Turned red and flushed within 5 minutes of vaccine administration. Lasted for about 60 minutes. No issues breathing.
46 2021-01-04 redness Anaphylactic reaction ( swelling and redness of face and torso, shortness of breath, constriction of... Read more
Anaphylactic reaction ( swelling and redness of face and torso, shortness of breath, constriction of airway and dizziness)
46 2021-01-04 redness Anaphylaxis Narrative: 12/22 received COVID-19 vaccine at 1209 and developed SOB at 12:15. Took her ... Read more
Anaphylaxis Narrative: 12/22 received COVID-19 vaccine at 1209 and developed SOB at 12:15. Took her own albuterol inhaler without relief. Transported to ED. PE: red hands with swelling, throat and lip swelling with difficulty swallowing. Later developed headache and dizziness then tachypnea and stridor. Meds given - See section 5 PLUS epinephrine IM and infusion @ 0.05 mcg/kg/min, Alb and ipratropium negs, racemic epi nebs. Admitted to the hospital on 12/22 and still hospitalized at the time of this report on 12/23. She remains on an epinephrine drip and was given methylprednisolone 125 mg IV x 2. No previous history of anaphylaxis. History of Reye's syndrome as a child when given aspirin.
46 2021-01-04 redness At 2pm, I felt very tired like I hadn't slept all night with warm rosy cheeks-low fever. I took an ... Read more
At 2pm, I felt very tired like I hadn't slept all night with warm rosy cheeks-low fever. I took an 800mg and went to bed, woke up the next morning feeling great with no reactions.
46 2021-01-04 injection site pain At about 10pm the injection site pain had radiated to my armpit and breast area. I took ibuprofen an... Read more
At about 10pm the injection site pain had radiated to my armpit and breast area. I took ibuprofen and tried to go to sleep. I was unable to sleep on my left side as normal. Around 12:30am I woke up cold, shivering violently, with a fever of 103.°3. My feet were also burning. I woke up around 2:30am. Fever was down to about 102.4°, feet were still burning and my face and eyes were swollen. I took more ibuprofen and put used cold compress on my eyes. Around 4:30am I woke up with abdominal pain and pain in my hips. Fever was lower, eyes were better but face still swollen and feet still burning. I called off work at that time. By about 8am fever broke and have just had an intense headache.
46 2021-01-04 rash, itchy rash, rash with redness Fine rash developed on arms and legs; Red, itchy patches on abdomen, back, neck and chin; Hot, burni... Read more
Fine rash developed on arms and legs; Red, itchy patches on abdomen, back, neck and chin; Hot, burning sensation to palms of hands and soles of feet; Red, itchy patches on abdomen, back, neck and chin; Hot, burning sensation to palms of hands and soles of feet; This is a spontaneous report from a contactable nurse, the patient. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EJ1685), via an unspecified route of administration on 25Dec2020 at 03:00 PM (at the age of 46-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. Medical history included anemia. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Concomitant medication included ethinylestradiol, etonogestrel (NUVARING) (MANUFACTURER UNKNOWN) and iron (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took sulfa (MANUFACTURER UNKNOWN), from unknown dates to unknown dates for unknown indications and experienced allergy. On 25Dec2020 at 08:00PM, a fine rash developed on arms and legs. Red, itchy patches on abdomen, back, neck and chin. Hot, burning sensation to palms of hands and soles of feet. The patient did not receive any treatment for the events. The clinical outcome of the events rash on legs & arms, Red, itchy patches on abdomen, back, neck and chin, and Hot, burning sensation to palms of hands and soles of feet was recovered on an unspecified date in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19. There were no other vaccines the patient received within 4 weeks of the vaccination.
46 2021-01-04 shingles, rash I experienced Fatigue, chest tightness, and increased blood pressure the first 2 days. Day 5 I start... Read more
I experienced Fatigue, chest tightness, and increased blood pressure the first 2 days. Day 5 I started having pain in my upper back, left side. The next day had increased discomfort and developed a rash. Today, it is extremely painful and spread from the upper back to across my left breast. My PCP agrees that it is Shingles. I am beginning a course of Valtex today, to lesson the severity of symptoms.
46 2021-01-04 injection site swelling, injection site redness Never pregnant, swelling and redness at injection site, Nausea in the morning, slight fever, no brea... Read more
Never pregnant, swelling and redness at injection site, Nausea in the morning, slight fever, no breathing difficulties, and weakness. Tylenol helped.
46 2021-01-04 hives Patient had SVT; flushing; hives; heart rate increased to 160's (had been 180's earlier in the day);... Read more
Patient had SVT; flushing; hives; heart rate increased to 160's (had been 180's earlier in the day); This is a spontaneous report from a contactable pharmacist. A 46-year-old female patient received the first dose of BNT162B2 (lot number: EK5730), via intramuscular, on 28Dec2020 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, it's unknown if the patient was tested for COVID-19. No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient's medical history and concomitant medications were not reported. The patient had SVT, flushing, hives 20 min after receiving vaccine on 28Dec2020. Patient was taken to ED and evaluated. SVT resolved. Patient sent home on heart monitor. Later that night while in bed, heart rate increased to 160's (had been 180's earlier in the day) and patient was admitted to hospital. Patient is a NP. Treatment received for the adverse event included cold water to face, vagal massage. The outcome of the event"Patient had SVT" was recovered on 28Dec2020 and of other events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events supraventricular tachycardia, flushing, hives, heart rate increased cannot be excluded based on the compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
46 2021-01-04 vaccination site pain severe intractable headache; photo sensitivity; generalised body malaise; pain & tenderness in injec... Read more
severe intractable headache; photo sensitivity; generalised body malaise; pain & tenderness in injection site; nausea; This is a spontaneous report from a contactable physician. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685), via an unspecified route of administration on 23Dec2020 01:00AM at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The facility type vaccine was hospital. The patient medical history was not reported. Concomitant medication included folic acid, ascorbic acid (VIT C), tocopherol (VITAMIN E), Multivitamins. The patient previously took metronidazole and experienced drug allergy, NTG and experienced drug allergy. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe intractable headache, photo sensitivity, generalised body malaise, pain & tenderness in injection site, nausea on 23Dec2020 12:00 PM. Patient received Tylenol, neurofen and rest as treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. The events were reported as non-serious.
46 2021-01-05 redness, injection site pain About 3 hours after I received the vaccine, my arm started to hurt. Then I started running a fever a... Read more
About 3 hours after I received the vaccine, my arm started to hurt. Then I started running a fever and some chills, along with body aches. I felt nauseous. I started feeling cramping in my stomach. Yesterday, my temp was just 99.4, face was really red. Felt over heated all day long. When they gave me the shot, after 20 mins I could feel my right nostril burning, and like I could taste a metal taste and taste the actual shot. At 9am, my temp was 100. I took a tylenol.
46 2021-01-05 injection site pain Headache, Myalgia, Arthralgia, NauseaVomiting, chills/ pain inj site
46 2021-01-05 injection site pain, injection site swelling, injection site redness Injection site pain, redness at injection site, then followed by chills and fever. Injection site sw... Read more
Injection site pain, redness at injection site, then followed by chills and fever. Injection site swelling about 2" with fever and redness at injection site - lasted about 5 days. Also was feeling unwell, tiredness & muscle pain for a few days.
46 2021-01-05 injection site redness RED SQUARE ON ARM AT VACCINATION SITE 2 WEEKS POST IMMUNIZATION. NO TREATMENT . RESOLVED
46 2021-01-05 itchy skin Received the vaccine in morning: Started developing itching on torso throughout the day. On 1/6/20... Read more
Received the vaccine in morning: Started developing itching on torso throughout the day. On 1/6/2021 starting at 0500, the opposite arm (Right) developed tingling and numbness. Thumb is twitching.
46 2021-01-05 rash with redness, rash macular Red splotches on body - mainly arms
46 2021-01-05 hives, rash SkinRash, Rash, sevdere fatigue and facial hives
46 2021-01-05 hives, itchy skin UrticariaPruritus Narrative: 0933 PT STATES SHE FELT "ITCHY"/ VS- 133/89; P-93; SAT 98%; TEMP 98.3. ... Read more
UrticariaPruritus Narrative: 0933 PT STATES SHE FELT "ITCHY"/ VS- 133/89; P-93; SAT 98%; TEMP 98.3. 0957 PT STATES NOW ITCHING TO PALATE; FEELS "SWOLLEN"; NO NOTED OBSTRUCTION TO AIRWAY NOTED; EMS CALLED; 1015 PT DECLINED TRANSPORT TO ER VIA EMS; REMAINS STABLE; SAT 98%; DENIES DIFFICULTY BREATHING. 1035- BENADRYL 25MG PO ONCE ORDERED BY DR, AND GIVEN BY RN. VSS; P-74; R-16; SAT-99%; BP-133/79; TEMP-98.6;PT ABULATED TO OFFICE; HUSBAND TO DRIVE PT HOME LATER TODAY.
46 2021-01-05 rash now 2 hours later I have a rash on my belly; Metallic taste almost immediately; This is a spontaneou... Read more
now 2 hours later I have a rash on my belly; Metallic taste almost immediately; This is a spontaneous report from a contactable other healthcare professional (hcp). A 46-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK9231, expiry date not reported), via an unspecified route of administration on 30Dec020 16:45 at a single dose in the left arm as Covid vaccine. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of the vaccination. The patient previously took iodine and experienced allergies. The patient was not in other vaccine in four weeks. The patient had no prior COVID vaccination and was not tested for COVID post vaccination. The patient experienced metallic taste almost immediately (30Dec2020 16:45) and now 2 hours (18:45) later patient have a rash on the belly. No treatments received in response to the events reported. The events reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect. The events metallic taste and rash on the belly was not recovered.
46 2021-01-06 injection site pain, injection site swelling 12 hours after vaccine I felt chills, headache, fever, dizziness, weakness, pain and swelling to inj... Read more
12 hours after vaccine I felt chills, headache, fever, dizziness, weakness, pain and swelling to injection site, body aches, lymph node swelling. 36 hours after, still have piercing headache, fever, body aches, lymph node swelling, weakness, on and off chills and dizziness.
46 2021-01-06 itchy skin About two minutes after vaccination the patient began to experience itchiness and throat tightening.... Read more
About two minutes after vaccination the patient began to experience itchiness and throat tightening. Was administered 50 mg capsules Benadryl PO and continued to have worsening symptoms. A physician on site ordered her sent to the Emergency Department for further treatment and observation. She was given famotidine and prednisone and had significant improvement of her symptoms. She was discharged to home
46 2021-01-06 rash macular, redness Fainting; Red Palms; blotching; sweating profusely; heart palpitations; Chest pain; Elevated BP; Thi... Read more
Fainting; Red Palms; blotching; sweating profusely; heart palpitations; Chest pain; Elevated BP; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 09:15 at single dose on left arm (Lot number: ek9231) for COVID-19 immunisation. Medical history included asthma, bronchitis, mitral valve regurgitation, herpes, depression, ADHD. COVID prior vaccination: Yes. Known allergies: tramadol, milk products. No other vaccine in four weeks. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), bupropion, and, losartan/hydrochlorothiazide. The patient experienced red palms/blotching, sweating profusely, heart palpitations, chest pain and fainting, elevated BP, all on 28Dec2020 09:15. All these events required Emergency room visit. Therapeutic measures were taken as a result of the events included 50 mg of Benadryl, 60 mg of Prednisone, omepresol. No COVID tested post vaccination. Outcome of events was recovered with sequelae.
46 2021-01-06 rash Presented to ER 12/23/2020 with Lightheadedness, chills, nausea, vomiting, rash. Iv fluids and antie... Read more
Presented to ER 12/23/2020 with Lightheadedness, chills, nausea, vomiting, rash. Iv fluids and antiemetics administered, pt reported feeling better. RX for Medrol Dosepak given.
46 2021-01-06 shingles Shingles outbreak 5-7 days after infection in C6-C7 dermatome of left arm (injection was in right ar... Read more
Shingles outbreak 5-7 days after infection in C6-C7 dermatome of left arm (injection was in right arm) limiting the use of this arm and causing excruciating pain and discomfort.
46 2021-01-06 injection site nodule, injection site swelling Swollen knot about the size is a silver dollar at the injection site that lasted 3 days
46 2021-01-06 hives jaw tightening; muscle spasms; entire face and around her mouth went numb; entire face and around he... Read more
jaw tightening; muscle spasms; entire face and around her mouth went numb; entire face and around her mouth went numb; heart palpitations; I had hives on my chest; a wave of heat rush up her back; This is a spontaneous report from a contactable nurse (patient). A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in left arm on 22Dec2020 10:30 at first single dose for COVID-19 immunization. Medical history included ectopic pregnancy, hay fever. Concomitant medication received within 2 weeks included: loratadine, colecalciferol (vitamin D), olly womens multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. About 15 minutes after the vaccine the patient experienced jaw tightening and muscle spasms. The patient was given oral Benadryl 50 mg. About 5 minutes after taking the Benadryl, her entire face and around her mouth went numb. The patient began having heart palpitations and felt a wave of heat rush up her back. She had hives on her chest. The patient received 1 dose of epinephrine from an Epi-Pen and transported to the emergency room for further treatment. Adverse event start date: 22Dec2020 11:00 AM. Events were considered as non-serious. Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for the adverse event included: Benadryl, Epinephrine, Solumedrol, Pepcid. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Test Name: SARS-CoV-2 by PCR (Nasal Swab) on 30Dec2020: Negative. Outcome of the events was not recovered.; Sender's Comments: The temporal relationship is suggestive of an acute anaphylactic reaction. Based on the temporal relationship and the known pattern of response, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
46 2021-01-07 rash Fine rash (almost petechiae appearance) upper body appeared 18 hrs post-injection - still present Fa... Read more
Fine rash (almost petechiae appearance) upper body appeared 18 hrs post-injection - still present Facial flushing accompanying rash Severe body and joint aches appeared 18 hrs post-injection - responsive to ibuprofen-still present Severe headache appeared 16 hrs post-injection - responsive to Excedrin/Tylenol - still present Low-grade fever 100.1F (taken 3 hrs post ibuprofen)
46 2021-01-07 injection site pain Injection site pain. Muscle pain. Joint pain. Chills. Headache. Eyes pain
46 2021-01-07 vaccination site swelling, vaccination site pain Lymphadenopathy. Lymph nodes under left arm (side of vaccine administration) became swollen and pain... Read more
Lymphadenopathy. Lymph nodes under left arm (side of vaccine administration) became swollen and painful. Lasted for approximately 1 week. No treatment, did not see anyone for it. I did not take any over the counter pain medication either. It gradually went away on its own.
46 2021-01-07 itchy skin With in my arm got soar. About four hours later I started getting a head ache and feeling cold, I co... Read more
With in my arm got soar. About four hours later I started getting a head ache and feeling cold, I couldn't get warm, I felt very tired. About the next thirty hours I had body ache and head ache my arm got very heavy and hurt, I did not run a fever but felt very restless and achy. I was very tired and didn't work the following day, didn't have much of an appetite. I had some mild itching on my arm.
46 2021-01-07 hives difficulty breathing/swallowing; difficulty breathing/swallowing; Hives/hives all over including in ... Read more
difficulty breathing/swallowing; difficulty breathing/swallowing; Hives/hives all over including in her mouth; This is a spontaneous report from a contactable consumer (spouse). A 46-year-old female patient (wife) received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, lot number: EH9899) via unspecified route of administration at arm right on 29Dec2020 at single dose for Covid-19 vaccine. Medical history included ongoing anxiety diagnosed 22 years ago. Concomitant medications were not none. Patient received the vaccine and was one big hive (01Jan2021). She went to the ER on sat and will have to go back. Caller is asking where she should go. patient went through the VAERS report 3 times. She did not have any sides effects. patient is a frontline worker. On 29Dec2020 she got the Covid vaccine. On Sat 02Jan2021 she went the ER with hives all over including in her mouth, stated she had difficulty breathing/swallowing, was given medication to take home and discharged. She was readmitted yesterday 05Jan2020 with worsening symptoms and needed to be given a prednisone nebulizer. they had two ER visits. No Investigation Assessment. patient was not recovered from the event hives/hives all over including in her mouth, the final outcome of other events was unknown.
46 2021-01-07 hives she received vaccine at 8:30 am. At approximately 11:00 am she developed sudden onset hives, scratc... Read more
she received vaccine at 8:30 am. At approximately 11:00 am she developed sudden onset hives, scratchy throat, swelling sensation of the throat, hoarse voice, difficulty breathing. Presented to the ED. Received IM Epi, IV Benadryl and Solumedrol.
46 2021-01-08 injection site swelling Fever, chills, night sweats, swollen glands under arm, swollen injection site, body aches, headache
46 2021-01-08 skin peeling Headache aches, peeling fingertips Narrative:
46 2021-01-08 injection site pain Headache, left arm numbness, mild left arm pain Injection site, moderate Myalgia, severe migrating ... Read more
Headache, left arm numbness, mild left arm pain Injection site, moderate Myalgia, severe migrating joint pain, chills leading to rigors. No fever. Incapacitating.
46 2021-01-09 hives, itchy skin Hives/itching
46 2021-01-09 itchy skin, hives Itching and hives.
46 2021-01-09 shingles Shingles
46 2021-01-09 injection site pain Sore to injection site-first day Palpitations up to 120bpm in resting lasting 4-5 hours-second day
46 2021-01-10 redness Erytema with facial flushing on neck and face, Nauseas, no vomit, No dyspness, no shortness of brea... Read more
Erytema with facial flushing on neck and face, Nauseas, no vomit, No dyspness, no shortness of breath. treatment Benadryl IV = Solumedrol + Famatidine IV
46 2021-01-10 injection site hardening, injection site redness, injection site swelling, injection site warmth Large indurated swelling on the left deltoid with a circumferential ring of erythema approximately 1... Read more
Large indurated swelling on the left deltoid with a circumferential ring of erythema approximately 1 cm out. Warm to the touch. Extensive swelling and lymphadenopathy of the axilla, lateral breast up into the pectoralis muscle and into the latissimus muscle. And I
46 2021-01-10 rash Rash and headache
46 2021-01-10 injection site tingling The patient began to experience heart palpitations about 10 minutes after receiving the Pfizer COVID... Read more
The patient began to experience heart palpitations about 10 minutes after receiving the Pfizer COVID vaccine (first dose). The HR was checked and marked to be 110bpm. The pt then began to experience tingling at the injection site as well as in the lower bilateral extremities. The pt was escorted to the holding area to lie down on the stretcher. VS checked (139/89 BP, HR 95, Temp 98.4, O2Sat 100%.). Dr in the ACC was called to assess and observe the patient. No further recommendation for treatment was given. Patient was observed for a total of thirty minutes. HR remained within normal limits and pt was cleared to be discharged to home safely. Pt ambulated to personal vehicle with nurse escort.
46 2021-01-11 itchy skin 1/6/2021, 5hrs and 20 min post vaccine: pounding headache, nausea, abd pain, tingly/itchy all over-t... Read more
1/6/2021, 5hrs and 20 min post vaccine: pounding headache, nausea, abd pain, tingly/itchy all over-took tylenol and benadryl 1/7/2021, 6:30 AM, pounding headache, very fatigue, itchy/tingling all over, slight upset stomach, felt feverish, left arm very sore, called into work 1/7/2021, 10:20 am, pounding headache, very fatigue, itchy/tingling all over, slight upset stomach, felt feverish, left arm very sore-took benadryl and tylenol 1/7/2021, 1:15 PM, very fatigue, fever, body aches, upset stomach, right ear throbbing, fever 100.6-employee health notified, was advised to self monitor for 48 hrs and if no improvement to be tested for COVID on 1/9/2021 1/7/2021, 7:27 PM, completely exhausted, on going headaches, chills off and on, body aches, decreased appetite-tylenol taken 1/8/2021, 10:02 AM, headache, body aches, arm swollen and very painful, the pain traveled to the armpit, felt about 60 % better this day, but still fatigue Symptoms remain the same for the day of 1/8/2021 1/9/2021, 9:38 AM, lingering headache, arm and armpit sore; otherwise, feel much better 1/10/2021, 7:27 PM, Felt much better this day, just little fatigue and arm soreness; otherwise not further symptoms.
46 2021-01-11 vaccination site pain Chills; tingling under her lip and chin area; tingling under her lip and chin area; said that she is... Read more
Chills; tingling under her lip and chin area; tingling under her lip and chin area; said that she is really cold; Caller is continuously coughing during the call.; Fever; Headache; joint and muscle achiness all over; joint and muscle achiness all over; Tiredness; joint and muscle achiness all over, it started in her right arm where she received the injection; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), intramuscularly in right arm on 05Jan2021 around 1315-1320 at single dose for covid-19 prophylaxis in hospital and vaccine was not administered at Military Facility. Medical history included ongoing asthma diagnosed as a child, leaky valve closed up in her heart from 2020 to an unknown date. Family medical history included her mother had Covid over around May2020 and the mother was positive for quite sometime and had to take 3-4 tests, her son had tested positive for Covid and the patient had been around him a little bit. Prior Vaccinations (within 4 weeks) were none and adverse events following prior vaccinations were none. Concomitant medication included fluticasone furoate, vilanterol trifenatate (BRIO INHALER) at 200/25 once a day by inhalation, nebulizer by inhalation every 4 hours as needed, salbutamol sulfate (PROAIR) at 2 puffs every 4 hours when needed, montelukast at 10mg every evening by mouth, all ongoing for asthma. The patient received the Covid-19 vaccine yesterday 05Jan2021 and reported that on 05Jan2021 she has had tiredness, headache, joint and muscle achiness all over. On 06Jan2021, she had fever and chills. She said that she was really cold. She also had a little tingling under her lip and chin area, but it is resolved. She stated that this was this morning 06Jan2021. She said that she did not have the physician details to provide at this time. She said that she had only seen this doctor once on a virtual appointment. She said that tiredness started around 1830-1900 05Jan2021. Headache started 05Jan2021 around when she got off of work at 1500. For event fever, she took her temperature 3 different times, it was at 101.2, then she had a temperature of 102. She last checked it about a half an hour ago on 06Jan2020. For event joint and muscle achiness all over, it was noticed the achiness around 9-10 pm 05Jan2021, she said that it started in her right arm where she received the injection, then moved down to her legs and her back. She stated that it was worse and when she went outside. For chills it started this morning on 06Jan2020 when she was still in bed before she got up at about 0500. She said that she called out of work. This was her first dose of the vaccine. Her next dose is supposed to be on 26Jan2021. The patient was continuously coughing during the call on 06Jan2020. The fever, joint and muscle achiness all over were worsened. The adverse events did not require a visit to emergency room or physician office. The outcome of tiredness, headache, fever, chill, joint and muscle achiness all over, it started in her right arm where she received the injection, were not resolved, outcome of the tingling under her lip and chin area were resolved on 06Jan2021, outcome of she was really cold and cough were unknown.
46 2021-01-11 rash, itchy skin, skin irritation Developed rash with itching and irritation.
46 2021-01-11 injection site pain Initially just had mild muscle soreness at injection site. At 1000 on 1/8/21 began having a headach... Read more
Initially just had mild muscle soreness at injection site. At 1000 on 1/8/21 began having a headache that worsened to a severe migraine throughout the day. Also that afternoon, developed sores/ulcers inside of mouth. Next day developed worsening sores in mouth and then my tongue began to swell and then noted sores on my tongue as well. This improved with Benadryl over the next 36 hrs.
46 2021-01-11 injection site pain, injection site numbness Pain, numbness, weakness in arm opposite site of injection. Time line regarding possible adverse e... Read more
Pain, numbness, weakness in arm opposite site of injection. Time line regarding possible adverse event from COVID 10 Vaccine Dec 21, received COVID-19 Vaccine #1 in right arm lot #EH9899 Dec 23- mild pain in left shoulder, did not do anything that I could pinpoint as the cause of this, no injuries, falls or accidents Dec 24, pain intensified Dec 28, 2020- went to primary MD for exam, gave several medications and ordered an MRI of C-spine which was completed on this day. Dec 29- pain has continued to intensify, now shoulder, and entire left arm. Fingers on left hand intermittently numb except for pointer finger that stays numb, and hand is colder than right hand Dec 29, 2020- results of C-Spine showed no significant issues. Small herniation in one of the disks. Per MD, ?more suspicious of a muscular issue or something external to spine pinching that nerve?. Pain has continued despite medications ordered. Dec 30, 2020 MD referred me to a Neuroversion for pain control. I did not want to go here yet, I wanted to know what was causing the issue, not just treat the pain, decided to wait to make this appointment and instead get an appointment with a Neurologist on Monday due to offices being closed on New Year?s Eve. January 4, 2021 pain, numbness and now weakness have persisted all weekend, appointment with Neurologist scheduled for Tuesday January 5, 2021. January 5, 2021, appointment with Neurologist, suspecting Parsonage-Turner Syndrome. Parsonage Turner syndrome (PTS) is characterized by the sudden onset of shoulder and upper arm pain followed by progressive (worsening over time) weakness and/or atrophy of the affected area. The pain is felt along the path of one or more nerves and often has no obvious physical cause. The network of nerves involved in this syndrome is called the brachial plexus and it controls movement and sensation in the shoulders and arms. The cause is still unknown (idiopathic). However, researchers believe that most cases are due to an autoimmune response following exposure to an illness or environmental factor. Suspected triggers include viral and bacterial infections, surgery, vaccinations, injury, childbirth, strenuous exercise, certain medical procedures, and various health conditions. Treatment is symptomatic and may include pain relievers, corticosteroids and physical therapy.[1][2] January 6, 2021- MRI of left shoulder completed January 8 2021- Follow up of MRI with neurologist. No abnormalities seen on MRI, ruled out any other tumors, or anatomical issues causing pain. Diagnosis Parsonage-Turner Syndrome. Increased dosages of current medications and added another to control nerve pain. January 9, 2021- pain seems to be lessening, numbness and weakness continues January 10, 2021- significant pain returned, numbness and weakness continues. I did get the 2nd dose of the COVID-19 lot # EJ1685 in R arm vaccine today, as MD did not advice against it and I still believe that the vaccine is important.
46 2021-01-11 redness Pt had vaccine at 0900, waited 15 mins without issue. Returned at 1420 c/o being hot, flushing, brai... Read more
Pt had vaccine at 0900, waited 15 mins without issue. Returned at 1420 c/o being hot, flushing, brain fog, chest red 1425 - bp 95/64, hr 82, rr 20, t 97.7, sats 98 1428 50 mg po Benadryl given 1432 - bp 118/68, 1440 - pt reports I am feeling better but it does come in waves. chest remains red 1445 - bp 112/74, hr 70, rr 16, sats 98. Pt reports fine to go home. does not live alone.
46 2021-01-11 injection site mass, injection site warmth, injection site pain, injection site redness, injection site swelling Red, swollen, slightly warm, slightly tender to pressure, small lump about three fingers below right... Read more
Red, swollen, slightly warm, slightly tender to pressure, small lump about three fingers below right deltoid injection of 2nd dose noticed on 1/12/21 at 05:30 which is 4 days post dose. No advert issues or need for medication treatment.
46 2021-01-11 rash rash and itching around neck and upper chest, tongue feeling funny and tickle in my throat
46 2021-01-12 redness 01/12/2021 reported redness in face, neck, stomach, and minimal on arms. Swelling on eyelids, slight... Read more
01/12/2021 reported redness in face, neck, stomach, and minimal on arms. Swelling on eyelids, slightly nauseated. Instructed by employee health to take Benadryl STAT and report to ED for worsening symptoms. 01/13/2021 Pt reports symptoms are no longer present and has no complaints.
46 2021-01-12 injection site pain Got vaccine at 10:30 am, took took Tylenol 500 mg with Benadryl 25mg 2 tabs at 11:30 as prophylaxis ... Read more
Got vaccine at 10:30 am, took took Tylenol 500 mg with Benadryl 25mg 2 tabs at 11:30 as prophylaxis Around 02:00 am injection site feels sore, chills, Temp 99.9 degrees F, applied warm compress to sore arm 06:00 T=102 degrees, took Tylenol with Benadryl again at 08:30 am, no further fever after, arm still sore but bearable.
46 2021-01-12 cellulitis Left elbow cellulitis within 48 hours of vaccine Seen PCP, diagnosed with cellulitis as an adverse ... Read more
Left elbow cellulitis within 48 hours of vaccine Seen PCP, diagnosed with cellulitis as an adverse reaction to the vaccine and put on antibiotics (Keflex 4Xday for 10 days)
46 2021-01-12 injection site pain Muscle ache Joint pain Injection site pain Headache
46 2021-01-12 hives, itchy skin Patient started itching and had mild hives. Reported to her manager who accompanied her back to the ... Read more
Patient started itching and had mild hives. Reported to her manager who accompanied her back to the Covid Clinic. Patient was assessed and was given Diphenhydramine 25mg orally x 1.
46 2021-01-12 injection site numbness Systemic: numbness at injection site-Severe
46 2021-01-13 itchy skin, rash Exanthema on fingers and lower back w pruritis on all of trunk
46 2021-01-13 itchy skin, rash Itchy, rash within 5 minutes of injection - given Pepcid, prednisone, benedryl and also a prescrip... Read more
Itchy, rash within 5 minutes of injection - given Pepcid, prednisone, benedryl and also a prescription for epipen Took prednisone, benedryl and Pepcid for a few days and notified PCP
46 2021-01-13 rash, itchy skin, hives Starting on 1/11/21 she developed a rash over her entire body with some areas of hives. This got wor... Read more
Starting on 1/11/21 she developed a rash over her entire body with some areas of hives. This got worse the following day. The rash is still present though the itching has improved.
46 2021-01-13 rash, itchy skin Systemic: Rash (other than injection site)-Medium, Systemic: Fever-Medium, Systemic: Felt itchy all ... Read more
Systemic: Rash (other than injection site)-Medium, Systemic: Fever-Medium, Systemic: Felt itchy all over body, no visible hives, flushed-Medium; symptoms lasted 0 days
46 2021-01-13 injection site pain, injection site pruritus, injection site redness, injection site swelling TWO DAYS OF SINTOMES, PAIN INJECION SITE, HEADACHE, MUSCULAR PAIN, SWELLING IN INJECTION SITE, INCHI... Read more
TWO DAYS OF SINTOMES, PAIN INJECION SITE, HEADACHE, MUSCULAR PAIN, SWELLING IN INJECTION SITE, INCHING ON INJECTION SITE AND REDNESS.
46 2021-01-13 injection site pain fever above 100, Bone muscle pain on a scale 7/10, injection site pain and burning 9/10, dizzi... Read more
fever above 100, Bone muscle pain on a scale 7/10, injection site pain and burning 9/10, dizziness, slight headache and decreased appetite
46 2021-01-13 itchy skin, rash flush, rash to face, trunk, and generalized to bilateral lower extremities , intense itchiness, thr... Read more
flush, rash to face, trunk, and generalized to bilateral lower extremities , intense itchiness, throat itchiness and was given Benadryl 25mg IM and took 20 -30 minutes to relieves the itching and hives subsided gradually
46 2021-01-13 vaccination site pain soreness in the left arm; This is a spontaneous report from a contactable healthcare professional re... Read more
soreness in the left arm; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 46-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730, expiry date 31Mar2021) via an unspecified route of administration in the left arm on 18Dec2020 right before 9:00 am for COVID-19 immunization. Medical history included migraine (she occasionally had migraines and treated it with ibuprofen). The patient's concomitant medication included ibuprofen for migraine. No other vaccine received within 4 weeks. The patient experienced soreness in the left arm on 18Dec2020. The event lasted for a day and a half and was resolved on 20Dec2020. The reporter considered the event soreness in the left arm was related to the vaccine.
46 2021-01-13 injection site redness swelling of arm vaccine administered in, redness at injection site, chills
46 2021-01-14 injection site swelling, injection site warmth, injection site pain, injection site redness I have Factor V Leiden, tested positive for Covid on Nov 9, 2020. I received my Covid vaccine on De... Read more
I have Factor V Leiden, tested positive for Covid on Nov 9, 2020. I received my Covid vaccine on Dec 29, 2020. On Jan 8, 2021 my upper right arm had a red area that was swollen, hot and painful. It continued to spread down my upper are to my forearm. On Jan 12, 2021 I spoke with nurse to see if anyone had reported blood clots as a reaction to the vaccine. Nurse did research this and stated he did not see any cases. After discussion with nurse, we agreed that I would get my PCP to order a venous doppler to rule out clots so we could make an informed decision to receive the 2nd dose vaccine. On Jan 14, 2021 the doppler showed superficial clots.
46 2021-01-14 redness Left arm went total numb for over 72 hours; Red and swollen all the way up to the shoulder; Red and ... Read more
Left arm went total numb for over 72 hours; Red and swollen all the way up to the shoulder; Red and swollen all the way up to the shoulder; Red and swollen all the way up to the shoulder; Tighten in chest; Weakness; dizziness; Slept for over 24 hours; Nausea; vomiting; This is a spontaneous report from a contactable other Health Professional (HCP) (patient). A 46-year-old non-pregnant female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231), via an unspecified route of administration on 07Jan2021 14:30 at single dose in her left arm for covid-19 immunization. Medical history included dermatitis contact and asthma. The patient had allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730) at single dose in her left arm on 17Dec2020 14:30 for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient experienced feft arm went total numb for over 72 hours, red and swollen all the way up to the shoulder, tighten in chest, weakness and dizziness, slept for over 24 hours, nausea and vomiting on 08Jan2021 04:30. The events result in doctor or other healthcare professional office/clinic visit. The patient received prednisone 100 mg to treat these events. The outcome of the events was recovered in Jan2021.
46 2021-01-14 vaccination site redness, vaccination site swelling Redness and swelling on injection site; Redness and swelling on injection site; This is a spontaneou... Read more
Redness and swelling on injection site; Redness and swelling on injection site; This is a spontaneous report from a non-contactable nurse (patient). A 46-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246), intramuscular in the left arm on 06Jan2021 15:30 at a single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products. Concomitant medication included colecalciferol (VITAMIN D) and Estro-Aid. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730), intramuscular in the right arm on 17Dec2020 at the age of 46-year-old for COVID-19 immunization and experienced mild cough. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 07Jan2021 20:00, the patient experienced redness and swelling on injection site. No treatment was received for the adverse events. Outcome of the events was recovering. The events were considered non-serious by the reporter. No follow-up attempts are possible. No further information is expected.
46 2021-01-14 vaccination site pain headache; chills; muscle & joint pain; muscle & joint pain; some GI Symptoms (nausea and diarrhea); ... Read more
headache; chills; muscle & joint pain; muscle & joint pain; some GI Symptoms (nausea and diarrhea); some GI Symptoms (nausea and diarrhea); injections site soreness; This is a spontaneous report from a contactable pharmacist reported for self. This 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 at single dose for covid-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation. She experienced injections site soreness on the day 07Jan2021 then resolved. The next day (08Jan2021) experienced headache, chills, muscle & joint pain, and some GI Symptoms (nausea and diarrhea). Outcome of the event injections site soreness was recovered. Outcome of other events was unknown. Information on batch/lot number was requested.
46 2021-01-14 vaccination site pain her whole body is achy; Chills; Temperature of 99.7; Tired all over; Headache; muscle and joint pain... Read more
her whole body is achy; Chills; Temperature of 99.7; Tired all over; Headache; muscle and joint pain; muscle and joint pain; GI Issues; having soreness of her left arm where she got the injection; This is a spontaneous report from a contactable pharmacist. A 46-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 07Jan2021 at single dose for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. The patient previously took first dose of BNT162B2 on 18Dec2020. The patient received her second dose. After getting the second dose she is having soreness of her left arm where she got the injection, it is painful and she expected that. It is not depriving her of moving or anything. Now (08Jan2021) her whole body is achy, has chills, she has a temperature of 99.7, she is tired all over. She is calling to see if it safe to take acetaminophen or something else OTC around the clock to pass the symptoms or will it cause a delay in anything with the vaccine? She mentioned she heard there was a time frame where could not take anything because it would cause a delay. She is wondering if she should be worried she has COVID and get tested since it came back? She doesn't want to report she is doing it online. The side effects she is experiencing are headache, chills, muscle, and joint pain. Also, last night she had GI issues. The outcome of the events was not recovered. Information on lot/batch number has been requested.
46 2021-01-14 redness, hives, skin warm, vaccination site pain, itchy skin severe aches; voice very raspy; headache/lingering headache; wiped out /fatigued/tired; lethargic; i... Read more
severe aches; voice very raspy; headache/lingering headache; wiped out /fatigued/tired; lethargic; it took a minute for her to catch her breath; flushed; itchy; muscle aches; something that look like hives on the arm/hives on the lower right arm; skin felt really hot to touch; fire engine red on the right upper arm; pain at the injection site; This is a spontaneous report from a contactable nurse (patient herself). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), via an unspecified route of administration on 06Jan2021 11:00 in deltoid left at single dose for covid-19 immunization. There were no medical history and concomitant medications. Family medical history relevant to event was none. Relevant tests were none. Patient reported she received the Pfizer COVID-19 vaccine on 06Jan2021 and had pain at the injection site. On 07Jan21 she started having muscle aches and got something that look like hives on the arm and her skin felt really hot to touch, it was fire engine red on the right upper arm. On 08Jan2021, she woke up and felt like she got hit by a tractor trailer, has severe aches, voice very raspy, and very wiped out with headaches. Patient mentioned injection site arm was bright red and warm to touch after injection, but has improved. When waking up this morning on 08Jan2021 even walking this morning from the bedroom to the bathroom she was fatigued and it has gotten better with her walking around, but she still felt wiped out. The muscle aches was very short lived. She went to do something at work and it took a minute for her to catch her breath and that and the muscle aches went away and that was it. An hour later she felt very flushed and itchy and coworkers joked with her about what she ate for lunch, which was nothing different. On the opposite arm from injection arm she had hives on the lower right arm. They were there about 15-20 minutes and it turned completely fire engine red and that lasted about half an hour. She showed the doctor she worked with and they recommended diphenhydramine hydrochloride (BENADRYL), which she didn't take, it was weird. All this subsided and she felt fine afterwards. Last night she felt very fatigued when walking around the house. This morning when she woke up she felt very, very, very fatigued. Walking took a lot of effort out of her. It is hard to explain, but people say this was how they felt when they had Covid. She felt very lethargic and very tired. Patient still had a lingering headache, but nothing like she felt earlier this morning. It's not terrible, but it wasn't pleasant for a couple of hours. Patient was unable to provide seriousness for today's events (08Jan2021), and stated it wasn't really life threatening, but more significant than yesterday. Patient denied having any other vaccines the same day or 4 weeks prior. No history of problems or adverse events with vaccines in past. Pfizer Covid-19 vaccine with events were reported as related. Events did not require a visit to emergency room or physician office. Outcome of severe aches, voice very raspy, headache/lingering headache, wiped out /fatigued/tired were not recovered; outcome of lethargic, it took a minute for her to catch her breath, flushed and itchy was unknown, and outcome of other events were recovering.
46 2021-01-14 vaccination site pain sleeping all day; pain at the injection site to left arm; Fever; Headache; legs hurting; This is a s... Read more
sleeping all day; pain at the injection site to left arm; Fever; Headache; legs hurting; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration in the left arm on 07Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on Dec2020 (reported as three weeks ago from 07Jan2021) for COVID-19 immunization and she was fine. The patient got the second COVID vaccine on 07Jan2021 afternoon. The pain at the injection site to left arm started on 07Jan2021 20:00. On 07Jan2021, in the middle of the night, the fever, headache, and legs hurting started. She has been sleeping all day on 08Jan2021 and she does not do this normally. Outcome of the sleeping all day was unknown, of the headache was recovering, of the pain at the injection site to left arm was recovered on 07Jan2021, of the legs hurting and fever was recovered on 08Jan2021.
46 2021-01-15 redness, skin burning sensation, hives 12:30 pm legs shaking, fatigue, dizziness, freezing under a couple of blankets, chills, brain fog. ... Read more
12:30 pm legs shaking, fatigue, dizziness, freezing under a couple of blankets, chills, brain fog. 2:30 -5 Skin on face feels like it is burning from the inside out & fatigue. Brainfog. 2:30 thru evening Face and neck puffy, red, hives & fatigue.
46 2021-01-15 injection site pain Injection site pain, headache, body aches, joint pain
46 2021-01-15 rash, itchy rash, skin warm, rash macular Previously reported when first started: report # 219108 on 1-3-21 Additional symptoms that occurred ... Read more
Previously reported when first started: report # 219108 on 1-3-21 Additional symptoms that occurred since then: extremely itchy blotchy rash that attacked underarms, under bra area, stomach, lower back, legs. Skin was hot to the touch, felt like a mild sunburn, sensitive to the touch, difficulty wearing clothes. Pain in muscles/joints in hands, and knees .
46 2021-01-15 hives, injection site pain, injection site rash Rash or hives covering the injection arm, plus a swollen index finger. And soreness at injection si... Read more
Rash or hives covering the injection arm, plus a swollen index finger. And soreness at injection site.
46 2021-01-16 injection site pain Besides soreness on the injection site on both times, a day after received the second dose of Covid-... Read more
Besides soreness on the injection site on both times, a day after received the second dose of Covid-19 vaccine I have experienced left-arm site soreness, aches all over my body i.e back pain and muscle pain, malaise, chills, and numbness on the fingers on my left arm.
46 2021-01-16 rash Generalized rash to be treated with oral steroids and Claritin, outcome not yet known
46 2021-01-16 itchy skin, redness, rash Itching, small bumps, red face and chest
46 2021-01-17 redness, injection site swelling, pain of skin, skin warm Arm had a baseball sized swelling on it the next morning and a dark red spot the size of a quarter. ... Read more
Arm had a baseball sized swelling on it the next morning and a dark red spot the size of a quarter. tender to touch and hot. The swelling has gone down but the red spot gets bigger everyday. currently it is the size of a baseball. We marked it this morning and its already passed the ink marks. Still tender and hot to touch.
46 2021-01-17 skin burning sensation, itchy skin I noticed that my arm started itching, tingling and my whole arm and hand became weak. I started bur... Read more
I noticed that my arm started itching, tingling and my whole arm and hand became weak. I started burning under my armpits. Then, I started having issues swallowing. I felt a general feeling of weakness all over. I went to the ER because I was scared I was having a stroke.
46 2021-01-17 itchy skin, hives Patient received second dose in series at 0730 today began developing itching and hives several hour... Read more
Patient received second dose in series at 0730 today began developing itching and hives several hours post administration. Also complained of runny nose and sneezing. Was given Zyrtec 10mg and Benedryl 25mg orally at 1530 on the same date.
46 2021-01-17 rash Pt developed left arm pain, shooting pain down the left arm and up in the the shoulder/ neck. Severe... Read more
Pt developed left arm pain, shooting pain down the left arm and up in the the shoulder/ neck. Severe pain and did to to urgent care for pain management on 1/16/21. 1/17/21, did develop a rash and is consistent with shingles.
46 2021-01-17 redness, skin warm, pain of skin SWELLING IN ARM THE SIZE OF A BASEBALL. Redness the size of a quarter that is increasing daily. Now ... Read more
SWELLING IN ARM THE SIZE OF A BASEBALL. Redness the size of a quarter that is increasing daily. Now the size of a baseball and growing. hot panful and tender to touch
46 2021-01-17 injection site redness, injection site warmth joint pain starting around 2pm the next day. By evening I had major body aches and pains, flu like s... Read more
joint pain starting around 2pm the next day. By evening I had major body aches and pains, flu like symptoms. By 9pm I started with fever. My fever got to 102. Over the weekend, allergy like symptoms. Injection site is red, warm to touch and extends down my arm. I am monitoring for now. Plan to take Benadryl when I get off work.
46 2021-01-18 injection site pain Day 1 sore arm at injection site Day 2 -4 am nauseous 6am vomiting every 30 min ... unable to ... Read more
Day 1 sore arm at injection site Day 2 -4 am nauseous 6am vomiting every 30 min ... unable to keep anything down. 1/2 phenergan suppository used. Still vomiting x 2. Additional 1/2 phenergan given. No more vomiting.
46 2021-01-18 rash First was Left arm pain (within 10 minutes of administration), then about 12 hours later started wit... Read more
First was Left arm pain (within 10 minutes of administration), then about 12 hours later started with shakes/chills (teeth chattering), cold sweats, fever (up to 100.1F), headache, muscle aches, mild joint pain,vomiting x 2 (shot given at 6:30 am and started feeling better at 7:00a.m then next day). Have had fatigue for several days after the shot a well as mild arm pain at injection site.
46 2021-01-18 injection site redness, injection site swelling, injection site pruritus Raised area, redness and itching at the injection 3 days post vaccination. No treatment. 13 days po... Read more
Raised area, redness and itching at the injection 3 days post vaccination. No treatment. 13 days post vaccination continued raised area with redness, itching resolved. Did not interfere with ADLs . Scheduled to primary care doctor
46 2021-01-18 injection site pain Strong headache, mild nausea, tired, arms were like Jell-O, those started 20 minutes after the vacc... Read more
Strong headache, mild nausea, tired, arms were like Jell-O, those started 20 minutes after the vaccine and lasted for 2 1/2 days. The next day was the soreness around the injection site.
46 2021-01-19 redness, skin warm A few minutes after injection, I experienced itching in the mouth and throat and heat in right ear. ... Read more
A few minutes after injection, I experienced itching in the mouth and throat and heat in right ear. Right ear was flushed red. No symtoms in left ear. No tongue swelling. Symptoms eventually resolved after approximately 1 hour.
46 2021-01-19 hives, itchy skin About 10 minutes after injection - extreme sedation, flushing, hives and itching on right side of ch... Read more
About 10 minutes after injection - extreme sedation, flushing, hives and itching on right side of chest, and continuous cough. Was administered one dose of epi-pen injection, steroid injection, and oral benedryl by doctor on site. 20 minutes later flushing, headache, and extreme nausea. Was given second dose of epi-pen and sent to the hospital in an ambulance for monitoring.
46 2021-01-19 itchy skin I began itching at the nape of my neck then all over my trunk and arms. I became hoarse, had visibl... Read more
I began itching at the nape of my neck then all over my trunk and arms. I became hoarse, had visible muscle spasms, and my teeth began to chatter uncontrollably.
46 2021-01-19 itchy skin Itching face/back-5 minutes after. tightness in throat-10 minutes after. fullness in ears- 30 min... Read more
Itching face/back-5 minutes after. tightness in throat-10 minutes after. fullness in ears- 30 minutes after. Taken to ER approximately 25-30 after injection for evaluation. Symptoms not escalating, eventually treated with Benadryl, steroids and Pepcid, held briefly for observation, released with Claritin and steroid prescription to take for the next few days. I was instructed to premedicate for the 2nd dose. Approximately 5-6 hours after dose developed tightness in chest, tingling face/lips/mouth/fingers. Symptoms persist still, self medicating with Benadryl and klonapin.
46 2021-01-20 itchy skin Itchy started within 3-5 minutes after injection. Started in scalp this time and then moved througho... Read more
Itchy started within 3-5 minutes after injection. Started in scalp this time and then moved throughout body down to feet. After 45 minutes of it not going away, received a shot of Benadryl in left hip. Itching started to subside within 30 minutes of getting the Benadryl shot. Nauseous feelings and joint pain started about 3.5 hours after vaccine was administered.
46 2021-01-20 injection site pain Nausea, headache, armpit pain, muscle pain, injection site pain, tiredness
46 2021-01-20 hives Patient developed one singular area of urticaria approximately one hour after the vaccination and th... Read more
Patient developed one singular area of urticaria approximately one hour after the vaccination and then developed an anaphylactoid reaction 3 days later including widespread urticaria and chest tightness. She took OTC antihistamines and recovered 6 days after the vaccine.
46 2021-01-21 skin swelling 1320: arrived in 30 minute observation. 1350 notified she had waited 30 minutes and if feeling well ... Read more
1320: arrived in 30 minute observation. 1350 notified she had waited 30 minutes and if feeling well she could leave. Patient stated she had had some left lateral hand numbness since just after the injection that now is feeling more like tightness than numbness, a new tickle in the throat and tongue which felt "puffy" like "taking up some more space than normal. Denied any other symptoms. 1400: VS 135/90, pO2 98-99%, HT regular at 84, stated throat tickle dissipating, tongue puffiness resolving and left had less tight. 1410: Patient asked to go to BR and returned without complaint. 1420: Patient drank small bottle of water without difficulty, "felt normal to swallow." Patient stated her symptoms had resolved and there were no new symptoms. Patient stated she felt normal and comfortable to drive home.
46 2021-01-21 rash with redness, rash Chills, myalgia and fatigue starting around 12 hours after vaccine dose. Nausea, photophobia and fe... Read more
Chills, myalgia and fatigue starting around 12 hours after vaccine dose. Nausea, photophobia and fever starting around 24 hours after vaccine dose, subsiding with medication after about 8 hours. Diarrhea and blanching red rash at chest, shoulders and back starting 48 hours after vaccine dose.
46 2021-01-21 hives Developed a single hive on my neck on the same side I received the Pfizer Covid-19 vaccine (first do... Read more
Developed a single hive on my neck on the same side I received the Pfizer Covid-19 vaccine (first dose)
46 2021-01-21 injection site pain Fatigue; muscle pain at injection site; joint pain; headache; low grade fever; chills.
46 2021-01-21 injection site pain I received the second dose of the vaccine on Tuesday morning, and took 800 mg ibuprofen afterward to... Read more
I received the second dose of the vaccine on Tuesday morning, and took 800 mg ibuprofen afterward to ward off arm soreness. I had quite a bit of pain at the injection site with this vaccine, more severe than the initial dose. I felt the same mild fatigue and headache as with the first dose, but yesterday (Thursday (01/20/21) afternoon, around 3-4pm), I noticed soreness in my right axillary area, and found lymphadenopathy with palpation. I took additional ibuprofen and tylenol, and the pain has lessened somewhat today (Friday 01/22/21, noon)
46 2021-01-21 injection site redness, injection site pain, injection site swelling, injection site warmth Initially sore arm at injection site. Approx 24 hrs later arm still sore but also red, swollen and w... Read more
Initially sore arm at injection site. Approx 24 hrs later arm still sore but also red, swollen and warm to touch in 1 and 1/2? diameter circle around injection site. still warm red swollen 3.5 days after injection.
46 2021-01-21 rash On 12/31/2020 patient received her 1st dose of Covid vaccine while she was on her 4th day of antibio... Read more
On 12/31/2020 patient received her 1st dose of Covid vaccine while she was on her 4th day of antibiotics to treat a UTI. On 1/6/2021, patient started to have a rash and experience difficulty breathing. Patient went to ER and her antibiotics was changed. Patient has not had a reaction to either antibiotics in the past. This may be a duplicate submission, but did not receive an email confirmation so I am resubmitting.
46 2021-01-21 rash Patient received the Pfizer Covid Vaccine on 12/31/2020 while she was on day 4 of antibiotics. On 1... Read more
Patient received the Pfizer Covid Vaccine on 12/31/2020 while she was on day 4 of antibiotics. On 1/6/2021, patient started to have a rash and difficulty breathing. Patient went to ER and was prescribed a different antibiotic. Patient has been on both antibiotics before and has never had a reaction to either. This may be a duplicate report. I did not receive an email confirmation so resubmitting.
46 2021-01-21 rash Patient received vaccine on 12/31/2020. Patient was on day 4 of antibiotics for UTI when she receiv... Read more
Patient received vaccine on 12/31/2020. Patient was on day 4 of antibiotics for UTI when she received the vaccine on 12/31/2020. On 1/6/2021, patient started to experience a rash and difficulty breathing and went to the ER. The ER started her on a new antibiotic. Both antibiotics that she received, she has been on before and has never had a reaction.
46 2021-01-21 hives Temp of 102 took Tylenol stated to go down them Spikes again 24 hours later back to 102 took more Ty... Read more
Temp of 102 took Tylenol stated to go down them Spikes again 24 hours later back to 102 took more Tylenol and has finally gone below 100 Hives on chest back behind knees back of legs and bottom of feet. Stated in one spot and progresses thought out the day and night. Took Benadryl and put Benadryl cream on has calmed down after several doses of Benadryl
46 2021-01-22 injection site swelling, injection site pain Pain and swelling at injection site (left arm), dry mouth, thirst, joint pain, lower back and right ... Read more
Pain and swelling at injection site (left arm), dry mouth, thirst, joint pain, lower back and right leg shooting pain
46 2021-01-22 itchy skin, redness Sleepy, tickle cough, and itchy and red all over
46 2021-01-22 redness, skin warm localized reaction to left arm with erythema swelling and warmth
46 2021-01-23 injection site pain Chills, fever and pain at injection site
46 2021-01-23 hives, itchy skin Hives itching headache fatigue nausea joint and muscle pain concentration problems
46 2021-01-24 itchy skin 46y/o female CC: "allergic reaction" Onset today after she received her first series of her COVID-19... Read more
46y/o female CC: "allergic reaction" Onset today after she received her first series of her COVID-19 vaccine. She states she started feeling itchy. denies any difficulty breathing or any hives/rashes. Administered 50mg diphenhydrhmine IM L Deltoid @1110. pt started feeling better and was cleared to RTW.
46 2021-01-24 injection site pain Headache, Sore arm at injection site, diarrhea
46 2021-01-24 hives Injection site was on left deltoid. Within hours experienced significant soreness on arm, left flank... Read more
Injection site was on left deltoid. Within hours experienced significant soreness on arm, left flank and left breast. Severe swelling and joint pain at left knee and hives down left leg calf. Significant rash and swelling of both eyelids and allover body soreness.
46 2021-01-24 itchy skin Itching bilateral hands, feeling warm for 2-3mins, anxiety, flushed ,Headache received Benadryl 25m... Read more
Itching bilateral hands, feeling warm for 2-3mins, anxiety, flushed ,Headache received Benadryl 25mg orally and chest tightness and heaviness received 2nd dose Benadryl 25mg . EMS /cardiac monitored and was transferred to a Hospital.
46 2021-01-24 injection site pain fever/had a 100.1 degree fever/temperature over 100.1; Sore ARM/Injection site; Headaches/massive he... Read more
fever/had a 100.1 degree fever/temperature over 100.1; Sore ARM/Injection site; Headaches/massive headache; eye pressure/Pressure in eyes; Body aches; Muscle spasms/Cramping; tired/tiredness/fatigue/feeling rundown; hot and cold chills; tremors; coughing; chest pain; swelling; unable to work; This is a spontaneous report from a contactable consumer (patient). This 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231), via intramuscular on 06Jan2021 09:45 at single dose on left arm for COVID-19 immunization. The patient's medical history included asthma, arthritis and COVID-19. No known allergies. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (lot number EH9899) on 16Dec2020 09:45 at single dose for COVID-19 immunization. Facility type vaccine was workplace clinic. Patient was not pregnant. No other vaccine received in four weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was a PCT Patient Care Technician. Patient had not been feeling well/sick on 06Jan2021 since receiving her second vaccine dose. Patient said she was unable to work, and was still feeling sick. Patient experienced massive headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms/cramping, tired/tiredness/fatigue/feeling rundown, hot and cold/chills on 06Jan2021 11:00. These adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient stated she had reactions coughing, chest pain, swelling, tremors in Jan2021. Patient said she couldn't bend without having a muscle spam. Patient clarified if she tries to wipe herself after she goes to the bathroom, she has muscle cramping. Patient clarified if she tries to turnover in bed, she has charley horses everywhere. Patient reported walking hurts from having so many charley horses. Patient said the headache seemed like it was progressing. Patient was feeling rundown and tired. Patient reported she had hot and cold chills over the weekend. Something didn't feel right on 11Jan2021, so she took her temperature and she had a 100.1 degree fever. Patient clarified she did not check her temperature prior to 11Jan2021. Patient reported she has been taking ibuprofen 800mg to maintain herself as treatment. She said she took some of the ibuprofen 800mg over the weekend, and then decided to take her temperature on 11Jan2021, and that was when she discovered she had a fever. Reported the ibuprofen 800mg was a prescription from her doctor and was dispensed in an amber pharmacy bottle. Patient stated she had lab work for, because of COVID her lungs has been messed up but before she had the shot she was doing pretty good. So, she would be getting tested periodically for her lungs and all that because she had COVID at one time. Patient stated the doctors gave her prednisone and antibiotics as treatment. For antibiotics name, Patient stated amoxycillin she believed it was and the doctors gave her another pill start with a M for swelling. Patient stated her doctor did said it had nothing to do with concomitant medication and other medication conditions. The doctor said it had to do with having the shot. Treatment for adverse events (headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms, cramping, tired, fatigue, temperature over 100.1, hot and cold/chills) included penicillin, amoxicillin, prednisone. Outcome of massive headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms/cramping, tired/fatigue, temperature over 100.1, hot and cold/chills were not recovered, outcome of other events was unknown.
46 2021-01-25 injection site pain Chills, fever of 102, body aches, headache, fatigue, dizziness, soreness at injection site and under... Read more
Chills, fever of 102, body aches, headache, fatigue, dizziness, soreness at injection site and under the arm
46 2021-01-25 rash Employee had first Covid-19 on 01/19/2021. On the night of 01/20/2021, she began to experience uncon... Read more
Employee had first Covid-19 on 01/19/2021. On the night of 01/20/2021, she began to experience uncontrollable shaking and chills. The next day, 01/21/2021, employee developed a total body rash and wen to urgent care where she received intramuscular steroids, oral steroids, and oral anti-pruritic medication.
46 2021-01-25 injection site pain Saturday, 01/09/21 1300-received 2nd vaccine Sunday, 01/10/21 0500 -severe left arm pain, began at i... Read more
Saturday, 01/09/21 1300-received 2nd vaccine Sunday, 01/10/21 0500 -severe left arm pain, began at injection site, radiated: up and across L shoulder blade area, up neck and into head, down to L fingertips 0600 -all above continued, R knee joint pain (sharp/stabbing) 1400 -all above continued except R knee joint pain; spinal pain and intercostal pain began 1900 -all above continued; TMJ, jaw, and 'tooth' pain began Monday, 1/11/21 TMJ, jaw, and 'tooth' pain, nausea, fatigue, night sweat Tuesday, 1/12/21 TMJ, jaw, and 'tooth' pain, nausea, fatigue, night sweat Went to dentist (scheduled appointment on Monday) for cleaning and thorough exam...exam was normal Wednesday, 1/13/21 continuation of symptoms from 1/12/21, but pain worse, ear pain Thursday, 1/14/21 0630 had eaten a full can of chicken noodle soup. Was sitting and working on CEs for work, had taken medications for the day, but added in hydrocodone, half of a 7.5/325mg tablet and ibuprofen 200mg. Felt a severe wave of nausea. Laid my head down on my arms on the table. Do not remember getting up, but remember walking through the kitchen in front of the refrigerator, reaching up to feel my pulse, felt two beats which were too far apart and thought to myself, "I'm going to faint". Apparently I was able to walk about 6 feet further, but I don't remember it. I don't know what time I fainted, but I think I must have fallen. I woke up sometime after 7, disoriented and my head hurt, lying on the kitchen floor. My husband came to my side after I called out to him about 5 times. I was drenched in sweat and very weak. When firefighters arrived they said my heart rate was 'all over the place', from 46 to I don't know what (did not hear). Ambulance arrived around 0730. Glucose was normal. Was taken for evaluation. Was given IV NS (I think 1000mls). Labwork was drawn. CXR, CT, and EKG. ER Dr recommended I follow up with my cardiologist, as she noted mitral valve regurgitation and thought a Holter monitor would be advisable. CXR and CT normal. EKG normal sinus rhythm, but showed anteroseptal infarct of unknown age, confirmed by cardiologist who read the EKG. Also seen by my PCP at 1430, he checked my ears, as they had been hurting as well, said they were clear. Advised alternating tylenol and ibuprofen Q4-6H. Friday and Sunday 1/15 and 1/16 night sweat, TMJ pain, nauseated, headache, neckache, fatigue, shoulders sore, eyes sore, inner ear pain Sunday, 1/17 0500 woke up, lying in bed, dizzy, clammy palms, chest pain (mid-clavicular, just below left breast, stabbing), night sweat, TMJ pain, nauseated, headache, neckache, fatigue, L & R flank pain, BP 115/70, HR 54 Monday 1/18, Tuesday, 1/19, Wednesday 1/20, Thursday 1/21, Friday 1/22, and Saturday 1/23 varying degrees of: fatigue, nausea, dizziness, TMJ, jaw, and 'tooth' pain, palpitations, and ear pain. TMJ and jaw pain worsens with activity.
46 2021-01-26 vaccination site pain Cold chills; Body aches; Nausea; Right arm sore/site of injection started to get sore; Headache; bac... Read more
Cold chills; Body aches; Nausea; Right arm sore/site of injection started to get sore; Headache; back is hurting a little more, and she is more achy; joints are starting to get tight; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231), via an unspecified route of administration into right arm on 12Jan2021 12:15 at a single dose for covid-19 immunisation. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity; Hashimotos Disease diagnosed 10 years ago; pre-diabetic diagnosed 5 years ago (she does not have to take insulin or take blood sugars daily). Concomitant medication included metformin for Pre-diabetic. The patient had no previous history of immunization. No additional vaccines administered on same date of the Pfizer covid vaccine. The patient experienced headache on 12Jan2021 13:30 with outcome of not recovered; right arm sore further described as site of injection started to get sore on 12Jan2021 19:00 with outcome of not recovered; cold chills on 13Jan2021 02:00 with outcome of not recovered; body aches on 13Jan2021 02:00 with outcome of not recovered; nausea on 13Jan2021 02:00 with outcome of recovering. The patient also reported on unspecified date in Jan2021, her back is hurting a little more, and she is more achy, joints are starting to get tight. No ER or physician's office required yet. No prior vaccinations within 4 weeks. Therapeutic measures were taken as a result of headache and cold chills as TYLENOL extra strength. Outcome of events back pain and tight stiffness was unknown.
46 2021-01-26 sensitive skin Severe muscle aches and fatigue, chills, night sweats, hypersensitivity of skin (prickly sensation0
46 2021-01-26 rash Systemic: Rash (other than injection site)-Severe, Systemic: Headache-Severe
46 2021-01-27 rash Exanthema on fingers and back; This is a spontaneous report from a contactable Other Health Professi... Read more
Exanthema on fingers and back; This is a spontaneous report from a contactable Other Health Professional reported for herself. The 46-year-old female patient that received second dose of bnt162b2 ( COVID 19, Pfizer Biotech, lot number: EL9231), via Intramuscular on 11Jan2021 09:30 AM on Left arm at a single dose for covid-19 immunisation. The patient is not pregnant at the time of vaccination. Medical history included Migraine w aura. No allergies to medications, food, or other products. Concomitant medications the patient received within 2 weeks of vaccination included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) Zyrtec, vitamin D and vitamin C. The patient previously took first dose of bnt162b2 (COVID 19, BioNTech/Pfizer, lot number: EL5730) via Intramuscular on 21Dec2020 01:00 PM on Left arm at single dose for covid-19 immunisation. The patient experienced Exanthema on fingers and back from 14Jan2021 06:00 AM. The outcome of the event was recovering. The event was assessed non-serious. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19.
46 2021-01-27 itchy skin, hives, blister, rash Itchy; Patchy rash with pin point spot and hives with blisters all over my right lower flank and bil... Read more
Itchy; Patchy rash with pin point spot and hives with blisters all over my right lower flank and bilateral posterior proximal leg. Rash started 2 days after the initial vaccine.; Patchy rash with pin point spot and hives with blisters all over my right lower flank and bilateral posterior proximal leg. Rash started 2 days after the initial vaccine.; Patchy rash with pin point spot and hives with blisters all over my right lower flank and bilateral posterior proximal leg. Rash started 2 days after the initial vaccine.; This is a spontaneous report from a contactable other hcp. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 11Jan2021 09:00 at a SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. Concomitant medication included magnesium citrate (MAGNESIUM CITRATE), turmeric [curcuma longa rhizome] (TURMERIC [CURCUMA LONGA RHIZOME]) and Organic multi vitamin. On 13Jan2021 16:30, the patient experienced itchy, patchy rash with pin point spot and hives with blisters all over my right lower flank and bilateral posterior proximal leg. It was noted that the rash started 2 days after the initial vaccine. The outcome of the event was not recovered. Information on the lot/batch number has been requested.
46 2021-01-27 injection site rash, injection site swelling, rash with redness, injection site redness, injection site pruritus Swollen, very itchy, red, circular rash near the injection site. I have been taking allergy medicati... Read more
Swollen, very itchy, red, circular rash near the injection site. I have been taking allergy medication, applied calamine lotion, as well as hydrocortisone cream to reduce the itching. The red rash mainly disappeared but is still itchy. I am afraid to scratch it believing the rash will come back and become even itchier. The itching was so back that it woke me up last night/early morning (1/28) and I had to apply hydrocortisone cream to relieve the itching. The itchy will go away for a day then return and this has been going on for a week.
46 2021-01-28 injection site pain I only experienced mild arm pain after the injection. Five days later, I was walking down a hallway ... Read more
I only experienced mild arm pain after the injection. Five days later, I was walking down a hallway at the hospital (I am a physician) when all of a sudden I experienced vertigo (I was not dizzy, but I felt my vision shift to the left). I fell down, landing against 2 crash carts that were in the hallway. I did not lose consciousness. I had persistent dizziness and nausea for at least 10 days afterwards.
46 2021-01-28 rash, rash with redness, rash macular, itchy skin itchy on upper buttocks and lower back; redness began and now I have red blotches and a rash from up... Read more
itchy on upper buttocks and lower back; redness began and now I have red blotches and a rash from upper buttocks, up my back and on the sides (flanks.); redness began and now I have red blotches and a rash from upper buttocks, up my back and on the sides (flanks.); itchy red rash spots on stomach; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 06:30 AM at left arm at single dose for COVID-19 immunization. Medical history included known allergies to milk products and seasonal allergies. Patient is not pregnant. Other medications in two weeks included fexofenadine hydrochloride (ALLEGRA). No other vaccine in four weeks. 8 hours after the first dose of vaccine (15Jan2021 02:30 PM) patient became itchy on upper buttocks and lower back. Then, redness began and now patient have red blotches and a rash from upper buttocks, up her back and on the sides (flanks.) Also, itchy red rash spots on stomach. No covid prior vaccination. No covid tested post vaccination. No treatment received for the events. Outcome of the events was unknown. Information about lot/batch number has been requested.
46 2021-01-28 itchy rash, injection site pain, rash sore at site 1 day after., headache 9-10 dsys after= generalized rash (itchy)- took benadryl subside... Read more
sore at site 1 day after., headache 9-10 dsys after= generalized rash (itchy)- took benadryl subsided after the 3rd day
46 2021-01-30 hives The evening after 2nd dose I developed itching and 3 hives over my left eye. I took Benadryl 25 m... Read more
The evening after 2nd dose I developed itching and 3 hives over my left eye. I took Benadryl 25 mg at 6 pm and again at about 2 am as itching intense and disrupting sleep (as did chills and myalgia.)
46 2021-01-31 itchy skin Complaints of itching neck, scalp, no rash. Denies shortness of breath, chest pain, difficulty breat... Read more
Complaints of itching neck, scalp, no rash. Denies shortness of breath, chest pain, difficulty breathing. Vital Signs : blood pressure 136/90, pulse 86, oxygen saturation 100% on room air.
46 2021-01-31 skin warm, injection site swelling, injection site pain, injection site redness I seem to have what others have described as "Covid Vaccine Arm" which seems to more typically be ca... Read more
I seem to have what others have described as "Covid Vaccine Arm" which seems to more typically be caused from the Moderna shot and develops 8 or so days post injection. It is a 4"x6" patch of skin at injection site that developed 48 hours post injection. It is hot to the touch and has 100.3 temperature while my forehead shows 99.2 degrees. It is swollen, raised and red. It is slightly sore where it has not been in the 48 hours post injection.
46 2021-01-31 vaccination site pain Injection site pain; Headache; Body aches; Joint pain; This is a spontaneous report from a contactab... Read more
Injection site pain; Headache; Body aches; Joint pain; This is a spontaneous report from a contactable consumer, reporting for herself. A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: Ek9213), via an unspecified route of administration at the left arm on 15Jan2021 14:00 at single dose for COVID-19 immunization. Vaccination was done in a health clinic. Medical history included diabetes, psoriasis, asthma and Covid (prior vaccination), all from an unknown date and unknown if ongoing. The patient was not pregnant. The patient had no known allergies. The patient's concomitant medications were not reported. On 16Jan2021 07:00, the patient experienced injection site pain, headache, body aches and joint pain. No treatment was received. There was no other vaccine in four weeks. The patient has not had covid tested post vaccination. The outcome of the events was recovering.
46 2021-01-31 injection site hardening, injection site pain Tenderness and induration without erythema at injection site that wrapped around outer arm, under ax... Read more
Tenderness and induration without erythema at injection site that wrapped around outer arm, under axilla and produced tender axillary lymphadenopathy . This occurred within 24 hours of vaccination and is still present 84 hrs after vaccination.
46 2021-01-31 injection site redness mildly swollen upper and lower lips, 24 hour onset after vaccine. Also having mild left axillary nod... Read more
mildly swollen upper and lower lips, 24 hour onset after vaccine. Also having mild left axillary node enlargement and mild localized redness at the left delt injection site. Pt received lip fillers slightly over one year ago. She does not remember which brand of name of filler.
46 2021-02-01 hives About two hours after the receiving the vaccine, I started getting a headache. I was rotating betwee... Read more
About two hours after the receiving the vaccine, I started getting a headache. I was rotating between Tylenol and Ibuprofen every 8 hours. The muscle spasms started Friday neck and shoulder. On Sunday I couldn't even turn my head. Today I noticed I broke out in hives arms, legs, back and stomach. Today I had a temperature 102 this morning, I just checked it again and it was down to 100. Today I went to my Doctor. She prescribed you Methylprednisolone dose pack and Cyclobenzaprine hydrochloride for muscle spasms.
46 2021-02-01 rash Chest tightness, shortness of breath, throat tickle then tightening, coughing, rash.... monitor ... Read more
Chest tightness, shortness of breath, throat tickle then tightening, coughing, rash.... monitor ( bp high, o2ok ekg looked like a fib then was ok) then epi, used inhaler, benadryl, epi and then taken to hospital where I received steroid injection and prilosec with continue monitoring. Next 5 days medrol pack, benadryl and prilosec
46 2021-02-02 skin warm, cellulitis, redness, hardening Cellulitis, redness, swelling, hard lump, heat, tired, headache, pain
46 2021-02-02 rash with redness, injection site pruritus Left arm became itchy after vaccination injected . Sl red rash. Benadryl 50 mg given
46 2021-02-02 redness, skin warm fever, body aches, sore arm, arm red and warm to touch
46 2021-02-02 rash left upper inner thigh rash, left leg pain
46 2021-02-03 rash -Palpitations -Rash -Tingling of Hands and Feet
46 2021-02-03 injection site pain Pain in the injection area (left arm), headache, Congestion, breathing difficulty. Consulted with th... Read more
Pain in the injection area (left arm), headache, Congestion, breathing difficulty. Consulted with the Dr. and prescribed the usual asthma treatment (Albuterol every 4 hours) and Acetaminophen for the pain. The 1st dose of the vaccine was received.
46 2021-02-03 injection site pain Reports symptoms began one hour after the 2nd COVID-19 vaccine. Symptoms were cough, chills, site te... Read more
Reports symptoms began one hour after the 2nd COVID-19 vaccine. Symptoms were cough, chills, site tenderness, sinus pressure, sore throat, eye pain (R), burning sensation and tingling. Seen at ED on 1/12/21.
46 2021-02-03 hives, itchy skin allergic reaction with welts on the body and face; allergic reaction with welts on the body and face... Read more
allergic reaction with welts on the body and face; allergic reaction with welts on the body and face; severe itching; This is a spontaneous report from a contactable pharmacist (patient's husband). A 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, Expiry Date: Apr2021, NDC number: 59267100002), intramuscular on 15Jan2021 ("8:30 8:45 PM ") at 0.3 mL, single on "left hip" (as reported) for COVID-19 immunization. Medical history included none. There were no concomitant medications. The first dose of the vaccine was given on 15Jan2021. The pharmacist (patient's husband) drew it up at the pharmacy and took the syringe home and gave it to her at home. He had been doing some of the clinics so he wanted her to get vaccinated just in case. Patient experienced an allergic reaction with welts on the body and face, and severe itching. The whelps on the body started Friday 15Jan2021 and they have resolved completely at this time. Patient's husband says her severe itching started 15Jan2021 and have also resolved completely at this time (also reported as "whelps and itching developed about 10 PM 18Jan2021"). The outcome of the events was recovered on an unspecified date. The adverse events did not require a visit to emergency room or physician office. The seriousness and causality were not provided. No prior vaccinations (within 4 weeks). No adverse events following prior vaccinations.
46 2021-02-03 vaccination site pain pain and numbness on left forearm near the injection site; pain and numbness on left forearm near th... Read more
pain and numbness on left forearm near the injection site; pain and numbness on left forearm near the injection site; mild hypertension; tachycardia; This is a spontaneous report from a contactable pharmacist. A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3249 and expiry date unknown) intramuscular at the left arm on 10Jan2021 at single dose for Covid-19 immunization in a hospital. Medical history was none. It was unknown if the patient was pregnant. The patient had no covid prior vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. In Jan2021, the patient experienced pain and numbness on left forearm near the injection site, mild hypertension and tachycardia. The patient was not covid tested post vaccination. The patient did not receive treatment due to the events. The outcome of the events pain and numbness on left forearm near the injection site was recovered in Jan2021, while mild hypertension and tachycardia was unknown.
46 2021-02-03 vaccination site redness really swollen and sore underneath her arm in her armpit; really swollen and sore underneath her arm... Read more
really swollen and sore underneath her arm in her armpit; really swollen and sore underneath her arm in her armpit/Incredibly sore arm; Fever and chills; Red at injection site; Very tired; Bad headache; This is a spontaneous report from a contactable other health professional reported for herself. A 46-year-old female patient received the first dose of BNT162 (PFIZER-BIONTECH COVID-19 VACCINE, brand: Pfizer, lot number: EL9262,) via unspecified route of administration at age of 46 years old on 21Jan2021 10:15 AM at single dose and vaccine location at left arm, for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included: prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications reported as there had other medications the patient received within 2 weeks of vaccination. The patient past drugs included: allergies to prochlorperazine (COMPAZINE) and amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported really swollen and sore underneath her arm in her armpit. Patient presented fever and chills. Red at injection site. Incredibly sore arm. Patient was very tired and bad headache, the adverse events reported started on 21Jan2021. It was reported the non-serious, no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. There was no treatment received for the adverse event. Outcome of events were not recovered.
46 2021-02-04 skin warm I got shot at 7 am Thursday morning. I had sore arm around 130 pm. And was all day. At 130 am Frid... Read more
I got shot at 7 am Thursday morning. I had sore arm around 130 pm. And was all day. At 130 am Friday morning. I woke with chills. I took my temp. It was 100.8. And he lot as high as 101.2. Between 130-430. I woke up again at 630 and it was 100.3. I have been warm all day now. I do not feel I need attention o am sweating it out.
46 2021-02-04 skin warm, itchy skin, redness No symptoms at time of shot A week later started to feel a lump and itchy and felt and looked like m... Read more
No symptoms at time of shot A week later started to feel a lump and itchy and felt and looked like mosquito bite. Next day the redness and circle is getting larger and heat coming from it.
46 2021-02-04 injection site warmth, itchy skin, injection site hives, redness red and itching on arms and chest - started at 7:00 pm and still itching next day at 1:50 pm red cir... Read more
red and itching on arms and chest - started at 7:00 pm and still itching next day at 1:50 pm red circle where injection when in is getting bigger - 2 quarters side by side size and hot to touch very tired
46 2021-02-06 blister, shingles, rash, rash with redness, skin discolouration On 2/1/2021 I noticed a cluster of bumps on my left forehead by my hairline. Flesh colored, not itch... Read more
On 2/1/2021 I noticed a cluster of bumps on my left forehead by my hairline. Flesh colored, not itchy. N 2/3/2021 I developed swollen and sensitive lymph nodes in front of left ear. On the evening of 2/4/2021 rash to forehead now red and sensitive and looking more blister like. Left eye blood shot and eyelid and left face swelling. Shooting pains into head on left side. 2/5/2021 made same day appointment with pap. Shingles diagnosed and started on Valacyclovir. Appointment with Ophthalmologist scheduled for 2/8/2021. Went to ER on 2/6/2021 for left eye pain. No change in treatment. Still to follow-up with eye doctor on 2/8/2021. Not able to work due to pain and nature of worK (around pregnant women and babies<1month old).
46 2021-02-06 itchy skin, rash Within 5 minutes of receiving the injection I started feeling dizzy and lightheaded. 10 minutes post... Read more
Within 5 minutes of receiving the injection I started feeling dizzy and lightheaded. 10 minutes post injection I started having a rash on my arms and chest. I reported it immediately and 15 minutes post injection Benedryl was taken. 30 minutes post injection the rash started to itch. One hour post injection symptoms were managed and starting to subside. At no time did I experience breathing issues.
46 2021-02-07 rash Rash
46 2021-02-07 rash Upper body shakiness, rapid heart rate Started within a minute of shot. Rash over face, neck and ch... Read more
Upper body shakiness, rapid heart rate Started within a minute of shot. Rash over face, neck and chest within 10 minutes of shot. Feeling of nausea after 25 minutes Selling of tongue with a fuzzy feeling 35 minutes after test.
46 2021-02-07 itchy skin had slight itching to arms; no trouble breathing; no other problems; observed additional 15 minutes;
46 2021-02-08 skin warm 7 mins after vaccine - flushing and palpitations. Then feeling of fullness in chest. Got taken to th... Read more
7 mins after vaccine - flushing and palpitations. Then feeling of fullness in chest. Got taken to the ER and had high bp 153/101 and tachy arrhythmia, such as trigeminy and bigeminy and heart rated in the 130?s. My ear also swelled and got hot and red on the same side as the shot. I was monitored for about three hours and then released after bp went down to 130?s/ 90?s and palps decreased.
46 2021-02-08 rash One hour after vaccine had swollen tongue while at work (in a hospital). I went straight to ER and w... Read more
One hour after vaccine had swollen tongue while at work (in a hospital). I went straight to ER and was short of breath unable to talk by the time I reached ER (anaphylaxis). Also rash to chest and arms.
46 2021-02-08 hives headache with hives; headache with hives; This is a spontaneous report from a contactable pharmacist... Read more
headache with hives; headache with hives; This is a spontaneous report from a contactable pharmacist. A 46-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at the right arm on 25Jan2021 (lot number EN5318 and expiry date unknown) at single dose for Covid-19 immunization in a nursing home. Medical history included latex allergy, mushrooms allergy. The patient has no covid prior vaccination. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 first dose at the right arm on unspecified date for Covid-19 immunization. The patient had no other vaccine in four weeks. On 25Jan2021, the patient experienced headache with hives and was taken to the hospital. The events resulted in emergency room/department or urgent care. The events caused hospitalization on 25Jan2021. The outcome of the events headache with hives was unknown.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of headache with hives cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
46 2021-02-09 itchy skin Day 4 I had sinus problems, swollen left lymph node in neck , back pain. Day 2 I itched everywhere, ... Read more
Day 4 I had sinus problems, swollen left lymph node in neck , back pain. Day 2 I itched everywhere, mainly my neck, stomach and back Day 10 Left eye is swollen and pain on eyelid and behind eye lid
46 2021-02-09 vaccination site pain Slight soreness at injection site; fatigue; feeling a little spacey.; This is a spontaneous report f... Read more
Slight soreness at injection site; fatigue; feeling a little spacey.; This is a spontaneous report from a contactable consumer (patient). The 46-years-old female patient (not pregnant at the time of vaccination) received first dose of bnt162b2 (BNT162B2, lot number: EL8982), via an unspecified route of administration in left arm on 25Jan2021 09:30 at SINGLE DOSE for covid-19 immunisation. Medical history included anxiety. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included hydroxyzine embonate (VISTARIL), sertraline hydrochloride (ZOLOFT), vitamin c [ascorbic acid], fish oil, acetylsalicylic acid ASPIRIN (E.C.). The patient previously took codeine and doxycycline and experienced Allergy. The patient experienced slight soreness at injection site, fatigue, feeling a little spacey on 25Jan2021 11:00. No treatment received. The outcome of the events was recovering. No follow-up attempts possible. No further information expected.
46 2021-02-09 injection site pruritus experienced nausea and vomiting within 20-30min after receiving 2nd dose. Was given 25mg of benadryl... Read more
experienced nausea and vomiting within 20-30min after receiving 2nd dose. Was given 25mg of benadryl PO at 10:50 then pepcid 20mg PO at 11:07am. Vitals remained stable from the start of the episode until the patient recovered at 12:30pm. No reddness or swelling was ever observed. Patient reported some itchiness around the injection site that improved with benadryl.
46 2021-02-10 hives, itchy skin Itching, hives on arms and torso.
46 2021-02-14 injection site pain Chills, body ache, fever, pain at the injection site., headache
46 2021-02-14 hives Patient received the Pfizer-BioNTech COVID-19 Vaccine at 0804. Reported onset of symptoms at 0808. P... Read more
Patient received the Pfizer-BioNTech COVID-19 Vaccine at 0804. Reported onset of symptoms at 0808. Patient developed urticaria and hives on RUE. Administered diphenhydramine 25mg po and asked patient to stay additional 15 minutes (20 mins.total).
46 2021-02-14 rash Rash to sore rash to upper chest , and bloating and diarrhea, swollen eyes where vision was like loo... Read more
Rash to sore rash to upper chest , and bloating and diarrhea, swollen eyes where vision was like looking through a glass of water.
46 2021-02-15 redness, hives welt formed on upper lip @ 2:37 PM; Took 2 Benadryl at 2:45 PM; Nose and cheeks became red and stiff... Read more
welt formed on upper lip @ 2:37 PM; Took 2 Benadryl at 2:45 PM; Nose and cheeks became red and stiff shortly after, before 3pm; By 3:15 welt and other areas on face diminished.
46 2021-02-16 redness, itchy skin DEVELOPED FACE AND THORAX PRURITIS AND ERYTHEMA. ON 1/26/2021 3:35PM. WAS GIVEN SOULMEDRO 125MG IVP... Read more
DEVELOPED FACE AND THORAX PRURITIS AND ERYTHEMA. ON 1/26/2021 3:35PM. WAS GIVEN SOULMEDRO 125MG IVP, BENADRYLS 50MG IV SLOWLY
46 2021-02-16 skin warm, rash with redness, injection site reaction Fever, chills, muscle pain, unable to swallow solid food and headache for 48 hours. Large rectangle ... Read more
Fever, chills, muscle pain, unable to swallow solid food and headache for 48 hours. Large rectangle red rash that is warm to touch surrounding injection site appearing at 48 hours and is still present 5 days after injection.
46 2021-02-16 itchy skin, rash, hives General achy muscle/bones same as after first injection. With second injection had HIVES beginning ... Read more
General achy muscle/bones same as after first injection. With second injection had HIVES beginning about 18 hours after injection that continued for 5 days; now gone but residual rash and serious itching
46 2021-02-16 itchy skin, rash Patient with history of latex allergy. No adverse reaction to first vaccine. After 2nd dose of COVID... Read more
Patient with history of latex allergy. No adverse reaction to first vaccine. After 2nd dose of COVID-19 vaccine today, pt complained of rash bilaterally upper extremities and trunk and general pruritis. Denied any swelling or itching of mouth or throat. VS: HR90, BP 140/100, O2 sat 97%. 20g IV started in Left hand and 25 mg Benadryl given IV. Patient transferred to ED for observation.
46 2021-02-16 itchy rash, itchy skin, rash papular, rash with redness, rash, skin warm Pfizer COVID-19 Vaccine EUA Pt received the 2nd dose of the Pfizer COVID vaccine on 2/8/2021. She d... Read more
Pfizer COVID-19 Vaccine EUA Pt received the 2nd dose of the Pfizer COVID vaccine on 2/8/2021. She discharged to home without issue, but about 48 hours after receiving the vaccine pt developed a red, warm, itchy rash over her torso, abdomen, and back. Rash progressively spread across pt's chest, became itchier and slightly raised. Pt denied SOB or difficulty breathing. Pt did endorse headache and fatigue following the second dose. Pt states she had no reaction to first dose. On 2/10/21, pt contacted their PCP via phone to discuss the issue. PCP prescribed a Medrol Dose Pak, as well as diphenhydramine 25-50 mg PO PRN for itching and famotidine 20 mg PO BID for the next few days. Pt reports her rash significantly improved within hours of the first dose of methylprednisolone and within 4 days the rash had resolved.
46 2021-02-17 vaccination site pain Soreness and tenderness near injection site; This is a spontaneous report from a contactable consume... Read more
Soreness and tenderness near injection site; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiry date not reported), via an unspecified route of administration in the left arm on 02Feb2021 15:00 at single dose for COVID-19 immunization. The patient was vaccinated at a workplace clinic. Medical history was not reported. Concomitant medications included diphenhydramine hydrochloride (UNISOM), and diphenhydramine hydrochloride, ibuprofen (ADVIL PM). The patient was not pregnant at the time of vaccination. The patient experienced soreness and tenderness near injection site on 02Feb2021 20:00. No treatment was received for the adverse event. Clinical outcome of the event was not recovered.
46 2021-02-17 rash, itchy skin This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old fem... Read more
This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: 30Apr2021), intramuscular on left arm, on 15Jan2021 13:15 at a single dose for COVID-19 immunization. Medical history included allergic to shampoo products and chemicals and vaccine has Peg). Patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient experienced severe itching and rash in right arm on the 11th day after vaccine administration on 26Jan2021 16:30. It grew from 3.5 inches to as big as 12 inches going around my arm. Patient had to go to emergency room. Adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Keflex 500mg 4 times a day and bacrim twice a day was given as treatment. Outcome of the events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
46 2021-02-18 redness A couple of minutes after receiving the vaccine, my cheeks and ears got really hot and red. The EMT... Read more
A couple of minutes after receiving the vaccine, my cheeks and ears got really hot and red. The EMTs talked to me, asked if I felt okay and if I wanted to them to take my vitals and then they said we could go. I took two benedryl that I had brought with me and that helped after about 20 minutes or so. I took another benedryl at bedtime because my cheeks were still feeling hot but not as badly as when it first happened.
46 2021-02-18 redness Tongue swelling; difficulty swallowing; raised blood pressure; body weakness; redness; This is a spo... Read more
Tongue swelling; difficulty swallowing; raised blood pressure; body weakness; redness; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: not available), via an unspecified route of administration on left arm on 01Feb2021 16:00 at single dose for COVID-19 immunization. Age at vaccination was 46 years. The patient was not pregnant at the time of vaccination. Medical history included food irritations. Concomitant medications included unspecified vitamins (received within 2 weeks of vaccination). The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, Prior to vaccination. The patient has not been tested for COVID-19, since the vaccination. The patient experienced tongue swelling, difficulty swallowing, raised blood pressure, redness, body weakness on 01Feb2021 at 16:30. The events resulted in emergency room visit/ department or urgent care visit. The patient received breathing treatments and unspecified IV medication for the events. The events were assessed as non-serious by the reporter. The outcome of the events was reported as unknown. Information on the lot/batch number has been requested.
46 2021-02-21 injection site swelling, injection site pain - Fever 105 + for over 24 hours, from Friday night to Sunday morning. I kept it down to 105 with OTC... Read more
- Fever 105 + for over 24 hours, from Friday night to Sunday morning. I kept it down to 105 with OTC meds. Sometimes too high for thermometer to read. - Swelling at injection site (and halfway to elbow), soreness. By Monday this was down to about a golf ball, and it resolved in a week. - Fatigue, slept all weekend and was tired but functioning the following week. - Severe joint pain and muscle aches Saturday and Sunday. I took OTC pain relievers. Went to bed. - Blindingly bad migraine Friday night, worse Saturday, and resolving some on Sunday, somewhat responsive to Naratryptin.
46 2021-02-21 rash, redness 40-60 tender red bumps, mostly on torso.
46 2021-02-21 itchy skin Fever; Chills; I feel very tired; I can hardly walk; Sore throat; I have a cold; The (most serious) ... Read more
Fever; Chills; I feel very tired; I can hardly walk; Sore throat; I have a cold; The (most serious) issue is my throat, I feel like I have something (stuck) in my throat; I feel like I can't breathe normally; I can't speak; I do not feel well/I feel terrible/I feel isolated; I have pain in my body; I could hardly stand up/I did not got to work; Feel an itch, like an allergy, it was not a rash, just an urge to scratch me; Feeling dizzy; Nauseous; Headache; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 01Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported that she received the COVID-19 vaccine at a hospital, patients were allowed to stay for 30 minutes, then they were released. After she left the hospital she started to feel an itch, like an allergy, it was not a rash, just an urge to scratch herself. She started feeling dizzy, nauseous, and a headache. Yesterday (02Feb2021), she could hardly stand up. Today (03Feb2021) she did not got to work, she do not feel well, she have pain in her body, fever and chills. The (most serious) issue was her throat, she feel like she have something (stuck) in her throat, she can't speak, she feel like she can't breathe normally. She haven't felt well at all, today is the 3rd day after receiving the vaccine and she couldn't go to work, she was nervous because she was fine (before receiving the vaccine). She does not want to go out because she feel very tired and dizzy, she was afraid of falling down in the street and getting hurt, she can hardly walk and she feel tired, experienced fatigue and sore throat. She have a cold, she feel terrible. she feel isolated and afraid. She will have to go to the hospital, if she cannot breathe well. Outcome of the events was unknown. Information about Lot/batch no has been requested.
46 2021-02-22 injection site redness, injection site numbness C/o right am numbness from injection site down back of arm. Full ROM of R. arm. Felt dizzy, slight... Read more
C/o right am numbness from injection site down back of arm. Full ROM of R. arm. Felt dizzy, slight redness below injection site. BP taken was elevated, sent to ED for additional monitoring
46 2021-02-22 hives Severe hives outbreak. Hives began on legs about 18 hours after second dose shot. After about 4 ho... Read more
Severe hives outbreak. Hives began on legs about 18 hours after second dose shot. After about 4 hours, all limbs covered in hives and throat felt irritated. Took a 5mg Claritin at that point (fearing hives would worsen during night). Awoke with no reaction next day or thereafter. No hives reaction after first dose. After both doses had typical sore arm for 48 hours; fatigue after second dose only.
46 2021-02-23 injection site tingling patient began feeling tingling sensation at injection site left arm. A few minutes later dizziness ... Read more
patient began feeling tingling sensation at injection site left arm. A few minutes later dizziness and (now stating shortness of breath) original evaluation, assessment and patient statements did not reveal shortness of breath. She was speaking softly, SaO2 was 98. Provided gatoraid and offered weather. Husband stated she had previous similar reaction post-anesthesia. at 1515. Patient began to feel weakness over entire body. Refused ambulance at that time. 1520- began having chest pain, tingling in legs and feet. Husband said he would take her to the ER due to BP continuing to be elevated. 1528- Unable to stand requesting an ambulance. a1530- EMS called at 1535 ambulance confirmed. 1540- Ambulance arrived. Turned over care to EMS
46 2021-02-24 redness, itchy skin 9 days after vaccination, arm became slightly itchy, red about 2? diameter, knot-like to touch
46 2021-02-24 hives Two hours after injection got hives on right palm of hand. Next at exactly the same time was upper ... Read more
Two hours after injection got hives on right palm of hand. Next at exactly the same time was upper arm and armpits, both arms. Inner thighs then got hives, back of leg. I am allergic to Benedryl but had no choice to take it. This morning I had hives on my left wrist and in between all of my fingers. Afternoon: hives on both wrists, inner thighs, and thumbs. Taking Benedryl currently.
46 2021-02-25 itchy skin General itching over body with extreme itching of the scalp. Took Claritin and Benadryl to no avail.... Read more
General itching over body with extreme itching of the scalp. Took Claritin and Benadryl to no avail. Prednisone alleviated symptoms a little. Used a steroidal skin cream and natural remedies the following day for final relief. Reported symptoms to doctor over telephone.
46 2021-02-27 itchy skin The same night of my 2nd shot, I experienced chills, body aches all over and a headache. When I wok... Read more
The same night of my 2nd shot, I experienced chills, body aches all over and a headache. When I woke up in the morning the chills had stopped and the aches where only from the waist down. I also kept having sharp shooting pain in my uterus on the left side off and on. And my left nipple itched off and on. I took an ibuprofen 800mg and the lower body aches went away, but I still had a slight headache.
46 2021-02-28 injection site pain About 5 minutes after the shot, I developed a sudden sharp pounding headache at the top of the head ... Read more
About 5 minutes after the shot, I developed a sudden sharp pounding headache at the top of the head & near the temple. I also got clammy/sweaty in my neck & the back of head. My hair got damp at the scalp. At nurse took my BP & it was 142/88 which is very high for me. I usually average a low BP. This reaction slowly subsided within 30 minutes. I was able to drive home. I felt nothing more on this day other than soreness in the injection site. On 2/23/21 I woke up with stomach cramping & had looser stools than usual. I also had fatigue & lethargy all day, which got stronger towards the evening. This lasted until 2/25/2021.
46 2021-02-28 injection site pruritus, injection site swelling, injection site pain, redness, skin warm Large red, hot, swollen circle area around injection site. Slightly painful and itchy
46 2021-02-28 vaccination site pain headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest an... Read more
headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; This is a spontaneous report from a contactable Consumer (patient). A 46-years-old female patient received bnt162b2 (BNT162B2, Lot number: EM5318) second dose, via an unspecified route of administration on 28Jan2021 at left arm at SINGLE DOSE for covid-19 immunisation. Medical history included known allergies: Sulfa from an unknown date and unknown if ongoing. Historical vaccine included first dose of BNT162B2 on 08Jan2021 (vaccine location=Left arm; lot number=EK41, administration time=01:45 PM). Concomitant medication included levothyroxine sodium (SYNTHROID), calcium (CALCIUM), hibiscus tea and green tea. The patient experienced headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back on 28Jan2021 16:00 with outcome of recovering. No treatment received for events. No covid prior vaccination. No covid tested post vaccination.
46 2021-02-28 vaccination site pain injection site is painful; chills; fever with temperature of 99.7 F; headache; tiredness; loss of ap... Read more
injection site is painful; chills; fever with temperature of 99.7 F; headache; tiredness; loss of appetite; joint pain; feeling unwell; received the first dose of Pfizer Covid 19 vaccine on 05Jan2021 and the second dose on 22Jan2021; This is a spontaneous report from a non-contactable consumer (patient). A 46-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE) at the vaccination age of 46-year-old via an unspecified route of administration in the left arm on 22Jan2021 13:15 (lot number: EL3302; expiration date: unknown) at a single dose for covid-19 immunization. Medical history included mental disease, seasonal allergy in spring and allergies to sulfa antibiotics. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medication included aripiprazole (ABILIFY). The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE) at the vaccination age of 46-year-old via an unspecified route of administration in the right arm on 05Jan2021 13: 45 (lot number: EJ1685) at a single dose for covid-19 immunization. The patient received the first dose of Pfizer Covid 19 vaccine on 05Jan2021 and the second dose on 22Jan2021. On 23Jan2021 02:00 AM, she had chills, fever with temperature of 99.7 F, headache, tiredness, loss of appetite, joint pain and feeling unwell for 2 days post vaccination. She also mentioned that the injection site was painful on 25Jan2021 for 4 days post vaccination. The patient did not received treatment for the adverse events. The patient has not been covid tested post vaccination. The outcome of the events was unknown.
46 2021-03-01 rash 12/30 vaccination 1/3 *I am going on week 9 with AE. I am taking methylprednisolone 4 mg (4th round... Read more
12/30 vaccination 1/3 *I am going on week 9 with AE. I am taking methylprednisolone 4 mg (4th round of this medication), Xylol antihistamine, ibuprofen and Tylenol prn, Conazole tablet for yeast infection. Continued rash to include armpits, under breasts, lower back, neck, hairline, legs, vaginal area. Black and blue spots on legs; comes and goes with medication. *Seram Sickness from vaccine per allergist **cannot get 2nd vaccine March 12, 2021 appt with Allergist *Anytime I go off the medication, my symptoms come back.
46 2021-03-01 injection site redness, injection site swelling, cellulitis after four days, swollen site injection with puffiness and redness. Painful, sore shoulder. looked l... Read more
after four days, swollen site injection with puffiness and redness. Painful, sore shoulder. looked like it had a bit of cellulitis so was advised to take advil and use hot compresses. swelling dissipated in 24-48 hrs.
46 2021-03-01 hives sore feet; soaked; shortness of breath; had welts on toes; swollen feet; Both feet and hand joints h... Read more
sore feet; soaked; shortness of breath; had welts on toes; swollen feet; Both feet and hand joints hurt; very large lymph node swelling on left (neck/collarbone/under arm).; cough; Spoke to MD regarding feet as it was difficult to walk; vaginal bleeding; headache; fever 101.9; felt like I was in shock; uncontrollable shaking; fast breathing; freezing; nauseous; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ), via an unspecified route of administration on 10Feb2021 at 11:00 AM (at the age of 46-year-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included allergy to sulfa drugs. The patient has pins in both feet from prior surgery. Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ) on 19Jan2021 at 11:30 AM (at the age of 46-year-old) in the left arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. The patient stated that it was unknown if prior to the vaccination, she had COVID-19. The vaccine was administered in a Nursing Home facility. Concomitant medications were not reported. The patient did not receive other vaccines within four weeks prior to the COVID vaccination. On 11Feb2021 the patient awoke at 1:30 AM with uncontrollable shaking, fast breathing, and she was freezing. She had no temperature at that time, almost felt like she was in shock. She took a shower and got calmed down. She was very nauseous but able to go back to sleep. At 04:30 AM she awoke again, this time with headache and a fever of 101.9. She continued with a fever in the 101.1 to 101.9 range for remainder of the day. The next day, 12Feb2021, she awoke feeling better and no fever but she had welts on her toes and her feet were swollen. Both feet and hand joints hurt and she had very large lymph node swelling on left (neck/collarbone/under arm). She also had developed a cough. She spoke to her MD regarding her feet as it was difficult to walk. They directed her to the Emergency Room (ER). The ER staff said to watch for two days. Later that evening (12Feb2021) she started having some shortness of breath and vaginal bleeding. She has an IUD and has not had a period for four years. She called the ER and they gave same advice. She had no fever that day (13Feb2021) but she woke around 3:30 AM soaked. As of 14Feb2021 she was still short of breath on/off and still has sore feet. The patient did not receive treatment for the events. Lab data included Fever of 101.9 on 11Feb2021 and fever in the 101.1 to 101.9 range also on 11Feb2021. The clinical outcome of shortness of breath was reported as not recovered. The clinical outcome of shock-like symptom, shaking, fast breathing, feeling cold, nauseous, headache, fever, welts, swelling of feet, arthralgia, lymphadenopathy, cough, gait disturbance, vaginal bleeding, hyperhidrosis was reported as recovering. The patient has not been tested for COIVD-19 after the vaccination. Information about lot/batch number has been requested.
46 2021-03-02 injection site pain, injection site swelling, injection site pruritus About 5 hours after the second dose I started feeling very fatigued, chills, and had a fever. I had... Read more
About 5 hours after the second dose I started feeling very fatigued, chills, and had a fever. I had these symptoms and flu-like symptoms for about 36 hours before they subsided. I then started to get over the hump and feel better. I also had a very sore, swollen, itchy injection site and arm. Then, Mon. evening, 3/1/21, 5 days after the second dose I was feeling somewhat dizzy, right before bedtime. So I just went to sleep. Today, 3/3/21, I am extremely dizzy and lightheaded and struggling to doing my daily activities. I'm not sure if this is still related to the 2nd injection or not, but I'm concerned.
46 2021-03-03 itchy skin, redness Itchy head, face, ears followed by redness and inflammation
46 2021-03-04 hives, itchy skin, rash One week from 2nd and final dose broke out in hives. Intense itching and skin rash on both arms and ... Read more
One week from 2nd and final dose broke out in hives. Intense itching and skin rash on both arms and entire trunk area. Also effected face and neck.
46 2021-03-04 injection site redness, injection site swelling Patient received vaccine at 10:39am and was in the observation area. At about 3 minutes (10:42 am) s... Read more
Patient received vaccine at 10:39am and was in the observation area. At about 3 minutes (10:42 am) she began to feel " a tingly sensation in my tongue" and felt warm. She also had localized redness and swelling at the site of injection (Right deltoid). She denied any symptoms of chest pain, SOB, palpitations, difficulty swallowing, drooling, nausea/vomiting, dizziness or light-headed or near syncope. Patient was observed by provider for a course of one hour. We recommended to be taken by EMS to ER for further observation, she refused. Patient drove herself and was not able to take Benadryl. Initial vital signs taken 10:54am 177/114; HR 92; O2 98% RA; RR 18 -sitting position Second vitals 11:35am 134/96; HR 79; O2 100% RA ; RR 16- sitting position Patient was observed for an hour and decided to drive home. Recommend hydration and call 911 if needed.
46 2021-03-04 vaccination site pain body aches; chills; pain at injection site; tiredness; This is a spontaneous report from a non-conta... Read more
body aches; chills; pain at injection site; tiredness; This is a spontaneous report from a non-contactable consumer who reported for herself. A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3248, via an unspecified route of administration in the left arm on 01Feb2021 01:15 PM at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination and patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3248, via an unspecified route of administration in the left arm on 12Jan2021 03:15 PM for COVID-19 immunization. On an unspecified date, the patient experienced body aches, chills, pain at injection site and tiredness. No treatment was received for the adverse events. Since the vaccination, patient has not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
46 2021-03-07 vaccination site pain Extreme soreness in the arm that received the shot; This is a spontaneous report from a contactable ... Read more
Extreme soreness in the arm that received the shot; This is a spontaneous report from a contactable consumer (patient herself). A 46-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date was unknown), via an unspecified route of administration in arm on 28Jan2021 10:15 AM at single dose for COVID-19 immunization in workplace clinic. The patient's medical history and concomitant medications were none. The patient did not have allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced extreme soreness in the arm that received the shot on 28Jan2021. The event was considered as non-serious by the consumer. No treatment was received for the adverse event. The outcome of the event was recovered on an unspecified date in 2021. Information on the lot/batch number has been requested.
46 2021-03-07 rash macular, redness, hives I woke up Sunday morning, two days after the shot with red welts from my nect down to my abdoment an... Read more
I woke up Sunday morning, two days after the shot with red welts from my nect down to my abdoment and my arms from shoulders to wrists. They did not itch or hurt, they were just on my body. I took an antihistamine and it did not quash the welts. This morning (monday) the welts were gone on my body except for a quarter sized splotch on my left wrist.
46 2021-03-07 rash, redness Rash, on the left side of my body, neck, both sides, and face. Looks similar to a heat rash on body ... Read more
Rash, on the left side of my body, neck, both sides, and face. Looks similar to a heat rash on body and neck, looks like a sunburn on my face.
46 2021-03-08 injection site redness, injection site pruritus, injection site swelling, injection site warmth, itchy skin, rash, bruising 2/26/21- At time of shot, itchy throat, mouth and face. Next day, felt like I had the flu, light hea... Read more
2/26/21- At time of shot, itchy throat, mouth and face. Next day, felt like I had the flu, light headed, tingly hands and face. On 3/6/21, woke up with swelling, hot, red, itchy swelling at injection site. On 3/8/21, patches of rash that would come and go, face, mouth, and throat itchy. Hand and arms tingly and felt like I was going to pass out. Later that day, had my 1st migraine in my life. 3/9/21-Today, hands, arms, face, mouth, and throat itchy. Finger tips went numb and ring finger on left hand showed signs of bruising (I didnt hurt it that I know of). By the time I got to urgent care, finger no longer bruised color. Light headed, felt like going to pass out again.
46 2021-03-08 injection site redness, injection site warmth 5 days out, injection site is still hot & red. 3 1/2"(h) x 3"(l) No pain, occasional itch, warm to t... Read more
5 days out, injection site is still hot & red. 3 1/2"(h) x 3"(l) No pain, occasional itch, warm to touch
46 2021-03-09 rash, rash papular, rash with redness 1005: Complaint of dizziness; BP 160/90s, P 115. No SOB or respiratory difficulty. No rash. Patient ... Read more
1005: Complaint of dizziness; BP 160/90s, P 115. No SOB or respiratory difficulty. No rash. Patient anxious. 1030: Red, raised rash noted to begin on forehead, cheeks, and upper chest. Shaking (slightly) noted in hands. Patient states "feeling cold." BP 162/94, P 108, O2 99% RA. Patient A&Ox3 sitting in chair. 1040: Patient complaint of "lips feeling 'tingly'". Quickly progressed to full facial tingling. Denies dyspnea or chest pain. Still states she " feels dizzy." 911 called. BP 142/88, P 95, O2 99% RA. 1045: Turned over to paramedics. Patient A&Ox3. Rash still present but no worse. Denies dyspnea or chest pain. Still shaky, slight diaphoresis. Husband & son with patient. Patients belongings given to husband. Taken by EMS offsite.
46 2021-03-09 shingles, hives, itchy skin Appear to be either Shingles or hives, itchy spots on neck face and scalp; Appear to be either Shing... Read more
Appear to be either Shingles or hives, itchy spots on neck face and scalp; Appear to be either Shingles or hives, itchy spots on neck face and scalp; Appear to be either Shingles or hives, itchy spots on neck face and scalp; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL9265), via an unspecified route of administration in left arm on 05Feb2021 10:30 at single dose for COVID-19 immunization. Medical history included Allergic to shellfish, Allergic to soy, Mould allergy, pollen allergies, Atopic dermatitis. There were no concomitant medications. The patient previously took dupilumab (DUPIXENT) from unknown date to 20Dec2020 for Atopic dermatitis. The patient experienced appear to be either shingles or hives, itchy spots on neck face and scalp on 06Feb2021 06:00. Treatment received for the events included Desoxymetasone steroid applied without any effect. The patient was not pregnant. The patient had no COVID prior vaccination. She had no COVID tested post vaccination. There was no other vaccine received at the same date of the COVID-19 vaccine. There was no other vaccine received in four weeks. The outcome of the events was not recovered.
46 2021-03-09 rash, redness, hives The first she had numbness in arm with the injection, hives and tingling in face. Sunday, everything... Read more
The first she had numbness in arm with the injection, hives and tingling in face. Sunday, everything went back to normal. Monday around 3:00 or 3:30, face was hot and had hives. She went to the ER. Was told she had a mild rash, and gave Benadryl and ordered EpiPen for emergency. Left ER to pick up prescription but tongue began to swell, went back to ER, gave you Cortisone 50 mg and Pepcid Benadryl IV for 7 days. Yesterday, had another face reaction, had hives very mild only in the morning. Today at 8:00a.m., had redness in face. Around 3:00pm, lips and tongue were swollen and has extremely dry mouth. Today, she is on her way to the ER because her tongue has swollen again.
46 2021-03-09 hair loss got vaccine - about a week later - she sent us a message saying "I have been having right calf pain ... Read more
got vaccine - about a week later - she sent us a message saying "I have been having right calf pain for about a week or more. I have more increased SOB and chest pain." was able to get ddimer which was elevated - and was admitted to the hospital for this since her vaccine - she has noticed increased chest tightness, SOB, hairloss, DVT/PE.
46 2021-03-10 itchy skin Fatigue, severe itchiness all over body, headache, restlessness while falling asleep, lightheadednes... Read more
Fatigue, severe itchiness all over body, headache, restlessness while falling asleep, lightheadedness
46 2021-03-10 hives, redness, rash Liver processing reactions and sensitity. Facial, neck and chest rash ( the same way liver sends tox... Read more
Liver processing reactions and sensitity. Facial, neck and chest rash ( the same way liver sends toxins to integumentary system in order to process a new introduced toxin, for example alcohol); hive bump on neck inferior to lymph nodes on same side of injection site. 4 days later, liver sensitivity (feels bruised as if I fell on my side). 8 days later, noticed mild yellowing of skin all over body. 11 days later, redness on chest and neck have faded, but redness in cheeks remain as well as jaundice tone. No previous liver history, disease, or infections.
46 2021-03-11 rash, itchy skin, redness, hives Symptoms: Rough rash started around inner bilateral wrists within an hour of received the 2nd dose o... Read more
Symptoms: Rough rash started around inner bilateral wrists within an hour of received the 2nd dose of COVID-19 vaccine Pfizer. Rash turned into extreme redness and hives when taken a shower. 2 days later, the rash radiated to the outer wrists, abdomen, and groin area. On the third day, the rash radiated to under the left breast. Whole-body is itching including the scalp. Treatment: On the third day, I was advised to go to employee health. I was advised to go to my physician. On the fourth day, I went to my physician. The treatment plan is: Zyrtec 10 mg daily for 2 weeks, Pepcid 20 mg for 2 weeks. I was advised to also use hydrocortisone cream twice a day for two weeks. After two weeks, I have a follow-up visit with my physician.
46 2021-03-14 itchy skin, rash March 10, 9am, received injection in left arm. Minor headache throughout the day. That afternoon (... Read more
March 10, 9am, received injection in left arm. Minor headache throughout the day. That afternoon (~3:00pm) noticed itchy neck and face. (Since I had a rash last year from skincare products I just thought it was same thing). March 11, rash worse. Treated with topical 2.5% hydrocortisone ointment. Back of head started feeling tender. March 12, evening, back of head feeling worse, took Ibuprofen. Rash much better on face/neck. Middle of night (March 12), head extremely painful and noticed swollen lymph nodes on back/right side of head. March 13, 8:00am, went to urgent care clinic. Received Cefdinir 300mg antibiotic for unknown infection causing swollen lymph nodes. Rash almost gone. Back of head extremely tender/painful. March 14, swollen lymph nodes multiplied on back of head and also on right side of neck. Saw neighbor anesthesiologist who thought my rash and swollen lymph nodes were caused by the vaccine. March 15, lymph nodes still swollen, but feels more burning/itching like a rash now with occasional throbbing pain. Spreading more in right side of neck, which is sore/tender. Slight rash on neck.
46 2021-03-14 hives, rash Patient C/o facial numbness, rash and hives on face and neck 25 minutes after vaccine given. lips sw... Read more
Patient C/o facial numbness, rash and hives on face and neck 25 minutes after vaccine given. lips swelling and numbness. Epi pen given. Patient rash and hives continued. patient shaky and nervous. patient denied difficulty breathing. BP elevated. O2 sats stable. IV placed in right AC , IV Benadryl 50mg given IV push. Paramedics on site. Patient transported to ED.
46 2021-03-14 vaccination site pain The next day injection site was sore.; This is a spontaneous report from a contactable other healthc... Read more
The next day injection site was sore.; This is a spontaneous report from a contactable other healthcare professional (HCP). A 46-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) Lot number EL9265, via an unspecified route of administration on 31Jan2021 11:30 (at the age of 46 years old) as a SINGLE DOSE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, high blood pressure from an unknown date and unknown if ongoing. Concomitant medication included amlodipine, montelukast sodium, fluticasone propionate, salmeterol xinafoate (ADVAIR) 500/50. Prior to the vaccination, the patient was not diagnosed with COVID-19. The vaccination was administered in a hospital. The patient experienced the next day injection site was sore on 01Feb2021. The patient did not receive treatment. Outcome of event was recovered in 2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
46 2021-03-15 rash with redness ENLARGED LYMPH NODES , RED RASH, AND VISIBLE LUMPS IN BREAST ON SAME SIDE OF VACCINATION WHICH LASTE... Read more
ENLARGED LYMPH NODES , RED RASH, AND VISIBLE LUMPS IN BREAST ON SAME SIDE OF VACCINATION WHICH LASTED APPROXIMATELY 2 WEEKS
46 2021-03-15 redness Face burning, severe redness to face, face swelling on the left side, twinge in left side of neck, c... Read more
Face burning, severe redness to face, face swelling on the left side, twinge in left side of neck, chills.
46 2021-03-15 itchy skin First dizziness and nausea; First dizziness and nausea; Then itching; Then tongue swelling/throat cl... Read more
First dizziness and nausea; First dizziness and nausea; Then itching; Then tongue swelling/throat closing; throat closing; This is a spontaneous report from a contactable consumer (Patient herself). A 46-Year-Old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9266), via an unspecified route of administration at Left arm on 16Feb2021 17:45 (at age of 46 years old) at single dose for COVID-19 immunisation. Relevant medical history included: Athsma-lasting trouble breathing after allergic reaction, Ehlers-Danlos Syndrome, PCOS (Polycystic ovarian syndrome), Hypothyroid. Known allergies was Cashews, pistachios, cat dander. The patient's concomitant medications were not reported. No other vaccine in four weeks. No COVID prior vaccination. COVID tested post vaccination. The patient experienced first dizziness and nausea Then itching Then tongue swelling/throat closing, all Adverse events started on 16Feb2021 17:45. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included COVID test type post vaccination was Nasal Swab, COVID test name post vaccination=PCR on 21Feb2021 with result Negative. Treatment (Epipen, IV Benadryl, Pepcid, Prednisone) received for all AE. The outcome of the events was recovered in 2021.
46 2021-03-15 injection site rash Got shot on Thursday woke up Friday 2am with achy arm, by 7am full body aches and mild temp of 99.4 ... Read more
Got shot on Thursday woke up Friday 2am with achy arm, by 7am full body aches and mild temp of 99.4 Friday all day arm ached,small rash developed right of injection site , brainfog, dizziness. Symptoms went away by Saturday Morning just had a achy arm until Sunday. still expierencing Brain fog . Also experienced Brain fog and dizziness with first dose
46 2021-03-15 itchy skin Itching all over body about 3-5 minutes after injection. I took 2 Benadryl when I got home. Symptom... Read more
Itching all over body about 3-5 minutes after injection. I took 2 Benadryl when I got home. Symptoms improved within 1-2 hours.
46 2021-03-15 rash Rash around the body.
46 2021-03-16 injection site pain Chills, body aches(especially in hips) sore arm where shot was given, minor headache. Symptoms last ... Read more
Chills, body aches(especially in hips) sore arm where shot was given, minor headache. Symptoms last about 13 hours Treatment was Ibuprofen and rest. Symptoms were bad enough that I couldn?t go to work.
46 2021-03-18 injection site pain 24 Hours after receiving the vaccine my arm was sore from my bicep all the way up to my lower neck. ... Read more
24 Hours after receiving the vaccine my arm was sore from my bicep all the way up to my lower neck. I noticed two bumps near my clavicle, as well that area is swollen.
46 2021-03-18 rash 3-18-21 2:46PM PT C/O 'RASH TO BOTH ARMS' DIME SIZED AREAS NOTED. NO SOB OR DYSPNEA, NO FACIAL, TONG... Read more
3-18-21 2:46PM PT C/O 'RASH TO BOTH ARMS' DIME SIZED AREAS NOTED. NO SOB OR DYSPNEA, NO FACIAL, TONGUE OR THROAT EDEMA. A/O, PINK, W/D, RESP REG WITH EASE. PT STATES SHE 'FEELS OK TO GO HOME'. HUSBAND HERE TO DRIVE HER HOME. 'HAS BENARDYL AT HOME AND WILL TAKE IF NEEDED.'
46 2021-03-19 itchy skin This was the second dose. No immediate reactions after injection. Approximately 6 hours later, inter... Read more
This was the second dose. No immediate reactions after injection. Approximately 6 hours later, internal itching began throughout my entire body. I also had a slight tingling of the tongue and lips. Benadryl did not ease the itching or mouth tingling. The internal itching by the next day and increased doses of Benadryl still did not help. Intense itching by day 3 as well as fever of 99.5. Saw an online doc who prescribed Hydroxyzine for itching. It is now day 9 after the second vaccine. Itching internally has worsened. Still have tongue and lip tingling as well. I saw another online doc to tell them symptoms have continued and have worsened a bit and that I have been 24 hours without the Hydroxyzine. The prescription ran out the day prior. Doctor prescribed more Hydroxyzine. This time around the Hydroxyzine does not seem to be as effective. While it helps a bit with me sleeping, the itching is still quite severe. The severe internal itching has been going on for 9 days and has affected my quality of life. The itching is nonstop and is happening in all parts of my body. No other antihistamine is effective and is able to be taken during the day except the Hydroxyzine which causes grogginess and has become less effective.
46 2021-03-20 hives, itchy skin Chills, itching and hives, low grade fever
46 2021-03-20 itchy skin Itchiness to left arm for a minute then went away. Same thing to right wrist then went away.
46 2021-03-20 rash Painful rash and lumps on arm.
46 2021-03-20 injection site pruritus, injection site pain, injection site swelling swelling, itching, pain began day after injection rash and further swelling appeared 8 days after i... Read more
swelling, itching, pain began day after injection rash and further swelling appeared 8 days after injection date
46 2021-03-21 itchy skin, hives, rash About a week after the shot was given I broke out in a rash and hives. Reaction was mostly on my to... Read more
About a week after the shot was given I broke out in a rash and hives. Reaction was mostly on my torso. Did spread to buttocks and forearms. After three days or so I started taking an OTC allergy medication and applying hydrocortisone cream. Seems to be responding to allergy medication and cream. A week later and hives are almost gone. Most of the itching has subsided.
46 2021-03-21 injection site swelling Day after injection: Swollen arm around injection site. Day two after injection: After swelling decr... Read more
Day after injection: Swollen arm around injection site. Day two after injection: After swelling decreased I had swelling under my arm with a knot the size of a golf ball. Very sore and tender to touch.
46 2021-03-22 itchy skin, redness Swelling of right hand, extreme itchiness, some redness
46 2021-03-23 itchy skin, blister, redness "Covid Toes" The toes on my left foot became red, swollen, blistered and Extremely itchy on the 5th ... Read more
"Covid Toes" The toes on my left foot became red, swollen, blistered and Extremely itchy on the 5th day following my first covid vaccine which lasted for approximately 6-7 days. This occurred again one week following my second vaccine (2nd shot 1/29), for approximately 5 days. It has occurred three times since then, all on the Friday anniversary of my getting the shot. The symptoms for the last 3 times lasted only 2 days, and the redness has decreased, but they are still extremely itchy and have now become scaly at the site of where the most severe itching took place. They do burn occasionally at the site of the scales.
46 2021-03-23 itchy skin Client c/o itching, throat tightening and increase cough
46 2021-03-23 itchy skin, hives I started having itching and hives about 3 hours after receiving the vaccine. No shortness of breath... Read more
I started having itching and hives about 3 hours after receiving the vaccine. No shortness of breath or other discomfort . I did an unscheduled Telehealth visit through my insurance and the doctor prescribed me Hydroxyzine, Fexofenadine and an anti itch cream. I took 1 Hydroxyzine and went to bed. i was completely fine the next morning.
46 2021-03-23 vaccination site pain Injection site soreness; fatigue; severe headache; feeling pressure behind my eyes/eye trouble; both... Read more
Injection site soreness; fatigue; severe headache; feeling pressure behind my eyes/eye trouble; both eyes are bright red; both eyes are bright red, watering, and aching; both eyes are bright red, watering, and aching; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 17Feb2021 at 23:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no concomitant medications. Prior to vaccination the patient was not diagnosed with COVID-19 and did not receive any vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number unknown) on 07Jan2021 at 14:00 (at the age of 46-years-old) in the left arm for COVID-19 immunisation. The patient reported that on 18Feb2021 she experienced injection site soreness, fatigue, severe headache and now (as of 21Feb2021) eye trouble. She had been feeling pressure behind her eyes and now (at of 21Feb2021) both eyes were bright red, watering, and aching. She didn't know if she would need to have her eyes treated. The events were reported as non-serious and did not require hospitalization. It was unknown if treatment was provided for the events. The clinical outcomes of feeling pressure behind her eyes/eye trouble, injection site soreness, fatigue, severe headache, both eyes are bright red, watering and aching were not recovered. It was also reported the patient had not been tested for COVID-19 since vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
46 2021-03-23 vaccination site pain chills; vomiting; headache; body aches; nauseous; Pain at injection site; This is a spontaneous repo... Read more
chills; vomiting; headache; body aches; nauseous; Pain at injection site; This is a spontaneous report from a contactable health care professional also reporter as contactable consumer, the patient. A 46-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EM9810), via an unspecified route of administration, administered in Arm Left on 19Feb2021 at 14:45 as SINGLE DOSE for covid-19 immunization. Facility in which the vaccine in was administered was (name of facility) Clinic. The patient medical history was not reported. Concomitant medications included bupropion (BUPROPION) , clonazepam (CLONAZEPAM), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), ergocalciferol (VIT D), ascorbic acid (VIT C). The patient previously took Imitrex and experienced allergy. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 20Feb2021 01:00 The patient experienced nauseous and On 20Feb2021 at 02:00 patient experienced chills, vomiting, headache, body aches and pain at injection site. The clinical course is as follows At approximately 1AM, I was nauseous. 2AM vomiting followed by chills, headache and body aches (no fever). Pain at injection site. The patient underwent lab tests and procedures which included sars-cov-1 test: negative on 11Dec2020 'Nasal Swab'. No treatment was given for the events. The clinical outcome of the event was nauseous, vomiting, chills, headache, body aches (no fever) and Pain at injection site was not recovered.
46 2021-03-23 itchy skin itching tightness in chest
46 2021-03-24 rash Follow injection of 1st dose Pfizer, she reports within 1-2 minutes both hands started feeling hot a... Read more
Follow injection of 1st dose Pfizer, she reports within 1-2 minutes both hands started feeling hot and began swelling. Within 5-10 minutes she developed a rash on hands, face, neck and chest. She notified the staff, who provided ice packs for the swelling and placed her in front of a fan. She was monitored for 45 minutes, then released with inst to call 911 if she developed airway problems. She began developing a mild headache. She drove home and took Benadryl 50 mg by mouth, and repeated the dose every 8 hours x 2 additional doses. She took Tylenol for headache. The headache and swelling resolved in 12 hours, and the rash resolved in 16-18 hours.
46 2021-03-24 rash Malaise, fatigue, muscle aches, rash
46 2021-03-24 redness, itchy skin Tingling sensation in tongue within 2 minutes of injection, swelling of tongue to twice the thicknes... Read more
Tingling sensation in tongue within 2 minutes of injection, swelling of tongue to twice the thickness, itchy mouth, and rapid heartrate within 10 minutes, redness, burning, swelling, and itchy skin on face within 15 minutes. Epi-pen given within 14 minutes, and transport to hospital, wheezing in bases of lungs noted by ER physician and diphenhydramine, famotidine, and solumedrol given. Swelling of tongue took 1.5 hours to reduce to half. Overnight stay at hospital, due to severity and duration of symptoms.
46 2021-03-24 bruising, vaccination site pain congestion and wheezing in left upper lobe of lung; congestion and wheezing in left upper lobe of lu... Read more
congestion and wheezing in left upper lobe of lung; congestion and wheezing in left upper lobe of lung; short of breath; left side of my face became numb; tachycardic; Blood Pressure 162/110; chills; burning in my mouth; tingling throughout body; dizziness; fog brain/Memory loss/felt as if out of body experience" or just not normal for about 12 to 14 days; fog brain/Memory loss; muscle pain; bruising not at site (in legs); lymph node swelling on injection arm sight; I finally felt pain at injection site; This is a spontaneous report from a contactable health care professional nurse, the patient. A 46-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899); intramuscular on 20DEC2020 at 22:30 (at the age of 46 years old) as a single dose, for COVID-19 immunization. Medical history included hypothyroid, Allergic to Latex. The patient previously took levonorgestrel and experienced drug hypersensitivity. The patient's concomitant medications were not reported. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 20Dec2020 The patient experienced congestion and wheezing in left upper lobe of lung, short of breath, left side of my face became numb, tachycardic, Blood Pressure 162/110, chills, burning in my mouth, tingling throughout body, dizziness, brain/memory loss/felt as if out of body experience" or just not normal for about 12 to 14 days, muscle pain, bruising not at site (in legs), lymph node swelling on injection arm sight and on about the 5th day Dec2020 experienced pain at injection site. The patient underwent lab tests and procedures which included blood pressure: 162/110 on an unspecified date and heart rate tachycardic on an unspecified date. The clinical course is as follows Shortly right at 15 minute mark of being monitored, I became short of breath, left side of my face became numb, then right, became tachycardic, Blood Pressure 162/110, developed chills, burning in my mouth, tingling throughout body, dizziness, developed "fog brain"/Memory loss prevalent for following 48 hours after injection, remained not as severe about a week after, muscle pain, bruising not at site (in legs) developed lymph node swelling on injection arm sight, developed congestion and wheezing in left upper lobe of lung. "felt as if out of body experience" or just not normal for about 12 to 14 days. Patent Refuse to go to ER, where advised to go after RAD team assessed, around the 5th day I finally felt pain at injection site-which that part would be normal, but I did not feel at 1st due to all the major reactions my body dealt with. As a result of the events the patient did visit a physician. Treatment was given for the events (Pulmonary congestion, wheezing, dyspnea, hypoesthesia, tachycardia, chills burning sensation, paranesthesia, dizziness, feeling abnormal, Amnesia, Myalgia, Contusion, Lymphadenopathy, Vaccination site pain) which included Benadryl, Tylenol, IBU, and steroids, Cold and cough meds OTC. The clinical outcome of the events Pulmonary congestion, wheezing, dyspnea, hypoesthesia, tachycardia, chills burning sensation, paranesthesia, dizziness, feeling abnormal, Amnesia, Myalgia, Contusion, Lymphadenopathy, and Vaccination site pain was recovering while blood pressure 162/110 was unknown.
46 2021-03-25 itchy skin, hives Metal flavor and swelling tongue, trouble breathing, hives, itching, fast heartbeat, mental confusi... Read more
Metal flavor and swelling tongue, trouble breathing, hives, itching, fast heartbeat, mental confusion, tingling, swelling lymph nodes, body ache, headache.
46 2021-03-26 redness Muscle aches, red face, chills, night sweat, headache, fever from 7:00 3/23 to 12:00 pm 3/25. Symp... Read more
Muscle aches, red face, chills, night sweat, headache, fever from 7:00 3/23 to 12:00 pm 3/25. Symptoms stopped as suddenly as they appeared.
46 2021-03-28 injection site pain, injection site tingling, injection site numbness Burning, tingling, numbness on left arm, shoulder, face. Most symptoms resolved in 36 hours. Resul... Read more
Burning, tingling, numbness on left arm, shoulder, face. Most symptoms resolved in 36 hours. Resulted in sinus disease left maxillary sinus and swollen lymph glands in neck
46 2021-03-28 injection site reaction, injection site pain, hives I had a welt the size of a quarter at the injection site. This was red, raised about 1/4" and lasted... Read more
I had a welt the size of a quarter at the injection site. This was red, raised about 1/4" and lasted for 10 days post vaccine. There was mild pain (not painful, but more annoying, although slightly painful to the touch).
46 2021-03-30 rash 3/22 When administered shot body felt a little warm 3/24 Burning pain like a yeast infection or bla... Read more
3/22 When administered shot body felt a little warm 3/24 Burning pain like a yeast infection or bladder infection. Treated at urgent care for a yeast infection 3/25 Woke up with a fever and a rash on my back and chest 3/27 Right side of face was droopy 3/28 Right side of face felt numb, more swollen, droopy, and tingly went to the doctor immediately as worried about Bell's Palsy or worse case a stroke
46 2021-03-30 redness increased blood pressure; reddening of the skin all over her body; This is a spontaneous report from... Read more
increased blood pressure; reddening of the skin all over her body; This is a spontaneous report from a contactable consumer, based on information received by Pfizer (manufacturer control number: US-AMGEN-USASL2021027233). This case was split from master case #2021218108 to capture a 46-year-old female patient taking BNT162B2 and experienced increased blood pressure and skin red. This non-serious solicited report (USASL2021027233) was reported on 18/FEB/2021 by a consumer from a commercial program (PSP00086) and involves a 46 years old female patient who experienced increased blood pressure/blood pressure has continued to be elevated 180/100 [PT: blood pressure increased], migraines [PT: migraine] while receiving Enbrel, Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis, increased blood pressure, reddening of the skin all over her body. It was further mentioned that on 08/JAN/2021, the patient had a Covid vaccine and had a reaction to it immediately that including increased blood pressure and reddening of the skin all over her body. No concomitant medications were provided. No co-suspect medications were reported. The patient began Enbrel, Single Dose Prefilled Autoinjector on 28/JAN/2021. On 28/JAN/2021, the patient's blood pressure has continued to be elevated 180/100, even with Enbrel medication. Additionally, on an unknown date in JAN/2021, the patient had migraines and possible fibromyalgia. No treatment information was received. The outcome of the event blood pressure increased was reported as not recovered/not resolved. The outcome of the event migraine was reported as unknown. Action taken with Enbrel, Single Dose Prefilled Autoinjector was continued for the event blood pressure increased. Action taken with Enbrel, Single Dose Prefilled Autoinjector was reported as unknown for the event migraine. The causal relationship between the events blood pressure increased, migraine and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up has been requested. Follow-up (08Mar2021): The following information was received: Narrative states, It was further mentioned that on 08/JAN/2021, the patient had a Covid vaccine and had a reaction to it immediately that including increased blood pressure and reddening of the skin all over her body. Kindly confirm Covid vaccine is co-suspect or concomitant. Response: As per the information in the case: 08/JAN/2021, the patient had a Covid vaccine. The patient began Enbrel, Single Dose Prefilled Autoinjector on 28/JAN/2021. Therefore, the Covid vaccine which was prior to Enbrel start is neither considered as co-suspect nor concomitant medication. The company is performing due diligence, and should further information be received, the case will be updated accordingly. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
46 2021-04-10 itchy skin, skin burning sensation 7 days after the second Covid vaccine shot, painful burning feet woke me up in the middle of the nig... Read more
7 days after the second Covid vaccine shot, painful burning feet woke me up in the middle of the night, it wouldn?t go away,, with pins and needles itching all day. Then again the following night (last night) my feet burned all night. In hindsight, I had had a very bad reaction after the second shot on 4/2 that started the night of the shot, when I woke up at 3 am feeling like my feet, legs and entire body was burning, then Saturday I had a high fever all day, 103.8, chills, burning sensation on and off, chest pain, heart pain, which I treated first with Tylenol then Motrin. It was a horrible two nights, but by Sunday 4/4 I was fine. I have been fatigued all week but didn?t think much about it. Then Friday night into Saturday of exactly a week after the second shot, this has happened. The burning sensation on my feet is intolerable and I haven?t slept for two nights.
46 2021-04-12 rash overwhelming since of hotness; Dizziness; broke out in a rash everywhere; heart rate went up; This i... Read more
overwhelming since of hotness; Dizziness; broke out in a rash everywhere; heart rate went up; This is a spontaneous report from a contactable Nurse. This female Nurse reported for herself that a 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot no: EP7534, Expire Date: 31Jul2021), 0.3ml intramuscular injection in left deltoid as a single dose for covid 19 immunisation on 26Mar2021 at 1:00PM. The patient medical history included blood pressure, migraine. The patient concomitant medication included Amitriptyline 100mg once a day for Blood pressure, Amlodipine Besilate at 5mg every day for Migraine, Sumatriptan (Sumatriptan)100mg as needed for Migraine. The patient received the first dose of Pfizer COVID19 vaccine on 26Mar2021 and had an immediate reaction. She needed 50mg of Benadryl, within 15 seconds of the vaccine. she had an overwhelming since of hotness and did not last very long, maybe 3 seconds and It washed over her. The feeling like she was going to pass out came after the overwhelming since of hotness. They put her feet up and put on nasal cannula with 2L of oxygen. The feeling like she was going to pass out came and went with the dizziness. She was dizzy on and off for 30 minutes. The rash started immediately, and It went away about 5 o'clock that evening and the Heart rate went up: it was 122 beats per minutes on 26Mar2021. It came down back to normal within an hour. All the events were assessed as medically significant. The outcome of felt like she was going to pass out, overwhelming since of hotness, Dizziness, broke out in a rash and heart rate went up was recovered on 26Mar2021. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect product BNT162B2 and all reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
46 2021-04-12 rash skin hurting like a neuropathy; chills; she experienced a rash; My blood pressure was high; anaphyla... Read more
skin hurting like a neuropathy; chills; she experienced a rash; My blood pressure was high; anaphylactic reaction; my throat was closing; my tongue swelled up to the back of my throat; she experienced Body aches; At home she started wheezing; Dry cough; Hoarse voice; Upper airway swelling; Difficulty breathing (without wheeze or stridor); bronchospasm; Respiratory distress; This is a spontaneous report from a contactable other hcp (patient). A 46-years-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8732), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 at 10:30 as single dose for COVID-19 immunisation. Medical history included celiac disease and asthma. The patient had allergies to medications, food, or other products. Concomitant medication(s) (received within 2 weeks of vaccination) included levocetirizine dihydrochloride (XYZAL), Dexalant and birth control pill. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the was not patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26 Mar2021, the patient experienced anaphylactic reaction, my tongue swelled up to the back of my throat, my blood pressure was high, my throat was closing, she experienced body aches and at home she started wheezing/bilateral wheeze. Within minutes of receiving the vaccine, my tongue swelled up to the back of my throat and she had a weird sensation in her throat, 15 minutes later she was not able to form words. The patient was given liquid Benadryl (oral) for my tongue swelled up to the back of my throat and her symptoms resolved. She went to the nurse station, who took her BP which was high, which it normally is not so the treating physician felt confident in letting me go home. She was monitored for an hour and was sent home with no more tongue swelling. At home she started wheezing. She called her HCP and was advised to take a nebulizer with no effect. At around 14:00, when the Benadryl wore off, her throat was closing so she was directed to epi-pen herself and call 911. She was taken by ambulance to the hospital and treated for anaphylactic reaction to the vaccine. She was given prednisone 50mg by mouth daily for four days and a refill for her Epipen. No additional Epipen was administered. On 29Mar2021, the patient experienced skin hurting like a neuropathy, chills and she experienced a rash. On an unknown date in Mar2021, she experienced bronchospasm, upper airway swelling, respiratory distress, dry cough, hoarse voice and difficulty breathing (without wheeze or stridor). No sneezing or rhinorrhea. She was treated with adrenaline, corticosteroids, antihistamine, IV fluids, Oxygen, bronchodilators and other. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The administering doctor not to take the second vaccine. The outcome of the events anaphylactic reaction, my tongue swelled up to the back of my throat, my blood pressure was high and my throat was closing was recovered with sequealae, skin hurting like a neuropathy, she experienced body aches, at home she started wheezing/bilateral wheeze, chills and she experienced a rash was recovered and bronchospasm, upper airway swelling, respiratory distress, dry cough, hoarse voice and difficulty breathing (without wheeze or stridor) was unknown. Follow up attempts are needed. Information on lot /batch number was obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
46 2021-04-13 injection site pruritus, injection site pain High heart rate (140-150) while sitting. High Blood Pressure (150/90) while sitting. Left side chest... Read more
High heart rate (140-150) while sitting. High Blood Pressure (150/90) while sitting. Left side chest pain. Heart palpitations. Welt at injection site, was painful and itchy. Stomach cramping and loose stool.
46 2021-04-14 itchy skin Slight itching began within minutes, but it was minor. Itching was mid way down left arm and in face... Read more
Slight itching began within minutes, but it was minor. Itching was mid way down left arm and in face? chin area. Within 39 minutes, left side of face was numb with tingling sensation and lips were fully numb and tingly. Tongue felt swollen and itchy, as well. Symptoms lasted several hours. It is now more than a week later and there is still slight numbness in lips and on left side of face. No visible changes have been noticed, just the sensation of numbness as of given Novocain at the dentist.
46 2021-04-15 itchy skin, redness Slightly blurry vision in 15 minutes. Then at the 31 minute mark, my throat started swelling and my ... Read more
Slightly blurry vision in 15 minutes. Then at the 31 minute mark, my throat started swelling and my chest was tight, so it was hard to catch my breath. My whole face and ears turned red and i was itchy on my arms. 2 doses of Benadryl made the allergic reaction ease. I was tired for the next two weeks, and then started having heart palpitations regularly. Went to ER was diagnosed with Tachycardia, Hyperkalemia, Hypomagnesemia, and Hypocalcemiaand. Corrected with intravenous drugs and overnight stay in the hospital. Slowing feeling some better, but struggling with inflammation and being exhausted. Felt 100% great before getting this vaccine. Advised by doctors not to get second shot and did not get it.
46 2021-04-20 injection site pain Fever, fatigue, body aches, loss of taste, loss of appetite burning at injection site immediately an... Read more
Fever, fatigue, body aches, loss of taste, loss of appetite burning at injection site immediately and hotness around site for three days, heaviness in chest all the way through to back, shortness of breath
46 2021-05-04 vaccination site pain Pain and pulling under the right arm; This is a spontaneous report from a contactable consumer (pati... Read more
Pain and pulling under the right arm; This is a spontaneous report from a contactable consumer (patient herself). A 46-Year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot/Batch number: BN6203), via an unspecified route of administration on 23Feb2021 at 05:15 pm on the right arm as a single dose for covid-19 immunisation. The patient's medical history included allergies, anxiety and depression. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. On 25Feb2021 at 04:00 am, the patient reported pain and pulling under the right armpit. Patient stated that she did not took any treatment medication for the events. The outcome of the events was not resolved.
46 2021-05-04 injection site pruritus, injection site pain, injection site redness, injection site vesicles, injection site swelling Swelling and severe itching on injection arm; blistering around injection site; redness. Pain radia... Read more
Swelling and severe itching on injection arm; blistering around injection site; redness. Pain radiating down arm and up neck. Swollen painful lymph nodes under arms and in neck (worse on side of injection) Treatment: benedryl and tylenol/advil. significant swelling and itching, blistering and lymph node swelling resolved on 5/42021. Minor itching and radiating pain continue, but are lessened by advil/tylenol and benedryl.
46 2021-05-04 vaccination site pain Throwing up; nausea; chest pain & tightness to the point I could not move my arm to use my emergency... Read more
Throwing up; nausea; chest pain & tightness to the point I could not move my arm to use my emergency inhaler prescribed after COVID/ I couldn't move; tremor increased; post COVID syndrome & orthostatic hypertension.; post COVID syndrome & orthostatic hypertension.; Lymph node pain; Tilt Table Testing confirmed Covid-induced POTS; mild injection site pain; COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain); COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain); COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain); COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain).; chest pain & tightness to the point I could not move my arm to use my emergency inhaler prescribed after COVID; dizzy; Fatigue; vasovagal response; Passed out; This is a spontaneous report from a contactable other health professional (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 05Feb2021 at 10:30 (Lot Number: EL9261) (at the age of 46-year-old) as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included infectious mononucleosis (Recent mono) in 2020 (Spring), urinary tract infection (UTI) in 2020 (Summer), venous Insufficiency on Dec2020, shingles in past on an unspecified date, lactose & gluten intolerance from an unknown date and unknown if ongoing, COVID-19 from Jun2020 to an unknown date (I had recovered from mild COVID in Jun and Oct2020 that required no hospitalization and was managed with DAYQUIL, XYZAL, Prednisone, Vit D and melatonin). Concomitant medications included ibuprofen at 2400 mg and 800 mg; pregabalin (LYRICA); progesterone; bifidobacterium bifidum/bifidobacterium lactis/bifidobacterium longum/lactobacillus acidophilus/lactobacillus rhamnosus (PROBIOTIC), all concomitants were taken for an unspecified indication, start and stop date were not reported. The patient experienced mild injection site pain, COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain), dizzy, fatigue, vasovagal response, passed out, nausea, throwing up, tremor increased, chest pain & tightness to the point I could not move my arm to use my emergency inhaler prescribed after COVID/ I couldn't move, post COVID syndrome and orthostatic hypertension, tilt table testing confirmed COVID-induced POTS (postural orthostatic tachycardia syndrome) and lymph node pain, all on 05Feb2021 at 11:00. All events were serious disabling and required hospitalization. The patient underwent lab tests and procedures which included computerized tomogram (CT): unknown results on an unspecified date, D-dimer: 1300 is very elevated, it shows that I have a lot of inflammation in my body or I could have the clot, 1300, almost 3 times the normal value; magnetic resonance imaging head (MRI): unknown results on an unspecified date, SARS-COV-2 test (nasal swab): negative on 19Feb2021, tilt table test: COVID-induced pots on 05Feb2021 . Unspecified therapeutic measures were taken as a result of the events. The patient outcome of the event passed out was unknown and not recovered for all the other events.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
46 2021-05-09 injection site redness Site: Redness at Injection Site-Mild, Systemic: Left ankle swelling, mild-Mild, Additional Details: ... Read more
Site: Redness at Injection Site-Mild, Systemic: Left ankle swelling, mild-Mild, Additional Details: Told patient to lift left ankle above heart level. Stayed for about 30 minutes. Provided patient education to decrease swelling. Patient bought Ibuprofen and Benadryl. Took 50 mg of Benadryl and 400 mg of Ibuprofen in the store. Warned patient about potential side effects of drowsiness of driving and she said she was fine due to her height and weight. Told patient to get in contact with her healthcare provider.
47 2020-12-31 itchy skin, hives, rash Severe rash with hive type welts on top of the rash. Extremely itchy. It appeared as a rash with wel... Read more
Severe rash with hive type welts on top of the rash. Extremely itchy. It appeared as a rash with welts covering the right side of rib cage and has progressed to covering scalp to ankles.
47 2021-01-01 rash Received covid-19 vaccine on 12/17/2020. On 12/23/2020, noticed small rash bumps on back of both ha... Read more
Received covid-19 vaccine on 12/17/2020. On 12/23/2020, noticed small rash bumps on back of both hands. On 12/26/2020, noticed rash on shoulders and middle back. Noted fatigue and malaise. No fever. On 12/28/2020, rash appeared on upper legs and back of both knees. Noted fatigue and malaise. No fever. On 12/29/2020, rash appeared on both lower legs and on arms. Noted fatigue and malaise. No fever. On 12/30/2020, attempted to make an appointment with primary care provider and was unable to be seen before Jan 6, 2021. On 1/1/2021, went to Urgent Care for evaluation and treatment of full body rash. The only part of my body not affected by the rash is my face. Was prescribed a methylprednisolone dose pack.
47 2021-01-01 itchy skin rec'd shot 1405, monitored for 30 min d/t flu vaccine allergy in past as recommended by physician on... Read more
rec'd shot 1405, monitored for 30 min d/t flu vaccine allergy in past as recommended by physician on call. 35 min in c/o itching to face and neck. monitored for 15 more min, declined cold compress, advised to monitor symptoms
47 2021-01-02 itchy skin BREATHING DIFFICULTY, STRIDOR, O2 SAT DROP, LIGHTHEADEDNESS, GENERALIZED ITCHING. AROUND 10 MIN POST... Read more
BREATHING DIFFICULTY, STRIDOR, O2 SAT DROP, LIGHTHEADEDNESS, GENERALIZED ITCHING. AROUND 10 MIN POST INJECTION. BEENADRY 100MG TAKEN, 4 DOSES OF TWO PUFF OF PROAIR HFA TAKEN. BREATHING NORMALIZED. ITCHING REMAINED, LIGHTHEADED SUBSIDED. GENERALIZED TOTAL BODY ITCHING CONTINUED THROUGH THE 3RD TODAY, LESSENDED YESTERDAT THE 2ND. BREATHING DIFFICULTY SOB AND TIGHTNESS RESUMED TODAY 1/3/2021 FOR ABOUT 2 HOURS BENADRYL 150 MG TAKEN , PEPCID 40 MG TAKEN, CLARATIN TAKEN PROAIR PUFFS TAKEN X 5 . CHEST TIGHTNESS CONTINUES, ITCHING CONTINUES AND BENADRYL CONTUNES TO BE USED WITH PUFFS FOR RELIEF. NORMAL MEDS TAKEN AS WELL XYZAL AND SIGULAR
47 2021-01-03 hives, redness EE presented to EH with c/o hives to face and racing heart rate at 1445
47 2021-01-03 injection site pain Initial 36 hours sore at injection site Day #4 pain in hip joints and moderate aching in legs bilate... Read more
Initial 36 hours sore at injection site Day #4 pain in hip joints and moderate aching in legs bilaterally Day #5 prickling needles feeling soles of feet bilaterally and palms of hands for short time. Palms have resolved. Soles of feet remain on Day #6.
47 2021-01-04 injection site pain Fever; feels weak; tired; lightheaded; pain at the injection site; back and hip pain; back and hip p... Read more
Fever; feels weak; tired; lightheaded; pain at the injection site; back and hip pain; back and hip pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history included sick with coronavirus infection from 11Aug2020. There were no concomitant medications. The patient was experiencing the expected side effects fever, feels weak, tired, lightheaded, pain at the injection site in the right deltoid, hip and back joint pain on Dec2020. She does not know exactly when these events started but that she noticed them when she was trying to sleep last night. Outcome of the events was not recovered. The events were considered serious due to being medically significant.; Sender's Comments: Based on temporal association, the causal relationship between BNT162b2 and the events pyrexia, asthenia, fatigue, dizziness, vaccination site pain, back pain and arthralgia cannot be excluded.
47 2021-01-04 hair loss Large bald spot on top of head!!! The size of a half dollar. No new soaps no no hair products no new... Read more
Large bald spot on top of head!!! The size of a half dollar. No new soaps no no hair products no new medication. Nothing new.
47 2021-01-04 injection site swelling, injection site pain Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain and swelling fever headache joint pain spe... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain and swelling fever headache joint pain specifically in hands wrists and neck chills muscle pain nausea feeling unwell
47 2021-01-04 itchy skin Pt reported itchiness and tingling on her neck and back around 20 minutes after receiving vaccine. P... Read more
Pt reported itchiness and tingling on her neck and back around 20 minutes after receiving vaccine. Pt given 25 mg of diphenhydramine tab, and she refused 2nd diphenhydramine tab. Pt reported cessation of itchiness and tingling 20 minutes after receiving diphenhydramine.
47 2021-01-04 rash, itchy rash Rash on my back, it is very itchy; Rash on my back, it is very itchy; This is a spontaneous report f... Read more
Rash on my back, it is very itchy; Rash on my back, it is very itchy; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old female received first dose of bnt162b2 (BNT162B2 also reported as Pfizer BioNTech Vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on Dec2020 at single dose (dose 1) for Covid-19 vaccination. The patient's medical history was not reported. Concomitant medications included levothyroxine sodium (SYNTHROID) and vitamin D. The patient experienced rash on her back, it was very itchy on an unspecified date in Dec2020. She reported that she took Benadryl but might not get any relief from it. She had lab work but it was more than 14 days ago, no results reported. The outcome of events not recovered. Information on the Lot/Batch number has been requested.
47 2021-01-04 hives, rash macular high heart rate, blotchy/flushed skin, urticaria
47 2021-01-05 shingles Began with symptoms for shingles 72 hrs post vaccine, severe outbreak that still not has resolved an... Read more
Began with symptoms for shingles 72 hrs post vaccine, severe outbreak that still not has resolved and currently on second round of anti-virals; delaying second vaccine until shingles resolve
47 2021-01-05 injection site pain Dizziness, Headache, Lightheadedness; Injection site pain Narrative: Dizzy and lightheaded 14 minut... Read more
Dizziness, Headache, Lightheadedness; Injection site pain Narrative: Dizzy and lightheaded 14 minutes after injection. Headache and injection site pain for 2 days after injection.
47 2021-01-05 itchy skin, redness Patient experienced skin redness and itching during the 15 minute post Pfizer COVID-19 vaccine injec... Read more
Patient experienced skin redness and itching during the 15 minute post Pfizer COVID-19 vaccine injection observation period. Patient was given 25 mg diphenhydramine po, and the symptoms were resolved at 1100. Vitals time 1005 1055 B/P 134/78 130/84 P 65 73 RR 20 16 O2 Sat 98% 99%
47 2021-01-05 injection site pain, injection site swelling soreness and swelling at injection site in small area, chills, and headache.
47 2021-01-06 itchy skin About 10 minutes after Covid vaccination was given patient experienced itching up and down left arm ... Read more
About 10 minutes after Covid vaccination was given patient experienced itching up and down left arm (which was the arm the injection was given in). Patient describes itching as mild. Vitals 1820: BP:129/94 P:83 SaO2: 99% Itching still present but has not worsened or moved to more areas of body. Vitals 1830: BP: 132/88 P: 85 SaO2: 99 Patient states itching has lessened somewhat. Patient denies the need for further care or medication. Patient was able to stand/walk without dizziness and had no other symptoms or complications. After her 30 minute wait time was complete patient left.
47 2021-01-06 hives, redness Approximately 30 minutes after vaccination she had swelling and redness in her hands and small hive ... Read more
Approximately 30 minutes after vaccination she had swelling and redness in her hands and small hive and redness on her chest. Symptoms lasted for about 2 hours and she took benedryl.
47 2021-01-06 hives, itchy skin Dizziness, UrticariaPruritus, HYPERtension, facial flushing, face felt warm
47 2021-01-06 injection site pain Headache, Arthralgia, Diarrhea, NauseaVomiting, fatigue, injection site pain Narrative: left work a... Read more
Headache, Arthralgia, Diarrhea, NauseaVomiting, fatigue, injection site pain Narrative: left work at noon on 12/31/20
47 2021-01-06 hives, itchy skin Headache, Myalgia, Fever, UrticariaPruritus, NauseaVomiting, temp 101.0 then 99.5 Chills Narrative:
47 2021-01-06 injection site pain Headache, fever, muscle pain, joint pain, chills, fatigue, pain at injection site, overall not feeli... Read more
Headache, fever, muscle pain, joint pain, chills, fatigue, pain at injection site, overall not feeling well
47 2021-01-06 rash, rash with redness, rash papular ON THE 7TH DAY AFTER THE VACCINE, RED, RAISED RASHES DEVELOPED ON CHEST AND ABDOMEN, AND CONTINUED T... Read more
ON THE 7TH DAY AFTER THE VACCINE, RED, RAISED RASHES DEVELOPED ON CHEST AND ABDOMEN, AND CONTINUED TO SPREAD ON SIDES OF THE BODY , WAIST AND BUTTOCKS. ON THE 8TH DAY IT CONTINUES TO SPREAD MORE ON GROINS, THIGHS, UPPER BACK AND BILATERAL ARMPIT. BENADRYL TAKEN AND HYDROCORTISONE CREAM APPLIED WITH LITTLE EFFECT, WILL START METHYLPREDNISOLONE TOMORROW
47 2021-01-06 itchy skin, injection site redness, injection site pain Patient presented to clinic with complaints of generalized itching, status post COVID vaccination 2 ... Read more
Patient presented to clinic with complaints of generalized itching, status post COVID vaccination 2 days ago on 12/22. Patient also reporting flushing, intermittent tachycardia, and headache x2 days. Vitals were taken and follow: blood pressure 108/117, heart rate 111, spO2: 100%. Injection site observed to be red and tender. Patient reports history of allergies to tetracaine. Patient did not take medication OTC prior to coming in to clinic. Patient was transferred and admitted to the emergency department. In the emergency department was given benadryl and monitored for symptom improvement. Was discharged on the same day.
47 2021-01-06 skin discolouration Roughly 9 days after first vaccine, noticed your right hand middle finger became purple, with pins a... Read more
Roughly 9 days after first vaccine, noticed your right hand middle finger became purple, with pins and needs sensation. This was followed by some swelling. Improved over 24 hours. Still feeling "tight" in knuckles.
47 2021-01-06 rash SkinRash swelling Narrative:
47 2021-01-07 hives Allergic reaction; Hives on back; Flushed; Chills; Swollen tongue; Burning tongue; This is a spontan... Read more
Allergic reaction; Hives on back; Flushed; Chills; Swollen tongue; Burning tongue; This is a spontaneous report from a contactable consumer (patient). This 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 07:00 at single dose on left arm for COVID-19 vaccination. There were no medical history and concomitant medications. The patient previously took flu shot. Vaccination Facility Type was hospital. Patient did not receive any other vaccines at time COVID-19 vaccine given and no vaccines given 4 weeks prior. Patient got the Pfizer COVID-19 vaccine on 29Dec2020 and had an allergic reaction to it. Had hives on her back, was flushed, had chills, and swollen tongue on 29Dec2020. There was swelling on either side of tongue not in the center. Swelling seemed to bounce around sides of tongue. Patient mentioned she also had burning sensation of tongue first on 29Dec2020 and then the swelling was after that. Adverse events hives, flushed, chills, burning sensation of tongue and swelling of tongue required a visit to emergency room. Patient was seen in the emergency room and given diphenhydramine hydrochloride (BENADRYL) and an Epi-pen to take home. This all happened after receiving the vaccine on 29Dec2020. Patient wasn't getting any better/feeling better and went back to the emergency room on 30Dec2020. Patient was treated with dexamethasone and told her to take diphenhydramine hydrochloride every 4 hours, her last dose was at 2pm 31Dec2020. Patient said all events still persisting, but there maybe a little more swelling of the tongue, but not much. Patient had had a flu shot before, but never had anything to happen like this. Outcome of allergic reaction, hives, flushed, chills and burning tongue was not recovered, outcome of swollen tongue was unknown. Information on the lot/batch number has been requested.
47 2021-01-07 vaccination site pain Prickling needles feeling soles feet bilaterally and some in palms hands; pain in hip joints; modera... Read more
Prickling needles feeling soles feet bilaterally and some in palms hands; pain in hip joints; moderate leg aches bilaterally; Sore arm at injection site; This is a spontaneous report from a non-contactable nurse (patient). A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EJ1685), via an unspecified route of administration in the right arm, on 30Dec2020 at a single dose for COVID-19 immunization. The patient was 47 years old when she received the vaccine. Medical history included RSD (Reflex sympathetic dystrophy), had allergies to medications, food, or other product particularly NSAID and to contrast dye. The patient is not pregnant. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with Covid-19 prior to vaccination. She had not been tested for Covid-19 since vaccination. The patient had sore arm at injection site for 36 hours after administration (02Jan2021) with outcome of recovered in Jan2021. In day #4 (03Jan2021), she had pain in hip joints and moderate leg aches bilaterally with outcome of unknown. In day #5 (04Jan2021), she had prickling needles feeling soles feet bilaterally and some in the palms of her hands with outcome of unknown. The events were reported as non-serious. No follow-up attempts are possible. No further information is expected.
47 2021-01-07 rash Rash on both legs; nausea; diarrhea; runny nose; epigastric pain; cough; This is a spontaneous repor... Read more
Rash on both legs; nausea; diarrhea; runny nose; epigastric pain; cough; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for herself. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number ej1685) on 20Dec2020 13:15 at single dose intramuscularly in the left arm for COVID-19 immunization. Relevant medical history included unspecified allergies (known allergies: Yes. Allergies to medications, food, or other products: yes). There were concomitant medications. The patient experienced rash on both legs, nausea, diarrhea, runny nose, cough, epigastric pain on 20Dec2020 20:00, which resulted in emergency room/department visit or urgent care. The reporter (patient) considered the events were non-serious. It's unknown if any treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. On 25Dec2020, the patient was tested for COVID-19 (Nasal Swab) and the result was negative. The patient recovered with lasting effects.
47 2021-01-07 itchy skin Reported itchy throat, tongue, face apprx 10 mins after vaccine. Later that night she had all over b... Read more
Reported itchy throat, tongue, face apprx 10 mins after vaccine. Later that night she had all over body itching with no rash and mouth swelling, eye swelling. No SOB, or difficulty swallowing.
47 2021-01-07 sensitive skin Severe headache, severe body aches, skin sensitivity, fatigue and diarrhea for 18 hours then spontan... Read more
Severe headache, severe body aches, skin sensitivity, fatigue and diarrhea for 18 hours then spontaneously resolved
47 2021-01-07 vaccination site pain Soreness at injection site and entire upper arm; Soreness at injection site and entire upper arm; He... Read more
Soreness at injection site and entire upper arm; Soreness at injection site and entire upper arm; Headache; Feeling sluggish and unwell; Feeling sluggish and unwell; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at right arm on 28Dec2020 10:00 at single dose for COVID-19 immunization. Medical history included none. No known allergies. Concomitant medication included Alive multivitamin which received within 2 weeks of vaccination. The patient experienced soreness at injection site and entire upper arm, headache, feeling sluggish and unwell, all on 28Dec2020 16:00. No treatment received. The most recent COVID-19 vaccine was administered at hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. This is a non-serious report. The outcome of the events was recovered on an unspecified date.
47 2021-01-07 injection site pain Terrible headache for 19 hours which started 1 hour after shot. Headache again with heaviness 25 hou... Read more
Terrible headache for 19 hours which started 1 hour after shot. Headache again with heaviness 25 hours after shot including dizziness with bending. 35 hours after dose, had dull pain on the inside prominence of my right elbow (arm I got my shot). This pain lasted for 8 hours. Also accompanied with fatigue.
47 2021-01-07 injection site redness, injection site swelling, injection site mass, injection site warmth Warm to touch upper left deltoid, large size swollen knot that is red on upper left deltoid, it seem... Read more
Warm to touch upper left deltoid, large size swollen knot that is red on upper left deltoid, it seems to be getting larger. first noticed on 01/06/21 about 4:30 pm and as of today 1/08/21 the area is still swollen, red and warm to touch.
47 2021-01-07 injection site pain When injected noted sharp shooting pain up shoulder. Site was three fingers down and also above arm... Read more
When injected noted sharp shooting pain up shoulder. Site was three fingers down and also above arm pit. Site confirmed by site contact as well. Ice applied
47 2021-01-07 rash, skin warm, redness Within 45 minutes, my neck and face became hot and red. No issues with breathing, 6 hours later, I r... Read more
Within 45 minutes, my neck and face became hot and red. No issues with breathing, 6 hours later, I received a rash over the arm in which I had the injection. Since the shot Monday, I have continued to have redness on neck and face and along with felling hot. I have been taking Benadryl since Monday and finally went to UC on Thursday 01/07/2021. At the appointment, I received a Decadron injection, which helped, but today I am back to red face/neck and warmth.
47 2021-01-07 itchy skin, redness dizziness; tongue and lip tingling; welt on bottom lip; chest tightness; SOB with activity for 2-4 h... Read more
dizziness; tongue and lip tingling; welt on bottom lip; chest tightness; SOB with activity for 2-4 hours; itching; burning; diarrhea; redness traveling up arm into chest; This is a spontaneous report from a contactable nurse reporting for herself. A 47-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the right arm on 29Dec2020 03:30 at single dose for COVID-19 immunization. Medical history included breast cancer, allergy to peanuts, dogs, cats, the outdoors. Concomitant medication included tamoxifen (unknown manufacturer). On 29Dec2020 04:00 the patient experienced dizziness, tongue and lip tingling, welt on bottom lip, chest tightness, SOB with activity for 2-4 hours, itching immediately after injection (as reported), then burning, then redness traveling up arm into chest, and immediate onset of diarrhea. The outcome of the events was recovered. The patient received famotidine (PEPCID) and Cetirizine as treatment for the event. No other vaccine was administered in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
47 2021-01-07 vaccination site swelling, vaccination site pain, vaccination site itchiness noticed an itch around that area (site of vaccine); heart started beating very fast; could not breat... Read more
noticed an itch around that area (site of vaccine); heart started beating very fast; could not breathe/difficulty breathing; light headaches; some soreness on the vaccine site; swelling on the area where she was vaccinated; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0142), via an unspecified route of administration in left arm on 30Dec2020 at single dose for Covid-19 immunisation. Medical history included high cholesterol (it was under control. Diagnosed a couple years ago). There were no concomitant medications. She did her first dose of Pfizer COVID vaccine on 30Dec2020, and she had a little experience, she didn't tell the nurse at that time, but she went through her paperwork and decided to call Pfizer. When she got the shot, she was told to go to the next room to sit down for 15 minutes. When she went to the next room, 1 minute later, her heart started beating very fast, then she started to feel like she could not breathe/difficulty breathing for that moment. So, she tried to calm herself down and she focused on her phone to play games and to not think about it. After a couple minutes, it had gone. it was probably gone maybe about 10 minutes later. After 15 minutes, she went back to her office, everything was ok. Her heart was beating but not that fast, it was calmer than before, and she had a light headache, then some soreness on the vaccine site, on the left side, 'she thinks that is normal, right?' Clarifies soreness as swelling and painful on the area where she was vaccinated. She wanted to know, was she able to go back for the second shot, she was scheduled for 20Jan2021. Regarding light headache, she took some paracetamol (Extra Strength Tylenol, strength: 500mg, expiration date: Jun2024, lot number: SJC214). Soreness outcome: It went away, maybe the third day (02Jan2021), it was completely gone. The third day it was ok to completely sleep and lean on that side. She has recovered completely. The third day (02Jan2021), she noticed an itch around that area (site of vaccine), but she was not scratching it. The itching had gone, she had recovered completely. The outcome of heart started beating very fast and could not breathe was recovered on 30Dec2020, light headache was not recovered, soreness at vaccine site was recovered on 02Jan2021, itching at vaccine site was recovered on an unspecified date of Jan2021, and swelling on the area where she was vaccinated was unknown.
47 2021-01-07 injection site swelling, injection site pain, injection site redness over 48 hrs after vaccination, significant erythema and edema of my injection site occured with tend... Read more
over 48 hrs after vaccination, significant erythema and edema of my injection site occured with tender skin. Expanded to approximately an area approximately 20 cm in diameter
47 2021-01-07 rash rash dots on back of both hands/rash on shoulders and mid-back/rash on upper legs/rash on lower legs... Read more
rash dots on back of both hands/rash on shoulders and mid-back/rash on upper legs/rash on lower legs and arms; This is a spontaneous report received from a contactable nurse (who is also the patient). A 47-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EH9899), intramuscular in left arm, on 17Dec2020 13:00, at single dose, for COVID-19 immunization. Medical history included ulcerative colitis diagnosed in 2002, and "Allergies to medications, food, or other products: Sulfa medications - cause rash". The patient is not pregnant. Concomitant medication included mesalamine, lithium, lamotrigine and an unspecified birth control pill. It was reported that on 23Dec2020 15:00 (also reported as 17:00, pending clarification), she noticed rash dots on back of both hands. On 26Dec2020 15:00, she noticed rash on shoulders and mid-back. On 28Dec2020 17:00, she noticed rash on upper legs. On 29Dec2020 17:00, she noticed rash on lower legs and arms. On 01Jan2021, she went to urgent care for evaluation and was treated with methylprednisolone dose pack. The patient did not receive any other vaccines with 4 weeks prior to BNT162B2. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovering. The reporter assessed the report as non-serious.
47 2021-01-07 vaccination site pain, vaccination site swelling sore left arm swelling at injection site; 15 hours after injection:Sore left arm swelling at injecti... Read more
sore left arm swelling at injection site; 15 hours after injection:Sore left arm swelling at injection site; Nausea; joint pain; specifically hands wrists and neck; muscle pain; headache; fever between 102.8 and 101.3; chills; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 04Jan2021 11:45 am at single dose at left arm for covid-19 immunization. The patient medical history was not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. The patient previously took codeine and zolpidem and experienced allergies. Prior to vaccination, patient was not diagnosed with COVID-19. 15 hours after injection, patient experienced sore left arm swelling at injection site, nausea, joint pain, specifically hands wrists and neck, muscle pain, headache, fever between 102.8 and 101.3, chills on 05Jan2021 03:00 AM. Patient took covid test /Nasal Swab on 04Jan2021 and on 05Jan2021 with unknown results. Patient didn't receive treatment for events. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Outcome of events was not recovered. The report is considered non-serious. Information on the lot/batch number has been requested.
47 2021-01-07 injection site pain swollen supraclavicular lymph node; headache; chills; soreness to injection site for 2 days; This is... Read more
swollen supraclavicular lymph node; headache; chills; soreness to injection site for 2 days; This is a spontaneous report from a contactable nurse, reporting for a patient. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EJ1685, via intramuscular on 22Dec2020 at 14:45 (at the age of 47 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included asthma, celiacs, and hypertension from an unknown date. The patient had known allergies to shellfish, latex, sulfa, Levaquin, Morphine. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included hydrochlorothiazide, zyrtec, dicyclomine, ibuprofen, benadryl, all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 23Dec2020, the patient experienced soreness to injection site for 2 days (23Dec2020 and 24Dec2020). On 26Dec2020 at 16:00, she started having chills and headache. On 27Dec2020 chills were to the point where she couldn't get warm. Shivering chills. She remained afebrile just bad chills for 2 days. On 28Dec2020, she noticed swollen supraclavicular lymph node to left clavicle area which was painful to touch and approximately quarter in size. It was not as painful today and swelling was starting to subside. The patient did not receive treatment for the events. The clinical outcome of soreness to injection site for 2 days was recovered on 25Dec2020. The clinical outcome for headache, chills, and swollen supraclavicular lymph node was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
47 2021-01-08 itchy skin, injection site pain, rash About 1 hour after injection, I started getting very itchy so I took a benadryl. This morning I woke... Read more
About 1 hour after injection, I started getting very itchy so I took a benadryl. This morning I woke you with body pain everywhere, especially to arm of injection. Running fever of 101.4 and higher, all over body rash that is extremely itchy. Very fatigued feeling.
47 2021-01-08 hives, itchy skin Myalgia, Fever, UrticariaPruritus, Anorexia, SOA, rhinorrhea, chills, Narrative: Self treated with B... Read more
Myalgia, Fever, UrticariaPruritus, Anorexia, SOA, rhinorrhea, chills, Narrative: Self treated with Benadryl and motrin
47 2021-01-09 injection site mass At 1700, felt malaise. .Woke up next morning on January 9th with 102 temp, 3cm lump at infection sit... Read more
At 1700, felt malaise. .Woke up next morning on January 9th with 102 temp, 3cm lump at infection site, body aches, chills, headache. Still feeling poorly on January 10th.
47 2021-01-09 injection site pain Location site pain X1 day and headache X2 days
47 2021-01-09 itchy skin, redness Pt stated about 10 mins after administration she had itching in her arms, Waited 5 min then requeste... Read more
Pt stated about 10 mins after administration she had itching in her arms, Waited 5 min then requested Benadryl. Redness on face and arms. 25 mg's of Benadryl given at 10:28AM. Caregiver discarded to home at 11:15 am.
47 2021-01-09 rash, itchy skin Severe itching and small rash on legs about 40 hours after the vaccine was given.
47 2021-01-10 rash 3 hours after receiving the vax. Got vax, went back to work and started feeling funny and then went ... Read more
3 hours after receiving the vax. Got vax, went back to work and started feeling funny and then went home and had rash to stomach, thighs, tachycardia, pulse about 130, hypotensive, swelling to tongue, eyes. Called provider when she got home and took Benadryl. Provider advised Pepcid, Benadryl, steroids x6 days. She is feeling ok now.
47 2021-01-10 injection site numbness, injection site tingling I experienced numbness, tingling sensations and weakness in my arm starting on the day of my vaccina... Read more
I experienced numbness, tingling sensations and weakness in my arm starting on the day of my vaccination (01/04/2021). It is especially troublesome on my left hand/fingers. It is worse in the morning when I wake up, but it gets better with movement of my arm/hand to complete my normal day activities.
47 2021-01-10 injection site pain Mucular pain Achy Joint pain Headache Injection site pain that radiated whole right arm
47 2021-01-10 injection site pruritus Received doe #1- left deltoid on 1/8/2021-within 10 minutes of receiving the vaccine had a "wave of... Read more
Received doe #1- left deltoid on 1/8/2021-within 10 minutes of receiving the vaccine had a "wave of warmth" come over my body and my heart rate suddenly increased to the 140's. Began to feel fullness in my throat and extremely tremulous. Nurse monitored my BP- elevated 140/101 with no hx of HTN. HR remained elevated for ~ 10 minutes than began to normalize. BP slowly began to decrease to more normal range. Tremors continued along with tingling sensation to extremities. Monitored by nurse for ~ 1 hour. Symptoms improved. Drove home. Extremely fatigued. Took dose of Benadryl. Fitful sleep with sporadic episodes of tachycardia on day #1. Following day 1/9- extreme fatigue, arm soreness, "spacey" feeling, weakness and nausea. Took additional doses of Benadryl. Slept 12 hours. Awoke on the following day ( 1/10), with persistent fatigue and nausea. Had insomnia that night and was restless, Awoke on 1/11 again with nausea, fatigue, arm soreness resolved but itchiness injection site.
47 2021-01-10 rash with redness Upon awakening on the day after receiving vaccine she noted a red non-itchy rash on her neck.
47 2021-01-10 shingles ball palsy, facial dropping; painful shingles; This is spontaneous report from a contactable consume... Read more
ball palsy, facial dropping; painful shingles; This is spontaneous report from a contactable consumer reported for herself. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number: EK5730; dosage form: injection) via an unspecified route of administration as injection to left arm on 24Dec2020 at 7:30 am at a single dose for COVID-19 immunization. Relevant medical history and concurrent conditions included slight hypertension from Jul2020 and ongoing. Concomitant medications included lisinopril from Jul2020 and ongoing for slight hypertension. The patient developed ball palsy, facial dropping which did not lasted long but she still had the painful shingles on 27Dec2020, after the first dose. She wanted to know the recommendations for taking the second dose which is due in 10 days. The patient wanted to know if she should receive the shingles vaccine. This caller was a lab tech who works in the healthcare industry and manages a medical office; but clarified she did not call on behalf of a healthcare professional. She was the patient who received her first dose of Pfizer SARS-CoV-2 Vaccine on 24Dec2020. She reported onset of what the Urgent Care Physician believed was Shingles on 27Dec2020. She called to ask if she should or should not receive the second dose of Pfizer SARS-CoV-2 Vaccine on 14Jan2021 as scheduled due to the Shingles. The Urgent Care Physician advised her to still get the second dose, as there was about a 1:10,000 chance of developing shingles with the vaccine. She reported shingles as a reaction subsequent to the Pfizer SARS-CoV-2 Vaccine. Initially on 27Dec2020 she developed sites of what she thought were canker sores or fever blisters in her mouth which had gotten pretty large and stopped her from being able to eat on 29Dec2020. Then on 30Dec2020 she developed sites on her face which have gotten scarily large; and was causing some deep nerve pain going to her eye and down her chin; the sites felt like lesions on her face with roots. The sites in her mouth were now completely gone; but the sites on her face are ongoing. Now it has kind of taken over her face. She saw the Urgent Care Physician regarding this who believed the sites to be shingles. She had never had fever blisters or shingles before this event. She was still kind of reeling. The report was reported as non-serious. The outcome of event ball palsy/facial dropping was resolved and of shingles was unknown.
47 2021-01-11 rash, hives, redness Anaphylactic reaction; Flushed; Diaphoretic; redness and rash; hives on chest; Tachycardia; shortnes... Read more
Anaphylactic reaction; Flushed; Diaphoretic; redness and rash; hives on chest; Tachycardia; shortness of breath; Chest tightness; Dizziness; Headache; This is a spontaneous report from a contactable nurse, the patient. A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283), via an unspecified route of administration on 08Jan2021 at 08:49 (at the age of 47-years-old) as a single dose for COVID-19 immunization. There were no known medical history or concomitant medications. The patient previously received the first dose of BNT162B2 on 18Dec2020 (Lot Number: EK5730) for COVID-19 immunization and experienced nausea, headache, and fatigue. On 08Jan2021, about 5-10 minutes after the second dose, the patient experienced anaphylactic reaction, flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness, reported as life-threatening. She reported that these events occurred within less than 10 minutes of receiving the vaccine. She went to the emergency room and was treated with methylprednisolone (SOLUMEDROL), diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID), and epinephrine (MANUFACTURER UNKNOWN). She was sent home and prescribed methylprednisolone and epinephrine (EPI-PEN). Later on 08Jan2021, she experienced dizziness and headache, which were consistent. She stated she would most likely take ibuprofen (MOTRIN) as treatment (not specified if taken). The clinical outcomes of the flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness were recovered on 08Jan2021; while the outcomes of the dizziness and headache were not recovered and that of the anaphylaxis was reported as recovering.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
47 2021-01-11 injection site pruritus, injection site hardening, injection site bruising, injection site redness I got the vaccine 12/21/2000. I had some initial hardness at the site. By the next day the harness... Read more
I got the vaccine 12/21/2000. I had some initial hardness at the site. By the next day the harness was gone and I developed a bruise. I never had any other side effects. On Wednesday 12/30/20 I noticed right under my bruise from the vaccine it became red, slightly itch, and hard.
47 2021-01-11 injection site warmth, injection site redness, injection site swelling, injection site pain Initially just had pain at the injection site down my bicep which resolved after 72 hours. On 1/10/... Read more
Initially just had pain at the injection site down my bicep which resolved after 72 hours. On 1/10/2021 I noticed a very red/warm/swollen area near my injection site.
47 2021-01-11 rash, itchy skin Rash and itching to chest, Periorbital and facial edema and rash. Onset aprox 36 hours post vaccinat... Read more
Rash and itching to chest, Periorbital and facial edema and rash. Onset aprox 36 hours post vaccination of dose 2 Treated with Prednisone 60mg and antihistamines in outpatient setting.
47 2021-01-11 redness Received first dose COVID vaccine at 6:30am on 1/5/21. Developed redness to face, arms, and chest (l... Read more
Received first dose COVID vaccine at 6:30am on 1/5/21. Developed redness to face, arms, and chest (like a sunburn) at 2pm. Also felt jittery. Spoke to ER physician and advised to take po Benadryl. Took 2 doses before redness cleared. Jitteriness cleared the next day without Benadryl.
47 2021-01-11 itchy skin, skin burning sensation, rash with redness, rash Reported to vaccine clinic approximately 4 hours after receiving dose one of Pfizer Covid-19 vaccine... Read more
Reported to vaccine clinic approximately 4 hours after receiving dose one of Pfizer Covid-19 vaccine with complaints of itching, burning feeling on skin and swelling in left arm. Red rash on chest and left arm. No sob, chest pain or difficulty swallowing. Ambulated to emergency room for evaluation.
47 2021-01-11 itchy skin Vaccine administered at 2pm. 1/8/21 @ ~ 4pm LEFT arm soreness (which persisted all evening) 1/9/21 ... Read more
Vaccine administered at 2pm. 1/8/21 @ ~ 4pm LEFT arm soreness (which persisted all evening) 1/9/21 @ ~ 1am I awoke from sleep with worsening LEFT Arm soreness, headache (bad) and body aches 1/9/21 @ ~ 11am Feeling more fatigued, chills, low grade fever 99.9 1/9/21 @ ~ 2 pm, continue to have body aches, fatigue, itchy nose/post nasal drip, chills fever 100.7 1/9/21 @ 8pm continued w/ prior symptoms, developed mild cough ( at this point I felt symptoms may be outside vaccine side effects, honestly wasn't sure if it was seasonal allergies w/ vaccine side effects) 1/10/21 ~ 10 am Awoke feeling better, remained fatigued and with mild intermittent cough but body aches/headaches resolved, opted to go for testing 1/12/21 informed of Covid + test (PCR), was advised by my hospital employee health to complete this form It should be noted I underwent mandated employee testing on 1/5/21 which was negative.
47 2021-01-12 injection site rash, injection site pain, rash, itchy skin I received the vaccine @ 3:26p on 1/7/21 by 9:30p I was dealing with itchiness. I woke up on 1/8 w/s... Read more
I received the vaccine @ 3:26p on 1/7/21 by 9:30p I was dealing with itchiness. I woke up on 1/8 w/soreness & rash around the injection site & on the left arm. By 6p I had a rash on both arms, back & on my right knee. By midnight I developed a rash on my r foot & belly area. It's 1/13 & I have been taking Benadryl on & off since 1/8 @ 2am. The rash comes and goes on different parts of my body. My physician is now ordering a low dose of prednisone that I will start taking today, 1/13.
47 2021-01-12 rash Pfizer-BioNTech COVID-19 Vaccine 1/13/2021, patient got 2nd dose of vaccine and minutes later exper... Read more
Pfizer-BioNTech COVID-19 Vaccine 1/13/2021, patient got 2nd dose of vaccine and minutes later experienced flushing and redness in chest area and sent to ED for evaluation. Arrived to ED at 9:52 am and was given diphenhydramine 50 mg and famotidine 20 mg. Clonidine 0.3 mg given at 12:18 pm for high BP. At 11:20 am rash almost resolved, feeling better; discharged at 12:30pm
47 2021-01-12 redness Pfizer-BioNTech COVID-19 Vaccine On 1/13/2021, patient got her 2nd dose of vaccine. After receiving... Read more
Pfizer-BioNTech COVID-19 Vaccine On 1/13/2021, patient got her 2nd dose of vaccine. After receiving the dose, she felt warm, flushing and redness in chest area. Patient was brought to ED for evaluation at 9:52am. Treated as allergic reaction, got diphenhydramine 50 mg and famotidine 20 mg. At 11:20am redness was resolving and patient felt better. Her BP was high and got clonidine 0.3mg at 12:18pm. Patient was discharged at 12:31pm
47 2021-01-12 rash Rash on both forearms and right elbow
47 2021-01-12 injection site pain Shortly after injection, pain at site; continued pain in arm today. Some fatigue yesterday and tod... Read more
Shortly after injection, pain at site; continued pain in arm today. Some fatigue yesterday and today. Major headache today, not all day just part of day.
47 2021-01-12 injection site warmth, injection site redness, injection site swelling, injection site pain nausea, malaise, GI upset, diarrhea; redness, swelling, warmth, pain at injection site
47 2021-01-13 vaccination site pain Fever; Chills; muscle soreness; joint soreness; fatigue; injection site pain; received the first dos... Read more
Fever; Chills; muscle soreness; joint soreness; fatigue; injection site pain; received the first dose of bnt162b2 on 21Dec2020, received the second dose on 07Jan2021; This is a spontaneous report from a contactable nurse. A 47-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), intramuscular in left arm on 07Jan2021 at a single dose for COVID-19 immunization. Vaccination was done in hospital. There were no relevant medical history. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 21Dec2020 12:00 via intramuscular route in left arm at a single dose for COVID-19 immunization. The patient experienced fever, chills, muscle soreness, joint soreness, fatigue, injection site pain on 07Jan2021 14:00 with outcome of not recovered. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. The events was considered non serious by the reporter. Information about lot/batch number has been requested.
47 2021-01-13 itchy skin I was a little itchy and took a Benadryl
47 2021-01-13 skin discolouration PATIENT WITH KNOWN HISTORY OF SEVERE ALLERGIES PRESENTED TO RECIEVE COVID-19 VACCINE AFTER RECIEVING... Read more
PATIENT WITH KNOWN HISTORY OF SEVERE ALLERGIES PRESENTED TO RECIEVE COVID-19 VACCINE AFTER RECIEVING CLEARANCE FROM HER PCP. DUE TO HISTORY OF ANAPHYLAXIS PATIENT MONITORED BY PROVIDER AFTER ADMINSITRATION OF VACCINE. WITHIN 20-30 MINS OF ADMINISTERING VACCINE PATIENT DEVELOPED COUGH AND COLOR CHANGE IN EXTREMETIES. PATIENT TRANSPORTED DOWN TO ED FOR FURTHER EVALUATION.
47 2021-01-13 rash Swelling right side of neck, shoulder, upper trapezius and tracheal area Slight rash Soreness in the... Read more
Swelling right side of neck, shoulder, upper trapezius and tracheal area Slight rash Soreness in the swollen areas
47 2021-01-13 injection site pain, injection site swelling THREE DAYS WITH SINTOMES , PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN,CHILLES,PAIN JOINTS,FEVE... Read more
THREE DAYS WITH SINTOMES , PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN,CHILLES,PAIN JOINTS,FEVER,SWELLING INJECTION SITE,NAUSIAS GANGLIOR INFLAMATION.PAIN ALL HER BODY.
47 2021-01-13 redness, skin tightness, redness, skin discolouration Voiced tingling to throat/tightness in face. Discoloration noted to face/neck/chest. Red in color.... Read more
Voiced tingling to throat/tightness in face. Discoloration noted to face/neck/chest. Red in color. Voices s/s of reaction to previous dose (swollen tongue). Initial compliant begin @ 1248, entered observation @ 1242. Benadryl 25mg was given @ 1249. S/S, relieved around 1305. Voices no other s/s of distress. Cold compress also applied to help alleviate s/s. Denies SOB or trouble breathing. Voices allergies to Aspirin, Morphine, Phenergan, Erythromycin. Left observation @ 1310.
47 2021-01-13 rash a weird rash on her left shoulder area; not feeling quite well; Fever of 99.5/ her fever continued a... Read more
a weird rash on her left shoulder area; not feeling quite well; Fever of 99.5/ her fever continued at 99.7 and her symptoms were 10 fold; Left arm soreness; Increased dry cough; Nasal congestion; Chills; Headache; Unable to sleep- tossing and turning; This is a spontaneous report from a contactable nurse reporting for self. This 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: Apr2021) on 04Jan2021 around 10:30 AM at 0.3 mL single by injection in the left arm for COVID-19 immunisation. Medical history and concomitant medications were none. Prior to getting the vaccine patient had her temperature taken on unspecified date, which was 97.4. She had the injection in her left arm on 04Jan2021 around 10:30 AM. After she felt perfectly fine that day. She felt nothing. Then around 8 PM her side effects started. That night her left arm got sore, she had increased dry cough (reported as feels like a bronchial spasm that an asthmatic would have), nasal congestion, chills, and a headache. She went to bed unable to sleep- tossing and turning. She woke up around 2 AM or so. The next morning, 05Jan2021, she felt somewhat okay. She went to work. She had a normal temperature that morning at work. Then around 10 AM, her arm was still sore, she was not feeling quite well, she started to feel chills again, and had a fever of 99.5, along with a headache still. They sent her home. The next day, 06Jan2021, her fever continued at 99.7 and her symptoms were 10 fold. Then her fever broke around 10 AM. On 05Jan2021, she took a shower from all the sweating with her fever, and she did not notice any rash. She took another shower this morning (07Jan2021) and she noticed a weird rash on her left shoulder area. It does not itch, it is just there. She took a picture of it so she could monitor it. It is blotchy. For left arm soreness, she can now move it without feeling it, but then you touch it, it is sore and tender. The event fever broke yesterday around 10 AM. This morning (07Jan2021) her temperature was 98.6. Chills would come and go with the fever off and on. Treatment for all events included over the counter medications. Lab data included COVID test was negative on 28Dec2020 and 04Jan2021. Outcome of left arm soreness, increased dry cough, nasal congestion was recovering, outcome of chills, headache, unable to sleep- tossing and turning was recovered on 06Jan2021, fever was recovered on 06Jan2021 10 AM, outcome of rash was not recovered, outcome of other event was unknown. Relatedness of product to all events was reported as related, the reporter considered all events as non-serious.
47 2021-01-13 itchy skin intense itching on back, neck, & scalp- muscle aches, headache, fatigue. EMS gave me double shot of... Read more
intense itching on back, neck, & scalp- muscle aches, headache, fatigue. EMS gave me double shot of Benadryl. via IV in right arm. I went home and slept for 3 hours. Woke up Right hand swollen and painful, muscle aches, headache, itching
47 2021-01-13 rash with redness red, raised rashes appeared on chest and abdomen/spread to waist, both sides of the body, and buttoc... Read more
red, raised rashes appeared on chest and abdomen/spread to waist, both sides of the body, and buttocks/more red, raised rashes continues to appear on upper back, groins, thighs, bilateral armpit; This is a spontaneous report from a contactable nurse reporting for herself. A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL0142, unknown expiration), via an unspecified route of administration on left arm, on 30Dec2020 at 12:45, at single dose, for COVID-19 immunization. Medical history included asthma, hypertension, shell fish allergy, and COVID. Concomitant medications included atenolol; fluticasone propionate, salmeterol (WIXELA INHUB); tocopherol (VITAMIN E); colecalciferol (VITAMIN D); ascorbic acid, bioflavonoids nos, hesperidin, malpighia glabra, rosa canina, rutoside (VITAMIN C); and bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC). The patient previously took chloramphenicol, diclofenac, and ketorolac, all experienced allergies. On 06Jan2021 at 05:30 AM, 7th day after vaccine, the patient experienced red, raised rashes appeared on chest and abdomen/continues to spread to waist, both sides of the body, and buttocks. On the 8th day, more red, raised rashes continues to appear on upper back, groins, thighs, bilateral armpit. The patient did not receive other vaccine in four weeks. The patient received benadryl, methylprednisolone, and hydoxyzin for the event. The patient was diagnosed with COVID-19 prior to vaccination and has been tested for COVID-19 post vaccination (pending result). The patient underwent lab tests and procedures which included COVID test: unknown result on unspecified date; Nasal Swab: negative on 06Jan2021; and PCR: Pending result on 06Jan2021. The adverse event result in doctor or other healthcare professional office/clinic visit. The patient had not yet recovered from the event. The event was assessed as non-serious.
47 2021-01-14 pain of skin, shingles, rash I developed left forehead and scalp pain associated with a rash-shingles. I did seek care with my ... Read more
I developed left forehead and scalp pain associated with a rash-shingles. I did seek care with my PCP and was treated.
47 2021-01-14 itchy skin On the 26th I began to have itching all over my body that kept me up at night. I went back to taking... Read more
On the 26th I began to have itching all over my body that kept me up at night. I went back to taking Claritin and it worked I did get relief when the Claritin wore off I had more intense itching. I tool Claritin around the clock the 24 hours and it stopped after two days. It was a delayed reaction, caught me by surprise. I had no new foods, medications. I did call the after hours Dr to maybe get a steroid injection but he didn't feel it was the best choice and told me to continue the Claritin
47 2021-01-14 injection site redness, injection site rash Symptoms began roughly 12 hours post vaccination Pain in left armpit into her chest and neck. Report... Read more
Symptoms began roughly 12 hours post vaccination Pain in left armpit into her chest and neck. Reports red solid rash in both armpits and a quarter sized red patch at the injection site. Notes One instance of diarrhea.
47 2021-01-16 injection site pain Day 1- sore at injection site Day 2- sore under arm of injection arm and side of that breast. Muscle... Read more
Day 1- sore at injection site Day 2- sore under arm of injection arm and side of that breast. Muscles aches through mid back and chills Day 3 - Exhausted and achy, nauseous, chills, sweats Day 4- Adverse reactions gone.
47 2021-01-16 hives I felt hot within 15-30 minutes after receiving the vaccine. Then 5 days later, I noticed hives on m... Read more
I felt hot within 15-30 minutes after receiving the vaccine. Then 5 days later, I noticed hives on my back, swelling of my eyelids, and lips.
47 2021-01-16 rash, shingles severe muscle, spine cord and joint pain, chills, lymphodenopathy started 12 hrs after 2nd vaccine d... Read more
severe muscle, spine cord and joint pain, chills, lymphodenopathy started 12 hrs after 2nd vaccine dose, extreme pain in right arm, leg, neck, and right side of the stomach started on day 2 - phone appointment with doctor , rash started on day 3 - urgent care visit, diagnosed with shingles after dermatology consult
47 2021-01-17 itchy skin Caregiver reported onset of itchy scalp and headache approximately 7 hours after receiving dose. Sym... Read more
Caregiver reported onset of itchy scalp and headache approximately 7 hours after receiving dose. Symptoms progressed to disorientation, fatigue, cough, shortness of breath and anxiety.
47 2021-01-17 injection site pain Fever, chills and body aches. Pain in the arm where the shot was given. Aleve and tylenol taken and ... Read more
Fever, chills and body aches. Pain in the arm where the shot was given. Aleve and tylenol taken and was relieved. Occured 12 hrs after shot and lasted 24hrs.
47 2021-01-17 injection site redness, injection site swelling, injection site pain Swelling, tenderness and erythema at site of previous dermal filler injections under eyes/upper chee... Read more
Swelling, tenderness and erythema at site of previous dermal filler injections under eyes/upper cheeks (tear troughs) noted 24 hours after receiving 2nd dosage of vaccine. Swelling gradually worsened to involve bilateral tear trough regions - with maximal edema/erythema noted at approximately 36 hours post-vaccine. Symptoms resolved gradually and were reported as minimal at 72 hours post vaccination. Patient had received dermal filler injection with Juvederm Volbella 0.55 ml approx 3 months prior to receiving the vaccination.
47 2021-01-18 skin tightness, skin warm Face flushed like a sunburn and sweating a lot since about 17 min after. Pain in left eye down to mi... Read more
Face flushed like a sunburn and sweating a lot since about 17 min after. Pain in left eye down to mid cheek and full face mild puffiness. Difficulty swallowing only for 5 min then sore throat since then. Nausea starting about 2 hours after. Left arm swelling and a lot of pain for a couple hours in the middle of the night and still very sore but better. Woke up with both eyes bloodshot. Feeling like my scalp was hot and tight for about a half hour but that went away.
47 2021-01-18 injection site pain I have slight soreness at the injection site and some fatigue, both of which I expected. However, I... Read more
I have slight soreness at the injection site and some fatigue, both of which I expected. However, I am also experiencing significant "brain fog". It is difficult to do my normal activities and I lose track of what I am doing. It feels like I have a cloud inside my brain. I have not gone to the doctor, but felt this should be noted.
47 2021-01-18 hives, itchy skin Intense itching that led to an outbreak of hives beginning at my ankles and spreading to the upper t... Read more
Intense itching that led to an outbreak of hives beginning at my ankles and spreading to the upper thighs. Intense itching was also present at all post surgical scars on my body however, hives were not present in these areas.
47 2021-01-18 rash, itchy skin i was vacinated at the 15th of january in the evening! Everything was perfect and i was happy, just ... Read more
i was vacinated at the 15th of january in the evening! Everything was perfect and i was happy, just my legs itched, but on Sunday I suddenly noticed the beginning of an allergie which i normally get just in summer if I swim in standing waters with reef inside. I got a rash on my neck and my tongue felt bit swollen and as my eyes. In the evening i took a cortisone tablet and ointment and it was much better. The ointment i still take, but no tablets anymore. I still do have rash but it is much better. now I am concerned about the second vacine, can you give me a recommendation?
47 2021-01-19 injection site pain, itchy skin, injection site warmth, injection site swelling, injection site redness At the time of the first injection on Dec 28th I noticed I began itching a few days later. I did no... Read more
At the time of the first injection on Dec 28th I noticed I began itching a few days later. I did not put the itching together with the injection due to the dry weather. As time went on I noticed the itching mainly on head and upper torso. I had pain by the injection site but lasted only 2 days and was not that bad. The itching improved over the past week but noticed after my second injection that the itching has started back full force. I wake up scratching during the night. The pain in the arm was worse this time and did interrupt my sleep. Today at work I noticed my arm being sore and increased itching and decided to check the site. I found the site to be sightly swollen, red and warm to the touch. Was advised by provider that I work with to take Benadryl which I cannot do at this time until I am off shift as it makes me drowsy.
47 2021-01-19 cellulitis CELLULITIS 3 DAYS AFTER INJECTION. ANTIBIOTIC
47 2021-01-19 injection site swelling HEADACHE,CHILLS AND SWELLING INJECTION SITE.
47 2021-01-19 injection site swelling, injection site redness Injection site slight red and swollen for a day; Injection site slight red and swollen for a day; my... Read more
Injection site slight red and swollen for a day; Injection site slight red and swollen for a day; my taste was bitter. Then for the next 30 hours everything smelled and tasted like spoiled or rotting meat. Even water tasted rotten.; everything smelled and tasted like spoiled or rotting meat. Even water tasted rotten.; taste was bitter; This is a spontaneous report from a contactable Nurse (patient). This 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EK9231), on 07Jan2021 at 10:00 AM in right arm at single dose for COVID-19 immunisation. Age at vaccination was 47-years-old. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EH9899), on 17Dec2020 at 02:00 PM in left arm (age of vaccination was 46-years-old). Medical history included hypothyroidism. Known allergies included metoclopramide (REGLAN) and tramadol hydrochloride (ULTRAM). Concomitant medications were unknown. The patient was vaccinated at hospital. No other vaccine was received in four weeks. The second injection was given in the AM. By the afternoon on 07Jan2021 at 04:00 PM noted that her taste was bitter. Then for the next 30 hours everything smelled and tasted like spoiled or rotting meat. Even water tasted rotten. No fever or chills. Injection site slight red and swollen for a day, no joint pain, no body pain. Outcome was recovering. No treatment was received for the events.
47 2021-01-19 injection site pruritus Patient started feeling itchy at the injection site. Patient felt not okay, No SOB, lightheadedness,... Read more
Patient started feeling itchy at the injection site. Patient felt not okay, No SOB, lightheadedness, hives or numbness. Rapid Response was called and was advised extra observation time. No other intervention.
47 2021-01-19 injection site pain Pfizer-BioNTech COVID-19 Vaccine EUA On the evening of 1/19/21 I noticed my arm in the area of my va... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA On the evening of 1/19/21 I noticed my arm in the area of my vaccine was sore to the touch. As the evening progressed, my shoulder joint became sore and got worse throughout the evening and became very sore to lift my arm. This morning it is still very sore, and now my neck feels ?stiff? and also it?s tender to move.
47 2021-01-19 hives Pt had vaccine at 1143, hives started at 1200, c/o itching throat at 1210 which progressed to diffic... Read more
Pt had vaccine at 1143, hives started at 1200, c/o itching throat at 1210 which progressed to difficulty swallowing. Epi given and pt transferred to ED
47 2021-01-19 injection site pain pain at injection site joint pain in bilateral hips, knees and wrists fatigue onset within 2 hours o... Read more
pain at injection site joint pain in bilateral hips, knees and wrists fatigue onset within 2 hours of vaccine, treated with otc naproxen 220 mg q12 hours prn pain continued next day, continued otc naproxen 220 mg 2 12 hours
47 2021-01-20 redness 10-20 seconds after administration of the COVID-19 vaccine (1st in series), patient became hot and f... Read more
10-20 seconds after administration of the COVID-19 vaccine (1st in series), patient became hot and flushed and experienced mild difficulty breathing. A rapid response was called, patient noted to have a swollen and red face and neck. 0.3mg IM Epinephrin given. HR 108, SpO2 98% on room air. Patient taken to the emergency department for follow-up. In the ED patient reported feeling anxious, nauseous, and having a dry mouth. Notes that she had never had a reaction to a vaccine before. Diagnosed with an allergic reaction to the COVID-19 vaccine. Benadryl, pepcid, and Solumedrol given.
47 2021-01-20 itchy skin, redness, skin burning sensation, blister First dose without incident. 18Jan2021 6:40am 2nd dose - 12hr later felt blah, 24hrs later extremely... Read more
First dose without incident. 18Jan2021 6:40am 2nd dose - 12hr later felt blah, 24hrs later extremely dizzy with moderate headache and body aches. then at 4am 20Jan2021 (right around 48hrs), I had erythema with a blister on left lateral side around rib region 8-10 with itching and burning. This improved to no erythema and this morning (21Jan2021) only 3 blisters with mild discomfort.
47 2021-01-20 injection site pain Left deltoid pain severe for 9 days. Could sleep pt dress my self . Left ark in sever pain. Heat and... Read more
Left deltoid pain severe for 9 days. Could sleep pt dress my self . Left ark in sever pain. Heat and cold compress no relief. Went to employee health got X-ray Dr felt muscle tissue fiber damage . Rx of 600 mg of advil x3 a day still having pain
47 2021-01-20 itchy skin Pt received Pfizer vaccine at 9:15 in left deltoid. At 9:30 pt complained of throat feeling itchy, a... Read more
Pt received Pfizer vaccine at 9:15 in left deltoid. At 9:30 pt complained of throat feeling itchy, and tongue feeling larger than usual and numb. Provider informed, provider assessment revealed no rash, no redness, no visible swelling of tongue, and patient reported an itch on right arm. Vitals 9:35 BP 126/70, HR 88, oxygen saturation 99% on RA, and respirations of 20/min. Vitals retaken at 9:40 BP 117/70, HR 75, oxygen saturation 98% on RA, and 20 breaths/min. Vitals retaken at 9:50 BP 115/71, HR 74, oxygen saturation 98% on RA< and 18 breaths/min. At 9:53 patient stated her throat is no longer itchy, and tongue no longer feels large.
47 2021-01-20 injection site redness, injection site inflammation, injection site warmth, injection site rash Warm, red and inflamed rash at site of injection started 1/20/21; 12 days after my 1st dose of covid... Read more
Warm, red and inflamed rash at site of injection started 1/20/21; 12 days after my 1st dose of covid vaccine on 1/8/21.
47 2021-01-21 injection site pain Migraine- the worse I?ve ever experienced. Shooting pain up the left side of neck to base of skull o... Read more
Migraine- the worse I?ve ever experienced. Shooting pain up the left side of neck to base of skull on the same side where I got the shot in my left shoulder
47 2021-01-22 injection site pain, injection site discomfort 6:00 pm onset of profound fatigue and moderate pain at the injection site 7:45 pm onset chilling/rig... Read more
6:00 pm onset of profound fatigue and moderate pain at the injection site 7:45 pm onset chilling/rigors lasting 90minutes, even under 5 blankets 9:15 pm fever up to 100.8, headache, bodyaches, unable to sleep 3:30 am 1/7/2021 took 800mg ibuprofen 4:00 am fever broke, went to sleep 6:30 am awoke with temp 97.4, tiredness and mild headache due to lack of sleep. Got up and went to work. -Fatigue, mild malaise, and injection site discomfort fully resolved after 72 hours with no further intervention.
47 2021-01-22 injection site pain About 10 hours after receiving the first dose of the Pfizer-BioNTech COVID-19 vaccine, I began exper... Read more
About 10 hours after receiving the first dose of the Pfizer-BioNTech COVID-19 vaccine, I began experiencing noticeable soreness in my upper left arm around the injection site, extending in a 2-3 in radius. The soreness lasted some 14-16 hours and was noticeable with virtually any movement of my arm. It was not incapacitating and didn't seem threatening or dangerous, but since this vaccine is so new, it seems useful to report any and all side effects. Timeline: 1. Vaccination received at 11:00 A.M.; 2. Soreness began around 9:00 P.M. (possibly as late as 10:00 P.M.); 3. Soreness ended between 12:00 P.M. (noon) and 1:00 P.M. the following day.
47 2021-01-22 hives GI inflammation, nausea, vomiting x2 the evening of. The next day hives over my abdominal region wo... Read more
GI inflammation, nausea, vomiting x2 the evening of. The next day hives over my abdominal region worsening each day and continue to be present.
47 2021-01-24 vaccination site pain 2030 arm became quite sore/remaining symptom slight soreness at injection site; 1700 achiness in upp... Read more
2030 arm became quite sore/remaining symptom slight soreness at injection site; 1700 achiness in upper back and neck; 1700 achiness in upper back and neck; 1200 extreme fatigue/tiredness became more pronounced; On day of 2nd shot:1100 dizziness and slight headache; On day of 2nd shot:1100 dizziness and slight headache; This is a spontaneous report from a contactable Healthcare Professional reporting for herself. A 47-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot # EL3246, via an unspecified route of administration on 12Jan2021 at 08:30, at 47-years of age, at single dose for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine (Lot # EL0140) in left arm on 22Dec2020 at 08:30 am; medical history included food allergy including fish, shellfish, seafood of all types and corn, gastrooesophageal reflux disease, an unspecified neoplasm malignant, Vertical Sleeve gastrectomy (VSG) and neuropathy peripheral, all from an unknown date. Concomitant medication included amlodipine, pantoprazole, cetirizine hydrochloride (ZYRTEC), zinc and magnesium. The patient was vaccinated in Hospital and she was not pregnant when she received the vaccine. On 12Jan2021, day of 2nd vaccine shot, at 11:00 the patient experienced dizziness and slight headache, at 12:00 she experienced extreme fatigue, at 17:00 she suffered from achiness in upper back and neck, at 20:30 her arm became quite sore; on 13Jan2021 all symptoms continued and tiredness became more pronounced and, on 14Jan2021, the only remaining symptoms were slight soreness at injection site and some achiness in upper back. All other symptoms had resolved. No treatment was received for the reported events. The patient has not been tested for COVID-19 after vaccination. At the time of the report the events dizziness, slight headache, extreme fatigue/tiredness became more pronounced had resolved and the events soreness at injection site and achiness in upper back were recovering.
47 2021-01-24 itchy rash Intense pruritic episode 4 hours post vaccine. Slight swelling in face. Lasted approx 24 hours per p... Read more
Intense pruritic episode 4 hours post vaccine. Slight swelling in face. Lasted approx 24 hours per patient.
47 2021-01-24 rash Mild headache progressing to intense throbbing headache with flashes of white light, lasting for sev... Read more
Mild headache progressing to intense throbbing headache with flashes of white light, lasting for several hours, severe myalgias, high fever, episodes of delirium, right shoulder and right neck burning pain, chills, sweating, intense fatigue, rash on arms/stomach/back/thighs
47 2021-01-25 vaccination site redness High fever; Nausea; Diarrhea; muscle/body aches; muscle/body aches; horrid headaches; large red spot... Read more
High fever; Nausea; Diarrhea; muscle/body aches; muscle/body aches; horrid headaches; large red spot size of softball where injection given; This is a spontaneous report from a contactable other health care professional reported that a 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection); first dose (lot number: eh9899) via an unspecified route of administration on 18Dec2020 09:00 at SINGLE DOSE at right arm, and second dose (lot number: EL1284) via an unspecified route of administration on 08Jan2021 09:00 at SINGLE DOSE at right arm for COVID-19 immunization. Medical history included depression, anxiety, and migraine. The patient has Known allergies with lisinopril, morphine, vancomycin, albuterol. On 09Jan2021 12:00, the patient experienced High fever, nausea, diarrhea, muscle/body aches, horrid headaches, large red spot size of softball where injection given. The outcome of the events was recovering. The patient did not receive treatment for the events.
47 2021-01-25 itchy skin, injection site hives I sneezed about 3-4 times after 3pm -7pm, and around 10:30pm 3-4 consecutive sneezes. 11pm -11:30p... Read more
I sneezed about 3-4 times after 3pm -7pm, and around 10:30pm 3-4 consecutive sneezes. 11pm -11:30pm-- one hive at injection site with itching on both arms, face, nose, inside of ears,, legs, back, hands and feet along with sneezing after almost 11 hours after injection. It wasn't a frenzy itch where you are scratching all at once. I took 25mg of Benadryl ,around 11:45pm or midnight. Attempted to reach out to hospital, who placed vaccine with no success. 1:00am, I took another 25mg of Benadryl because the inside of my ears were still itching, but most of the other itching had stopped. I reached out to my own PCP and was instructed to take my Epipen with me for the second dose. It has been 3 days, and my nose is still itching and I have sneezed 6 times today. *****I normal don't sneeze since taking allergy shots years ago.******
47 2021-01-25 rash Low grade temp chills muscle aches sore arm and lacey rash on chest for about 36 hours. Onset was ab... Read more
Low grade temp chills muscle aches sore arm and lacey rash on chest for about 36 hours. Onset was about 14 hours after injection
47 2021-01-26 itchy skin Flushing, heart racing, itching in fingers
47 2021-01-26 injection site pain Moderate Nausea, chills, fever x 2 days, extreme fatigue x 4 days, moderate ongoing injection site p... Read more
Moderate Nausea, chills, fever x 2 days, extreme fatigue x 4 days, moderate ongoing injection site pain. Headache.
47 2021-01-26 injection site pain Pain at injection site began at 8pm. Fever at Midnight, fatigue and body aches on Wednesday the 20t... Read more
Pain at injection site began at 8pm. Fever at Midnight, fatigue and body aches on Wednesday the 20th. Fever lasted approximately 24 hours body aches 48 hours. Fatigue lasted about 4-5 days. A high fever started on 1/27/2021. Lasting about 8 hours. Along with severe headache and fatigue.
47 2021-01-26 injection site pain chills and fever of 101.4, body aches, sore arm at injection site
47 2021-01-27 injection site pain Immediately following shot my blood pressure drop felt like I was going to faint. With in a couple h... Read more
Immediately following shot my blood pressure drop felt like I was going to faint. With in a couple hours sore arm at injection site. With in 12 hours headache, slight fever achy body. 24 hours in my arm pit on the same Injection arm was swollen and uncomfortable and has remained so for 4 days so far.
47 2021-01-27 injection site numbness, injection site tingling Roughly 10-13 minutes after injection patient reports numbness and tingling in arm of administration... Read more
Roughly 10-13 minutes after injection patient reports numbness and tingling in arm of administration. Also complains of sharp chest pain. VS-152/92, 92, 24, 99% on RA. Advised to go to ER for further evaluation. Spouse came and picked patient up and took to the ER she did not want to go via ambulance.
47 2021-01-27 injection site swelling, injection site swelling Site: Swelling at Injection Site-Medium, Systemic: Other- patient felt tightness in trachea; nurse p... Read more
Site: Swelling at Injection Site-Medium, Systemic: Other- patient felt tightness in trachea; nurse practitioner ordered for administration of epipen
47 2021-01-27 itchy skin facial flushing, mild generalized puritis
47 2021-01-27 vaccination site pain muscle soreness; She had some arm soreness at the injection site/injection area hurt; This is a foll... Read more
muscle soreness; She had some arm soreness at the injection site/injection area hurt; This is a follow-up spontaneous report from Pfizer-sponsored program, from a contactable physician. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), intramuscular on 30Dec2020 at a single dose for COVID-19 vaccination. Medical history included pains in her arm (so any injection would hurt). There were no concomitant medications. Physician had muscle soreness after getting the 1st dose of the COVID 19 vaccine last 30Dec2020. Took ibuprofen (ADVIL) for pain management and wondering if this will affect the antibody response. Requesting for data regarding people that took pain medications during the clinical trials and asking for antibodies titer after taking pain medications. She will have the 2nd dose on 20Jan2021 and wants to know the options. On 14Jan2021, it was reported that right after the patient took the vaccine, she took some ADVIL because the injection area hurt. She is now seeing she was not supposed to take ADVIL, acetaminophen (TYLENOL), ibuprofen. She also wanted to know during the clinical trials, did they notice a decrease in antibodies after taking ADVIL or TYLENOL. Confirms she took ADVIL right after the injection. She already had pains in her arm so any injection would hurt. She was explaining she is now seeing on Medical (Social site name), a study in mice shows with COVID infections, NSAIDS were given, clarified as meloxicam, and it reduces the neutralizing antibody response. Now, all over Medical (Social site name), physicians are saying you shouldn't take ibuprofen, Naproxen, or Tylenol after receiving a dose. Wanted to know what was seen in the clinical trial data. Mice are mice. It's now all over Medical (Social site name). She has her second dose coming on Wednesday. She also wants to know what is she going to tell her patients? They are not going to want to know what happened in mice, they are going to want to know what happened in Phase 3 of Clinical trials. She had some arm soreness at the injection site. She confirms the arm soreness was gone in less than 48 hours, but she took ADVIL every 8 hours. Once the soreness was gone, she didn't take it. But now she is freaking out, wondering if she didn't get an antibody response? She received the standard dose, which she believes is 3mL of the solution, but she isn't sure. Therapeutic measures were taken as a result of muscle soreness and 'she had some arm soreness at the injection site'. The outcome of the event muscle soreness was unknown, while of 'She had some arm soreness at the injection site/injection area hurt' was recovered on Jan2021. Information on the lot/batch number has been requested.
47 2021-01-28 skin burning sensation, itchy rash, injection site pain, rash First dose given 12/24/2020 injection site pain developed 12 hours after vaccine given and resolved ... Read more
First dose given 12/24/2020 injection site pain developed 12 hours after vaccine given and resolved by 24 hours post vaccination. Trunk rash developed 48 hours after vaccine and resolved within hours. Twelve hours after second dose on 1/14/2021, developed chills, aches, burning neuropathic pain all over, temperature of 101 degrees F. After 5 hours took 600 mg ibuprofen with relief and required another dose at noon the day after vaccination. Symptoms resolved within 24 hours. Developed pruritic trunk rash that lessened within hours but took > 2 weeks to resolve.
47 2021-01-28 skin discolouration Patient is a 47 y.o. female that presents from employee health after receiving the COVID-19 vaccinat... Read more
Patient is a 47 y.o. female that presents from employee health after receiving the COVID-19 vaccination in her left arm. Within the 15-minute observation. She started developing a dry cough. She subsequently felt shaky, short of breath and felt a tingling in her throat. She states it feels funny when she swallows. She has noted tingling in her fingertips with associated discoloration. She has not noted any redness or swelling at the injection site. She has not developed a rash on her skin. She does have a history of COPD and uses inhalers and nebulizers. She has not tried an inhaler for the cough. She has had multiple medication allergies in the past including reactions to the Pneumovax and MMR. She denies chest pain. She has no abdominal pain. No nausea or vomiting. No leg pain. The patient presents to the emergency department after developing a cough, throat discomfort, shortness of breath and paresthesias following COVID-19 vaccination at 4 PM. She has no evidence of swelling of the lips, tongue or oropharynx on exam. She has no stridor or wheezing on exam. Her pulse oximetry readings are in the high 90s on room air. She received Benadryl, prednisone and a nebulizers treatment. She was observed in the emergency department for 2 hours and had improvement in symptoms. She was discharged in stable condition.
47 2021-01-29 skin irritation, itchy skin 20 min after vaccine skin itching and irritation, no resp involvement , improved with PO Benadryl an... Read more
20 min after vaccine skin itching and irritation, no resp involvement , improved with PO Benadryl and IV solumedrol
47 2021-01-29 injection site reaction, rash Skin rash on shoulder where the shot was administered.
47 2021-01-29 skin burning sensation Woke with severe pain in right cervical spine muscles, right upper shoulder. Sharp burning radiatin... Read more
Woke with severe pain in right cervical spine muscles, right upper shoulder. Sharp burning radiating pain progression to right deltoid. Treatment, tried Aleve, Tylenol, massage without relief. Emergency room visit 1/27 8am due to worsening Symptoms. Dx of muscle spasms, prescribed Valium a 8 hours, lidocaine patch and Tylenol, heat. No relief to of pain. TeleHeath with pcp on 1/28, who again dx muscle spasm. Changes script to flexeril. No relief in pain and now new onset of numbness right . uncertain if this is related to covid but occurred less than 24 hours after vaccine and have never experienced this issue before and no other mitigating cause known
47 2021-01-30 hives On Sunday morning I woke up with a mildly swollen right eye. I took Benadryl, but later developed h... Read more
On Sunday morning I woke up with a mildly swollen right eye. I took Benadryl, but later developed hives on my back, shoulder, and torso. Continued to take Benadryl that night. The next morning, Monday I woke up with continued hives on my torso, back, additionally on my bikini line area, and lower back area. I called my doctor's emergency line, to which I was instructed to continue with Benadryl, if it became worse, seek immediate medical attention. Tuesday morning I woke up with both arms covered in hives from shoulder of wrists, some on my neck and lower chin, swollen upper lip which also felt numb. I sought medical attention from primary care physician, Tuesday morning, by the time I arrived, the hives were also on my legs.
47 2021-01-31 rash Days 1-3: Fatigue Day 4 (2/1/21): Fever of 100.5, shakes, and rash on left forearm
47 2021-01-31 vaccination site pain, itchy rash Itchy Rash; fever; debilitating joint pain; nausea; fatigue; headache; inj site pain; This is a spon... Read more
Itchy Rash; fever; debilitating joint pain; nausea; fatigue; headache; inj site pain; This is a spontaneous report from a contactable other health care professional (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302 and expiration date was not provided), intramuscular (left arm) first dose on 14Jan2021 12:30 at single dose for covid-19 immunisation. The patient's medical history Asthma, adrenal insufficiency, hypokalemia, chronic migraine, Vit D deficiency, Known allergies: IV Contrast dye, and Covid. The patient was not pregnant at time of vaccination. The patient's concomitant medication includes unspecified drug. On 14Jan2021 13:00, the patient experienced itchy rash, fever, debilitating joint pain, nausea, fatigue, headache, and injection site pain. The patient did not received treatment for the events. The outcome of the events was recovering.
47 2021-01-31 rash Onset of headache during wait time. 2130 chills, feverish, headache, rash. 0230 rash, itchy throat, ... Read more
Onset of headache during wait time. 2130 chills, feverish, headache, rash. 0230 rash, itchy throat, flush, feverish, chills 1/23/21 headache, irritated throat, chills, feverish, rash, night sweats, swelling hands and feet, fatigue 1/24/21 itchy throat, rash, headache, chills, feverish, flush, swelling hands and feet 1/25/21 rash, irritated throat, headache, chills, feverish 1/26/21 mild rash, headache, chills, feverish 1/27/21 chills, feverish, mild rash 1/28/21 itchy throat, flushed, itchy, rash on entire body, feverish 1/29/21 mild rash, chills. 1/30/21 flushed and itchy, itchy throat, chills, feverish
47 2021-01-31 injection site warmth, injection site swelling, injection site pain, injection site nodule, injection site redness Swelling (a hard lump formed), redness, pain, skin warm to the touch at site of injection
47 2021-01-31 rash with redness, rash, rash macular my right arm started to feel like it was on fire; This feeling quickly spread up my neck and across ... Read more
my right arm started to feel like it was on fire; This feeling quickly spread up my neck and across my chest; red splotchy rash; right side of my head was tingling; I was mildly tachycardic; This is a spontaneous report from a contactable other Health Professional (patient). A 47-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1284), via an unspecified route of administration on 06Jan2021 12:30 at single dose for covid-19 immunisation. Medical history included allergies to adhesive and nickel. Patient did not have COVID prior vaccination. Patient did not have COVID tested post vaccination. There were no concomitant medications. It was reported that the day after vaccination, patient's right arm started to feel like it was on fire. This feeling quickly spread up neck and across chest and this area had a red splotchy rash. The right side of head was tingling. Patient took 50 mg diphenhydramine hydrochloride (BENADRYL) and headed to ER (Emergency Room) where patient received Dexamethasone. Patient was mildly tachycardic. Above events started on 07Jan2021 at 12:30. Outcome of the events was resolved.; Sender's Comments: The events are considered related to the suspect product based on the strong temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
47 2021-01-31 rash on 1/27/21 I starting seeing a rash on my face. It has worsened each day since the 27th. I have take... Read more
on 1/27/21 I starting seeing a rash on my face. It has worsened each day since the 27th. I have taken Benadryl 25mg for 3 days with no relief. I have consulted the Rheumatologist to see if this could be a result of the prednisone and the vaccine together.
47 2021-02-01 rash, injection site rash 12/28 Vaccine 6:30 AM. 2 hours later rash appeared @ injection site and 3" around in diameter. Aroun... Read more
12/28 Vaccine 6:30 AM. 2 hours later rash appeared @ injection site and 3" around in diameter. Around 8 hours after, I felt SOB and rash spread to all extremities. I took hydrosteroids; prednisode and benadryl. The rash started to get better about 4 hours later. 12/29 Body aches, fatigue. Swollen lymphnodes for at least 5-6 days. History of Severe allergies; eggs, shellfish, sulfa, etc. (listed on first page). Carry epi pen 24/7. Have not had Anaphylaxis reaction for 4 years. *premedicated with benadryl before 2nd vaccine. No rash. but still had body aches.
47 2021-02-01 rash Almost immediately after the shot I could feel it/taste it in my mouth. I had some swelling/tingling... Read more
Almost immediately after the shot I could feel it/taste it in my mouth. I had some swelling/tingling of the tongue mouth. They had me wait the additional 15 mins. Did the pulse/ox. I was normal. Advised to take antihistamine, which I did when I got home. Felt better that day. On Friday, Jan. 29 I noticed a rash on my torso - stomach, back from bra line down to buttocks. I texted a pic to my friend who is a pediatrician. She said it looked pityriasis rosea. It doesn't itch. I also began having tingling on my tongue again. As of today, 2/2, I still have the rash and some tingling on the tongue. I've been taking a generic claritan in the morning and a benadryl in the afternoon and before bed. I also received a notice at work on Friday and a phone call from the county on Saturday that I may have been exposed to covid on Jan. 26. I have had none of the symptoms typical of covid. Just the rash and the tongue tingling. I called the number today. They advised I complete this form. I am getting a covid test tonight.
47 2021-02-01 injection site pain, injection site warmth, injection site redness FEVER 100.4, BODY ACHES, HEADACHE, LEFT ARM PAIN - INITIALLY AT INJECTION SITE LATER ON FIRST DAY, A... Read more
FEVER 100.4, BODY ACHES, HEADACHE, LEFT ARM PAIN - INITIALLY AT INJECTION SITE LATER ON FIRST DAY, AND THEN ON 1/3/2021 NOTICED RED SPOT JUST BELOW INJECTION SITE THAT WAS TENDER AND WARM TO TOUCH, ROUGHLY 3X3 IN SIZE. ALSO FELT PAIN IN ARMPIT, TENDER TO TOUCH, BUT NO REDNESS. SINCE 1/30/2021 TOOK TYLENOL 5OOMG 1 - 2 TABS EVERY 6-8 HOURS AS NEEDED. RELIEVED MOST OF PAIN FEVER AND BODY ACHES SUBSIDED BY DAY 2 WHICH WAS 2/1/2021. HEADACHE AND ARM AND ARMPIT PAIN PERSIST
47 2021-02-01 injection site pain, sensitive skin Moderate pain at site x 1 day, short intermittent sharp pain in chest, nausea; left side facial sens... Read more
Moderate pain at site x 1 day, short intermittent sharp pain in chest, nausea; left side facial sensitivity to touch and cold, nausea, and diarrhea
47 2021-02-01 injection site pain The day following the injection, I experienced mild pain/stiffness at the injection site. The second... Read more
The day following the injection, I experienced mild pain/stiffness at the injection site. The second day after the vaccine, I began coughing. Since then, I've experienced chills, body aches, fatigue, increased coughing and diarrhea, as well as a low fever and a touch of laryngitis.
47 2021-02-01 injection site tingling throat closing; tingling immediately in left arm; rapid heartbeat; This is a spontaneous report from... Read more
throat closing; tingling immediately in left arm; rapid heartbeat; This is a spontaneous report from a contactable healthcare professional, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL 1283), intramuscular in the left arm on 08Jan2021 at 17:00 (at the age of 47-years-old) as a single dose for Covid-19 immunization. Medical history included migraines. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food or other products. The patient's concomitant medications included minocycline (MANUFACTURER UNKNOWN) for unknown indications from unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 08Jan2021 at 17:00, the patient experienced tingling immediately in left arm following injection, rapid heartbeat and throat closing. The patient was treated for the throat tightness, paraesthesia and heart rate increased which included diphenhydramine (BENADRYL), oral steroids, EKG and blood pressure monitoring. The events did initiate an emergency room visit. The clinical outcome of the events throat tightness, paraesthesia and heart rate increased was recovered with sequel. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "throat closing" and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
47 2021-02-02 itchy skin, hives Employee complained of itchyness, blurry vision, feeling dizzy 10 minutes after vaccine was injecte... Read more
Employee complained of itchyness, blurry vision, feeling dizzy 10 minutes after vaccine was injected, and then complained she feels burning sensation in her throat. Denies difficlty of breathing, headache. Transported to ED and treated with Benadryl. Took Benadryl for 3 days. Headaches lasted about 1wk and took ibuprofen. Employee reported she had hives for 3 days after her 1st dose. Took Benadryl. This wasn't previously reported to us.
47 2021-02-02 itchy skin pt with h/o generalized itching 15 min after first does of covid who received 2nd dose of covid a/w ... Read more
pt with h/o generalized itching 15 min after first does of covid who received 2nd dose of covid a/w localized itchy of the left flank 5 min after the vaccination but no flushing, no hives, no pulmonary or cardiovasc sx no angioedema. symptom resolved with 25mg oral benadryl
47 2021-02-03 vaccination site pain, vaccination site swelling Body aches, pain; pain and swelling at injection site; pain and swelling at injection site; HSV2 out... Read more
Body aches, pain; pain and swelling at injection site; pain and swelling at injection site; HSV2 outbreaks; This is a spontaneous report from a nurse (patient herself). A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 also reported as COVID 19 vaccine, brand Pfizer), second dose in left arm on 13Jan2021 (lot EL1283) and first dose in right arm on 23Dec2020 09:15 (lot EK5730), via an unspecified route of administration at single dose, for Covid-19 immunisation. Medical history was none. No any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included colecalciferol (VITAMIN D). On 15Jan2021 20:00, she had body aches, pain and swelling at injection site and HSV2 outbreaks with both doses. First was more severe than the second and took longer to heal. No treatment was given. The outcome of events was recovered.
47 2021-02-03 redness Employee began complaining about a "cold feeling" in her rt arm followed by numbness and "pins and ... Read more
Employee began complaining about a "cold feeling" in her rt arm followed by numbness and "pins and needles" like sensation. She also complained that her rt arm was feeling swollen and red. Mild redness noted upon assessment but no obvious swelling visually. Observed employee for 30 minutes after vaccine and symptoms persisted. Employee has a history of severe reactions to food and medications. Vital signs obtained and BP noted to be in 150s/90s, Hr in 90's, temperature and oxygen saturation were both within normal limits. Employee denied any feeling of swelling of face or throat, but was taken to emergency department onsite for further evaluation as her numbness continued to persist past 30 minutes observation. Employee reported that she was triaged only and was in lobby for about 2.5 hours after which time she left since she felt her symptoms were improved. She called her PCP when she arrived home and was instructed to take 25 mg of Benadryl orally. Employee reported that her symptoms completely resolved after that and that she had no subsequent symptoms.
47 2021-02-03 vaccination site itchiness Feeling itchy at the injection site; Felt not okay; This is a spontaneous report from a contactable ... Read more
Feeling itchy at the injection site; Felt not okay; This is a spontaneous report from a contactable pharmacist. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL1284), via intramuscular (left arm) on 30Dec2020 12:15 at SINGLE DOSE for COVID-19 immunisation. Medical history included depression, Hyperlipidemia, Migraine with aura, NASH, Known allergies: penicillin from unspecified dates. The patient was not pregnant during vaccination time. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included atorvastatin, fluoxetine, fluticasone (FLUTICASONE), omeprazole, for unspecified indications; rizatriptan for migraine, and norethisterone (MICRONOR) for Oral contraceptive, all from unspecified dates. The patient experienced feeling itchy at the injection site, and felt not okay on 30Dec2020 12:15. No SOB, lightheadedness, hives or numbness. Rapid Response was called (emergency visit) and was advised extra observation time. No other intervention. Treatment was not given. Outcome of events was recovered. Events were considered non-serious.
47 2021-02-03 vaccination site pain I tested positive for covid on 09Jan2021; I tested positive for covid on 09Jan2021; Fatigue, sore ar... Read more
I tested positive for covid on 09Jan2021; I tested positive for covid on 09Jan2021; Fatigue, sore arm up to 48 hours post injection. Started feeling feverish with chills on 03Jan2021. I tested positive for covid on 09Jan2021; Fatigue, sore arm up to 48 hours post injection. Started feeling feverish with chills on 03Jan2021. I tested positive for covid on 09Jan2021; Fatigue, sore arm up to 48 hours post injection. Started feeling feverish with chills on 03Jan2021. I tested positive for covid on 09Jan2021; Fatigue, sore arm up to 48 hours post injection. Started feeling feverish with chills on 03Jan2021. I tested positive for covid on 09Jan2021; This is a spontaneous report from a contactable nurse. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EK5730), intramuscular in Left arm on 30Dec2020 17:00 at single dose for covid-19 immunisation. Medical history included asthma (as a child). Concomitant medication included loratadine (CLARITIN [LORATADINE]), cyanocobalamin (B12 [CYANOCOBALAMIN]), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]). The patient previously took morphine and experienced Known allergies. The patient experienced fatigue, sore arm up to 48 hours post injection. Started feeling feverish with chills on 03Jan2021. I tested positive for covid on 09Jan2021. The patient received just fluids, vit c,zinc, and vitd as treatment. No covid prior vaccination. Covid tested post vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Jan2021, sars-cov-2 test: positive on 07Jan2021. The outcome of the event Feverish and Chills was resolved on Jan2021, Vaccination site pain and Fatigue was resolved on an unspecified date, while the outcome of the other events was unknown.
47 2021-02-03 itchy skin Itchy, lightheaded, high blood pressure, seeing stars, diarrhea
47 2021-02-03 skin warm Warm , tingly arm, dizziness, lightheaded, tongue swelling, difficulty swallowing, high blood pressu... Read more
Warm , tingly arm, dizziness, lightheaded, tongue swelling, difficulty swallowing, high blood pressure
47 2021-02-04 rash Patient felt like a rash was developing Symptoms improved
47 2021-02-04 sensitive skin Severe arm pain and arm sensitivity changes
47 2021-02-07 skin discolouration, injection site bruising, injection site redness, injection site mass, injection site pain, injection site warmth #1 The injection site was sore, red, and hot to touch, the site then had a large lump under the surf... Read more
#1 The injection site was sore, red, and hot to touch, the site then had a large lump under the surface of the skin, then it was black and blue. From start to finish from the redness to the bruising was about 3 days. #2 Sore throat, followed by hoarseness and then ultimately loosing my voice, body aches, headache, fever and chills with the fever lasting 4 days and ranging from 99.5 to 106.1. Also have had a runny nose, followed by congestion with a course and constant productive cough. I still have all the symptoms listed above today 02/08/2021 except the fever, chills and body aches.
47 2021-02-07 itchy skin Experienced pruritis immediately after injection. Pt had pruritis with first vaccine 1/15/21 howeve... Read more
Experienced pruritis immediately after injection. Pt had pruritis with first vaccine 1/15/21 however, did not report symptoms and took Benadryl 50mg po and symptoms resolved on their own. Pt thoroughly examined, no swelling noted to tongue, lips, uvula midline, vss, no urticaria present, no nausea. Pt. Given 25mg po of Benadryl and observed for 30 mins: after and remains without s/s of anaphylaxis. Pt. Reports improvement of itching.
47 2021-02-07 injection site redness, injection site swelling, injection site warmth Injection site is red, swollen, and hot going on three days. Fever, chills, aches , pains, headache,... Read more
Injection site is red, swollen, and hot going on three days. Fever, chills, aches , pains, headache, and fatigue lasted two days.
47 2021-02-07 shingles, rash Rash on chest. Treatment : Triamcinolone Acetonide Shingles on back of neck/. Treatment Valacyclo... Read more
Rash on chest. Treatment : Triamcinolone Acetonide Shingles on back of neck/. Treatment Valacyclovir and Methylprednisolone mg
47 2021-02-08 cellulitis Cellulitis in the arm; Fever; strong muscle pain; chills; headache; muscle weakness; This is a spont... Read more
Cellulitis in the arm; Fever; strong muscle pain; chills; headache; muscle weakness; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL1283), intramuscularly on 25Jan2021 at 10:00 AM in Left arm at single dose for COVID-19 immunization. The patient medical history included Hypothyroidism and COVID prior vaccination. No known allergies, no allergies to medications, food, or other products. The patient's concomitant medications reported as no. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Ek4176), on 07Jan2021 in Left Arm at single dose for COVID-19 immunization at age of 47-year-old. The patient experienced fever, strong muscle pain, chills, headache and muscle weakness on 26Jan2021 at 03:00 AM; Cellulitis in the arm on 27Jan2021 at 08:00 AM. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events fever, strong muscle pain, chills, headache and muscle weakness included Acetaminophen, ibuprofen; no treatment was received for the event Cellulitis in the arm. The outcome of the events was not recovered. The report was reported as non-serious for event "Cellulitis in the arm", with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
47 2021-02-08 injection site swelling, injection site redness, injection site warmth Having redness, swelling and site of injection is warm to the touch still today 2/9 .. 2 days after ... Read more
Having redness, swelling and site of injection is warm to the touch still today 2/9 .. 2 days after injection. Yesterday 2/8 I had flu like symptoms all day including hot flashes followed by cold sweats, body aches all over body and extreme fatigue.
47 2021-02-08 hives Hives, chest tightness, sinus drainage, and pressure
47 2021-02-09 vaccination site redness, vaccination site swelling, vaccination site pain Arm and head hurt badly; Sick to her stomach; Lost most of the taste and smell; Lost most of the tas... Read more
Arm and head hurt badly; Sick to her stomach; Lost most of the taste and smell; Lost most of the taste and smell; Weird taste in her mouth; Headache; Swelling in her throat; Injection site pain; Muscle pain; Injection site swelling and redness; Injection site swelling and redness; Swollen lymph node; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration, on 24Jan2021 at a single dose for COVID-19 immunization. Medical history included asthma from an unknown date. Concomitant medications were not reported. It was reported that the patient got the COVID-19 vaccine shot on 24Jan2021. When she sat there for 15 minutes, she got a weird taste in her mouth and got a headache. At 2 PM she still had a headache and she lost most of the taste and smell; at 4 pm she was sick to her stomach; by 5:15, her arm and head hurt badly, the taste in her mouth was like super weird but it was not exactly metallic taste it was weird bizarre taste she never had before. Her smell came back. She was extremely nauseated and had a bad headache. She stated that all of her symptoms were gone away except the swelling in her throat. She further stated she called the hospital and stated she got injection site pain, headache, and muscle pain. She also got injection site swelling and redness, nausea, swollen lymph node and a headache and the weirdest part that really bothered her was the strange taste in her mouth. She got some of the smell and taste back and now it's gone; it's really bizarre like the injection site pain, the headache everything was gone literally gone. The only things that was still hanging on was her lymph nodes and throat. The second due dose of vaccine was on 14Feb2021. The patient has not recovered from swelling in her throat and swollen lymph node, and has recovered from other events. Information on the lot/batch number has been requested.
47 2021-02-09 vaccination site pain Chill; fever; body aches; migraine; dizziness; soreness at injection site; headache; lymph node swol... Read more
Chill; fever; body aches; migraine; dizziness; soreness at injection site; headache; lymph node swollen on left arm pit area; This is a spontaneous report from a contactable other healthcare professional(patient). A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El3302), intramuscularly into the left arm on 23Jan2021 11:45 at a single dose for covid-19 immunisation. Medical history was reported as none. Patient was not pregnant. Concomitant medication included escitalopram oxalate (LEXAPRO), riboflavin (RIBOFLAVIN), multivitamins and antihistamine (unspecified). The patient was previously administered with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El0140), intramuscularly into the left arm on 02Jan2021 12:30 at a single dose for covid-19 immunization. On 23Jan2021 20:30, patient experienced chill, fever, body aches, migraine and dizziness. On 23Jan2021, patient experienced soreness at injection site, headache and lymph node swollen on the left armpit area. The patient did not receive treatment for the events reported. Outcome of events were recovering.
47 2021-02-09 vaccination site pain Fever up to 102.5; nausea; dizziness; muscle aches; joint aches; headache; fatigue; weakness; heart ... Read more
Fever up to 102.5; nausea; dizziness; muscle aches; joint aches; headache; fatigue; weakness; heart rate racing; injection site pain; This is a spontaneous report from a non-contactable consumer (patient herself). A 47-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN5318), via an unspecified route of administration (left arm), on 21Jan2021 16:30, at single dose, for covid-19 immunization. The patient has no medical history and has no known allergies. The patient's concomitant medications were not reported. The patient experienced fever up to 102.5, nausea, dizziness, muscle aches, joint aches, headache, fatigue, weakness, heart rate racing, and injection site pain - all on 22Jan2021 02:00. No treatment was received for the events. The patient had not recovered from the events at the time of the report. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination. No follow-up attempts are possible. No further information is expected.
47 2021-02-09 vaccination site pain prod cough; SEVERE body aches; shortness of breath on exertion; inj site pain; exhaustion; headache;... Read more
prod cough; SEVERE body aches; shortness of breath on exertion; inj site pain; exhaustion; headache; fever; patient received IMURAN concomitantly; patient received IMURAN concomitantly; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL 0142) via an unspecified route of administration in left arm on 21Jan2021 17:30 at single dose for COVID-19 immunization. Medical history included Crohn's disease, migraine. Concomitant medication included azathioprine (IMURAN), propranolol, sertraline hydrochloride (ZOLOFT). The patient previously took infliximab (REMICADE) and morphine, both experienced drug allergy; received the first dose of bnt162b2 (Lot number: EL1284) in left arm for COVID-19 immunization and experienced severe body aches, headache, heavy feeling injection arm unable to lift it, cough and exhaustion. The patient experienced prod cough, severe body aches, shortness of breath on exertion, inj site pain, exhaustion, headache, fever, all on 22Jan2021 05:00. No treatment received for the adverse events. Reporter considered the events as non-serious. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
47 2021-02-10 hives Headache and fatigue day after - took Ibuprofen. Hives all over body day after receiving vaccine.
47 2021-02-10 hives Hives on face and neck worsening to stridorous breath sounds.; Hives on face and neck worsening to s... Read more
Hives on face and neck worsening to stridorous breath sounds.; Hives on face and neck worsening to stridorous breath sounds.; This is a spontaneous report from a contactable nurse. A 47-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in left arm on 21Jan2021 10:15 at a single dose for COVID-19 immunization. Vaccination was done in a hospital. Medical history included asthma, ulcerative colitis, sub clinical Hashimotos, and known allergies to eggs and dairy. Concomitant medication included mesalamine (MESALAMINE), levocetirizine dihydrochloride (XYZAL), budesonide, formoterol fumarate (SYMBICORT), procaterol hydrochloride (PRO-AIR), and montelukast sodium (SINGULAIR). The patient previously received the first dose of bnt162b2 on 31Dec2020 09:30 in left arm(lot number: EL0142) for COVID-19 immunization. The patient experienced hives on face and neck worsening to stridorous breath sounds on 22Jan2021 12:00. The outcome of the events was recovering. The event resulted in an emergency room/department or urgent care. Treatment included Epinephrine, Benadryl, Prednisone. The patient did not have CVOID-prior to vaccination and was not tested for COVID-19 post vaccination.; Sender's Comments: Based on currently known drug safety profile, a causal association between the reported events hives on face and neck worsening to stridorous breath sounds and bnt162b2 cannot be excluded. The patient's underlying risk factors/predisposing condition asthma is considered as a risk factor to develop the event stridorous breath sounds. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
47 2021-02-10 skin burning sensation her face feels swollen; her legs are really achy; Chills; skin burns/ skin burning, sore to touch; f... Read more
her face feels swollen; her legs are really achy; Chills; skin burns/ skin burning, sore to touch; fever; her right carotid on her neck felt swollen; right carotid on her neck felt swollen and her face felt swollen, but her right carotid hurt; tired and achy; tired and achy; feeling sick; muscle and joint pain; muscle and joint pain; cough; the back of her ribs hurt; Nausea; she is having shooting pains in different spots; This is a spontaneous report from a contactable nurse reporting for self. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot Number EL3249, via an unspecified route of administration from 25Jan2021 14:00 (at the age of 47 years old), Dose 2, as a single dose in the left arm for COVID-19 immunization. Medical history included she had her tonsils out on an unknown date. She was a nurse that works with COVID patients; she got tested twice last week (Jan2021), both were negative. She had no pre-existing medical conditions. She has never had a problem with vaccines. There were no concomitant medications. The patient previously received dose 1 of BNT162B2 on 04Jan2021 (Lot # EX9231) and experienced no reaction then. The patient had the second dose of the Pfizer vaccine around 2 PM yesterday (25Jan2021) and she kept moving around in bed and feeling sick last night. That night she was just tired and achy but she thought that could just be from working. She went to bed early and she woke up around 1:50 or 2 AM with chills so she went and got a thermometer. She woke up at about 2 AM (26Jan2021) with a 103 fever and chills and her right carotid on her neck felt swollen and her face felt swollen, but her right carotid hurt. Her skin just burns; she went to take a shower. With the skin burning she knew it was sore to touch but when she got in the shower, that was when she noticed it hurt. She was really achy; her legs were aching and she was having shooting pains in different spots. She commented that she called out today (26Jan2021), she never calls out; all she wanted to do was take a shower and she wondered if she needed to go to the doctor. Her skin burns even when she was showering; every part her skin burns. She was also having muscle and joint pain and cough and the back of her ribs hurt (Jan2021). The other thing was nausea (Jan2021). The fever and chills were persisting and were about the same. She was hoping for it to go down so she could go to work to tomorrow (27Jan2021). The clinical outcome of the fever, chills, and her right carotid on her neck felt swollen and hurt was not recovered. The clinical outcome of feeling sick, tired and achy, face feels swollen, skin burning, muscle and joint pain, cough, back of her ribs hurt, nausea, and shooting pains in different spots was unknown. The reporter states she thinks what she is reporting was directly related to the product.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
47 2021-02-11 injection site redness, injection site swelling Pfizer BioNTech COVID 19 Vaccine EUA 20 hours later Headache. Tired. Body aches. redness and swellin... Read more
Pfizer BioNTech COVID 19 Vaccine EUA 20 hours later Headache. Tired. Body aches. redness and swelling at the site. 1 pm. At 630 pm low grade fever 100, took Tylenol. Took a second round at 1 am. Illness ended. Swelling and redness grew around site and left armpit. Continues to grow 2-12-2021
47 2021-02-14 itchy rash, shingles, rash Headache and fatigue 2/11 and 2/12 followed by itchy rash on left front chest 2/13. Rash spread to b... Read more
Headache and fatigue 2/11 and 2/12 followed by itchy rash on left front chest 2/13. Rash spread to back and became painful on 2/14. Got diagnosed with shingles at Urgent Care on 2/15.
47 2021-02-14 itchy skin Uncontrolled itchiness - body; Headaches; Mild fever; Nasal congestion; This is a spontaneous report... Read more
Uncontrolled itchiness - body; Headaches; Mild fever; Nasal congestion; This is a spontaneous report from a contactable other hcp. A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EL1283, intramuscular, in the left arm, on 24Jan2021 12:00 at SINGLE DOSE for covid-19 immunization. Medical history included diabetes mellitus, asthma and hypothyroidism. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EJ1685, intramuscular, in the left arm, on 03Jan2021, 12:00 for covid-19 immunization. The patient's concomitant medications were not reported. On 25Jan2021 19:00, the patient experienced uncontrolled itchiness - body, headaches, mild fever and nasal congestion. The patient underwent lab tests and procedures on 25Jan2021 which included fever: mild and nasal swab: negative. The outcome of events was unknown. Patient did not received treatment due to the events. The events were considered as non-serious. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
47 2021-02-14 redness, skin discolouration lymph node swelling/pain beginning in my neck with neck pain. Progressively spreading until 2/14, l... Read more
lymph node swelling/pain beginning in my neck with neck pain. Progressively spreading until 2/14, large lump in breast, red streaks. Pain in groin and shoulder, all on left side.
47 2021-02-15 injection site pain Arm was very achy the first 12-14 hours. Kept me awake that night. Injection site was very sore to... Read more
Arm was very achy the first 12-14 hours. Kept me awake that night. Injection site was very sore to touch. After 5 days, still have severe joint pain in left shoulder (side which injection was given) which is constant.
47 2021-02-15 rash, itchy skin With the first dose I felt sick for 1 day. I called out. The morning after receiving the 2nd dose ... Read more
With the first dose I felt sick for 1 day. I called out. The morning after receiving the 2nd dose I had severe fatigue, joint pain, my wrist and my armpit was budging, I noticed swelling my clavicle on my left side, chills, and dizzy. I had to miss work for 2 days. I had to lay bed in for 2 days. By 3rd it was much improved but I still feel weak. About 4 days after receiving the vaccine I was back to feeling my self. On 2/14-15/2021, my face was itching, I scratched it, and there is a small abrasion. My face started to swell, around 2AM this morning I had to go to the ER because my eyes were getting small, the swelling was getting worse. I also had bumps that looked like hives on my face, there was some fluid coming out of my face. I went to early this morning, The ER doctor said she thinks it is not infected she thinks it is inflamed. I did not mention that I had recently received the COVID vaccine and did not realize that it may be linked to the vaccine until later in the day. She prescribed Hydrocortisone 0.5 % cream and Mupirocin 2% cream. Since I have been home the ER the swelling has worsened. My face is painful, it feels like an orange peel when you touch.
47 2021-02-16 itchy skin Patient received COVID vaccine and approximately 15 minutes later she was reporting itchiness and na... Read more
Patient received COVID vaccine and approximately 15 minutes later she was reporting itchiness and nausea.
47 2021-02-18 rash After the first injection, I got a upper chest rash but did not relate this to the vaccine. After 4... Read more
After the first injection, I got a upper chest rash but did not relate this to the vaccine. After 48 hours of the second injection on 1/8/2021, I had angioedema facial swelling on the lids of my eyes bilaterally, facial burning- lips, nose, and right side of face, as well as the upper chest rash. Tried cool compresses, ibuprofen and rest however did not go away. Went to employee health, threw away all my make up incase, prednisone taper and antihistamine QD, eat clean, lots of water. The swelling went away after a few days of cool compresses and when on 10 mg of the prednisone taper, it came back. Went to PCP this time and gave me dexamethasone injection, prednisone taper, antihistamine BID and continue all other o
47 2021-02-18 blister, injection site pain Injection site soreness developed 5 hours later. Body aches, headache and fever noted upon waking 15... Read more
Injection site soreness developed 5 hours later. Body aches, headache and fever noted upon waking 15 hours later on Saturday morning. Highest fever 101.2. Symptoms lasted approximately 13 hours. Sunday morning woke feeling fine. On Monday morning I felt a tingle on my lip. By mid-day there were vesicles and by evening an apparent cold sore forming on right upper lip. Large cold sore still present 5 days later.
47 2021-02-18 hives Pt had hives, syncopal episode, and airway management issues within 30 minutes of receiving vaccine.
47 2021-02-21 injection site redness, injection site pruritus, injection site pain, hives, itchy skin Developed itchiness on face and mild palpitation 20 minutes after injection Developed headache an... Read more
Developed itchiness on face and mild palpitation 20 minutes after injection Developed headache and injection site soreness 12 hours after injection Developed dizziness about 20 hours after injection Developed itchiness, redness, and welt below the injection site 3 days after injection and lasted for about 5-7 days
47 2021-02-22 rash, itchy skin Itchy and bumpy face started on February 17th. Woke up on the 18th with a swollen face and continue... Read more
Itchy and bumpy face started on February 17th. Woke up on the 18th with a swollen face and continued with bumps and itchiness. Went to Urgent Care on February 20th and started steroids. The swelling increases while I am sleeping.
47 2021-02-23 vaccination site redness, vaccination site swelling, vaccination site pain Little bit of arm soreness; 8 days after vaccine I experienced swollen lymph nodes under arm; Swelli... Read more
Little bit of arm soreness; 8 days after vaccine I experienced swollen lymph nodes under arm; Swelling and pain of injection site; Swelling and pain of injection site; Fever; Chills; 3 by 5 inch red circle and swelling around injection site/arm turned red; This is a spontaneous report from a contactable other healthcare professional (medical receptionist -patient). A 47-years-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number, EL3246, expiration date unknown), via an unspecified route of administration on the left arm on 20Jan2021 at 17:30 at the age of 47 years old at a single dose for COVID- 19 immunisation in the hospital. Medical history included mitral valve prolapse, gallstones , hypertension and crab allergy. Concomitant medications included lisinopril and hydrochlorothiazide. The patient did not receive vaccines in four weeks. On 28Jan2021 at 07:00 AM, the patient had a little bit of arm soreness initially. The patient experienced swollen lymph nodes under arm, swelling and pain of injection site, fever and chills. On the 9th day after vaccine (29Jan2021), patient had a 3 by 5 inch red circle and swelling around injection site. It was also reported that the arm and lymph nodes swelled. The patient had fever and chills. Then her arm turned red. As of 05Feb2021, the swollen mark which is about 5x4 inches is swelling again. The patient's next dose is scheduled for 10Feb2021. She is really concerned about getting the second dose. The events were assessed as non-serious by the reporter. It was unknown if the patient received a treatment in response to the events. The patient was not diagnosed with COVID-19 prior t vaccination and was not tested for COVID-19 post vaccination. The outcome of the event was unknown.
47 2021-02-23 itchy skin Patient reports her hands feeling itchy approximately 5 minutes after the injection. The itching pro... Read more
Patient reports her hands feeling itchy approximately 5 minutes after the injection. The itching progressed into involving her hands, arms, face, and feet over the next 24 hours. She reports no hives or rash, just an intense itching sensation under her skin. She saw her primary care physician's Physician Assistant today, February 24th, 24 hours after her injection. They prescribed hydroxyzine 25mg, prednisone 20mg, and an Epipen injector. The itching was still present when I spoke with her, but she hadn't started the new prescriptions yet.
47 2021-02-24 shingles, rash Night of vaccine I felt prickly all over, like pins. By Tues 2/23, day after injection, I had a shin... Read more
Night of vaccine I felt prickly all over, like pins. By Tues 2/23, day after injection, I had a shingles rash forming under my right arm. Confirmed shingles Wed 2/24 AM @ urgent care. On 7 day dose of Valtrex 3xs/day.
47 2021-02-25 itchy skin Around 4:00pm-4:15pm, began pin and needles discomfort in joints between fingers on right hand. Betw... Read more
Around 4:00pm-4:15pm, began pin and needles discomfort in joints between fingers on right hand. Between 4:15pm-4:30pm, the palms of both hands, and my left wrist began to itch uncontrollably. Reported to EMT on duty to exam. Experienced elevated blood pressure of 163/93. No itching of throat nor any other body parts. Was advised to take Benadryl.
47 2021-02-26 itchy skin Pt shortly after vaccine had throat itching, skin itching, severe nausea and vomiting, respiratory d... Read more
Pt shortly after vaccine had throat itching, skin itching, severe nausea and vomiting, respiratory distress with coughing. Arrived in the ED with no hypoxia on room air but possible wheeze. Pt was given IM 0.3 mg of Epinephrine and IV diphenhydramine, dexamethasone, famotidine, and ondansetron. She was still vomiting and wretching and req additional ondansetron and more itching so another dose of diphenhydramine given.
47 2021-02-26 itchy rash Within several minutes of the injection in the left deltoid (as I was pulling into the staged observ... Read more
Within several minutes of the injection in the left deltoid (as I was pulling into the staged observation area) I developed mild puritis in the area of my inner right antecubital area. During the 15 minute observation period it did not worsen, therefore I discounted the itch and did not report it at that time with the intention to observe the area. About an hour and a half later the itch was persistent so I removed my jacket sleeve and viewed the area which was now an evident rash about the size of my palm. I took Benadryl 50mg at bedtime and the rash appeared to be improving upon wakening this morning. I did not have any other accompanying symptoms.
47 2021-02-26 shingles shingles
47 2021-02-28 injection site reaction, injection site pain After my first vaccine, I developed an axillary lymph node to my left arm which was painful; it felt... Read more
After my first vaccine, I developed an axillary lymph node to my left arm which was painful; it felt like it was ripping out of my left arm and it was tender. The lymph node subsided after two days of the vaccination. I also had two menstrual cycles back to back which was out of the ordinary for me since I am regular on my periods. I saw my gynecologist due to my menstrual symptoms. I was regular up to that point of my vaccination. One week ago I had better range of motion to my left arm.
47 2021-02-28 injection site pain Patient experienced headache, fatigue, muscle aches, joint pains, nausea, and local injection site p... Read more
Patient experienced headache, fatigue, muscle aches, joint pains, nausea, and local injection site pain
47 2021-02-28 injection site pain, itchy skin Perfectly fine until about 25 minutes after the injection. Then, nausea and dizziness started, foll... Read more
Perfectly fine until about 25 minutes after the injection. Then, nausea and dizziness started, followed by burning and itching on both sides of tongue. Then the back of the throat started hurting, and it became hard to swallow, followed by becoming very cold, chills, and dry mouth. Finally the skin area around mouth and lips and up through the cheek/jawline became very itchy. It was not anaphylaxis because my breathing was okay. We drove home, and I took two Benedryl (50 mg) upon arriving home. Within 2 hours all symptoms subsided with the exception of a nasty headache. Today, I am fine, but just have a sore arm at the site.
47 2021-03-02 rash with redness, injection site pain, injection site reaction, rash macular, rash, injection site warmth Blotchy rash at injection site on shoulder, going all the way down the left arm and up into left sid... Read more
Blotchy rash at injection site on shoulder, going all the way down the left arm and up into left side of my neck. . Almost looks like a sunburn. I had the same neck blotches with the first dose, but didn?t attribute them to the vaccine then. Now I see that it is the same anomaly as with the first dose. I called my doctor to let him know and I will monitor the rash for the next several hours. I first noticed the rash in the morning after waking, 19 hours post Pfizer #2. The rash accompanies the normal pain and slight heat at injection site, as well as armpit pain. The left side of the body is quite sore. No fever or other complaints.
47 2021-03-02 vaccination site pain Her upper lip is a little swollen; Injection site soreness; This is a spontaneous report from a cont... Read more
Her upper lip is a little swollen; Injection site soreness; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on 31Jan2021 at 08:43 (at the age of 47-years-old) at single dose for COVID-19 vaccination. Medical history included seafood allergy (also happens when she gets seafood from, company name, it makes her lips puffy). Concomitant medications were not reported. The patient stated everything was fine except for some injection site soreness on 31Jan2021 that lasted about two hours then completely resolved. On 01Feb2021, the patient stated this morning her upper lip is a little swollen (puffy). The puffiness as if a 2 year were to head butt you and it left your lip puffy. The patient stated last night for dinner she ate ham which was a different brand than usual and was wondering if it may have had some preservatives in it that could have caused the lip swelling and did not have any lip swelling before she went to bed at 10 pm last night. The outcome of the event lip swelling was unknown. The outcome of the event injection site soreness was recovered on 31Jan2021 after 2 hours. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
47 2021-03-02 redness redness in face an neck/chest. Mildly swollen/red eyes. Developed within 15 minutes. Improved with... Read more
redness in face an neck/chest. Mildly swollen/red eyes. Developed within 15 minutes. Improved with 50mg benadryl. Stayed an additional 30 minutes after benadryl and symptoms continued to improve.
47 2021-03-03 injection site swelling, injection site redness, itchy skin, skin burning sensation, hives, injection site warmth 2 days after injection, injection site swollen, bright red and hot. Full body hives, intense itchin... Read more
2 days after injection, injection site swollen, bright red and hot. Full body hives, intense itching and burning with extreme exhaustion and joint pain still active as of 3/4/2021. Urgent center visit, given a 6 day pack of steroids, told to monitor symptoms and sent home.
47 2021-03-03 injection site redness, injection site pruritus, injection site hardening, injection site swelling, injection site warmth After 8 days of vaccination the area of application is swollen as a dime size, red, itchy and hot to... Read more
After 8 days of vaccination the area of application is swollen as a dime size, red, itchy and hot to the touch. Day 9 the swollen area is larger than a quarter, hard, swollen, itchy and warm to the touch. Taking antibiotics for a UTI and piridium plus acetaminophen.
47 2021-03-03 rash, itchy skin Tightness in the throat within 1 hour of the first does and resolved by taking Benadryl for two cons... Read more
Tightness in the throat within 1 hour of the first does and resolved by taking Benadryl for two consecutive days. Also, three days after the first dose I developed rash on my torso, abdomen, chest, upper arms and thighs. I had pityriasis rosea 4 years ago and it seems that the COVID-19 vaccine reactivated this skin condition. It is very itchy and feels internally prickly around my chest and neck.
47 2021-03-04 injection site redness, injection site pain, injection site warmth About 2 days after receiving the second dose I started experiencing redness and pain at the injectio... Read more
About 2 days after receiving the second dose I started experiencing redness and pain at the injection site. It was also warm to the touch. It was about almost 2 in in diameter. It got worse on the next day and it slowly started getting better, it went away in about 4 days. Then I had a gallbladder surgery that was scheduled on 01/29/2021. On 02/03/2021 I was feeling excruciating pain that I believe it was related to the gallbladder surgery. I went to the ER, the same hospital where I got the vaccine at and they ran a lot of tests on me, blood work, CT scans, ultrasounds and they told me my D Dimer was elevated: 2371. They attributed it to my recent surgery and told me to FU with my PCP. When I FU'd with my PCP Dr., she requested new blood work and this time my D Dimer was even higher than the results at the ED: 2610. That was on 03/01/2021. She is trying to get me in the Clinic she is concerned about cancer. I think it might be something regarding the vaccine.
47 2021-03-04 injection site pain, injection site swelling, injection site warmth, injection site redness About 2 days after the vaccine headache and sore throat started and I had a site reaction, looked li... Read more
About 2 days after the vaccine headache and sore throat started and I had a site reaction, looked like a bug bite, it got red, swollen, warm to the touch, an inch around, painful for about 2 days it got a little bit bigger and then slowly went away. The headache I took Ibuprofen and Tylenol and felt better by the next day.
47 2021-03-04 redness Client report her nose hurting 3.5 hours after vaccine administration. Her nose began to hurt, noti... Read more
Client report her nose hurting 3.5 hours after vaccine administration. Her nose began to hurt, noticed some swelling, slightly red and pain in the inside. Client report her nose was worse today in the morning. Her nose continues to hurt on the outside, the middle and sides. She is not having any breathing issues or nasal drainage. No follow up done with a medical provider.
47 2021-03-04 redness, itchy skin, hives Nursing Notes: Employee had second shot on Feb 23rd. Initially only had soreness and inflamed lymphn... Read more
Nursing Notes: Employee had second shot on Feb 23rd. Initially only had soreness and inflamed lymphnodes, general malaise. By Friday night, developed a hive below her lips and her left arm was 'itching" severely. Took benadryl again. Didn't have problems Sunday night. Today arm started itching a lot throughout the day. About 45 minutes ago, experienced redness and hives again, a 1 inch by 4inch welt. Pt also states she has multiple conditions that have cause allergic reactions. Son has Mast Cell Activation symptom Disposition: ER. Concern for allergic reaction.
47 2021-03-06 itchy skin Scratchy throat and tingly lips almost immediately, itchy inner wrists and ankles Growing to worst ... Read more
Scratchy throat and tingly lips almost immediately, itchy inner wrists and ankles Growing to worst point about 36 hours after injection: Swelling in throat, tongue, face, lymph nodes, generalized swelling (all the way to fingers and toes). Tingling in lips, tongue, face, scalp, left leg and left arm Shaking hands and racing heart, intermittently 48 hours later Entire left hemisphere of body want numb for about three hours. I freaked out and cried. *I had the vaccine in my left bicep, and I have a pinched nerve in that shoulder, which is teemed to activate. The nerve has never caused numbness beyond my left arm before, however, Last round of trembling about 48 hours after injection 72 hours later: Left tonsil and throat and armpit lymph nodes still swollen, but markedly less. Moderate numbness in left cheek and left side of throat, but less.
47 2021-03-07 injection site pain, injection site swelling 3/5/2021 Patient began feeling pain in arm where dose one of COVID Vaccine Pfizer was injected. 3/7/... Read more
3/5/2021 Patient began feeling pain in arm where dose one of COVID Vaccine Pfizer was injected. 3/7/2021 evening of 3/7/2021 patient noticed a bump begin on injection site. 3/8/2021 pain and bump still present according to Patient.
47 2021-03-07 rash I have a rash on the left side of my neck going down to my chest. does not itch really but looks aw... Read more
I have a rash on the left side of my neck going down to my chest. does not itch really but looks awful.
47 2021-03-08 injection site pain 102 fever, joint pains, chills, headache, body aches, injection site very painfull.
47 2021-03-08 injection site warmth, injection site pruritus, injection site redness, injection site swelling Headache, tired, could not stay awake, chills, fever of 102, dizzy, sore muscles, sick at stomach, v... Read more
Headache, tired, could not stay awake, chills, fever of 102, dizzy, sore muscles, sick at stomach, vomited... started 3/5/2021 early morning, felt some better by 3/6/2021 in the morning, but still headache, sore muscles, and tired, felt significantly better morning of 3/7/2021. On 3/7/2021 injection site on left arm became red, swollen, warm, and itchy about the size of a hand, also had a similar spot on thigh about size of golf ball. Arm very sore. Redness, swelling, and warmth on arm and thigh getting better within 24-36 hours after appearing. By 3/8/2021 all symptoms seem to be gone or extremely minor.
47 2021-03-08 injection site redness, injection site swelling, injection site pruritus On 3/8/21 patient reports itchiness noted to injection site. On the following day 3/9/21, swelling ... Read more
On 3/8/21 patient reports itchiness noted to injection site. On the following day 3/9/21, swelling and redness noted to the area and feelings of slight nerve pain noted to left wrist area.
47 2021-03-09 redness I experienced red face/flushed face. I was already experiencing asthmatic symptoms the day before. ... Read more
I experienced red face/flushed face. I was already experiencing asthmatic symptoms the day before. I received benadryl at the vaccination site as they were concerned it was allergic. However, after follow up with my allergist/immunologist this was not determined to be an allergy. I have never had an allergic reaction to vaccinations in the past. She has cleared me to receive the second dose.
47 2021-03-09 rash Severe Rash, Itchy Red Swollen Eyes
47 2021-03-09 itchy skin swollen throat, itching all over body and swelling around base of the head, groin and buttocks. Tre... Read more
swollen throat, itching all over body and swelling around base of the head, groin and buttocks. Treatment- took Benadryl orally and topical Outcome- swelling and itchiness still exists
47 2021-03-10 injection site pain 03/05/2021: Sore arm at injection site, fever, severe headache, severe fatigue. 03/08/2021: Symptoms... Read more
03/05/2021: Sore arm at injection site, fever, severe headache, severe fatigue. 03/08/2021: Symptoms subsided except for moderate fatigue; new symptom: 'brain fog.' Current: Moderate fatigue continues; 'brain fog' with confusion is increasing in severity. Family is noticing that something is wrong. Examples: I did not know what medicines I was taking. I could not fill this form out within 20 minutes. I did not know how many pizzas to order for dinner. I signed the wrong name to a check. I had to look up how to spell the word signed. *Dates are accurate on v-safe if needed.
47 2021-03-10 shingles Shingles
47 2021-03-11 injection site pain Injection site soreness started a few hours after the initial dose. That seem to ease up after three... Read more
Injection site soreness started a few hours after the initial dose. That seem to ease up after three days, but did not resolve. Between day five and seven, the soreness continued and progress into my arm and hand. By day eight, a deep cold sensation would randomly occur at the injection site that would radiate into the hand. Rubbing in the area intensified the cold. This has continued on and off over the past 10 weeks. Constant, Chronic soreness at the injection site that radiates into the arm with episodes of cold sensation
47 2021-03-11 redness, hives Lips started swelling, heart rate doubled, bright red hives from head to toe, profuse perspiration, ... Read more
Lips started swelling, heart rate doubled, bright red hives from head to toe, profuse perspiration, tightness in chest and throat, numb mouth and throat and chest, blood pressure very high, difficulty breathing, fever, PVCs (detected by EKG from EMS); benadryl 62.5mg then EMS arrived and gave IV steroid 125mg; EMS transported to ED where another 25mg Benadryl was administered and Pepcid 20mg; symptoms improved enough to discharge patient
47 2021-03-11 redness, injection site pain, injection site swelling, skin warm Swollen arm at site @ 4 PM grew to shoulder by morning pain through whole arm. Headache, fatigue at ... Read more
Swollen arm at site @ 4 PM grew to shoulder by morning pain through whole arm. Headache, fatigue at 5 PM slept the rest of the day through 11 AM . Arm still swollen and red hot to the touch have put ice on it still getting bigger, tightness in chest and short of breath 2 days later , seen my dr she stated it is an allergic reaction and she recommended I do not get the second dose since this one has made me sick.
47 2021-03-12 injection site discolouration, injection site redness, injection site pain Next day after first vaccination (Feb9) I developed large purple- pinkish spot below the place of a ... Read more
Next day after first vaccination (Feb9) I developed large purple- pinkish spot below the place of a shot with a purple dot in the middle, looked like a ring worms ( I googled) but it did not itch. Looked very weird. I applied anti fungal cream and it got better. I decided it was not related to a vaccination. But a day after second doze of vaccine ( March 4) I developed huge bright red spot below the place of a shot the size of my palm. It was tender and looked very strange. It took 4 days for it to turn purple and then it started to disappear.
47 2021-03-14 rash After my second vaccine, I developed severe right earache. It was inflamed and by the night my left ... Read more
After my second vaccine, I developed severe right earache. It was inflamed and by the night my left wrist had a rash that looked like shingles. I told my doctor about my symptoms and he suspected cellulitis. My doctor gave me ear drops and placed me on antibiotics. So my rash was still present and by the next day I experienced headaches and nausea and felt out of place. I called into work since I did not feel good. On Thursday 01-14-2021, I went back to work but now the same rash I developed on my left wrist was in my right ear. My ENT doctor did lab work and a culture test to check for herpes or shingles, both of these exams were negative and these symptoms lasted one week then they resolved.
47 2021-03-14 injection site redness, injection site swelling Low grade fever Body aches Red and swollen injection site Headache
47 2021-03-14 vaccination site pain bad front of the head headache; injection site is slightly sore when touched; This is a spontaneous ... Read more
bad front of the head headache; injection site is slightly sore when touched; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 28Jan2021 13:45 at single dose for COVID-19 immunization in workplace clinic. The patient's medical history included asthma, chronic sinusitis with nasal polyps. The patient have allergies to medications, food, or other products. Concomitant medications included other medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient received other medications within 2 weeks of vaccination. It was reported that, woke up the next morning on 29Jan2021 07:00 AM with a bad front of the head headache and injection site was slightly sore when touched. The events were considered as non-serious by the consumer. No treatment received for the adverse events. The outcome of the events was not recovered.
47 2021-03-15 vaccination site pain Severe injection site pain; fever of 101.5 for 24 hours; severe chills; body aches; migraine; This i... Read more
Severe injection site pain; fever of 101.5 for 24 hours; severe chills; body aches; migraine; This is a spontaneous report from a contactable consumer reporting for herself. A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 11Feb2021 at 14:00 (at the age of 47 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on an unspecified date for COVID-19 IMMUNIZATION. Relevant medical history included Epstein Barr. The patient did not have any known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included "Fiornel" and ibuprofen (ADVIL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient experienced severe injection site pain, fever of 101.5 for 24 hours, severe chills, body aches and migraine. The patient received treatment for these events which included ibuprofen (ADVIL), acetaminophen, (TYLENOL) and "fiornel". The outcome of the events severe injection site pain, fever of 101.5 for 24 hours, severe chills, body aches and migraine was unknown. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
47 2021-03-15 injection site swelling, injection site pruritus, injection site warmth Today is the 8th day after 1st vaccination and I have swelling about the size of a quarter, heat and... Read more
Today is the 8th day after 1st vaccination and I have swelling about the size of a quarter, heat and itching at the vaccine site on my left arm. I also noticed earlier this morning around 6:45am that I had tenderness in the underneath [armpit] area of that same arm.
47 2021-03-16 itchy skin Itchiness of torso, given Benadryl 25 mg PO. BP 152/101 (pulse 68), 125/90. O2 sat 99%.
47 2021-03-16 rash macular Swelling red blotches burning feeling wierd shape tierd
47 2021-03-16 itchy skin This is a follow up report starting from day after that first report was made -Report # 244159 - Sta... Read more
This is a follow up report starting from day after that first report was made -Report # 244159 - Starting with the 17th of January - I was still having facial numbness/tingling/pressure in my head/feeling like head was going to swell; arms were so heavy - couldn't lift my arms - like a heavy pressure on my chest; breathing was a problem; Swelling in my head caused eye issues. 18th - tingling started on back of neck; affecting my hearing and eyes (swelling in head); a lot of cognitive challenges. 1-20-2021 - heart racing; itchy all over; blood pressure spikes. Heart can feel like it's too fast and then going too slow. 1-21-2021 - legs burning from waist to hip; chest pain; heart racing; struggling to breath. 1/22 - chest pain and discomfort - pain shooting through arms; didn't sleep well. Arms wanted to pull into my chest. Stomach cramping on 1/23 - stabbing pain in wrists and hands; left side on heart pain. Pain was like having a beating. Left knee pain - January 24 - up all night with shooting pain in arm; fine motor pain skills shot - can't do what I need to do. January 25 - Elevated heart rate; elevated blood pressure. 1/26 - vision challenges; fuzzy. Heart racing; feet swollen; face feels puffy doesn't look puffy - pressure/tingly feeling in left cheek. Ongoing and Changing symptoms every day/week - with no let up. 3/11/ - buckling of legs started. Big thing now is my legs are buckling (happening from the hips) - when I try to get up or walk. I haven't fallen yet but I know it's coming. 3/12/2021 - heavy weight back in the arms. I still don't have the fine motor skills. I still can't drive and don't have control over my body and reflexes enough. Still having Pressure in chest and the face and head swelling - is unbearable and affecting my vision. I will see a neurologist next month. Dr is not sure what to do. Jan 12 - first ER visit. I have specific notes/log on all of my symptoms each day. If anyone wants to call - please call on Mondays or Wednesdays only( or Saturday or Sunday.) Also, Menstrual cycle is wonky. I had a normal period before the vaccine - 12/28-12/31/2020 - but didn't have one in January and I had one in February 10th - but just one day; 3/11/2021 - I had my next one and it was four days long and fourth day was very heavy then all the rest of the days.
47 2021-03-17 rash Felt shaky and a warmth went from my feet to head causing a low grade headache. Shaking was internal... Read more
Felt shaky and a warmth went from my feet to head causing a low grade headache. Shaking was internal but then became external. I felt light headed as if my BP was low. The next day I have a rash on my neck with bumps on the side I received the vaccine. I also have had a headache all day as well.
47 2021-03-17 hives Hives on both arms and face but resolving. No SOB. O2-98; HR-94; BP 174/103
47 2021-03-17 injection site pain, injection site reaction Injection site reaction - severe .. painful touse my arm.. lasted almost 24 hours
47 2021-03-17 injection site pain Shoulder pain where shot was administered, arm still, hard to move. Took some Aleve and symptoms ha... Read more
Shoulder pain where shot was administered, arm still, hard to move. Took some Aleve and symptoms have lessened.
47 2021-03-18 hives Felt faint at first , hives with in 10 mins, chewed 12.5 Benadryl, more hives chewed another Benadry... Read more
Felt faint at first , hives with in 10 mins, chewed 12.5 Benadryl, more hives chewed another Benadryl. Seemed ok after 45 post shot was allowed to leave drove home. Then about 1 hr post shot tight chest , itchy lips, puffy feeling lips, drive to urgent care, oxygen sat was 92 coughing swollen tongue gave myself epi, taken by ambulance to ER. Given more epi, Pepcid, steroids, Benadryl and Ativan. Was stable and discharged after 4 hrs. Next day very tired, throat sore lymph nodes swollen. Day 2 worse fever exhausted, sore muscles and joint pain. Increased Pepcid to 2 a day and 3 antihistamine a day. Day three increased steroids to 40 mg a day. Day 2 of increased steroids. Lymph nodes down , still exhausted, nausea, sore.
47 2021-03-18 injection site pain I had my vaccine shot at 6:50 in the afternoon, went home, felt sore and pain in my right shoulder w... Read more
I had my vaccine shot at 6:50 in the afternoon, went home, felt sore and pain in my right shoulder where I had the shot, sleep, took some advil pm so I can sleep, wake up today to get ready for work,(March 19), I cant move my right hand especially when im trying to lift it, causing too much pain, texted and called my company that i cant come to work because moving my right hand causing too much pain, called my doctor also
47 2021-03-18 rash with redness, rash patient developed red/rash on face; no difficulty breathing or other anaphylactic reactions
47 2021-03-19 hives, rash 20 minutes post vaccination, patient developed rash, hives, swelling in both arms, neck and eyes, an... Read more
20 minutes post vaccination, patient developed rash, hives, swelling in both arms, neck and eyes, and headache. The patient did not report trouble breathing. Patient was given 600 mg ibuprofen and 50 mg diphenhydramine
47 2021-03-19 injection site vesicles, injection site redness I had both vaccines injected on the left arm. The first one was on Feb 5th. My arm got very sore at ... Read more
I had both vaccines injected on the left arm. The first one was on Feb 5th. My arm got very sore at the site of injection the next day for about 24 hr. I started to notice pulsation on my ears. Then as the days went by, this turned into hyperacusis and I consulted about it on Feb 26th. the day of the second shot.. My physician referred me to an ENT. I saw the ENT on Feb 29 and had a hearing test the same day, they found no signs of hearing loss or abnormal conditions. I was diagnosed with pulsation tinnitus and hyperacusis. After the second dose, I had a skin reaction. I had redness at the site of the injection and developed a blister the same day. Then, two days later I noticed a swollen lymph node on the left side of the neck. My arm was very sore from the injection again. I noticed that the joints on my right arm are in acute pain.
47 2021-03-20 injection site pain Arm soreness at injection site, which was better he next day. And mild upper body aches that evening... Read more
Arm soreness at injection site, which was better he next day. And mild upper body aches that evening, which were gone in the morning. Tired for about 3 days.
47 2021-03-21 injection site redness, injection site pain, injection site swelling 7 days after 2nd shot began to develop 3 swollen lymph nodes under left arm. This is same arm as in... Read more
7 days after 2nd shot began to develop 3 swollen lymph nodes under left arm. This is same arm as injection. Swelling was red and painful. (I also became very sick after 2nd injection and was in bed for 2 days... had sweats, nausea, chills and brain was foggy.)
47 2021-03-21 injection site pain Patient states she is having soreness to her injection site and soreness up her arm, neck and into h... Read more
Patient states she is having soreness to her injection site and soreness up her arm, neck and into her left jaw.
47 2021-03-21 injection site swelling, injection site pain received vaccine 3/19/21 at 23:30 pm. Woke up at 4:20 am 3/20/21 with extreme pain and burning sen... Read more
received vaccine 3/19/21 at 23:30 pm. Woke up at 4:20 am 3/20/21 with extreme pain and burning sensation at injection site. swelling noticed at injection site 2 hours later. iced area. Congestion and coughing began around this time. Fatigue began around 5 pm. Kept falling asleep. Arm still swollen and burning. Iced again. Went to bed at 8:30 pm. Woke up at 10:30pm with diarrhea and heart racing. Heart raced for 30 minutes. Went back to bed and slept for 10 hours. Woke up at 9 am with grogginess and some cough and congestion.
47 2021-03-22 redness, rash 10:45am Injection, mild headache 11am slightly dizzy 11:30am Arm sore - cont. to get more painful as... Read more
10:45am Injection, mild headache 11am slightly dizzy 11:30am Arm sore - cont. to get more painful as the day/night went on. Eventually, painful to lift. 12:30pm: Nauseous and not feeling well. Headache increasing. 7pm Migraine, chills, feeling awful, tired, muscle & joint pains, body aches, fever, left arm super painful. Slept restlessly Friday: Slept all day restlessly, chills, fever high of 102, tired, migraine, muscle & joint pain, no appetite. Sat: Migraine, some chills, muscle, joint, arm pain. Sun: Feeling much better, joint pains, arm sore, headache. Sun PM: Red, swelling, tingling on face around chin and mouth. - right side of face Mon: Rash on neck - right side of face Tues: Rash on torso
47 2021-03-22 bruising PER PT, they have a bruised muscle due to the covid19 vaccine. they've visited the dr numerous times... Read more
PER PT, they have a bruised muscle due to the covid19 vaccine. they've visited the dr numerous times and the md has confirmed that it is bruised. ever since the shot, pt cannot lift or move arm like before and is in pain.
47 2021-03-22 rash RASH ON LEGS, ARM, FACE- OCCURRED 8 DAYS POST INJECTION
47 2021-03-22 shingles Shingles symptoms 3 days after injection. Valtrex prescribed by doctor.
47 2021-03-22 hives, redness, itchy skin Upon leaving vaccination site I realized my face, neck, chest & lips were red, hot, & itchy. I imme... Read more
Upon leaving vaccination site I realized my face, neck, chest & lips were red, hot, & itchy. I immediately went to the emergency room. The staff took my blood pressure 177/111, they administered Benadryl, Pepcid, & Prednisone. I got to the ER around 6:45 pm and left after observation around 11pm. I was sent home with prescriptions for Prednisone, Epi pen, Pepcid and was told to buy OTC Benadryl to take for the next few days. The next day the redness & hives were not as bad, later that night I felt that I had hives around my lips again. I also had a hoarse/scratchy throat. Spoke to Primary Physician the next day (Saturday) she said to follow the course of action from the hospital & that I could receive the 2nd dose of the vaccine however the ER Dr's said I should not.
47 2021-03-22 injection site bruising, injection site pain Very mild side effect symptoms. Slight soreness in arm at vaccine site. Feels similar to other vacci... Read more
Very mild side effect symptoms. Slight soreness in arm at vaccine site. Feels similar to other vaccines, a bruise, etc. Next morning sore throat, fatigue. Both mild. No problem, just reporting to add additional data.
47 2021-03-22 injection site pain Weakness, body aches, joint pain, left arm in pain, intermittent pain in right thigh
47 2021-03-22 injection site pain When I received the Pfizer-BioNTech COVID-19 I experienced soreness at injection site on the day of ... Read more
When I received the Pfizer-BioNTech COVID-19 I experienced soreness at injection site on the day of and the next day. I began having swollen lymph nodes 2 days after the injection and weakness in the upper arm and elbow area. I cannot lift my arm without discomfort.
47 2021-03-23 hives, rash at the time of vaccine at the location, I had a rash and hives within 5 minutes of the vaccine. At ... Read more
at the time of vaccine at the location, I had a rash and hives within 5 minutes of the vaccine. At 30 min past the vaccine the vaccine center gave me 25 mg of benadryl and had me follow up with an urgent care center. I went home and took hydrozine because I continued to have hives and a rash, I could not afford to seek emergency help at the urgent care center and stated that to the vaccine center. The vaccine center said because I was able to breathe they could not transport me to the emergency room or urgent care center.
47 2021-03-24 shingles Developed mouth ulcers on left incide cheek and left side of tongue; Dentist thinks shingles; This i... Read more
Developed mouth ulcers on left incide cheek and left side of tongue; Dentist thinks shingles; This is a spontaneous report received from a contactable consumer (patient). A 47-year-old female patient (non-pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3302), via an unspecified route of administration on arm right on 19Feb2021 00:15 at single dose for COVID-19 immunisation in hospital. The patient medical history was not reported. Concomitant medications included piper methysticum (KAVA); vitamin D [vitamin D NOS]; cetirizine hydrochloride (ZYRTEC) and ashwaganda. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed mouth ulcers on left inside cheek and left side of tongue on 22Feb2021 15:00. Dentist thinks shingles. Ulcers increased in pain and amount over the three weeks since the first vaccine. The events result in doctor or other healthcare professional office/clinic visit. The patient received treatment with unspecified antiviral medication. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient has not been tested for COVID-19 Since the vaccination. Later the patient received her second dose of BNT162B2 (Lot number: En6208) on 11Mar2021, on right arm. The events were assessed as non-serious by the reporter. The outcome of the events was reported as unknown.
47 2021-03-24 hives Full body flushing, mild tingling on face, mild hives on neck Duration ~12 hours 50mg Benadryl at on... Read more
Full body flushing, mild tingling on face, mild hives on neck Duration ~12 hours 50mg Benadryl at onset 25mg Benadryl at 4 and 8 hours after onset 650mg Tylenol at 4 and 8 hours after onset
47 2021-03-24 itchy skin Generalized pruritus, lightheadedness, Shortness of breath
47 2021-03-24 itchy skin, hives Patient received her first pfizer vaccine on 3/4. She reports being itchy after first shot while in ... Read more
Patient received her first pfizer vaccine on 3/4. She reports being itchy after first shot while in observation. When she went home she developed hive to her back. She called her PCP and he suggested she take some benadryl. The hives resolved but she has continued to have mild generalized itching since then. She reports she was cleared by PCP to receive second shot. She reports itching worsened after second vaccine. She was seen in 1st aid bay and was given Benadryl 25 mg PO. Her symptoms improved slightly. She refused transport to ED for eval with EMS. Husband picked her up. She will take more benadryl at home.
47 2021-03-24 injection site pain Severe pain in right arm immediately after injection. Weak, range of motion very limited. Pain is f... Read more
Severe pain in right arm immediately after injection. Weak, range of motion very limited. Pain is from my shoulder blade down to my bicep. 11 days later still in pain
47 2021-03-24 redness, itchy skin approx. 30 minutes post vaccine, c/o itching all over and became red from mid chest to mid face and ... Read more
approx. 30 minutes post vaccine, c/o itching all over and became red from mid chest to mid face and upper back. Epinephrine vial 1:1000 - 0.5 ml given rt arm. EMS notified. Transported to Hospital.
47 2021-03-24 vaccination site warmth, vaccination site hardening, vaccination site redness overlying skin with faint hyperpigmentation and feels like sandpaper on palpation; cutaneous/subcuta... Read more
overlying skin with faint hyperpigmentation and feels like sandpaper on palpation; cutaneous/subcutaneous reaction at the site of the first injection - pruritic, erythematous, indurated, warm; cutaneous/subcutaneous reaction at the site of the first injection - pruritic, erythematous, indurated, warm; overlying skin with faint hyperpigmentation and feels like sandpaper on palpation; cutaneous/subcutaneous reaction at the site of the first injection - pruritic, erythematous, indurated, warm; This is a spontaneous report from a contactable physician. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6200), second dose, intramuscular, administered in left arm on 19Feb2021 17:00 as single dose for covid-19 immunisation. Medical history included depression, ADHD (attention deficit hyperactivity disorder), obesity, allergic rhinitis, penicillin allergy (rxn in childhood - suspect not actually allergic). Concomitant medications included Fluoxetine, Bupropion, Adderall, Cetirizine and Ibuprofen. On 19Jan2021 11:00 patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) Lot number=EL9264, intramuscular on left arm. In the hours following the second injection patient developed a cutaneous/subcutaneous reaction at the site of the first injection - pruritic, erythematous, indurated, warm, size approx 12mm x 5mm, minimal depth below skin surface. Itching waxed and waned in intensity, was worst early on, but still had some occasional itching two days later at which point lesion was sort of like a pin-point sized scab in appearance. Induration gradually resolved but was still detectable the day after the injection. Currently (4 days after injection) overlying skin with faint hyperpigmentation and feels like sandpaper on palpation, no warmth, induration, or erythema. (Healing, non-concerning, is sort of like a not-quite-a-scab, 8mm x 1mm - though I did not note any abrasions or watery exudate while it was symptomatic. On an unspecified date the events outcome was recovered. No follow-up attempts are possible. No further information is expected.
47 2021-03-25 itchy skin, hives About 25-30 minutes after my shot I had a histamine type reaction... itchy all over, creepy crawly f... Read more
About 25-30 minutes after my shot I had a histamine type reaction... itchy all over, creepy crawly feeling going up my scalp, hives. I took half a Xyzal which helped. About 3 hours later the feeling returned and I took another half of a Xyzal.
47 2021-03-25 redness Client returned to LHD on 3/25/21 at 9:40am complaining of significant swelling into neck and axilla... Read more
Client returned to LHD on 3/25/21 at 9:40am complaining of significant swelling into neck and axillary lymph nodes, redness, and difficulty moving arm. Redness was in an area over right deltoid approximately 4in vertically X 3 in horizontally. Redness did not go into shoulder, but started approximately 2 finger breaths below shoulder. Appeared vaccination was given in proper location. Client stated she was taking .Motrin and using the arm very frequently. She was tearful when moving arm. Client feels her pain threshold is high due to hx of broken hip in past and this pain seems worse. Client was very concerned about a worse reaction with a second vaccine. Client did state, " the nurse said I was a really small person so she was going to use a smaller needle." This nurse believes that means nurse at mass vaccination clinic used a 5/8 in needle. Client probably weighs 120-130lbs. Client did not and did not want to sign up for Vsafe. After discussion client decided to go to Urgent Care. Follow-up phone call to client at 12:30pm on 3/26. Client states Urgent Care Dr did not think it was cellulitis. Client was very fatigued and stated she then went to daughters and took 2 hour nap. She felt she did not want to go home by self as she was still very concerned. Client states, 'has hx of developing significant tongue swelling throat closing reaction to Bactrim about 4 days after starting and physician telling her in the ER she could have died if she did not come in'. Advised her to get 2nd vaccine. Client is still undecided about getting 2nd vaccine. Pain has decreased, but arm remains swollen and is now itchy. Client will continue to monitor and return to urgent care if symptoms get worse.
47 2021-03-25 injection site pain Started with mild headache 2hours after vaccine shot, mild headache continued day 2-6, headache jump... Read more
Started with mild headache 2hours after vaccine shot, mild headache continued day 2-6, headache jumped to severe on day 7 & 8, 49 hours of severe headache, day 7 &8 also included symptoms of nausea & vomiting, other symptoms post shot included mild pain of muscle at injection site day 1-6, mild to moderate muscle soreness day 2-6, mild to moderate fatigue day 2-9, mild to moderate tiredness day 2-9, severe diarrhea day 6-9.
47 2021-03-26 injection site swelling, itchy skin, injection site pruritus patient was complaining of reaction s/p 1st dose covid vaccine approximately 15-20minutes after vacc... Read more
patient was complaining of reaction s/p 1st dose covid vaccine approximately 15-20minutes after vaccine administration. Patient was alert and oriented and states that she is "itchy all over" including her throat. Her SBP at the time is 180s and elevated HR in the low 100s. O2 sat remained >98%. She denies any reactions to previous vaccinations but had an anaphylactic reaction to walnuts before. Patient examined with no visible rashes, patent airway, no enlargement or swelling of tongue or lips. Verbal order from Dr to start IV access and was given Benadryl 25 mg and Dexamethasone 4mg IV. Patient tolerated well. Vital signs rechecked every 2 mins with SBP trending down and HR stabilizing in the 90s. Patient denies any chest pain, SOB, cough, but complains of mild nausea. Patient was kept in clinic for observation for 2 hours and was discharged in stable condition. Spouse came to drive patient home as she was somnolent from benadryl 25mg IV administration. Spoke with patient again today 3/27 to check on her. She states there is still some pruritis at R deltoid injection site with some swelling. She notes it is about 50% improved in itchiness and swelling since the evening of vaccination. Patient reports that she did not have any swelling of tongue, lips, or throat during observation post vaccination and since being released from clinic observation.
47 2021-03-28 cellulitis Covid vaccine monitoring documentation. Patient admitted 3/25/21 for cellulitis. SARS-CoV-2 COVID-19... Read more
Covid vaccine monitoring documentation. Patient admitted 3/25/21 for cellulitis. SARS-CoV-2 COVID-19 documented positive 03/25/21 21:43, patient documented to be asymptomatic. Patient received both doses of Covid-19 vaccine, of note, documentation stated patient husband not vaccinated. Dose 1, Pfizer 2/26/21 EN6200, Dose 2, Pfizer 3/19/21 EN6204.
47 2021-03-28 skin infection at injection site, injection site hardening, injection site swelling, injection site warmth, injection site redness This is a continuation of temporary VAERS report ID 384198 filed on 3/26/21. This update was report... Read more
This is a continuation of temporary VAERS report ID 384198 filed on 3/26/21. This update was reported to Vaers reporter by phone at 10:30 am on 3/29/21. Client returned to the Urgent Care on 2/28/21 because site had become hard, hot, and red. Client states "it was the size of a baseball, you could tell it was infected". At Urgent care physician diagnosed cellulitis. Client was prescribed Keflex BID for 7 days (she thinks the dosage was 300mg). At time of the phone call client does feel her arm feels better than it did yesterday although still red and swollen, with pain at a 4 on a 10 point scale.
47 2021-03-30 itchy skin, hives Arm hurt; Little tired today/Exhaustion; Chills; Legs look swollen; Itching everywhere; Tested posit... Read more
Arm hurt; Little tired today/Exhaustion; Chills; Legs look swollen; Itching everywhere; Tested positive for Covid/can't stop coughing/ like the whole kind of flu symptoms, body aches, arm hurt; Tested positive for Covid; Hives all over body and tested for Covid 2 days later; This is a spontaneous report from a contactable consumer. The consumer (patient) reported that the 47-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, brand: Pfizer), via an unspecified route of administration, administered in Arm Left on 05Mar2021 15:15 at single dose for covid-19 immunisation. Medical history was none. Allergies to medications, food, or other products was nope. Concomitant medications were not reported. The patient previously took dose of bnt162b2 (BNT162B2, COVID 19, brand: Pfizer), via an unspecified route of administration, administered in Arm Left on 12Feb2021 15:15 at single dose for covid-19 immunization. The patient experienced tested positive for covid on 07Mar2021 with outcome of unknown, hives all over body and tested for covid 2 days later on 06Mar2021 06:00 AM with outcome of recovering, can't stop coughing on an unspecified date with outcome of unknown, like the whole kind of flu symptoms on an unspecified date with outcome of unknown, body aches on an unspecified date with outcome of unknown, arm hurt on an unspecified date with outcome of unknown, little tired today/exhaustion on an unspecified date with outcome of recovering, chills on an unspecified date with outcome of unknown, legs look swollen on an unspecified date with outcome of unknown, itching everywhere on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 07Mar2021. She is not pregnant. She is not pregnant at the time of vaccination. No covid prior vaccination. Covid tested post vaccination included Nasal Swab, Pcr, on 07Mar2021with result of Positive. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was none. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 and test name was Pcr. The clinical course was reported as follows: Consumer stated, The other day, on Friday, I got my second dose of the Pfizer COVID-19 vaccine. And of course that's why I have like horrible symptoms, but since then I am covered in hives and it's really itchy. When paraphrased the concern, consumer stated, And then I just have a question, what happened was, we found out the same day, my son tested positive for COVID when I got the shot. And then like within 4 hours later of the shot, I can't stop coughing either. Means yesterday, I had like the whole kind of flu symptoms, body aches, arm hurt, you know, which are definitely going away. Little tired today but I still have the cough more in the throat and I am covered in hives. Consumer further stated, My husband and my other son were tested, they are negative. I am supposed to go today. Like I do not know what to do and I do not know what's going on but I am itching everywhere. Yesterday, I had like kind of the symptoms they said like body aches, like flu like symptoms, chills. I did not have a fever, just exhaustion and I did have hives yesterday but today I feel like my legs look swollen. I am itching everywhere and they are not away and I still have a 'cough like in ear through my throat' (not clarified). So, do you think should I still get tested today? Consumer was informed about the role of Pfizer Drug Safety and Pfizer Medical Information. Consumer stated, What should I do as I got the rash and everything. I would rather, I just need to get tested for the rash and the 'cough' (not clarified). Consumer stated, And they are going to give me information on these hives and everything? Inofrmation regarding lot/batch number has been requested.
47 2021-03-30 redness Full blown allergic reaction to vaccine within minutes of administration/redness all over her body, ... Read more
Full blown allergic reaction to vaccine within minutes of administration/redness all over her body, lip swelling, severe allergic reaction; redness all over her body, lip swelling, severe allergic reaction; redness all over her body, lip swelling, severe allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 11Mar2021 (at the age of 47 years old) at a single dose for COVID-19 immunization. Vaccination was done in a Public Health Clinic/Veterans Administration facility. Medical history included connective tissue disorder, high cholesterol, and chronic hip/labrum issues, all from an unknown date and unknown if ongoing. Patient was not pregnant. There was no COVID prior vaccination and not COVID tested post vaccination. The patient's concomitant medications were not reported. The patient previously received flu vaccine for immunization and experienced known allergies: flu vaccine. The patient experienced full blown allergic reaction to vaccine within minutes of administration/redness all over her body, lip swelling, severe allergic reaction on 11Mar2021. It was reported that the patient was taken to the ER by EMS for observation, treated and released, all on 11Mar2021. She took Benadryl at the vaccination site and was given prednisone treatment at the hospital. The outcome of the event was recovering. Information on the batch/lot number has been requested.
47 2021-03-30 vaccination site pain dizziness; nausea; Temp 102.3; joint pain; injection site pain; general muscle ache; Fatigue; Chills... Read more
dizziness; nausea; Temp 102.3; joint pain; injection site pain; general muscle ache; Fatigue; Chills; Generally did not feel well; This is a spontaneous report from a contactable Nurse. A 47-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 06Feb2021 07:45 (Batch/Lot Number: em9810) at single dose for covid-19 immunisation. Medical history included myasthenia gravis Hx chronic reactive airway do and myasthenia gravis from 16 years ago in pregnancy but resolved, allergies to Sulfa. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (Lot no: EL8982) On 16Jan2021 07:45 AM at single dose in left arm. on 06Feb2021 12:00 patient experienced dizziness, nausea, temp 102.3, joint pain, injection site pain, general muscle ache, fatigue, chills, generally did not feel well. Patient had no COVID prior vaccination, COVID not tested post vaccination and no other vaccine in four weeks. Outcome of the events was recovering.
47 2021-04-02 rash, blister, itchy skin A mild rash developed on chin Within a week, the rash spread to neck, upper lip, nose, and eyebrows.... Read more
A mild rash developed on chin Within a week, the rash spread to neck, upper lip, nose, and eyebrows. By two weeks, the rash worsened.; By two weeks, the rash worsened and developed red bumps and blisters with intense itching and burning 24 hours/day; By two weeks, the rash worsened and developed red bumps and blisters with intense itching and burning 24 hours/day; By two weeks, the rash worsened and developed red bumps and blisters with intense itching and burning 24 hours/day; This is a spontaneous report from a contactable Consumer (patient). A 47-year-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL9264, Expiration date was not reported), via an unspecified route of administration, in right arm on 27Jan2021 15:30 as single dose for covid-19 immunisation. Relevant medical history reported as none. Concomitant medication included metronidazole (FLAGYL), levocetirizine dihydrochloride (XYZAL) and melatonin all are taken for an unspecified indication, start and stop date were not reported. It was reported that a mild rash developed on chin within 48 hours. Within a week, the rash spread to neck, upper lip, nose, and eyebrows. By two weeks, the rash worsened and developed red bumps and blisters with intense itching and burning 24 hours/day on 29Jan2021 05:00 PM. No changes in diet, facial products, cleaning/detergent products and have been wearing a mask since August with no issues. Patient did not have covid prior vaccination. Patient did not test for covid post vaccination. Patient received the treatment of adverse event was Prescribed Elidel, Montelukast, Allegra, Doxepin. The outcome of the events was not recovered.
47 2021-04-09 hives About 30 seconds after my shot, my throat felt like it was closing and my face started to swell up a... Read more
About 30 seconds after my shot, my throat felt like it was closing and my face started to swell up as well as my hands. Then My right ankle swelled up. My face and hands had hives on them. My throat felt better, I thought but about 1/2 hr. Later I started wheezing and my right ankle and leg were swollen so, I went to the urgacare. They saw me but told me that I should've gone to the ER. I have a history of anaphylaxis. They gave me steriods and Benadryl via shots and sent me home with the same. I woke the next morning with a sore arm, a horrible headache and my face broke out into hives and was swollen again. Today is the 4th day after and my face still feels a little swollen, I have a headache and now an earache in my left ear. Today I also felt nauseous and couldn't eat.
47 2021-04-11 rash Severe reaction began with flu like symptoms and burning face to into head to toe severe body rash
47 2021-04-13 skin warm hit the timer on my watch when the injection was given. By minute 2 my body was hot and my throat wa... Read more
hit the timer on my watch when the injection was given. By minute 2 my body was hot and my throat was starting to swell. Used Epi pen #1 . I did not get better. I felt even more on fire and my skin was hot to the touch. My tongue was really swollen and things get super fuzzy after the I might die feeling. Epi#2 Given around 5 minutes after Epipen 1. Medics took me to the ER and more rescue meds were given. I was admitted to the nuero trauma floor for 24 hrs and given meds and iv fluids. I got out the next afternoon. By the next day I was back in urgent care. They gave me meds and sent me home. By 9pm that night I was using epi#3 and going back to the ambulance. I have been to urgent care 2 times since for continued issues. I have zero appetite and my whole GI system hates me. I am alive and breathing but still feeling the impact of all of this.
47 2021-04-14 injection site pruritus, injection site swelling, injection site redness Swollen, red, tender, itchy at site injection area
47 2021-04-20 injection site pain 1. injection site pain 6. cough 2. throat itchiness ... Read more
1. injection site pain 6. cough 2. throat itchiness 7. dizziness 3. generalized aches 8. hard to breath 4. joint pain 5. tiredness
47 2021-04-20 injection site pain, injection site swelling 1. injection site pain, swelling for ~7days ... Read more
1. injection site pain, swelling for ~7days 6. joints pain 2. unable to lift up arm pass 15-degree angle for days 7. fatigue 3. left arm got numb/tingling, cool to touch- required long sleeve shirt & gloves (resolve next day) 4. itchiness of throat for ~3-4 days 5. generalized body aches for @ least ~ 5 days
47 2021-04-20 rash positive COVID test; positive COVID test; felt dizzy and fainted; Blacked out several weeks ago whil... Read more
positive COVID test; positive COVID test; felt dizzy and fainted; Blacked out several weeks ago while going to bathroom; felt dizzy and fainted/light-headed; abnormal EKG; got head injury; Had a weird rash on elbows; headaches; concussion; sore throat; Started feeling more unwell several days ago; been fatigued for weeks; coughing with phlegm; mouth sores; laryngitis; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration, administered in right arm on 14Jan2021 at 08:30 at a single dose, second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration, administered in right arm on 03Feb2021 at a single dose for COVID-19 immunisation at hospital. Medical history included known_allergies Penicillin, sulfur, NSAIDs. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The patient received medications within 2 weeks of vaccination. Concomitant medications included gabapentin, trazodone, fluoxetine hydrochloride (PROZAC), oxymetazoline hydrochloride (CLARITIN ALLERGIC). Since the vaccination, patient has been tested for COVID-19. After second dose, but before patient left waiting area, on 17Mar2021, felt dizzy & fainted. Taken to ER. Had an abnormal EKG. Followed up with heart doctor. Blacked out several weeks ago while going to bathroom & got head injury. Husband and 2 sons tested positive for COVID mid March. Had a weird rash on elbows, been having headaches. Went to doctor about rash; not sure of cause. Told representative several times during contact updates for sons; representative said patient can't get COVID if she has been vaccinated. Went to doctor about head injury (diagnosed concussion on 17Mar2021. Supposed to see cardiologist and orthopedist for follow up but need to postpone due to positive COVID test on 17Mar2021. Started feeling more unwell several days ago; been fatigued for weeks. Symptoms included coughing with phlegm, headache, light-headed, mouth sores, sore throat, laryngitis, extreme fatigue, muscle aches. Positive rapid test 05Apr2021; PCR test on 05Apr2021; waiting for results. Treatment received for the adverse events. The outcome of the event positive COVID test was unknown and patient was recovering from all other events.
47 2021-04-22 shingles, blister, rash I had Shingles three years ago and was diagnosed with Shingles again on 04.22.21. It effects my left... Read more
I had Shingles three years ago and was diagnosed with Shingles again on 04.22.21. It effects my left leg and thigh. Rash/blisters started on 04.18.21. It is possible the Covid Pfizer vaccine reactivated the virus.
47 2021-04-24 cellulitis Cellulitis; This is a spontaneous report received from a contactable Other Health Professional (pati... Read more
Cellulitis; This is a spontaneous report received from a contactable Other Health Professional (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 26Feb2021 15:15 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation. Medical history included asthma, GERD (gastrooesophageal reflux disease) and HTN (hypertension). Patient was allergy to Sulfa, mometasone furoate (NASONEX) and ciclesonide (OMNARIS). Concomitant medications included pantoprazole, prednisone, phentermine and more. The patient experienced cellulitis "10 days" on 10Mar2021 with outcome of recovered. Patient received treatment included cefalexin (KEFLEX) then doxycycline. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Lab test on 27Mar2021 included RT-PCR of SARS-CoV-2 test and nasal swab were both negative. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the event of cellulitis and the suspect vaccine BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
47 2021-04-26 vaccination site swelling diagnosed with Bells Palsy; fever; muscle aches; headache; throwing up; chills; swollen lymph nodes/... Read more
diagnosed with Bells Palsy; fever; muscle aches; headache; throwing up; chills; swollen lymph nodes/swollen glands; swollen injection site; tired; mouth ulcers; extreme nerve pain; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 08Apr2021 15:00 (Batch/Lot number was not reported) at single dose (at the age of 47 years old) for COVID-19 immunisation. Medical history included "if covid prior vaccination: Yes". Concomitant medications included potassium, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), cetirizine and chlorthalidone, all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 for COVID-19 immunisation. The patient reported, "fever, muscle aches, headache, throwing up, chills, swollen lymph nodes, swollen injection site, tired. After chills, fever, throwing up, mouth ulcers. On day 7 I have extreme nerve pain, swollen glands, and paralysis on left side of face. Went to DR and they diagnosed with Bells Palsy. Left side of face does not move at all", 09Apr2021 09:00. The patient received no treatment. The outcome of bells palsy, extreme nerve pain, mouth ulcers and swollen lymph nodes/ swollen glands were not recovered and other events was recovering. Information about lot/batch number has been requested.
47 2021-04-27 itchy rash, rash with redness Fatigue (still ongoing), Swollen lymph nodes in neck and underarms (still ongoing), Fever (day 1 e... Read more
Fatigue (still ongoing), Swollen lymph nodes in neck and underarms (still ongoing), Fever (day 1 evening and into day 2), Nausea (day 1 evening and into day 2), Headache (day 1 and into day 4), Chills (day 1 and into day 4), Red itchy rash causing swelling on top of wrists on both arms (started day 3 and still ongoing)
47 2021-04-27 vaccination site pain Fatigue; mild soreness at injection side; moderate headache; This is a spontaneous report from a con... Read more
Fatigue; mild soreness at injection side; moderate headache; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL3247, Expiration date was not reported), via an unspecified route of administration on 26Jan2021 13:00 left arm as single dose for covid-19 immunisation. The patient medical history was not reported. Allergies to medications, food, or other products reported as no. Concomitant medications included sertraline hydrochloride (ZOLOFT), vitamins nos (MULTIVITAMINUM), desogestrel, ethinylestradiol (VOLNEA) and doxycycline all are taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced mild soreness at injection side, moderate headache, fatigue on 27Jan2021. As per the reporter seriousness criteria reported as non-serious. Patient did not received treatment for the adverse events. The outcome of the events was recovering.
47 2021-04-27 injection site redness, injection site pain, injection site warmth, injection site rash injection site sore with red rash ( 3in diameter) and warm to touch Recommend cold compresses to si... Read more
injection site sore with red rash ( 3in diameter) and warm to touch Recommend cold compresses to site (10min on /10min off); NSAIDS and antihistamines if able to tolerate. Caller verbalizes understanding 4/27-f/u call made; no answer
47 2021-05-04 injection site pain, injection site swelling, injection site warmth, injection site pruritus 5 DAYS OUT I STILL HAVE SWELLING & PAIN AT THE INJECTION SITE, IT IS ALSO WARM/HOT TO TOUCH AND STAR... Read more
5 DAYS OUT I STILL HAVE SWELLING & PAIN AT THE INJECTION SITE, IT IS ALSO WARM/HOT TO TOUCH AND STARTED TO ITCH ON 5/3/21
47 2021-05-04 itchy skin fainted; weak; tired; itching; trouble breathing; face swelling; unstable vital signs; This is a spo... Read more
fainted; weak; tired; itching; trouble breathing; face swelling; unstable vital signs; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration, administered in left arm on 05Apr2021 10:00 as single dose for covid-19 immunisation. Medical history included hypothyroidism, high cholesterol, allergies to penicillin and shell seafood. here were no concomitant medications. The patient previously took Percocet [oxycodone hydrochloride;paracetamol] and experienced allergies. The patient experienced fainted, weak, tired, itching, trouble breathing, face swelling and unstable vital signs on 05Apr2021 21:30. The patient was hospitalized. It was unknown if the patient received any treatment. The outcome of the events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.
47 2021-05-04 injection site pain low fever (<100.0); joints ache; slight headache; injection site is sore; This is a spontaneous repo... Read more
low fever (<100.0); joints ache; slight headache; injection site is sore; This is a spontaneous report from a contactable consumer (patient, self-reported). A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247 and expiration date was not reported), via unspecified route of administration in left arm on 18Feb2021 at 13:00, as single dose for COVID-19 immunisation. The patient's medical history included AERD and asthma. The concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247 and expiration date was not reported), via unspecified route of administration in left arm on 28Jan2021 at 13:30, as single dose for COVID-19 immunisation. On 18Feb2021 at 23:00, the patient experienced low fever (<100.0), joints ache, slight headache and injection site sore. The adverse event does not required the treatment. No COVID prior vaccination and not COVID does not tested post vaccination. The outcome of the events was not recovered.
47 2021-05-11 redness, itchy skin, rash Red hot itchy bumpy rash on arms, breast, chest, stomach, back and groin area; Red hot itchy bumpy r... Read more
Red hot itchy bumpy rash on arms, breast, chest, stomach, back and groin area; Red hot itchy bumpy rash on arms, breast, chest, stomach, back and groin area; Red hot itchy bumpy rash on arms, breast, chest, stomach, back and groin area; This is a spontaneous report from a contactable consumer from a non-measurable supplier. A 47-year-old female patient received first dose of BNT162B2 (BNT162B2 solution for injection, Lot Number: EW0175) via intramuscular route in arm left on 29Apr2021 at 13:45 for covid-19 immunisation. Medical history included allergy. Concomitant medication was not reported. On 30Apr2021 at 19:00, the patient had experienced hot itchy bumpy rash on arms, breast, chest, stomach, back and groin area. Tthe patient was hospitalized and the patient received treatment with Steriod pak and pepcid. The outcome of events was recovering. Information on Lot/Batch number was available. Additional information has been requested.
48 2020-12-31 injection site pain After monitoring for 15 min post-vaccination, I drove away. On the 17th minute, my face got hot, the... Read more
After monitoring for 15 min post-vaccination, I drove away. On the 17th minute, my face got hot, then I headache started. A minute later fatigue hit and I was starting to fall asleep at the wheel. I live 1 mile away so I made it home. Now my head was getting fuzzy. Called a co-worker to tell her what was happening and she said my speech was slurring. I felt drunk and hungover at the same time. I went to bed and slept for an hour. I woke up and felt very fatigued. I finally went to bed for the night then was awoken with severe arm pain. My entire upper arm felt so tight but I it was soft upon palpation. I fell asleep and awoke to terrible arm pain again. I started crying in bed but fell asleep again. I woke up in the morning with severe upper arm pain and minor headache. I couldn't rotate my arm back to put my bra on so I took some ibuprofen. That had immediate relief for my arm and headache. I ran one errand and was wiped out. The fatigue hit again. The arm pain came back so I took another ibuprofen with relief. I had no energy so laid around for the rest of the day. I woke up on Sunday and finally felt normal with just pain at the injection site. The 2 other medical people that have had similar reactions like mine with dizziness and feeling light-headed have one thing in common with me...we are all vegetarians. I don't know if that makes a difference with protein metabolism or other enzymatic activity, but we are the only 3 that I know of out of all of our co-workers who have received the vaccine to react like this.
48 2020-12-31 itchy skin, redness C/O ITCHINESS, NO REDNESS NOTED, 50 MG BENADRYL GIVEN. 154/92, 93, REDNESS TO NECK APPEARING AT 0924... Read more
C/O ITCHINESS, NO REDNESS NOTED, 50 MG BENADRYL GIVEN. 154/92, 93, REDNESS TO NECK APPEARING AT 0924. 0938 NO NEW S/S, NECK REDNESS REDUCING.
48 2020-12-31 injection site pain Very sore injection site muscle. Hurt to lay on it.
48 2021-01-02 injection site pruritus, injection site warmth, injection site hardening 1 week after receiving dose 1 area is hard, warm to touch and itchy
48 2021-01-03 injection site pain, injection site hardening Initially had arm pain in the left deltoid area with mild induration, chills and some bodyaches. Gen... Read more
Initially had arm pain in the left deltoid area with mild induration, chills and some bodyaches. Generalized fatigue. Two days ago(1/2/21) a large left supraclavicular lymph node came up, it is a little sore. No redness. Moveable. No coughing or SOB. No difficulty swallowing. No rash to that area. No sore throat or other known cause at this time for the adenopathy
48 2021-01-03 vaccination site pain Within a couple hours severe pain in left arm at injection site and deltoid; burning in left scapula... Read more
Within a couple hours severe pain in left arm at injection site and deltoid; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees; Pain remains 7/10 in shoulder blade and arm; Still do not have full AROM 23+ hours after injection; muscle spasms around left shoulder blade 4-5 hours later; 130 resting heart rate 6 hours after; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees/ Pain remains 7/10 in shoulder blade and arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), intramuscular in the left arm on 21Dec2020 13:15 at a single dose for COVID-19 immunization. Medical history included partial motor seizures face. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included lisdexamfetamine mesilate (VYVANSE 40 mg), escitalopram oxalate (LEXAPRO 10 mg), brivaracetam (BRIVIACT, 100 mg). On 21Dec2020 4pm, within a couple hours severe pain in left arm at injection site and deltoid, muscle spasms around left shoulder blade 4-5 hours later, 130 resting heart rate 6 hours after, burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees. On 22Dec2020, by 9 am this morning back to 90 degrees shoulder flexion and abduction with pain. Pain remains 7/10 in shoulder blade and arm. Still do not have full AROM 23+ hours after injection. The patient was not hospitalized for the events and did not receive any treatment for the events. The events were reported as non-serious. The vaccine was administered in a workplace clinic. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Dec2020 with sequel. Information regarding lot/batch number has been requested.
48 2021-01-04 hives 30 minutes after receiving the vaccine I had developed a welt and itchiness on an ear. About 45 minu... Read more
30 minutes after receiving the vaccine I had developed a welt and itchiness on an ear. About 45 minutes to 1 hour after the receiving the vaccine I developed some additional spots on my face and my throat felt like something was stuck in it. I purchased some oral Benadryl from the Outpatient pharmacy took 50mg and in 30 minutes my symptoms were resolving.
48 2021-01-04 redness, skin warm Chest and arms red and warm; metallic taste in mouth; no signs of distress when monitoring discontin... Read more
Chest and arms red and warm; metallic taste in mouth; no signs of distress when monitoring discontinued. Proceeded to PCP office the following day due to face, neck and arm stiffness, edema in hands, legs, and face, continued metallic taste, and elevated BP (160/100). PCP prescribed oral steroids, antihistamine, and Epi-Pen.
48 2021-01-04 rash, shingles I was diagnosed with shingles on my left side on 12/31/2020, with symptoms (burning/skin sensitivity... Read more
I was diagnosed with shingles on my left side on 12/31/2020, with symptoms (burning/skin sensitivity on my back (probably on 12/27, definitely by 12/28 progressing to waves of pain in my back to abdomen). On 12/30, a rash appeared on my abdomen starting below my navel and going around my left side to about an inch before my spine. I submitted a picture and it was diagnosed as shingles via a virtual visit. It is responding to antiviral therapy, although I still have a rash and pain (but improving). I did not go through the COVID vaccine side effect virtual visit route because I did not really think it was a side effect and knew I had a history of chicken pox and have been experiencing ongoing stress. The provider for the virtual visit told me to still report it for it to be investigated, but she too, thought it was likely unrelated, but still should be investigated.
48 2021-01-04 injection site nodule, hives, itchy skin, injection site swelling Post vaccine 12/18 Shoulder and upper/mid-back soreness pretty quickly; left arm feels stiff shortly... Read more
Post vaccine 12/18 Shoulder and upper/mid-back soreness pretty quickly; left arm feels stiff shortly after leaving observation area (32 min in observation) 9:30 lip tingling/ numbness, headache, back soreness/tightness/ pressure continues 9:40 hearing muted, fullness/mild pressure in ears - first left then right a little later Headache waxes and wanes - at times feels like vice squeezing my head 11:50 heartburn sensation 12:00 localized swelling/ knot at injection site 12:04 wave of nausea/ mild heartburn Headache continues off and on 3:30 ear ache, nausea, stiff joints, arm/shoulder/back pain, neck pain 16:00 dizzy/ nausea 16:22 flushed feeling in cheeks and neck; itchy cheeks, neck, chest 16:50 still flushed, itchy all over, heart palpitations. Fitbit shows HR 78 Hives for several hours. Hives gone by morning but still intermittently itchy. Eyes itchy/ feels like a contact lens is stuck in a wrong spot (have not worn contacts in 12+ years) Very mild cough started in evening 12/19 Hives in afternoon; itching off and on all day HR 91 (21:30) 21:43 HR 97 dizziness, headache 22:00 hives on face and abdomen 23:09 eye hurts again and is so itchy I want to rip it out of the socket, headache persists 12/20 Mild-to moderate itchiness upon waking, Itchiness off and an Mild headache off and on 9:15 heaviness in chest - feel I like do just before I get bronchitis, very mild cough Itchiness throughout the day. Hives on face in evening/Skin has a sunburn-type feeing Hives on neck and chest at bedtime Eyes itching then hurting - feels almost like pink eye type sensation As I was dozing off to sleep, heart palpitations - HR 97 12/21 Itchy/ hives on face, neck, upper chest By 12/21 afternoon, itchiness and hives abated. No further symptoms
48 2021-01-04 vaccination site pain deltoid muscle pain in left arm where she got the shot; Left arm feeling heavy in within 2 hours of ... Read more
deltoid muscle pain in left arm where she got the shot; Left arm feeling heavy in within 2 hours of vaccination, hard to lift up; she was feeling very tired and in day-2 she felt fatigue; This is a spontaneous report from a contactable consumer reporting for a patient. A 48-year-old female patient received first dose of BNT162B2, (Pfizer-BioNTech Covid-19 Vaccine, lot number EH9899) , via an unspecified route of administration on 28Dec2020 10:00 at single dose on left arm for COVID-19 vaccination. The patient's medical history was not reported. Concomitant medications were none. The patient experienced deltoid muscle pain in left arm where she got the shot (28Dec2020 12:00). Left arm feeling heavy in within 2 hours of vaccination, hard to lift up (28Dec2020 12:00). In the afternoon she was feeling very tired and in day-2 she felt fatigue, took Tylenol multiple times a day. On day-3 she felt perfectly fine and no pain was left. Functioning properly. No known allergies. The patient did not receive other vaccine in four weeks. No covid prior vaccination; no covid tested post vaccination. The patient was not pregnant at the time of vaccination. Therapeutic measures were taken as a result of deltoid muscle pain in left arm where she got the shot. The outcome of the events was resolved on an unspecified date.
48 2021-01-04 injection site numbness had a little side step/unbalance moment; left hand started tingling/tingling in left foot and left s... Read more
had a little side step/unbalance moment; left hand started tingling/tingling in left foot and left side of face; neck on left side felt like someone had hit it; injection site and whole deltoid was numb.; Left side of face, left foot and left ear all felt numb but with tingles; This is a spontaneous report from a contactable other HCP (patient). A 48-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL0140), via an unspecified route of administration in Left arm on 28Dec2020 16:30 at single dose for covid-19 immunisation. The COVID-19 vaccine was administered at workplace clinic. Medical history included known allergies to food - vegetables, berries, shellfish, environmental. Concomitant medication in two weeks included desogestrel, ethinylestradiol (MIRCETTE), fluticasone propionate (FLONASE), iron, multi vitamin, elderberry w/z. The patient previously took benzoyl peroxide and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient waited 20min, went up to leave and while walking out had a little side step/unbalance moment. The patient thought nothing of it and went to car and was waiting in car for an extra 10 min. Her left hand started tingling, same tingling like if it was asleep and was waking up. Then she started to drive home, on the way home, noticed tingling in left foot and left side of face, neck on left side felt like someone had hit it. About 50 min after receiving injection, was at home, injection site and whole deltoid was numb. Left side of face, left foot and left ear all felt numb but with tingles. She had stopped timer after 2 hours. Tingling and numbness subsided sometime after 2 hours of receiving vaccine. Today (29Dec2020), everything felt fine. Injection site just felt like I got a shot, can barely notice it. Adverse event start date provided as 28Dec2020 05:15 PM. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on 29Dec2020.
48 2021-01-05 vaccination site pain Arm pain at injection site; general body aches; This is a spontaneous report from a contactable cons... Read more
Arm pain at injection site; general body aches; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot: EK 5930, intramuscularly on 30Dec2020 11:30 (at the age of 48-years-old), as a single dose in the left arm for COVID-19 immunization. Medical history included penicillin and cephalosporins allergy, possible Behcet's Syndrome, allergies and COVID-19 (diagnosed prior to the vaccination). The patient was not pregnant at the time of vaccination. Concomitant medications were not reported; however, it was reported that the patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously took codeine and experienced allergies. On 30Dec2020 at 20:00 on the second day (as reported), the patient experienced arm pain at the injection site and general body aches. The patient did not receive treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the arm pain at the injection site and general body aches was resolving.
48 2021-01-05 injection site pain Chills, shivering , body aches, nausea, fatigue, extreme pain and tenderness at the injection site
48 2021-01-05 injection site pain, injection site pain Chills/shivering, body aches, nausea, fatigue, extreme pain and tenderness at the injection site
48 2021-01-05 vaccination site pain, vaccination site mass Increased fatigue; Medium to large 3-inch knot to left deltoid with increase soreness and tender to ... Read more
Increased fatigue; Medium to large 3-inch knot to left deltoid with increase soreness and tender to touch; Medium to large 3-inch knot to left deltoid with increase soreness and tender to touch; This is a spontaneous report from a contactable healthcare professional (patient). A 48-year-old female (non-pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL0142), via an unspecified route of administration in left arm, on 30Dec2020 08:15, at a single dose, for COVID-19 immunization. The patient's medical history included COVID-19. The patient's concomitant medications included topiramate and bupropion hydrochloride (WELLBUTRIN). The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Most recent COVID-19 vaccine was administered in the hospital. On 30Dec2020 at 4:30 PM, the patient had increased fatigue on the day of vaccination. Also, the patient had a medium to large 3-inch knot to left deltoid with increase soreness and tender to touch. No treatment was received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient was recovering from the events.
48 2021-01-05 itchy skin Itching
48 2021-01-05 rash with redness left ear fullness 1327pm left throat fullness 1328pm Nausea 1328pm sent to emergency room/arrived at... Read more
left ear fullness 1327pm left throat fullness 1328pm Nausea 1328pm sent to emergency room/arrived at emergency room 1330 symptoms increased. airway not obstructed. No tongue swelling reported by MD. Light red rash/flushing on chest. 25mg IV benadryl administered. IV Solumedrol administered, Vital signs stable. Cardiac monitor: regular rate and rhythm. O2 saturations 98% on room air. Symptoms improving at 1345pm. Monitored in emergency room for 1 hour. Discharged in stable condition with instructions to repeat Benadryl 8 hours after first dose if needed Throat fullness ( left side) with mild difficulty swallowing continued. Headache 5pm. Left sided face fullness/tingling: jaw, cheek. Left eye: mild swelling. 25 mg Po Benadryl taken. 01/06/21 0800 AM symptoms Left sided facial fullness/tingling continues: mild. No difficulty breathing. Left eye mild/yet decreased puffiness continues.
48 2021-01-05 rash patient received vaccine and shortly became warm and felt her arms were getting red and splotchy. ... Read more
patient received vaccine and shortly became warm and felt her arms were getting red and splotchy. Patient taken to ER and was given PO Benadryl 50mg and observed. Discharged 2 hrs later
48 2021-01-06 injection site vesicles An irregular shaped Blister at site of vaccination was noticed a day after the first vaccine dose, a... Read more
An irregular shaped Blister at site of vaccination was noticed a day after the first vaccine dose, and which then burst producing clear liquid with open skin when the bandage was removed. It healed later with a scar.
48 2021-01-06 rash Headache, Myalgia, Rash, Hypoglycemia, subjective tachycardia (heart racing) Narrative: Within minu... Read more
Headache, Myalgia, Rash, Hypoglycemia, subjective tachycardia (heart racing) Narrative: Within minutes of vaccination, employee experienced sternocleidomastoid tenderness/tightness on the side of the vaccination with a feeling of her heart racing. She was transferred to the ED. Evaluation revealed mild rash, vital signs stable, normal oxygen saturation, no SOB, normal sinus rhythm on EKG. No evidence of pulmonary involvement, lung sounds clear. Assessment: Mild allergic reaction. After 5 hours of observation in the ED, patient experienced resolution of her subject tachycardia. She was treated for a headache with APAP during her stay, and reports improvement. She also had a mild hypoglycemia and was given ginger ale and graham crackers. Discharged to home.
48 2021-01-06 injection site pain Headache, soreness at injection site, extreme muscle aches and fatigue lasting from 12/25 to 12/30.
48 2021-01-06 rash with redness, skin warm, rash, rash papular I received my covid -19 vaccine at work at hospital. I sat for my fifteen minutes after vaccination ... Read more
I received my covid -19 vaccine at work at hospital. I sat for my fifteen minutes after vaccination and felt fine. When I got home two hours later from work and got in the shower, I noticed that I had a red, slightly raised, pinpoint and very defined red rash. The rash was all over my abdomen, my back and my neck. The areas felt warm but I did I not have itching, pain or any other anaphylaxis symptoms. The rash faded entirely in the next 48 hours.
48 2021-01-06 injection site pruritus Itching on arm in area of injection site, reports feeling weird, eyes are reddened and itchy. Patie... Read more
Itching on arm in area of injection site, reports feeling weird, eyes are reddened and itchy. Patient reports feeling short of breath but no noted drop in oxygen saturation. Oral diphenhydramine 50mg administered.
48 2021-01-06 redness NauseaVomiting, HYPERtension, facial reddness to the chest. Went to the ER Narrative: Reports having... Read more
NauseaVomiting, HYPERtension, facial reddness to the chest. Went to the ER Narrative: Reports having facial redness to the chest. Had severe nausea and hypertension. Went to the ER and discharged later that day. Still having nausea today.
48 2021-01-06 hives On January 4th we were made aware of the following: A few minutes after receiving the vaccine at 8 a... Read more
On January 4th we were made aware of the following: A few minutes after receiving the vaccine at 8 am on 12-23-2020, the associate suffered from a severe headache 8/10, tingling sensation, BP checked Systolic in 180s, Extremely weak and tired, Severe nausea and dry heaving. Rapid response called, and associate was sent to ER. Headache 7/10. 1 gram Tylenol. Associate states ?Shaking, and I experienced delayed response when questioned by staff. 1 liter saline. Hives treated with Benedryl. In ER from 8am to 11:30am. It was determined that this was not an anaphylactic response. Associate went home with a headache 4/10. Groggy all day from Benedryl. I still have headaches constantly in frontal lobe. The headache pain Can rise from 2 / 10 to 8 /10. The constant headache is in the left frontal lobe. When the headache increases, It radiates into the temporal area as well. Dec 31, I went to Patient First. I was given Toradol IM, but the headache didn?t go away. I was given Flexeril, but it doesn?t help the pain. I am now using Excedrin to take the edge off. Associate is awaiting physician?s return call, but Dr. is out of town. Another doctor in the clinic would not see associate, as they don?t cover other physician?s patients. No fever, no respiratory symptoms.
48 2021-01-06 rash Shortly after receiving the vaccine, the patient reported feeling flushed and hot with rash, shaking... Read more
Shortly after receiving the vaccine, the patient reported feeling flushed and hot with rash, shaking, shivering, and pain in upper chest, which the patient described as being normal because of her COVID pneumonia. I would rate the reaction as moderate. Diphenhydramine 25mg capsule was given by mouth, ice water was offered. Patient was closely monitored but no further intervention was necessary. After about 25 minutes, symptoms subsided and patient decided to leave.
48 2021-01-06 injection site pain Site injection pain (days 1-3) 12/30/2020, Days 6-present (1/6/2021-present) nausea, dizziness/heada... Read more
Site injection pain (days 1-3) 12/30/2020, Days 6-present (1/6/2021-present) nausea, dizziness/headaches, muscle pain, joint pain, arm weakness/unable to lift my arm, fatigue/tiredness
48 2021-01-07 injection site pain, hives, itchy skin Initial event was soreness at site which resolved on its own within a few days. 2 days after receiv... Read more
Initial event was soreness at site which resolved on its own within a few days. 2 days after receiving vaccine, I began having an allergy reaction to the same brand N95 that I had been utilizing since the beginning of the pandemic. Symptoms are swollen cheeks and welts , sudden itchiness at the site of my mask placement. The reason for this report is a sudden onset of excruciating and debilitating pain throughout my body specifically pain of my right shoulder radiating down my sprightly arm. I have been receiving testing and treatment for ongoing neuropathy due to Longhauler syndrome, however This recent pain is so debilitating, I spend most of my time in bed. I have been experiencing chills then profuse sweating. I also so fatigued, I sleep much of the day. I have been having episodes of tachycardia with chest tightness which has increased since after having the vaccine. I also become short winded on exertion. I?ve been waking up in a panic and sweating.
48 2021-01-07 vaccination site pain Initially, soreness at the injection site. Over the next 4 days (today is day 4), pain in left shoul... Read more
Initially, soreness at the injection site. Over the next 4 days (today is day 4), pain in left shoulder, back, and up the back of head/neck is getting progressively worse - now excruciating.; Initially, soreness at the injection site. Over the next 4 days (today is day 4), pain in left shoulder, back, and up the back of head/neck is getting progressively worse - now excruciating.; Initially, soreness at the injection site. Over the next 4 days (today is day 4), pain in left shoulder, back, and up the back of head/neck is getting progressively worse - now excruciating.; Initially, soreness at the injection site. Over the next 4 days (today is day 4), pain in left shoulder, back, and up the back of head/neck is getting progressively worse - now excruciating.; Initially, soreness at the injection site. Over the next 4 days (today is day 4), pain in left shoulder, back, and up the back of head/neck is getting progressively worse - now excruciating.; This is a spontaneous report from a contactable nurse (patient herself). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) intramuscular (left arm), on 03Dec2020 at 16:00, at a single dose, for COVID-19 immunization. Medical history included hypertension (HTN). The patient has no known allergies. Concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a Public Health Clinic/Veterans Administration facility. On 04Dec2020, at 05:00 a.m., the patient initially experienced soreness at the injection site. Over the next 4 days (today is day 4), patient experienced pain in left shoulder, back, and up the back of head/neck which was getting progressively worse - now excruciating. Ibuprofen managed the pain for the first two days, but the soreness/pain was no longer managed with NSAID's and other comfort measures. Patient was hoping that these are normal and was hoping they will get better. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since vaccination.
48 2021-01-07 injection site pain Pfizer-BioNTech COVID-19 vaccine: Extremely sorry injection site, chills, sweating, body aches, stuf... Read more
Pfizer-BioNTech COVID-19 vaccine: Extremely sorry injection site, chills, sweating, body aches, stuffy nose, headache, feeling "foggy".
48 2021-01-07 rash Shortness of breath, cough, rash on face and neck, arthralgia
48 2021-01-07 redness Soreness arm then swelling, very tender, redness. Fever 101-103 with Tylenol/ibuprofen, nausea, mala... Read more
Soreness arm then swelling, very tender, redness. Fever 101-103 with Tylenol/ibuprofen, nausea, malaise, myalgia, dizziness.
48 2021-01-08 rash macular Elevated Heart Rate, Elevated Blood pressure (160/100), difficulty swallowing, blotching to chest an... Read more
Elevated Heart Rate, Elevated Blood pressure (160/100), difficulty swallowing, blotching to chest and neck
48 2021-01-08 rash Elevated Heart rate and blood pressure. Blotching to chest and neck. difficulty swallowing.
48 2021-01-08 redness Within 10 minutes after vaccine, my face became extremely hot and red and left ear red and profuse s... Read more
Within 10 minutes after vaccine, my face became extremely hot and red and left ear red and profuse sweating. Within 30 minutes heart rate increased and a little clearing of throat. A little over an hour nausea started and increased clearing of throat , slight feel of constricture in throat and a slight feeling of heaviness in chest, and jittery and heart rate still feels increased. Nurse at Nursing home watched for 45minutes until I chose to leave. In my vehicle and home is when nausea started. Phone call contacts with nursing home staff continued for an hour. I took 2 benadryl and 2 Tylenol, napped. Felt better. Nausea 3 days. Tired and neck lymph achy.
48 2021-01-09 injection site pain 1: 12/20/20: 4:30pm: headache, injection soreness, tiredness, feeling worn out: started around 8pm l... Read more
1: 12/20/20: 4:30pm: headache, injection soreness, tiredness, feeling worn out: started around 8pm lasting through next day 2: 1/9/21: 9am: headache, injection soreness, tiredness, feeling worn out, chills, body aches, chest tightness: started around 8pm lasting to next day (today)
48 2021-01-09 sensitive skin Within couple of minutes developed uneasiness, some tingling sensation, tachycardia and stomach quea... Read more
Within couple of minutes developed uneasiness, some tingling sensation, tachycardia and stomach queasiness. HR was 156, sats were 100 % on room air. Seemed to subside after 30 minutes . However throughout the rest of the day, waves of similar symptoms recurred predominantly tachycardia and GI along with skin sensitivity. Overnight did ok, but the following morning, again re urged with sustained tachycardia at which time sought ED evaluation. Had one episode in ED with HR in 151, other vital signs maintained. Received solumedrol and Benadryl. After treatment and monitoring without recurrence, discharged home on prednisone , Benadryl. Ativan if needed.
48 2021-01-10 redness, injection site pain I waited 15 minutes and was fine. As I was driving to my work, my injection site began to hurt sever... Read more
I waited 15 minutes and was fine. As I was driving to my work, my injection site began to hurt severely and I felt my throat swelling, it became increasingly difficult to swallow. My tongue felt larger and my lips and face began to feel numb. I felt flushed and I became tachycardic. It lasted about 45 seconds and then waned and then would flare again. I was able to speak and called my husband (a physician) who stayed on the phone with me while I drove to the hospital. I went straight to an outpatient unit and was given hydrocortisone IV, loratidine PO and famotidine. By the time I was on the unit, my throat only felt slightly tight with tachycardia down to 103. Following the injection of steroids, I only had one further flare of throat tightness and tachycardia that was transient lasting 30-40 seconds. Everything resolved within 40 minutes of receiving therapy. Of note, I apparently had erythema on the anterior of my neck which corresponded to the area of throat tightness.
48 2021-01-10 itchy rash Itchy rash like break out on left side lower back
48 2021-01-10 injection site swelling, injection site redness Low grade fever 100.5, headache, severe body aches, redness and swelling at the site of injection.
48 2021-01-10 injection site pain Patient experienced low grade fever, chills, headache and soreness at injection site.
48 2021-01-10 injection site pain, pain of skin Patient report bones hurting, skin hurting, eyes and scalp hurts, chills, pain at injection site and... Read more
Patient report bones hurting, skin hurting, eyes and scalp hurts, chills, pain at injection site and fever, night sweats and spreading pain throughout the body. Also reporting weakness
48 2021-01-11 rash I am having bad rash all over; I started getting in middle in my back and now it just everywhere; Th... Read more
I am having bad rash all over; I started getting in middle in my back and now it just everywhere; This is a spontaneous report from a contactable consumer reporting for herself. A 48-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in the right arm on 03Jan2021 at single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient experienced bad rash all over; she started getting in middle in her back and now it just everywhere on 03Jan2021 shortly after vaccination with outcome of unknown. The patient was doing anti-histamine and hydrocortisone cream as treatment. Information on the Batch/Lot number has been requested.
48 2021-01-11 injection site pain L axillary lymph node swelling and pain ( shot was in L deltoid injection site_)
48 2021-01-11 itchy skin Patient got Pfizer COVID-19 vaccine and had vomiting x 4 and pruritus 15 minutes after administratio... Read more
Patient got Pfizer COVID-19 vaccine and had vomiting x 4 and pruritus 15 minutes after administration. She was given Benadryl, Pepcid, Solumedrol with symptom relief. She did not require epinephrine.
48 2021-01-11 redness Patient states that she felt the vaccine go through her body. She says that after about 20 minutes s... Read more
Patient states that she felt the vaccine go through her body. She says that after about 20 minutes she developed dizziness and throat tightness. She developed erythema across her chest. BP 180/108. O2 sats 98%. No SOB or difficulty breathing
48 2021-01-11 skin irritation, hives, itchy skin itching; irritation; hives/they are welty feeling and looking; This is a spontaneous report from a c... Read more
itching; irritation; hives/they are welty feeling and looking; This is a spontaneous report from a contactable nurse. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, from 02Jan2021 16:45 to 02Jan2021 16:45 at 0.3 mL, single for covid-19 immunization. Medical history reported as "none". There were no concomitant medications. The patient noticed hives on the back of her legs this morning 05Jan2021. She has taken oral Benadryl which took all the itching and irritation away but the hives are still there. Further described as "they are welty feeling and looking". She added that she was not scheduled for the second injection yet, they told her to wait for an email to arrive for her to set it up. She has informed her primary HCP of her hives. Outcome of events itching and irritation was recovered whereas the patient had not recovered from hives at the time of this report.
48 2021-01-12 hives (1035 VAC. ADMINISTERED); 1415- RETURNED TO VACC. CENTER- C/O RT ARM VAC. SITE REACTION OF HIVES. E... Read more
(1035 VAC. ADMINISTERED); 1415- RETURNED TO VACC. CENTER- C/O RT ARM VAC. SITE REACTION OF HIVES. EMS ON SCENE. VS: 98.5 F, 02 SAT: 96% R.A.; P: 74; BP: 159/85; 1422: NO C/O. VSS. 1426: LEFT AND WENT TO ER.
48 2021-01-12 injection site pain Approximately 8 hours after receiving the vaccine, I started to have body aching and intense right a... Read more
Approximately 8 hours after receiving the vaccine, I started to have body aching and intense right arm pain where I received the injection. That evening/night the symptoms progressed to headache and severe chills through the night.
48 2021-01-12 shingles Developed Shingles rash on 1/23/2020
48 2021-01-12 injection site pain Fever, chills, body aches, headache, injection site pain, swollen lymph nodes left axilla
48 2021-01-12 injection site pruritus Patient complained of itchy feeling to the left deltoid area of injection site. Patient took band-ai... Read more
Patient complained of itchy feeling to the left deltoid area of injection site. Patient took band-aid off and stated she has a history of itching with adhesives prior. Alert and oriented x3. Respirations easy and unlabored. Skin pink warm and dry. Denies any SOB, feeling of doom, etc. Sipped on H2O without difficulty swallowing. Upon inspection of injection site, no swelling, rash, hives, etc. Denies N/V.
48 2021-01-12 injection site pruritus Patient received dose of vaccine at 1630. At this time, Alert and oriented x 3, respirations easy an... Read more
Patient received dose of vaccine at 1630. At this time, Alert and oriented x 3, respirations easy and unlabored, skin pink warm and dry, denies any distress/discomfort. At 1640, patient complained of itching at injection site. Patient stated she has a history of developing itchy feeling due to adhesive from bandages. Patient removed the bandage. RN administering IM injection inspected site: no swelling, rash, hives, or other s/s of inflammation. Patient still alert and oriented x 3, respirations easy and unlabored, skin pink warm and dry, denies any feeling of doom, nausea, vomiting, shortness of breath, elevated heart rate, etc. RN administering injection gave patient an ice pack to apply to left upper arm. Monitoring patient. Patient sitting in chair in vaccine clinic waiting room area. Sipping on H2O due to complaint of feeling thirsty. No difficulty swallowing water. EMS called to Vaccine Clinic for unrelated issue. Once EMS on scene, patient further evaluated by EMS (Biox 98%). Patient asking to be transported to ER. EMS taking patient per patient request.
48 2021-01-12 itchy skin Some itching during stay started 10 minutes after observation period started. kept 45 min. improved ... Read more
Some itching during stay started 10 minutes after observation period started. kept 45 min. improved after went home. Declined need for ED visit.
48 2021-01-13 vaccination site pain Day 1-3 Injection site pain; Muscle pain; Joint pain; Headaches; Dizziness; Nausea; Unable to raise ... Read more
Day 1-3 Injection site pain; Muscle pain; Joint pain; Headaches; Dizziness; Nausea; Unable to raise my arm/arm weakness; Pain was at a 10 and I had to go to the ER for care; Fatigue/tiredness; This is a spontaneous report from a contactable other HCP (patient). A 48-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK5730), on 30Dec2020 14:15 at single dose in Left arm for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included Breast cancer, Hypertension (HTN), high cholesterol, lymphedema, endometriosis, hysterectomy, myomectomies x 2, anxiety, seasonal allergies, hx of pleurisy x 3. Known allergies included adhesive glue in tape and bandaids, pollen, dust, pet dander. The patient was not pregnant at the time of vaccination. Concomitant medication included escitalopram, losartan potassium 50 mg, anastrozole (ARIMIDEX). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Day 1-3 Injection site pain Day 6-7-muscle pain, joint pain, headaches, dizziness, nausea, unable to raise my arm/arm weakness, pain was at a 10 and had to go to the ER for care, fatigue/tiredness. All the events were reported onset on 06Jan2021 18:00. AE resulted in Emergency room/department or urgent care. Received Morphine, Muscle relaxer, steroid via IV, RX as treatment. The events were assessed non-serious.
48 2021-01-13 injection site pain H/A, low grade fever up to 100.0, chills, muscle and body aches, pain at site, pain in front underar... Read more
H/A, low grade fever up to 100.0, chills, muscle and body aches, pain at site, pain in front underarm area of affected side. Symptoms have lasted from about 10 hours after the dose and are continuing now (82 hours after the dose)
48 2021-01-13 rash Immediate flushing followed by HTN and rash. Became dizzy and throat "tightness". Was surprised at... Read more
Immediate flushing followed by HTN and rash. Became dizzy and throat "tightness". Was surprised at the reaction since she is ex-military and had received a full complement of vaccine for overseas deployment with no issues.
48 2021-01-13 rash Patchy red rash extending to forearm
48 2021-01-13 redness Patient was given the Covid 19 vaccine and was being monitored following vaccination. Within 15 minu... Read more
Patient was given the Covid 19 vaccine and was being monitored following vaccination. Within 15 minutes her upper lip started to swell and redness in the face. Blood pressure was monitored and was high ( around 230/110). Pulse ox was put on her finger. Oxygen levels were stable. Gave patient two benedryl tablets. No throat closing or trouble breathing. Patient went with wife to ER. From what I am told, patient given steroids in the hospital. She was released a few hours later and is at home now. Patient is currently stable at home.
48 2021-01-13 shingles Shingles outbreak 5 days after vaccination; This is a spontaneous report from a contactable other he... Read more
Shingles outbreak 5 days after vaccination; This is a spontaneous report from a contactable other healthcare professional. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0140), intramuscular on 22Dec2020 at single dose on the right arm for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient previously took morphine and experienced allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. COVID-19 vaccine was administered in the hospital. The patient experienced shingles outbreak 5 days after vaccination on 27Dec2020. The event was assessed as non-serious. Acyclovir pills were given as treatment. Since the vaccination, the patient has not been tested for COVID-19. It was also reported that "Did the adverse event result in any of the following?: Doctor or other healthcare professional office/clinic visit". Outcome of the event was not recovered.
48 2021-01-13 injection site pain, skin warm got vaccine yesterday. 4 am this morning staff wake up with warm and chill, injection site so painfu... Read more
got vaccine yesterday. 4 am this morning staff wake up with warm and chill, injection site so painful, headache and body ache. Took a day off today.
48 2021-01-13 injection site pain headache, tiredness, extreme pain at injection site
48 2021-01-13 redness knot developed behind left ear, swelling and redness in lower part of face; confusion and cognition ... Read more
knot developed behind left ear, swelling and redness in lower part of face; confusion and cognition issues; dizziness
48 2021-01-14 injection site pain Extreme fatigue, strong headache, pain on injection site, muscle pain all over the body
48 2021-01-14 hives Hives on neck, chest, and back; This is a spontaneous report from a contactable consumer (patient). ... Read more
Hives on neck, chest, and back; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration in left arm, on 07Jan2021 at 10:15, at a single dose, for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications included ethinylestradiol/ ferrous fumarate/ norethisterone acetate (LO LOESTRIN FE), prednisone, azithromycin (Z-PAK), and guaifenesin (MUCINEX). The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital. On 07Jan2021 (10:45), the patient experienced hives on neck, chest, and back starting about 30 minutes after the vaccine was received. It is 11Jan2021 and the patient still have them. The event was considered non-serious. Treatment was received for the adverse event including diphenhydramine hydrochloride (BENADRYL). Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the event.
48 2021-01-14 redness Lightheaded briefly at about 15 minutes. Lips tingling and red, chest and neck hot and very flushed... Read more
Lightheaded briefly at about 15 minutes. Lips tingling and red, chest and neck hot and very flushed at about 25 minutes. Feeling winded at about 30 minutes, lips very slightly blue-ish. Vitals were all normal and no treatment was given. Approx six hours later I experienced a "lump in my throat" for about two to three hours - took Benadryl, which resolved it. Also around five or six hours later ordinary side effects began - fatigue, aches, headache, sore arm. These all resolved by the following morning.
48 2021-01-14 hives, rash, itchy skin, injection site redness, redness Patient states she noticed a welt on her arm 3 days after receiving the 2nd dose of the vaccine. She... Read more
Patient states she noticed a welt on her arm 3 days after receiving the 2nd dose of the vaccine. She tried applying ice on the most red part on the arm but the swelling continued to grow. Then she started applying heat in addition to applying HPR+ cream that she uses for urticaria. The only thing that the patient stated that helped a little was the ice pack. The patient ended up going to the emergency department on 1/14/2020 for the rash / welt that developed beyond her arm and to the neck and eyelid area which she described as itchy. The patient was prescribed a 4 day prednisone 50mg daily course along with Benadryl as needed and Pepcid 40mg daily which she states have helped alleviate the itchiness but has not completely resolved yet as of today 1/15/2020. Per ED note, patient presented with mild erythema around the injection site and non-specific rash to the neck. Patient has clear speech and no oral swelling and no signs of anaphylaxis. Patient discharged home in stable condition and advised to follow up with primary care doctor in 2-3 days.
48 2021-01-14 sensitive skin Per patient: I received the 2nd vaccine on 1/6/2021. That night, I developed a headache. By Thursday... Read more
Per patient: I received the 2nd vaccine on 1/6/2021. That night, I developed a headache. By Thursday morning, I was aching all over and still had a headache. The aches were so severe that I was unable to tolerate anything or anybody touching me. By that afternoon, I was weak and fatigued. I was sent home by my director and by that evening I had developed a temp of 101.0. Friday morning, I was not feeling any better so I went to Urgent Care at around 0800. COVID test was negative but possibly too early to detect. Here we are today and I am still having body soreness that has become unbearable. I went to the walk-in clinic here at the hospital and have now been told that I will have to be admitted based on my lab results that indicates rhabdomyolysis.
48 2021-01-14 rash, itchy skin Slight rash, itchy all over
48 2021-01-14 injection site pain, injection site redness, injection site swelling, injection site pruritus Within 24 hrs of injection, I had chills and headaches, no fever; these went away after 24 hrs, then... Read more
Within 24 hrs of injection, I had chills and headaches, no fever; these went away after 24 hrs, then my injection site on my L arm was swollen and red the following day after injection, my arm was sore. On the 13th of Jan, I was at work from 7am-7pm and my arm was even more swollen, sore, itchy and reddish, no fever, I was still able to work, but my L axillary area was sore the whole day. I went home and took a shower and noticed that my L armpit was swollen, like the size of a tennis ball! No redness, no fevers but sore and discomforting due to the swelling.
48 2021-01-14 redness, skin warm day 1- no side effects Day 2- low grade temp, very sore arm, red, swollen, chills, felt lethargic, w... Read more
day 1- no side effects Day 2- low grade temp, very sore arm, red, swollen, chills, felt lethargic, woke up in wet clothes from sweat, headache, runny nose Day 3- sore arem, red and swollen, warm to touch, felt lethargic day 3- arm just red and warm to touch. big red circle where shot was given day 4- sitting down and out of nowhere a sharp pain felt in back by neck and shoulders. could not move my neck. arm still a little red but not warm to touch. swelling went down. (went to ER on day 4. blood work and xrays were negative for anything. was given muscle relaxer.) day 5 sore muscles but on muscle relaxer to help day 6 until day 10 - just fatigue and sore muscles/joint pain but tolerable.
48 2021-01-14 itchy skin itchiness (like something crawling in my face and extremities) all over intermittently lasted 2 days... Read more
itchiness (like something crawling in my face and extremities) all over intermittently lasted 2 days; This is a spontaneous report from a contactable nurse. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration, at the left arm on 23Dec2020 09:30 at single dose for COVID-19 immunization at a hospital. Medical history included dry eyes, carcinoma in situ, and procedure of complete hysterectomy. The patient was not pregnant at the time of vaccination. Concomitant medications included camellia sinensis extract (GREEN TEA), ciclosporin (RESTASIS), estradiol (VIVELLE DOT). The patient previously took augmentin and experienced allergies. The patient experienced itchiness (like something crawling in my face and extremities) all over intermittently lasted 2 days on 23Dec2020 09:30 and was treated with cetirizine hydrochloride (ZYRTEC) x1 on the second day. The patient recovered from the event on 25Dec2020.
48 2021-01-15 shingles, rash 1/8 back pain, 1/9 lesion L flank, 1/11 Md prescribed acyclovir for shingles, 1/13 rash progress tow... Read more
1/8 back pain, 1/9 lesion L flank, 1/11 Md prescribed acyclovir for shingles, 1/13 rash progress toward spine, 1/15 spots under navel L side, blood test comes back negative for shingles On 1/7 son dx covid
48 2021-01-16 injection site pain @1106 on 1/16/21 experienced arm tenderness at injection site. @1400 on 1/16/21 experienced head... Read more
@1106 on 1/16/21 experienced arm tenderness at injection site. @1400 on 1/16/21 experienced headache and took ibuprofen and headache resolved about 1 hour later @2130 on 1/16/21 began to experience chills and general malaise and another headache, took ibuprofen. @0130 on 1/17/21 woke up sweating, with a headache, continued malaise, and chills, took ibuprofen @0730 on 1/17/21 woke up with headache, took ibuprofen @1300 on 1/17/21 fatigue, chills and malaise returned. Still present at time of this submission. Rest and ibuprofen have provided minimal relief.
48 2021-01-16 vaccination site pain A metallic taste when through my mouth & got my mouth dry as soon as they where putting the vaccinat... Read more
A metallic taste when through my mouth & got my mouth dry as soon as they where putting the vaccination. Then I got a really bad headache & very nauseas within 5 min of getting the vaccine. I had pain on the vaccine area. I also felt very tired very exhausted about 4 or 5hrs later. I started getting chills & achiness started the next day on 12/24/2020. On 12/25/2020 I felt nauseas, still had the chills, headaches, still felt fatigue, achiness, sore throat & also had diarrhea. I had all this symptoms all the way till 12/29/2020. Seen doctor on 12/28/2020 and they decided I should get tested for Covid.
48 2021-01-17 injection site pain Chills, muscle pain, tiredness, injection site pain, feeling malaise
48 2021-01-17 injection site redness, injection site pain Fever day after vaccine pain redness soreness at injection site body aches fatigue fever up to 102.4... Read more
Fever day after vaccine pain redness soreness at injection site body aches fatigue fever up to 102.4 Nausea loss of appetite headache
48 2021-01-17 hives Hives and welts with itching starting around the mouth, under the arms, around outside of both brea... Read more
Hives and welts with itching starting around the mouth, under the arms, around outside of both breasts and wrapping around the back for aprox 4 days with some shortness of breath at onset. After day 4 just areas of some hives under arms a bit.
48 2021-01-17 rash, itchy skin I had a full body sensation of being hot, a little dizzy, not well, I figured it was waiting in a la... Read more
I had a full body sensation of being hot, a little dizzy, not well, I figured it was waiting in a large room that was busy with my mask, jacket and glasses on, I calmed down but did not feel well. I walked to my car, my fingers were a little tingly, then when I took my mask off the left side of my face was swelling, tingly, red (I have rosacea- but this was different) I did not panic, but I knew something was wrong. I decided to drive to the hospital instead of driving home, the valet said my face was swelling. I went to the ER - was given Pepic and Benadryl via an IV - I was there for observation - as I was waiting for my medication, I began to feel itchy at the base of my neck and on my chest
48 2021-01-17 itchy skin, redness On Tuesday (1/12/21) night face and neck started itching and burning. Face was starting to swell an... Read more
On Tuesday (1/12/21) night face and neck started itching and burning. Face was starting to swell and neck was red and had small bumps on it. Took some Benadryl and went to bed woke up this morning and eyes were swollen and face was a little worse. No record that patient sought medical attention or visited the ED. Patient reported swelling and itching went resolved the weekend of 1/16/21.
48 2021-01-18 redness ear congestion Bilateral hand swelling, redness BP 132/92 HR 107 P 70 99% RA
48 2021-01-19 injection site pain Chills, Fever 100.6, Joint/Muscle Pain, Fatigue, Injection Site Arm Pain, Abdominal Pain, Unable to... Read more
Chills, Fever 100.6, Joint/Muscle Pain, Fatigue, Injection Site Arm Pain, Abdominal Pain, Unable to work.
48 2021-01-19 itchy skin Client received vaccine at end of our clinic day around 4:05 pm. No history of severe allergies, onl... Read more
Client received vaccine at end of our clinic day around 4:05 pm. No history of severe allergies, only prior sensitivity to Avocado. During clients 15 minute wait she stepped outside complaining of being hot. A nurse provided water for client, as well as juice. She stated she felt better. Nurse accompanied her back in side, and went over other signs and symptoms of anaphylaxis. Client stated she was not experiencing any of those symptoms and that she felt better. When her wait was complete, she walked to the coat room with other employees, and her throat and ears began to itch, and she was coughing to help itch her throat. At this time the vaccine director was alerted and anaphylactic protocol was initiated. EMS was called- the time was 4:37 pm, pulse was 80, blood pressure was 178/108. 4:39- client refused epi, so 1mL/50Mg, IM Benadryl was given in the right deltoid. Simultaneously, a tourniquet was placed above the vaccine site on the left deltoid. Distal pulses monitored in left arm every 5 minutes. 4:41 itching and coughing increased, client agreed to Epi. 0.3 mg Epi pen given in right thigh. EMS arrive and transported client to hospital for observation.
48 2021-01-19 injection site pain Fever, body aches, nausea, vomiting, injection site pain
48 2021-01-19 itchy skin, rash HEADACHE, TIRENESS, ITCHING, BURNING SENSATION OF THE SKIN, MILD FINE, GENERALIZED SYMETRICAL RASH, ... Read more
HEADACHE, TIRENESS, ITCHING, BURNING SENSATION OF THE SKIN, MILD FINE, GENERALIZED SYMETRICAL RASH, WORSE IN ARMS, CHEST AND ABDOMEN. NOW NO HEADACHE/PAIN IN INJECTION SITE, BUT CONTINUES WITH RASH, BURNING SENSATION AND ITCHING DESPITE SOLUMEDROL INTRAVENOUS ON 10/13/2020 AT DOCTOR'S OFFICE, HYDROXYZINE 25 MG THREE TIMES A DAY, BETAMETHOSNE CREAM SINCE 01/13/2020 AND PREDNISONE 50 MG BY MOUTH DAILY SINCE 1/18/2020
48 2021-01-19 vaccination site pain Injection soreness; headache; tiredness/feeling rundown; This is a spontaneous report from a contact... Read more
Injection soreness; headache; tiredness/feeling rundown; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249) on 20Dec2020 16:30 at single dose in left arm COVID-19 immunization. Medical history included Allergies to Sulfa, Factor IV Leiden, diabetes. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN), colecalciferol (VITAMIN D), lisinopril and Multivitamin (unspecified) . On 20Dec2020 at 20:00 the patient experienced injection soreness, headache, tiredness/feeling rundown. No treatment given and patient recovered from all the events on an unknown date. Patient was tested pot vaccination: a Nasal Swab was done on 29Dec2020 and was negative. On 09Jan2021 at 21:00 patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3249) at single dose in Left arm for COVID-19 immunization.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021015299 same patient, different event and vaccine
48 2021-01-19 rash, injection site pruritus Site: Itching at Injection Site-Severe, Systemic: Anaphylaxis-Medium, Systemic: Rash (other than inj... Read more
Site: Itching at Injection Site-Severe, Systemic: Anaphylaxis-Medium, Systemic: Rash (other than injection site)-Medium
48 2021-01-19 rash body rash, lip swelling and tingling
48 2021-01-19 vaccination site pain injection site pain; headache; body aches; chills; joint pain; T 99.3; L axillary swollen lymph node... Read more
injection site pain; headache; body aches; chills; joint pain; T 99.3; L axillary swollen lymph node; administration date=24Dec2020,dose number=1/administration date=11Jan2021, dose number=2; administration date=24Dec2020,dose number=1/administration date=11Jan2021, dose number=2; This is a spontaneous report from a contactable nurse reported for herself. The 48-year-old female patient (not pregnant) received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) , via an unspecified route of administration at left arm on 11Jan2021 16:15 at single dose for covid-19 immunisation. Medical history included none, had no allergies to medications, food, or other product. Concomitant medication included ethinylestradiol/norgestimate (ORTHO TRI-CYCLEN). Patient previously received first dose BNT162B2 ( lot number: EK5730) , via an unspecified route of administration at right arm on 24Dec2020 at 08:30Am at single dose for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Jan2021 04:00AM, 12hrs after 2nd dose injection she experienced injection site pain, headache, body aches, chills, joint pain, T 99.3, L(Left) axillary swollen lymph node; Symptom improvement with Tylenol and Ibuprofen. 48hrs later(14Jan2021)- all symptoms resolved except left axillary swollen lymph node. There is no covid prior vaccination. Patient had covid tested post vaccination, rapid antigen via nasal swab on 12Jan2021 with negative result. Treatment (Tylenol and Ibuprofen) were taken as a result of all events. Outcome of left axillary swollen lymph node was recovering, of injection site pain, headache, body aches, chills, joint pain, T 99.3 was recovered on 14Jan2021. Events were non-serious by reporter.
48 2021-01-20 injection site pain, injection site nodule Arm very sore and swollen with "knots" near injection site starting 1/4 and continuing through 1/21.... Read more
Arm very sore and swollen with "knots" near injection site starting 1/4 and continuing through 1/21. Took tylenol at onset and after seeing PCP instructed to use low-dose ibuprofen and voltaren cream. PCP has considered possibility that injection technique may be responsible for prolonged symptoms.
48 2021-01-20 vaccination site pain, vaccination site swelling Fever 100.5; chills; joint pain; nausea; headache; tachycardia; shortness of breath; dizziness; pain... Read more
Fever 100.5; chills; joint pain; nausea; headache; tachycardia; shortness of breath; dizziness; pain & swelling at injection site and up my neck; pain & swelling at injection site and up my neck; worst patient have ever felt, felt like body had been poisoned; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1686 and expiry date: unknown), via an unspecified route of administration on the left arm on 09Jan2021 at a single dose for COVID-19 immunization. Medical history included heart disease, diabetes and allergies to sulfa antibiotics. Patient's concomitant medications were not reported. The patient received the first dose on 21Dec2020 (lot number: EH9899) on the left arm. The patient experienced fever 100.5, chills, joint pain, nausea, headache, tachycardia, shortness of breath, dizziness, chills, pain & swelling at injection site and up my neck, inability to lift even a water bottle without having pain on 10Jan2021. In summary it was the worst patient have ever felt, felt like body had been poisoned. Outcome of the events was recovering. No treatment was given for the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No follow up attempts are possible. No further information is expected.
48 2021-01-20 injection site pain Fever 37.3 C and 37.6 C Muscle pain Chills Headache Pain in the left arm at the site of injection Sy... Read more
Fever 37.3 C and 37.6 C Muscle pain Chills Headache Pain in the left arm at the site of injection Symptoms started 12 hours after the injection. They last about 12-14 hours. I took aspirin, ibuprofen and Tylenol.
48 2021-01-20 itchy skin, rash, redness Flushing accompanied by redness started about 25 minutes after shot while driving home. Chest heavin... Read more
Flushing accompanied by redness started about 25 minutes after shot while driving home. Chest heaviness without SOB or difficulty swallowing. Itching began starting with face then neck, chest and torso. Itching then spread to the whole body with a patina rash appearing on the face, neck and chest a few hours later. Immediately took dose of liquid Benedryl upon arriving home. Followed up by dose of Zyrtec. Continued monitoring sxs throughout the evening. Took additional 2 doses of Benedryl with a dose of Singular. Sxs severity lessoned though the night and into the next day. Mild itching and a few patches of the rash remained the next day 1/20/21. Continued taking antihistamine and allergy medication. All sxs have resolved as of 1/21/21
48 2021-01-20 vaccination site pain Injection pain; headache; tiredness/feeling wornout; chills; body aches; chest tightness; This is a ... Read more
Injection pain; headache; tiredness/feeling wornout; chills; body aches; chest tightness; This is a spontaneous report from a contactable consumer. A 48-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3249), via an unspecified route of administration in the left arm on 09Jan2021 at 09:00 at 48-years-old at a single dose for COVID-19 immunization. Medical history included Sulfonamide allergy, Factor V Leiden mutation, diabetes; all from an unknown date and unknown if ongoing. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), colecalciferol (VITAMIN D [COLECALCIFEROL]), lisinopril (MANUFACTURER UNKNOWN), vitamins nos (MULTIVITAMIN); all taken for an unspecified indication from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: injection pain on 09Jan2021 20:00 with outcome of recovering , headache on 09Jan2021 20:00 with outcome of recovering, tiredness/feeling wornout on 09Jan2021 20:00 with outcome of unknown, chills on 09Jan2021 20:00 with outcome of recovering, body aches on 09Jan2021 20:00 with outcome of recovering, chest tightness on 09Jan2021 20:00 with outcome of recovering. The patient did not receive other vaccines in four weeks; there was no treatment for the adverse events; there was no prior COVID vaccination; there was no post vaccination COVID test.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021015284 same patient, different event and vaccine
48 2021-01-20 redness, rash Mild at present, no treatment, just notifying of redness to chest.
48 2021-01-20 vaccination site pain Severe headache; chills; body pain; intermittent nausea; extreme fatigue; brain fog; arm pain at inj... Read more
Severe headache; chills; body pain; intermittent nausea; extreme fatigue; brain fog; arm pain at injection site; This is a spontaneous report from a non-contactable nurse (patient). A 48-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as Pfizer BioNTech COVID VACCINE; lot number: EL3249; expiration date: unknown), via an unspecified route of administration left arm on 08Jan2021 16:00 at a single dose for covid-19 immunization. Medical history included asthma, pain and allergies to sulfa drugs. Concomitant medication included montelukast sodium (SINGULAIR), estradiol, meloxicam and fexofenadine (FEXOFENADINE). The patient received her first dose of bnt162b2 (BNT162B2 reported as Pfizer BioNTech COVID VACCINE; lot number: EJ1685) via an unspecified route of administration left arm on 19Dec2020 04:45 PM at a single dose for covid-19 immunization. The patient has not received other vaccines in four weeks. The received her vaccine in a hospital. On 08Jan2021 5:30 PM, the patient experienced severe headache chills, body pain, intermittent nausea, extreme fatigue, brain fog and arm pain at injection site. No treatment was received from the adverse events. The patient was not diagnosed with Covid prior to vaccination and has not been tested for Covid post vaccination. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
48 2021-01-21 redness Patient was given Covid-19 vaccine. No previous reactions to vaccines, allergy to Nitro (swelling). ... Read more
Patient was given Covid-19 vaccine. No previous reactions to vaccines, allergy to Nitro (swelling). She was being monitored and within 15 minutes her upper lip was swelling. She also had redness on her face. Oxygen levels were stable. Blood pressure monitored and was high (200s/ low 100s). Gave patient 2 tablets of Benadryl. Patient had no throat swelling or trouble breathing. She was taken to the local ER. At the ER, the patient was given steroids. She was release from the ER within a few hours. She is currently at home and is stable.
48 2021-01-22 injection site pain, injection site redness, injection site nodule, injection site hardening, injection site pruritus, injection site swelling Day of vaccination: headache and right side face tingling. Followed by 2 days of fatigue. Day 9 pos... Read more
Day of vaccination: headache and right side face tingling. Followed by 2 days of fatigue. Day 9 post vaccination: raised redness, hard knotted area, pain and itching at injection site. And 2-3? diameter around injection site.
48 2021-01-22 rash Rash, benadryl, 12 hours
48 2021-01-22 itchy skin tingling/itching on back and neck, shoulders arms; pt denies SOB, wheezing, rash, hives, nausea, sta... Read more
tingling/itching on back and neck, shoulders arms; pt denies SOB, wheezing, rash, hives, nausea, states "it may be nerves"; recommended to take benadryl when getting home; info given
48 2021-01-23 injection site pain Patient returned to clinic 3 weeks after her first dose of the Pfizer COVID19 vaccine to complete th... Read more
Patient returned to clinic 3 weeks after her first dose of the Pfizer COVID19 vaccine to complete the second dose in the series. When nurse asked regarding post vaccination response, patient reported expected muscle soreness at site (right deltoid) for 2 days, however expressed new localized symptoms at the site that began the evening of the second day. Symptoms included pain radiating down the length of right arm, tingling fingers, and weakness in right arm. Patient was able to manage pain with OTC analgesics, however expressed concern with length of the symptom's duration. After 21 days post vaccine administration, she expressed she continues to have pain in right arm when held in certain positions. Nurse took down information, notified supervisor and encouraged patient to follow up with her doctor. Nurse explained to the patient that a report would be completed and that further communication with her could be possible after reporting. Patient was in agreement with plan. Nurse completed assessment and education for second dose finding no contraindications. Patient consented to receiving her second Pfizer COVID19 vaccine in her left arm. Administration was completed in left deltoid with no immediate adverse effects.
48 2021-01-23 rash papular, skin warm Rash, hot raised grew in size over 2 days
48 2021-01-23 redness chest tightness, cough, runny nose, nausea, dizzy, red chest, high pitch voice, difficulty speaking.... Read more
chest tightness, cough, runny nose, nausea, dizzy, red chest, high pitch voice, difficulty speaking. anaphylaxis EKG monitoring, IVF, IM Epinephrine, IV Benadryl, IV Pepcid, Albuterol dual neb, CXR, Labs sent home after 6 1/2 hours of treatment and monitoring. Sent home with Epi pen
48 2021-01-24 injection site swelling 23 Jan-Saturday-severe Headaches Sunday-24th Jan-Left under arm-swollen lymph nodes 25th Jan -Severe... Read more
23 Jan-Saturday-severe Headaches Sunday-24th Jan-Left under arm-swollen lymph nodes 25th Jan -Severe HA, site of injection-left deltoid-swollen-swollen behind neck-lymph nodes-she said Motrin-HELPS
48 2021-01-24 injection site pain Fever 102, + covid test 2 weeks ago, Body aches, chills, fatigue, headache, BOB, sweats, Soreness at... Read more
Fever 102, + covid test 2 weeks ago, Body aches, chills, fatigue, headache, BOB, sweats, Soreness at injection site.
48 2021-01-24 injection site pain Fever, body aches, SOB, fatigue, sweats, Injection site soreness.. Was Covid + 2 weeks prior to vacc... Read more
Fever, body aches, SOB, fatigue, sweats, Injection site soreness.. Was Covid + 2 weeks prior to vaccine.
48 2021-01-24 rash, itchy skin, hives ITCH, RASH, THEN HIVES TREATED WITH epi
48 2021-01-25 rash Chills, rash, sore throat, low grade fever starting one week after the vaccine
48 2021-01-25 vaccination site pain Left arm pain in armpit; swollen lymph nodes; led to whole left arm pain; This is spontaneous report... Read more
Left arm pain in armpit; swollen lymph nodes; led to whole left arm pain; This is spontaneous report from a contactable nurse (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on left arm single dose for COVID-19 immunization on 10Jan2021, 09:30 AM, at 48-year-old. Medical history and concomitant medication were not reported. No known allergies. The patient did not have COVID prior vaccination. The patient did not have other vaccine in four weeks. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on left arm for COVID-19 immunization on 20Dec2020, 05:30 PM, at 48-year-old. On 11Jan2021, 05:00 PM, the patient had left arm pain in armpit with swollen lymph nodes, led to whole left arm pain. No treatment received. The patient was not tested for COVID post vaccination. Action taken for BNT162B2 was not applicable. Outcome of the events was not resolved. Information on the lot/batch number has been requested.
48 2021-01-25 itchy skin Pruritus; paresthesia across body, particularly extremities; This is a spontaneous report from a con... Read more
Pruritus; paresthesia across body, particularly extremities; This is a spontaneous report from a contactable physician. A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on 13Jan2021 10:15 at a single dose on left arm for COVID-19 immunization. Medical history included hypertension (HTN). Concomitant medication included amlodipine besilate (NORVASC) and metoprolol tartrate (LOPRESSOR). About 8 hours after immunization, patient started to have pruritus and paresthesia across body, particularly extremities on 13Jan2021 06:00 PM. Therapeutic measures were taken as a result of the events which included Hydroxyzine Hcl (ATARAX). The outcome of the events was not recovered. The patient was not pregnant. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine in four weeks. AE resulted in Doctor or other healthcare professional office/clinic visit. No covid prior vaccination. Not covid tested post vaccination. Information on the lot/batch number has been requested.
48 2021-01-25 skin tightness, redness Red swollen face, swelling in hands fingers. Face was tight and felt as if it were burning. Claritan... Read more
Red swollen face, swelling in hands fingers. Face was tight and felt as if it were burning. Claritan was provided, issue resolved in about two hours.
48 2021-01-25 itchy skin Same day of injection, recipient felt itching in back of throat, had to keep clearing throat; same d... Read more
Same day of injection, recipient felt itching in back of throat, had to keep clearing throat; same day recipient was seen in the ED with itchiness and dry heaves. Was treated with steroids, Benadryl, and Pepcid. On 1/17/2021 recipient returned to the ED with complaints of shortness of breath and itchy throat; she was unable to take oral steroids
48 2021-01-25 injection site pain Sore Injection Site, Neck Pain, Nausea and Weakness
48 2021-01-25 injection site hives, hives While at vaccine pod patient developed hives on left deltoid and neck/chest region. Patient given B... Read more
While at vaccine pod patient developed hives on left deltoid and neck/chest region. Patient given Benadryl and brought back to first aid tent. Patient developed sore, scratchy throat and headache. No further symptoms before resolve. Give ibprofen.
48 2021-01-25 rash skin rash; possible shingles
48 2021-01-26 rash, injection site pain Client report at this time not having a reaction but did have a runny nose, back pain. fatigue, and ... Read more
Client report at this time not having a reaction but did have a runny nose, back pain. fatigue, and pain at the site on the day following the vaccination (01/24). When asked about rash developing on both legs after vaccination (01/23) that was reported to COVID hotline, she denied having a rash at this time. Per client she spoke with her PCP regarding reported symptoms and have resolved.
48 2021-01-26 rash Developed rash on neck, superior to clavicles bilaterally. Treating with Triamcinolone 0.025% cream... Read more
Developed rash on neck, superior to clavicles bilaterally. Treating with Triamcinolone 0.025% cream topically
48 2021-01-26 redness, itchy skin My eyelids swelled and my face became red/itchy and burn. It's been a week and I'm still experienci... Read more
My eyelids swelled and my face became red/itchy and burn. It's been a week and I'm still experiencing it all.
48 2021-01-26 injection site redness, injection site swelling, injection site pain My right shoulder had intense deep muscle and surface soreness around the injection site that kept ... Read more
My right shoulder had intense deep muscle and surface soreness around the injection site that kept me awake the first night of receiving the first vaccination. The site was slightly swollen and warm to the touch with a few red dots that did not itch. I did use 500mg of Tylonal to help alleviate the pain. Within 35 hours of the first injection, my arm was not as tender or sore to the touch and did not keep me awake at night. Although still sore, 48 hours later, there is no more swelling and the redness and red spots are gone.
48 2021-01-26 rash, rash macular, itchy rash Postvaccination day 2: woke up in the morning with macular rash on upper chest and neck, mildly prur... Read more
Postvaccination day 2: woke up in the morning with macular rash on upper chest and neck, mildly pruritic. No problems with breathing or chest pain. Rash lasted entire day.
48 2021-01-26 hives Sore Arm, Fatigue, General feeling of sick, Hives,
48 2021-01-26 injection site swelling, itchy skin, rash Sudden headache, nausea, then itching all over, rash on chest then stomach. Swollen and redness lik... Read more
Sudden headache, nausea, then itching all over, rash on chest then stomach. Swollen and redness like golf ball size at and around site the next morning. Still itching the next morning after taking Benadryl and Tylenol every 4 hours as suggested by physician.
48 2021-01-26 injection site mass, rash, itchy skin rash knot soreness fatigue headache itching fast heartrate body aches
48 2021-01-26 vaccination site swelling swelling in shot arm; swelling in left side of neck; Facial swelling; The arm, neck, face swelling s... Read more
swelling in shot arm; swelling in left side of neck; Facial swelling; The arm, neck, face swelling seemed to be lymphatic; shoulder swelling; This is a spontaneous report from a contactable healthcare professional (patient). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm on 12Jan2021 09:45 at single dose for COVID-19 immunization. Medical history included nasal sinus allergies (otherwise healthy), some shellfish sensitivities and mouth swelling with some spices allergy from an unknown date and unknown if ongoing. Concomitant medication included clarithromycin (CLARITIN). The patient previously took codeine and experienced itching reaction. The patient stated, "The night of the vaccine I awoke at 1am with moderate amount of swelling in shot arm, swelling in left side of neck and facial swelling on 13Jan2021 01:15 AM. No breathing problems so I did not go to hospital. Some swelling went down with Benadryl. On the second night, swelling came back in same places with neck/shoulder swelling being worse." The patient called her doctor who set up an appointment for 15Jan2021. Sweeping is some better on the third day have continued to take Benadryl, Motrin seemed to make it worse (as reported). The patient further stated, "My doctor has advised me not to take the second dose of Pfizer COVID 19 vaccine due to the swelling going beyond just arm swelling. The arm, neck, face swelling seemed to be lymphatic." all on 13Jan2021 01:15 AM. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment was given to the patient for the event, over the counter medications - Benadryl and Motrin. The outcome of the events was recovering. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events ware considered non serious as it did not result in death, were not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and were not a congenital anomaly/birth defect. The patient was not pregnant.
48 2021-01-27 redness, skin warm Arm was very sore couldn't move it started taking ibuprofen that night. On Sunday arm started turnin... Read more
Arm was very sore couldn't move it started taking ibuprofen that night. On Sunday arm started turning red a size of a softball was extremely red swollen and hot to the touch, shoulder area and under arm pit was swollen and hurt to touch are move. Was informed by employee health to start taking antihistamines (which I already take) so she told me to increase the amount by taking Benadryl as well and icing it on and off for 30 minutes at a time, The people here at my work checked it regularly and slowly it is improving each day as long as I ice and take extra antihistamines.
48 2021-01-27 itchy skin Itching, vomiting, feeling flush, chest tightness
48 2021-01-27 redness Pt developed redness and swelling to neck, along with lightheadedness several minutes after injectio... Read more
Pt developed redness and swelling to neck, along with lightheadedness several minutes after injection. BP, pulse, oxygen saturation and breath sounds were all within normal limits. She denied any dyspnea or difficulty swallowing. EMS was called promptly and pt was given Benadryl 50mg x1 while EMS was en route. Her symptoms remained stable and she was taken to the hospital by Rescue.
48 2021-01-27 hives, bruising Welt on her left groin; Maybe infected lymph node; Skin breakdown; Bruise; Could not walk on right f... Read more
Welt on her left groin; Maybe infected lymph node; Skin breakdown; Bruise; Could not walk on right foot; Ligament in back of right ankle felt injured; This is a spontaneous report from a contactable healthcare professional (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899), intramuscular in left arm, on 22Dec2020 at 10:30, at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital. On 05Jan2021 at 04:45 PM (2 weeks after the first dose), the patient developed a welt on her left groin - maybe infected lymph node, and skin breakdown which later turned into a bruise that improved slowly with cleanse and bacitracin/ neomycin sulfate/ polymyxin B sulfate (NEOSPORIN). Though applied with bacitracin/ neomycin sulfate/ polymyxin B sulfate, the patient was still with visible bruising one week later. A few days later (Jan2021), the patient could not walk on right foot and ligament in back of right ankle felt injured. The patient was administered with the second dose of BNT162B2 (Lot Number: EL3302) on 12Jan2021 in left arm. The patient had not been tested for COVID-19 post-vaccination. The patient was recovering from "Skin breakdown". The patient had not recovered from the remaining events.
48 2021-01-27 itchy skin, rash rash on fash and I believe on scalp that is itchy, tried taking benedryl but it did not make a diff... Read more
rash on fash and I believe on scalp that is itchy, tried taking benedryl but it did not make a difference. shoulders and back also itchy but rash does not appear to have spread there. hands are trembling.
48 2021-01-28 itchy skin 24 hours after vaccine, both arms began to hurt very bad, felt hot and tingly. Shooting pains in bot... Read more
24 hours after vaccine, both arms began to hurt very bad, felt hot and tingly. Shooting pains in both wrists and left knee. Became very dizzy. The pain lasted for about 8 hours then moved into both legs with shooting pains in both ankles. The leg and ankle pain lasted for about 8 hours. Now I am just very sore in all extremities and joints. Moving very slowly compared to my usual. Feel very run down. Also had very itchy arms about 8 hours in only for a few minutes, no rash.
48 2021-01-28 pain of skin, redness FEVER OF 101-103 FOR 24 HOURS.SEVERE ALL OVER BODY PAIN, FEET INFLAMMED UNABLE TO WALK UNTIL PAIN ME... Read more
FEVER OF 101-103 FOR 24 HOURS.SEVERE ALL OVER BODY PAIN, FEET INFLAMMED UNABLE TO WALK UNTIL PAIN MEDICATION (TYLENOL AND IBUPROPHEN) HELPED RELEIVE ENOUGH OF THE PAIN. READ AND SWOLLEN FEET LOWER LEGS. UPPER BACK PAIN LINGERING. TOP OF HEAD PAIN, SCALP PAIN. SEVERITY OF PAIN HAS GONE AWAY, FOOT AND LEG ISSUES HAVE GONE AWAY. UPPER PART OF BODY AND HEAD STILL HURT.
48 2021-01-28 injection site warmth, injection site swelling Fatigue, chills and fever (which I was told about prior) lasting 24 hours but the continued body ach... Read more
Fatigue, chills and fever (which I was told about prior) lasting 24 hours but the continued body aches for 48 hours was horrible and injection spot was very swollen, raised and hot to touch
48 2021-01-28 hives Post injection of 2nd COVID-19 Pfizer dose, pt suddenly vomitted (15 min post injection), had uticar... Read more
Post injection of 2nd COVID-19 Pfizer dose, pt suddenly vomitted (15 min post injection), had uticaria of arms and legs (30 min post injection), and asthma like symptoms such as wheezing, SOB (35min post injection). Diphenhydramine 50mg PO given and pt transferred to ED for observation. In ED, pt received albuterol 0.083% neb, diphenhydramine 25mg IV, famotidine 40mg IV, hydroxyzine 25mg PO, Duoneb 3mL, and Solumedrol 125mg IV. All reactions resolved prior to ED discharge several hours later.
48 2021-01-28 injection site pain Total body joint pain, low grade fever, headache x 16hrs Injection site pain, axillary pain/tenderne... Read more
Total body joint pain, low grade fever, headache x 16hrs Injection site pain, axillary pain/tenderness x 1 week
48 2021-01-28 vaccination site redness, vaccination site warmth, vaccination site mass injected way below her deltoid and at the time of the report it had been a red hot bump; injected wa... Read more
injected way below her deltoid and at the time of the report it had been a red hot bump; injected way below her deltoid and at the time of the report it had been a red hot bump; injected way below her deltoid and at the time of the report it had been a red hot bump; it was inadvertently administered subcutaneously; This is a spontaneous report from a contactable physician (patient). A 48-year-old female patient received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via subcutaneous on 14Jan2021 at single dose for COVID-19 immunization. The relevant medical history was not reported. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) for birth control. The patient had the second dose of the COVID-19 vaccine yesterday (14Jan2021) and it was inadvertently administered subcutaneously. She said that the vaccine was injected way below her deltoid and at the time of the report it had been a red hot bump. She also mentioned that she had 0 symptoms and no muscle paint. She was wondering whether there were recommendations for her disposition. The patient also stated that it was subcutaneous, it was way off, it was not her deltoid at all. The outcome of the event was unknown. Information about Lot/Batch number is requested.
48 2021-01-29 skin warm Cough Throat tongue swell Dizzy Cold/ hot sweats Nausea Given 4 Benadryl immediately Numbness and... Read more
Cough Throat tongue swell Dizzy Cold/ hot sweats Nausea Given 4 Benadryl immediately Numbness and tingling in vaccine arm Went to ER for monitoring Ten minutes after started the worst headache of my life and I get migraines Have had pulse racing and slight chest pains all afternoon Went home after 4 hours observing Got a steroid through IV Fever has started after 12 hours
48 2021-01-30 skin tightness For approximately 8 hours the peripheral portion only (at the hairline) of my face felt tight like a... Read more
For approximately 8 hours the peripheral portion only (at the hairline) of my face felt tight like a mud mask. The sensation went away on it's own with no treatment.
48 2021-01-31 vaccination site pain Fever chills, headache, nausea , vomiting , a large amount of pain from vaccination. The first one n... Read more
Fever chills, headache, nausea , vomiting , a large amount of pain from vaccination. The first one no pain . The second one really hurt maybe due to the person giving it . I had a fever low grade till noon 1/31/21. The scariest was pain and swelling in my lower armpit on my left arm where vaccinated. I found a study that it can happen but I freaked out . 48 after I experienced the lymphnodes swelling the pain went away but still swollen . I think this should be listed as people with a cancer history will freak out if they think their cancer is back . Lymphoma or breast . I aldd also read that vaccinated women need to alert their radiologists before a mammogram as the swollen lymphnodes could mimic Breast cancer and lymphnodes involvement, which would scare women to death . Physicians should be made aware and the public should be iNformed of the above to reduce panic and unnecessary testing .
48 2021-01-31 hives Intermittent hives continuing since 1/9/21 and started 20-25 minutes after administration of vaccine... Read more
Intermittent hives continuing since 1/9/21 and started 20-25 minutes after administration of vaccine.
48 2021-01-31 rash Patient reports a six day hx of constant rash over torso 30 minutes after covid vaccine. denies sob/... Read more
Patient reports a six day hx of constant rash over torso 30 minutes after covid vaccine. denies sob/cp/wheezing/palpitations/swelling of tongue/throat. +pruritic
48 2021-01-31 rash Rash down entire left and right arm
48 2021-01-31 rash Systemic: Rash (other than injection site), Systemic: Fever, Systemic: Generalized Body Aches; sympt... Read more
Systemic: Rash (other than injection site), Systemic: Fever, Systemic: Generalized Body Aches; symptoms lasted 1 day
48 2021-01-31 itchy skin itching left arm right arm neck. Pink on next ee premedicated with Benadryl 1 pm. gave Benadryl 2... Read more
itching left arm right arm neck. Pink on next ee premedicated with Benadryl 1 pm. gave Benadryl 25 mg at 4:23 pm
48 2021-02-01 injection site swelling, injection site pain 15hrs after the covid vaccine felt the chills,slight temp 99.1, body aches, sore on the site, follo... Read more
15hrs after the covid vaccine felt the chills,slight temp 99.1, body aches, sore on the site, following day felt better BUT my injection site still sore all the way to my armpit forward & swollen, today 2/2/21@8pm swollen decreased but still tender.
48 2021-02-01 rash with redness, rash Patient honked horn 10 minutes after receiving vaccine. C/o numbness in left side of face and in le... Read more
Patient honked horn 10 minutes after receiving vaccine. C/o numbness in left side of face and in left hand. No SOB. BP 110/64, HR WNL. 911 called at 3:54PM and 25mg of liquid Benadaryl given orally. Red rash on patient's chest appeared at 3:46 PM, continued numbness. EMS arrived at 3:59PM. Report given and patient transferred to Hospital with normal vital signs and no SOB.
48 2021-02-01 rash papular, itchy skin, rash with redness had sx 27 hours after 2nd vaccine of red raised rash on back, chest and upper neck, itchy, swollen ... Read more
had sx 27 hours after 2nd vaccine of red raised rash on back, chest and upper neck, itchy, swollen lymph nodes on neck and both arm pits on 2/2, very fatigue
48 2021-02-01 vaccination site pain nauseous; mild to moderate arm pain; injection site pain; Pain was from wrist to shoulder; moderate ... Read more
nauseous; mild to moderate arm pain; injection site pain; Pain was from wrist to shoulder; moderate vasomotor symptoms; body aches; This is a spontaneous report from contactable nurse (patient herself). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 10:00 in right deltoid at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included estrogens conjugated, medroxyprogesterone acetate (PREMPRO). On 19Jan2021, patient experienced mild to moderate arm pain in arm that had shot, more than just injection site pain. Pain was from wrist to shoulder. 2-3 hours later moderate vasomotor symptoms followed with body aches. She took celecoxib (CELEBREX)and paracetamol (TYLENOL), body aches got better. 7 hours post injection, she felt nauseous and took ondansetron (ZOFRAN). Outcome of events were unknown. Information on the lot/batch number has been requested.
48 2021-02-02 injection site warmth Client stated she felt a warm sensation going down her left arm. "almost like a hot flash, but just... Read more
Client stated she felt a warm sensation going down her left arm. "almost like a hot flash, but just in my arm". Client continued to be coherent. 4:20 pm B/P 122/90/98 pulse=78 Pulse Oximeter 98% 4:25 pm B/P 122/88 pulse=79 Pulse Oximeter 98% 4:30 pm B/P 128/88 pulse=80 Pulse Oximeter 99% Client stated she felt fine. Released from clinic site. Encouraged to contact medical provider if symptoms returned.
48 2021-02-03 itchy skin, hives Administration date=13Jan2021, dose number=2/ administration date=21Dec2020, dose number=1; Starting... Read more
Administration date=13Jan2021, dose number=2/ administration date=21Dec2020, dose number=1; Starting 36 hr after 2nd dose had 4 days of whole body systemic hives, itching; Starting 36 hr after 2nd dose had 4 days of whole body systemic hives, itching; This is a spontaneous report from a contactable nurse. A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on the Right arm on 13Jan2021 07:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing, hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient had the first dose of BNT162B2 on 21Dec2020. On 15Jan2021 03:00 PM, starting 36 hours after 2nd dose, the patient had 4 days of whole body systemic hives and itching. There were no respiratory symptoms. Therapeutic measures (Pepcid, Zantac, Benadryl oral and cream) were taken as a result of hives and itching. The outcome of the events was recovered on an unspecified date.
48 2021-02-03 skin warm, redness Headache, neck ache, dizziness, hot and red skin. From about 15 minutes after injection lasting for... Read more
Headache, neck ache, dizziness, hot and red skin. From about 15 minutes after injection lasting for 3 hours.
48 2021-02-03 vaccination site warmth, vaccination site redness, vaccination site pain, vaccination site swelling Injection site redness, swelling, warm to touch and hurts; Injection site redness, swelling, warm to... Read more
Injection site redness, swelling, warm to touch and hurts; Injection site redness, swelling, warm to touch and hurts; Injection site redness, swelling, warm to touch and hurts; Injection site redness, swelling, warm to touch and hurts; patient with compromised immune status received bnt162b2; patient with compromised immune status received bnt162b2; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231), via an unspecified route of administration at the left arm on 16Jan2021 09:00 at a single dose for COVID-19 immunization. The patient medical history includes being diagnosed with allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. She had COVID in Nov2020. She did not take any medication when she had it. There were no concomitant medications. The patient received the vaccine on 16Jan2021, and by that evening at 19:00, she started to have a reaction. She experienced injection site redness, swelling, warm to touch and hurts. She went to the doctor on 19Jan2021 and the doctor said it was a reaction from the vaccine. He gave her steroids (Prescribed Medrol dose pack). On 16Jan2021 09:00, a patient with compromised immune status received bnt162b2. The vaccine was administered in a hospital, not in military facility. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events injection site redness, swelling, warm to touch and hurts was not recovered.
48 2021-02-03 rash Patient states she was waiting in post vaccination area when she began to become very anxious. Her h... Read more
Patient states she was waiting in post vaccination area when she began to become very anxious. Her heart was racing, felt hot, rash on chest, and felt throat feel thick. EMS was on site and took vital signs. Transported patient to Emergency Department via ambulance. Benedryl and Prednisone were administered IV. Patient was monitored for 4 hours at Emergency Department. Followed up with patient today. She is continuing to take Benedryl. Feels much better.
48 2021-02-03 rash Rash chest and face. Face and throat swelling. Difficulty swallowing. Taken to ER and given steroid... Read more
Rash chest and face. Face and throat swelling. Difficulty swallowing. Taken to ER and given steroid, benadryl, and pepcid. Systemic affects x3 days. Medications given for a total of 5 days.
48 2021-02-03 vaccination site pain Right eyelid feels heavy; She slept all day Sunday; Extreme fatigue; Flushed feeling; lightheaded/di... Read more
Right eyelid feels heavy; She slept all day Sunday; Extreme fatigue; Flushed feeling; lightheaded/dizzy; lightheaded/dizzy like she was going to pass out; Had a heavy feeling in her throat and chest/Had a heavy feeling on her face- had removed her mask but it still felt like she still had it on; Had a heavy feeling in her chest; Tingling sensation on her lips; Tingling sensation on the right side of her face, and cheek; Severe burning in her right ear; Sore throat on the right side; When she was speaking it sounded like she had a thick tongue; Tongue feels swollen; Pain at the base of her skull on the right side; Pain on the right side of her forehead; Pinpoint pain that went down the right side of her spine; Metallic taste in her mouth; felt off; Pain at the injection site; It was so bad that it would wake her up if she rolled over; This is a spontaneous report from a contactable Nurse reporting for herself. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL3248), via an unspecified route of administration on 15Jan2021 at single dose (Once by injection in the right arm) for COVID-19 immunisation. The patient medical history was not reported. Historical vaccine included Hepatitis B vaccine. There were no concomitant medications. On 15Jan2021, after 15 minutes of monitoring she was fine. 5 minutes later or so (after 20 minutes), she had a flushed feeling and was lightheaded/dizzy like she was going to pass out. She returned to her office. She had someone check her blood pressure which was fine. It was 110/60. Normally it runs low in the 90s. Again, she thought she looked flushed. It was reported she had a heavy feeling in her throat and chest and on her face. She had removed her mask but it still felt like she still had it on. She had brought Benadryl with her, as she has had a reaction to the Hepatitis B vaccine before. She took the Benadryl since she felt off. She thinks this first part of what she experienced triggered everything else. By the time she got home, she had a tingling sensation on the right side of her face, on her lips and cheek. She had severe burning in her right ear. She also had a sore throat on the right side. Heaviness in her throat and chest- resolved late Saturday to early Sunday (Jan2021). Her husband noticed on Friday evening (15Jan2021) when she was speaking it sounded like she had a thick tongue. Saturday morning it was more normal. Her tongue does feels swollen. She also developed pain at the base of her skull on the right side. This started about 2 hours after the vaccine. She had pain on the right side of her forehead. She had pinpoint pain that went down the right side of her spine. She also developed a metallic taste in her mouth. She had pain at the injection site. It was so bad that it would wake her up if she rolled over. On 17Jan2021, she slept all day Sunday and also had extreme fatigue. On 18Jan2021, her right eyelid feels heavy on 18Jan2021. She does not think any of these are serious, but stated they are concerning. Vaccination card does not have the NDC or expiration date on it. Patient asked is getting the second dose of the injection recommend. She is leaning towards no but wanted to see what was recommended. She has reached out to her primary care about this. Outcome of the events flushed feeling, lightheaded/dizzy, lightheaded dizzy, like she was going to pass out was recovered on 15Jan2021. Outcome of the events when she was speaking it sounded like she had a thick tongue was recovered on 16Jan2021; Outcome of the events pain at the base of her skull on the right side, pain on the right side of her forehead, pinpoint pain that went down the right side of her spine, extreme fatigue, pain at the injection site was recovered on 17Jan2021; Outcome of the events Had a heavy feeling in her throat and chest/Had a heavy feeling on her face- had removed her mask but it still felt like she still had it on, and Had a heavy feeling in her chest was recovered on Jan2021. Outcome of the events severe burning in her right ear, sore throat on the ride side, tingling sensation on her lips, tingling sensation on the right side of her face and cheek was recovering. Outcome of the events tongue feels swollen, metallic taste in her mouth, right eyelid feels heavy was not recovered. Outcome of the events it was so bad that it would wake her up if she rolled over, she slept all day Sunday, and felt off was unknown. The reporter considered the events as non-serious. Causality assessment for events for felt off, she slept all day Sunday, It was so bad that it would wake her up if she rolled over was not reported. Causality assessment for all other events was reported as related.
48 2021-02-03 vaccination site pain Site pain; Headache; Nauseous; Cough; Felt congested; No taste or smell; No taste or smell; This is ... Read more
Site pain; Headache; Nauseous; Cough; Felt congested; No taste or smell; No taste or smell; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EF9231; Expiration date was not reported) on 11Jan2021 (09:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included breast cancer and hypertension. The patient's concomitant medications were not reported. On 18Jan2021, the patient had site pain; headache; and was nauseous. On 13Jan2021, the patient had cough. In Jan2021, after the vaccination, the patient had felt congested. In Jan2021, almost two weeks after the vaccination, the patient had no taste or smell. The reported events had resulted in the emergency room/department or urgent care. The outcome of the events, 'site pain', 'headache', 'nauseous', 'cough', 'felt congested' and 'had no taste or smell', was unknown. The patient was not diagnosed with COVID-19 prior to vaccination. On 20Jan2021, the patient had a nasal swab COVID-19 test, and was negative.
48 2021-02-04 redness -increased anxiety, had redness on left forearm and right forearm. After two days redness was gone. ... Read more
-increased anxiety, had redness on left forearm and right forearm. After two days redness was gone. -took Tylenol that night which helped.
48 2021-02-04 redness, hives, skin burning sensation About 8 hours after receiving vaccine, the skin around my face, arms and chest became red and had wh... Read more
About 8 hours after receiving vaccine, the skin around my face, arms and chest became red and had whelps and burned like it was on fire. I had a horrible headache. Later around midnight I started vomiting and had uncontrollable chills but skin was still burning never had a fever. The whelps and burning went away completely after about 12 hours and taking 2 (25 mg) Benadryl. The nausea , headache and chills lasted several days.
48 2021-02-04 rash Rash on abdomen, groin area and legs. Developed 3 days after vaccine
48 2021-02-04 itchy skin Within 5 minutes of receiving COVID vaccine, she had SOB, throat tightness, coughing, itchiness. BP ... Read more
Within 5 minutes of receiving COVID vaccine, she had SOB, throat tightness, coughing, itchiness. BP 182/91 HR106, RR 30. Lung were clear. Patient was given PO diphenhydramine 25 mg x1 with no change in symptoms. EMS on site evaluating symptoms. Repeat BP 142/100 HR 97, RR 22. Patient's symptoms continued to remain unchanged therefore EMS called for transport to local ED. One hour post initial event patient was being evaluated in ED with improvement of symptoms.
48 2021-02-07 injection site rash Injection site rash; Swollen lymph nodes; Headache; Teeth hurt on left side; Hot/cold flashes; Hot/c... Read more
Injection site rash; Swollen lymph nodes; Headache; Teeth hurt on left side; Hot/cold flashes; Hot/cold flashes; Nausea; Vomiting; Symptoms of perimenopause; This is a spontaneous report from a contactable consumer. A 48-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number=EL9262), via an unspecified route of administration at Left arm on 19Jan2021 15:00 at single dose for covid-19 immunization. The patient medical history included known allergies: penicillin. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL0142), on 01Jan2021 12:00 PM at Left arm at single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced injection site rash, swollen lymph nodes, headache, teeth hurt on left side, hot/cold flashes, nausea/vomiting, symptoms of perimenopause on 20Jan2021 at time of 12:00. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.
48 2021-02-08 injection site swelling Bilateral arm weakness/dysesthesia; Bilateral arm weakness; Severe fatigue; Pretty bad swelling in t... Read more
Bilateral arm weakness/dysesthesia; Bilateral arm weakness; Severe fatigue; Pretty bad swelling in the shoulder joint that she had the shot in; stiffness in her neck and joints, and in both of her hands, fingers, and elbows.; stiffness in her neck and joints, and in both of her hands, fingers, and elbows; her neck and joints, and in both of her hands, fingers, and elbows; stiffness in her neck and joints, and in both of her hands, fingers, and elbows.; She also had pain in both biceps; Within 20 minutes she had a really weird sharp pain in her upper back the size of a cantelope; This is a spontaneous report from a contactable Nurse. A 48-Year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 07Jan2021 at single dose via an unspecified route of administration in right deltoid for COVID-19 immunization. Relevant medical history included Multiple sclerosis/Diagnosed in 1991 or 1992. She also had 2 previous reactions to a pneumonia vaccine two years in a row. About 30-45 minutes after she had fainting episodes. On 07Jan2021 within 20 minutes she had a really weird sharp pain in her upper back the size of a cantelope. On the same day she complained pretty bad swelling in the shoulder joint that she had the shot in, along with stiffness in her neck and joints, and in both of her hands, fingers, and elbows. She also had pain in both biceps. On 08Jan2021 the patient experienced severe fatigue and 10Jan2021 Bilateral arm weakness/dysesthesia. They were floppy noodles and she could hardly use them. She could not hold her purse in her hands. She has not had this issue before with her Multiple Sclerosis. This took about a full week and a half for that to go away. It was like weakness/dysesthesia. She talked to her doctor and he said he felt like the shot had exacerbated her Multiple Sclerosis potentially. At the time of the reporting the patient was recovering from Bilateral arm weakness/dysesthesia. She recovered from fatigue on 09Jan2021, from 'Within 20 minutes she had a really weird sharp pain in her upper back the size of a cantelope' on 10Jan2021and from other reported events on 12Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in triggering the onset of bilateral arm weakness/dysesthesia cannot be excluded. The events are confounded by underlying multiple sclerosis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
48 2021-02-08 injection site bruising, injection site bleeding Local bruising and bleeding with injection followed about 12-15 hrs later with moderate severe left ... Read more
Local bruising and bleeding with injection followed about 12-15 hrs later with moderate severe left arm stiffness which localized to left lateral epicondilitis sxs.
48 2021-02-09 redness After vaccination, patient reports swelling to the size of a golf ball over the course of 3 days. P... Read more
After vaccination, patient reports swelling to the size of a golf ball over the course of 3 days. Patient went to urgent care. They determined that the vaccine had inadvertently been administered sub-q, not IM, leading to granuloma formation. Urgent care outlined site of reaction and instructed patient to take antiinflammatories until swelling subsides; if swelling increases beyond the drawn border then go to ER. Swelling decreased over the next several days, only small amount of redness remains on 2/8.
48 2021-02-09 injection site pain All over body / muscle aches - unable to sleep well due to extreme discomfort. Pain started around 8... Read more
All over body / muscle aches - unable to sleep well due to extreme discomfort. Pain started around 8pm and intensified through the night. Started to abate early afternoon next day. Did take extra strength Tylenol 4 times between 8pm 2/8/21 and 2pm 2/9/21. As of today, 2/10/21, still have joint pain in right hand knuckles and mid back / right shoulder blade and at injection site.
48 2021-02-09 itchy skin ITCHING, LOWER BACK PAIN, AND HEADACHE.
48 2021-02-09 vaccination site swelling Start Date/Time: [pfizer] 19-JAN-2021 01:00 PM/Start Date/Time: [pfizer] 23-DEC-2020 01:00 PM; right... Read more
Start Date/Time: [pfizer] 19-JAN-2021 01:00 PM/Start Date/Time: [pfizer] 23-DEC-2020 01:00 PM; right arm swelling; This is a spontaneous report from a contactable other HCP (patient). This 48-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 19Jan2021 13:00 at single dose on the right arm for covid-19 immunization. The patient medical history included diabetes mellitus (DM), hypertension (HTN), depression, obesity, known allergies: TB serum and hair dye. Patient took other medications the patient received within 2 weeks of vaccination. The patient previously took first dose of bnt162b2 via intramuscular on 23Dec2020 13:00 on the right arm for covid-19 immunization, took lisinopril and experienced drug allergy. Patient was not pregnant at the time of vaccination. Facility the most recent COVID-19 vaccine administered was public health clinic/veterans administration facility. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced right arm swelling in Jan2021. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No treatment received for the adverse event. Outcome of right arm swelling was recovering. The event was assessed as non-serious. Information on the lot/batch number has been requested.
48 2021-02-09 injection site pain Within about 12 hours, mild to moderate soreness at site of injection, headache, muscle aches and fa... Read more
Within about 12 hours, mild to moderate soreness at site of injection, headache, muscle aches and fatigue. Symptoms lasted less than 12 hours and were relieved with one dose of Tylenol.
48 2021-02-09 vaccination site pain swollen, painful left axilla area; swollen, painful left axilla area, gotten progressively worse; di... Read more
swollen, painful left axilla area; swollen, painful left axilla area, gotten progressively worse; difficult to raise arm due pain; difficult to raise arm due pain, very tender to touch, felt like burning; This is a spontaneous report from a contactable Other HCP(patient). A 48-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL3248), via an unspecified route of administration at Arm Left on 16Jan2021 07:00 at the 48 years old at single dose for COVID-19 immunization. The medical history included HTN(Hypertension), HLD(Hyperlipidemia), Migraines, Depression, Herniated Discs, Arthritis. There were concomitant medications but unspecified. The patient previously took Codeine and experienced allergy. On 22Jan2021 6 days after vaccine, the patient experienced swollen, painful left axilla area, gotten progressively worse, difficult to raise arm due to pain, very tender to touch, felt like burning had continued for 3 days. The patient taken Ibuprofen, Tylenol, and Iced area as treatment for all the events. There was no other vaccine in four weeks. There was no covid prior vaccination. There was no covid tested post vaccination. The outcome of the event was not recovered.
48 2021-02-10 redness 1/4 Vaccination. 12 hours later; arm pain, lump on arm with redness. Within 24 hours, lump was large... Read more
1/4 Vaccination. 12 hours later; arm pain, lump on arm with redness. Within 24 hours, lump was larger. Lymph nodes swollen. Lump was about size of a softball, all lymph nodes swollen. Symptoms about a week. Sought attention from NP. She stated to ice and Ibuprofen.
48 2021-02-10 rash macular, rash, rash with redness Diffuse red, blotchy, non raised rash noted on stomach, breasts, flank area 36 hours after COVID vac... Read more
Diffuse red, blotchy, non raised rash noted on stomach, breasts, flank area 36 hours after COVID vaccine. Non-itchy, non-painful, no blisters. Still present 12 days after vaccine.
48 2021-02-10 rash Headache; fatigue; rash on palm of hands (bilateral, began the day after the vaccine, not other plac... Read more
Headache; fatigue; rash on palm of hands (bilateral, began the day after the vaccine, not other place on body other than all fingers); This is a spontaneous report from a contactable other healthcare professional (patient). A 48-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: E3247), intramuscular on 23Jan2021 09:15 at single dose in left arm for COVID-19 immunisation. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient was vaccinated at hospital. Patient age at time of vaccination was 48 years. Medical history included asthma, seasonal allergies, scoliosis, and allergy to Sulfa. Concomitant medications included sertraline hydrochloride (ZOLOFT), cetirizine hydrochloride (ZYRTEC), montelukast (MONTELUKAST), fluticasone (FLUTICASONE), fluticasone propionate, salmeterol xinafoate (ADVAIR), bifidobacterium lactis (PROBIOTIC) and multivitamin. On 24Jan2021 at 12:00 AM the patient experienced headache, fatigue, rash on palm of hands (bilateral, began the day after the vaccine, not other place on body other than all fingers). The events resulted in doctor or other healthcare professional office/clinic visit. The patient was prescribed prednisone and topical hydrocortisone for the events. The events were resolving. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.
48 2021-02-11 itchy skin, rash Chills, fever, muscle spasms, convulsing, splitting headache, bone and joint aches, muscle aches, ra... Read more
Chills, fever, muscle spasms, convulsing, splitting headache, bone and joint aches, muscle aches, rash on neck, chest and back, itchy back, swollen lymph nodes (under jaw) really large lymph node in groin area appeared 10 days post vaccination, trouble breathing, exhausted, light headed, nausea, white chalky furry tongue., diarrhea.
48 2021-02-15 injection site pain 1. Shortness of breath - tightness in chest; moderate x 1 day; intermittent; 2. Headache moderate - ... Read more
1. Shortness of breath - tightness in chest; moderate x 1 day; intermittent; 2. Headache moderate - severe x 2 days 3. Muscle/joint pain entire body and injection site - moderate x 2 days; mild continuous; 4. Fever, chills x 1.5 day 5. Fatigue - mild ongoing; 6. Swollen lymph node in neck on the left side (same side received injection).
48 2021-02-15 injection site pain Nausea within 20 minutes after the shot that dissipated within 45 minutes. No treatment. 5.5 hours a... Read more
Nausea within 20 minutes after the shot that dissipated within 45 minutes. No treatment. 5.5 hours after shot injection site soreness. Muscle pain at injection site. Tylenol to mitigate pain.
48 2021-02-16 skin spots Hemorrhagic stroke, abnormal platelet count, petechai. Patient had my!triple CTs, MRI and angiogram ... Read more
Hemorrhagic stroke, abnormal platelet count, petechai. Patient had my!triple CTs, MRI and angiogram after finding brain bleed. Once released home from brain bleed patient developed petechai, weakness, shortness of breath
48 2021-02-16 injection site pain Second vaccination given on the 02/12/2021 at 07:35. Began to have symptoms at 16:30 on 2/12/2021. B... Read more
Second vaccination given on the 02/12/2021 at 07:35. Began to have symptoms at 16:30 on 2/12/2021. Body aches, weakness, fever, chills, headache, and sore arm at injection site. These symptoms lasted until Monday 2/15/2021. I took Acetaminophen for the above symptoms. I left work early Friday night and called employee health Monday morning.
48 2021-02-16 itchy skin received 1100 pruritis all over body 1110. pt took benadryl 15-20 minutes prior to arrival due to s... Read more
received 1100 pruritis all over body 1110. pt took benadryl 15-20 minutes prior to arrival due to similar symptoms with first vaccine pt reports improved symptoms at 1140. no sob, throat swelling, lip swelling or visible hives.
48 2021-02-21 rash, injection site redness, injection site swelling, injection site pain Friday injection site hurt almost immediately (first dose didn't feel anything until 6 hours after s... Read more
Friday injection site hurt almost immediately (first dose didn't feel anything until 6 hours after shot)... started to ice arm an hour after appointment and continued to ice throughout the day Friday. Saturday morning the injection side was significantly swollen (bump and felt like a knot) and continues to be swollen and ache as of Monday a.m. Have a red circular patch around injection site which also occurred after first shot and lasted 10 days. Saturday woke up with bad headache... took tylenol and slept.. headache gone by late afternoon. Sunday morning woke up covered in a rash that was from my neck to below my belly button on front side, entire back area (including neck) and both sides of torso. Took 2 doses of Benadryl on Sunday. Rash has faded (not as red) and took another dose of Benadryl Monday morning.
48 2021-02-21 injection site swelling, injection site hardening I had a sore arm and a raised bump for about 3 days, It went away. 10 days later it is back. Har... Read more
I had a sore arm and a raised bump for about 3 days, It went away. 10 days later it is back. Hard raised bump at injection site.
48 2021-02-21 itchy skin, rash On Sunday 2/21/21, I noticed a rash had formed on the right side of my lower stomach/hip. I applied... Read more
On Sunday 2/21/21, I noticed a rash had formed on the right side of my lower stomach/hip. I applied lotion and when I got home from work at 7 p.m., the rash was more painful and prominent. I took Benadryl and applied Cortizone cream. This morning when I woke up, the rash was still there. All day I have periodically applied Cortizone cream to keep the itching and slight pain at bay. The rash consists of small red bumps over a 3 inch by 3 inch area.
48 2021-02-21 redness arm very painful; swollen and tender left axillary and left supraclavicular nodes; swollen and tende... Read more
arm very painful; swollen and tender left axillary and left supraclavicular nodes; swollen and tender left axillary and left supraclavicular nodes; chills; red x 5 days; This is a spontaneous report from a contactable healthcare professional (patient). This 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249; dose 2) via an unspecified route of administration on 20Jan2021 at 1:30 PM (at the age of 48-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included hypertension and mild asthma. The patient was not pregnant at the time of vaccination. It was unknown if the patient had COVID-19 prior to vaccination. The patient took concomitant medications which were unspecified. The patient did not received any other vaccines within four weeks prior to the vaccination. The patient previously took penicillin on unknown dates for an unknown indication and experienced allergy. The patient received dose 1 of BNT162B2 (lot number: EL0104) on 30Dec2020 at 11:30 AM in the left arm as a single dose for COVID-19 immunization. On an unspecified date after the second vaccination, the patient had arm very painful, red for 5 days, and swollen and tender left axillary and left supraclavicular nodes. On 21Jan2021, 24 hours after the vaccine, the patient experienced chills lasting three to four hours. The patient did not have adverse effects at all after the first vaccine. The events resulted in a doctor or other healthcare professional office/clinic visit. The patient did not received treatment for the events. The outcomes of arm very painful and red, swollen and tender left axillary and left supraclavicular nodes, and chills were recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
48 2021-02-22 hair loss I received the first vaccine 1/11/2021 and the second dose on 02/03/2021. On 02/16/2021 my hair fe... Read more
I received the first vaccine 1/11/2021 and the second dose on 02/03/2021. On 02/16/2021 my hair fell out in clumps. I am post COVID and was Dx on 07/14/2020. I was discharged from the hospital on 09/17/2021. From my stay in the hospital on 07/14/2020 up until 02/15/2021 I had the minimum hair loss that one would loss in a day. I am not sure if the vaccines caused it , but my hair literally came out in clumps. I also started experiencing heart palpitations along with SOB in the evenings after the first vaccine. Upon the second week in February, I started experiencing the palpitations and SOB in the evenings. Again, I am not sure if the vaccines caused this as I am post COVID.
48 2021-02-22 redness Significant Left under arm swelling (area swollen approximately size of baseball in half) Significa... Read more
Significant Left under arm swelling (area swollen approximately size of baseball in half) Significant pain under left arm Redness along outside of left breast Pain in Left breast Pain Left shoulder to Left elbow Nausea and hot flashes - Mild
48 2021-02-22 rash transient rash to bilateral legs
48 2021-02-23 itchy rash, redness, rash -Common severe fatigue for roughly 36 hours -low grade fever resolved hour 40 -rash covering trunk f... Read more
-Common severe fatigue for roughly 36 hours -low grade fever resolved hour 40 -rash covering trunk front and back beginning at approx. hour 42, itchy and red -elevated HR noticed at hour 48 (100BPM)
48 2021-02-23 injection site pruritus, injection site warmth, injection site redness Redness, warmth, itchiness at injection site, 2 inch diameter redness. Facial flushing bilateral. Sh... Read more
Redness, warmth, itchiness at injection site, 2 inch diameter redness. Facial flushing bilateral. Shoulder lymph and neck lymph on left side.
48 2021-02-23 rash breakout rash on her chest, neck, and under her chin; This is a spontaneous report from a contactabl... Read more
breakout rash on her chest, neck, and under her chin; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262, expiry date: May2021), via intramuscular route of administration on 23Jan2021 at 16:25 at 0.3 mL, single for COVID-19 immunization. Medical history included allergy, penicillin allergy, allergic to bee stings, and allergic to baby powder. The patient's concomitant medications were not reported. On 23Jan2021 at 23:30, the patient had breakout rash on her chest, neck, and under her chin. She says she took Benadryl, which puts her right to sleep, and she slept 12 hours. The outcome of the event was unknown.
48 2021-02-23 rash with redness red rash over her torso including her back and lower stomach and a slight rash on her arms and legs;... Read more
red rash over her torso including her back and lower stomach and a slight rash on her arms and legs; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN5318) in a Public Health Clinic, via an unspecified route of administration on 21Jan2021 at 16:00 at a single dose on the left arm for COVID-19 immunization. Medical history included diabetes and high blood pressure both from an unknown date and unknown if ongoing. The patient had COVID-19 prior to vaccination on an unspecified date. The patient had no known allergies. The patient has not been tested for COVID-19 post vaccination. Concomitant medication included metformin hydrochloride, pioglitazone hydrochloride (ACTOPLUS MET), olmesartan medoxomil (BENICAR), loratadine (CLARITIN) and montelukast sodium (SINGULAIR). The patient had red rash over her torso including her back and lower stomach and a slight rash on her arms and legs on 24Jan2021 at 12:00. The event resulted in a doctor or other healthcare professional office/clinic visit. The patient was administered a steroid shot by her primary physician as treatment for the event. The outcome of the event was not recovered.
48 2021-02-24 injection site pain Onset Sunday February 21, 2021: headache, stomach cramping, diarrhea, fatigue, muscle aches Monday F... Read more
Onset Sunday February 21, 2021: headache, stomach cramping, diarrhea, fatigue, muscle aches Monday Feb 22: symptoms not as severe Tuesday Feb 23: headache and stomach cramps remain, with some gastrointestinal distress Weds Feb 24: symptoms diminished significantly Thursday Feb 24: symptoms dissipated completely
48 2021-02-24 rash macular, rash with redness Patient received her first COVID vaccination today at 8:30 pm. Within 15 min of injection, she bega... Read more
Patient received her first COVID vaccination today at 8:30 pm. Within 15 min of injection, she began to look distressed and reported sensations of tingling in her elbows and behind her knees. No SOB, facial swelling, or heart palpitations. It was felt she may be nervous and she was given water and monitored closely. Vitals taken with O2 100%, HR 58, BP 134/89 Pt received Benedryl 25 mg when she began to note mild erythematous blotching on neck 10 min later vitals stable with bp 138/82 and pulse 62 Pt was given a second 25 mg dose to take if any symptoms worsened on way home- she was driving therefore I did not want to give her another dose at the time. She understands to call for emergency care if any SOB, facial swelling, or any distress Pt confirmed at 10 pm that she made it safely home with some improvement in her symptoms. I will follow up with her in the morning as well and will complete a VAERS report. I have educated her that at this time CDC would recommend not receiving the second vaccination, given potential allergic reaction within first 4 hours. We will review this again tomorrow I communicated with patient morning of 2/25/21- she states still mild tingling of arms but no new or worsening symptoms. She feels this is more consistent with anxiety and hesitant to not receive her second dose. I suggested she discuss with her primary care provider before her next visit and if she were to proceed with her second vaccination, I would suggest someone being with her to drive and she take 50 mg of benedryl 1 hr prior to vaccine. She was appreciative.
48 2021-02-24 skin burning sensation Started 2/17/21 two days after vaccine shot. Left arm and shoulder pain upon waking. Intense burn... Read more
Started 2/17/21 two days after vaccine shot. Left arm and shoulder pain upon waking. Intense burning sensation across top of shoulder, down over shoulder blade and entire left arm, including hand. Sharp pain with cramping feeling. Difficulty finding a comfortable position because entire arm is tender, sore to the touch, as well burning feeling. Duration: 2/17/21 - still ongoing. 2 ER Visits. 2 PCP Visits
48 2021-02-24 skin warm since about 3 days after the shot, my arm has been feeling a cold sensation in the deltoid area and ... Read more
since about 3 days after the shot, my arm has been feeling a cold sensation in the deltoid area and the forearm area. When I touch the arm, it is warm. I also have had a tingling in my left leg which comes and goes.
48 2021-02-25 rash macular, itchy rash, injection site rash, rash Patient reported blotchy itchy rash on right cheek, neck and upper chest. No difficulty breathing, ... Read more
Patient reported blotchy itchy rash on right cheek, neck and upper chest. No difficulty breathing, chest pain or shortness of air. Ambulatory and needed no assistance moving. Vitals HR 85 BP 126/82 pulse ox room air 98%. Benadryl 50 mg administered IM right arm at 11:40 am. Patient observed until 12:35 pm when discharged to home (HR 60 BP 110/78 100% O2). Rash was much improved by this time. Patient called 11:20 am. 2/26. Rash almost entirely gone - just one spot on check. Will take benadryl PO. Mentioned she had small spot of rash around injection site following first dose of vaccine.
48 2021-02-25 skin warm Perspiration all over body, clammy, warm, BM
48 2021-02-25 injection site pain Stabbing abdominal pain for 18 hours, brain fog, fatigue, headache, sinus congestion, mild pain at i... Read more
Stabbing abdominal pain for 18 hours, brain fog, fatigue, headache, sinus congestion, mild pain at injection site. Symptoms started 2.5 hours after injection and lasted 30 hours.
48 2021-02-25 vaccination site pain, rash chills; moderate shoulder pain at injection site/shoulder pain; severe headache for 28 hours; axilla... Read more
chills; moderate shoulder pain at injection site/shoulder pain; severe headache for 28 hours; axillary rash under armpit/painful armpit rash; burning on injection on left arm; This is a spontaneous report from a contactable other healthcare professional (who is also the patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9266, expiry date unknown), intramuscular on the left arm, on 12Feb2021 16:00, at single dose, for COVID-19 immunization, at the pharmacy/drug store. The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. There were no allergies to medications, food, or other products. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiry date: unknown) received at age 48 years, intramuscular on the left arm, on 22Jan2021 15:45, for COVID-19 immunization and the patient experienced moderate shoulder pain on injection arm. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 12Feb2021 at 16:00, the patient experienced burning on injection on left arm. On 12Feb2021 at 19:45, the patient experienced moderate shoulder pain at injection site for 24 hours and there was no shoulder pain 36 hours after the injection 14Feb2021 at 04:00; severe headache for 28 hours; and axillary rash under armpit/painful armpit rash which was still present 45 hours after the injection. On 13Feb2021 at 20:00 (reported as 28 hours after injection), the patient experienced chills which lasted for 2 hours. The patient was not tested for COVID-19 since the vaccination. No treatment was given for the events. The patient recovered from chills on 13Feb2021 at 22:00, severe headache on 13Feb2021 at 23:45, and moderate shoulder pain at injection site/shoulder pain on 14Feb2021 at 04:00. The outcome of burning on injection on left arm, axillary rash under armpit/painful armpit rash was not recovered.
48 2021-02-27 rash, itchy skin swollen tongue, difficulty swallowing and breathing, itching, rash, headache, ache, fatigue
48 2021-02-28 rash macular I waited in the holding area (mass vax clinic) for 20 min. No symptoms. The lights were very bad an... Read more
I waited in the holding area (mass vax clinic) for 20 min. No symptoms. The lights were very bad and bright flourescent so admittedly I was bothered by them or it could have been the beginning of the whooseyness from the shot. My husband picked me up in the car out front, we were driving and I began to get pressure in my sinuses and mostly the sides of my nose. I did have some head congestion but this feeling had never happened (it should be noted I had negative covid tests to make sure stuffy head was nog covid related). Then I felt pressure in my ears and my face began to feel flush as my cheeks. All of this began at about 35 minutes after the injection. Then my lips began to feel strange. It was a cross between tingly and numb. I made as many faces in the car makeup mirror to make sure my face muscles were moving properly And they were. But there was definitely numbness occurring in my mouth. Tingly-numbness. This all happened within about 10 min of the first onset. Then I noticed some splotchiness on my lower arms. Mostly my left (shot was given in right- no redness at the injection site). I also got some splochiness on my chest and neck. Cheeks were also ruddy and flush. I did NOT have any problem breathing or swallowing at anytime. Nor did my pulse race (other than from a pit of panic from nerves over the reaction). I didnt have a thermometer but don?t think I had a fever either. We pulled over and I called a nurse on call. She told me if things worsened to go to hospital. I did have a little bit of the feeling you get when you are about to pass out and you feel like things are closing in a bit. But it never got past about a 2 on a scale of 1-10. I decided I wanted something to eat (I HAD eatten before) and I went to get a sandwich. I still was a bit light headed but the symptoms did start to subside in about an hour. After that I was only tired and took a nap. Nothing else after those initial reactions.
48 2021-02-28 injection site redness, injection site swelling Patient presented to ED three post vaccine with increasing redness/swelling at the injection site. ... Read more
Patient presented to ED three post vaccine with increasing redness/swelling at the injection site. No issues identified. Patient received Doxycycline and Benadryl prescriptions.
48 2021-02-28 rash with redness, rash Red rash on face and back
48 2021-03-01 rash 13 hours post shot I had fever, chills, body aches, headache-lasted about 14 hours. 2 days later I ... Read more
13 hours post shot I had fever, chills, body aches, headache-lasted about 14 hours. 2 days later I developed a rash all over my chest, belly and up the sides of my neck.
48 2021-03-01 itchy skin 253p 154/99, 139 HR, 24 RR, 100% O2 ? dizziness, itching on arms and face, R arm numbness ? gav... Read more
253p 154/99, 139 HR, 24 RR, 100% O2 ? dizziness, itching on arms and face, R arm numbness ? gave diphenhydramine elixir 25 mg x1 307p 120 HR, trouble with BP cuff 313p R arm numbness, legs heavy, face and mouth tingling ? gave diphenhydramine elixir 25 mg x1 315p 142/89, 110 HR ? legs ?wonky?, R arm numbness remains, itching improving 330p symptoms significantly improved, ?feeling better?; family member with patient and able to drive patient at home and continue observation Telephone follow-up performed at 430p. No problems.
48 2021-03-01 injection site pain Injection site pain Headache Significant, any use of prescription pain reliever or prevents daily ac... Read more
Injection site pain Headache Significant, any use of prescription pain reliever or prevents daily activity
48 2021-03-01 itchy skin Report fever, body aches, itching bilateral legs. Treatment: Nothing, Outcome: Complete resolution ... Read more
Report fever, body aches, itching bilateral legs. Treatment: Nothing, Outcome: Complete resolution of symptoms day 3 post vaccination.
48 2021-03-02 hives Hives; This is a spontaneous report from a non-contactable consumer (patient). A 48-year-old female... Read more
Hives; This is a spontaneous report from a non-contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9262), via an unspecified route of administration on 28Jan2021 at a single dose on the right arm for COVID-19 immunization. Medical history included asthma and postpartum cardiomyopathy on unknown dates and unknown if ongoing. The patient had allergies to sulfa and penicillin. Prior to vaccination, the patient has not had COVID-19. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), carvedilol (manufacturer unknown), cefixime (FLEXERIL), losartan (manufacturer unknown) and montelukast sodium (SINGULAIR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took Cipro, Biaxin and Ampicillin and allergies. Since the vaccination, the patient has not been tested for COVID. The patient experienced hives on 30Jan2021. The patient did not receive any treatment for the event. The patient has not recovered from the event. No follow-up attempts are possible. No further information is expected.
48 2021-03-02 rash Sneezing; swollen, itchy eyes; swollen throat, difficulty swallowing, rash
48 2021-03-02 skin mass left side of neck was very sore; felt a swollen lump /lymph about halfway between my ear and bottom ... Read more
left side of neck was very sore; felt a swollen lump /lymph about halfway between my ear and bottom of my neck; This is a spontaneous report from a contactable consumer (Patient). A 48-year-old female patient (also the age at vaccination) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown: Unable to locate or read the details), via an unspecified route of administration at the left arm on 23Jan2021 12:45 PM at SINGLE DOSE for Covid-19 immunization. Medical history included Chiari Malformation (reported as other medical history). The patient has no COVID prior to vaccination, also not COVID tested post vaccination. The patient had no known allergies. The patient is not pregnant. There was no other vaccine in four weeks. It was reported that the patient had other medications in two weeks (unspecified). The patient had the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Jan2021 at 12:45 PM at the left arm for COVID-19 immunization (Lot number not reported: Unable to locate or read the details, facility type vaccine: Other). It was reported by the patient that: "I woke up this morning (on 31Jan2021 at 08:00 AM) and my left side of neck was very sore. I went to rub it and immediately felt a swollen lump /lymph about halfway between my ear and bottom of my neck. It is about the size of a dime. My second dose was 8 days ago (23Jan2021). I am assuming this is normal response to Pfizer vaccine, but all I read said reactions should be over 2 to 4 days after vaccine. Is this considered normal or should I contact my PCP? " No treatment was received. The outcome of the events was not recovered. Information about Lot and batch number has been requested.
48 2021-03-03 injection site pain, rash About 5 days after vaccine I noticed a bump above my collar bone. Located on the same side I receiv... Read more
About 5 days after vaccine I noticed a bump above my collar bone. Located on the same side I received the vaccine. I started to have soreness in the same arm again but different location then where the vaccine was given. Bump is still there as of today. I am monitoring it.
48 2021-03-04 injection site swelling Arm Pain - onset 6h post injection Body aches - 24h post injection Arm pit pain & swelling - 34h pos... Read more
Arm Pain - onset 6h post injection Body aches - 24h post injection Arm pit pain & swelling - 34h post injection Headache -34h post injection Injection site swelling/lump - 38h post injection Lightheaded - 44h post injection
48 2021-03-04 rash, redness Around 2/13/21: Right Hand second finger with rash, swelling, mottled color with redness on knuckle ... Read more
Around 2/13/21: Right Hand second finger with rash, swelling, mottled color with redness on knuckle and dorsal side of skin from knuckle to nail. Same day I developed a growth on right hand middle finger similar to a cyst or nodule. 2-3 days later I developed a reddened raised lesion on my left hand 4rth finger dorsal side near the joint. Doctor looked at it over zoom but not in person and thought it was contact dermatitis or allergic dermatitis from hand sanitizer or glove use. Steroid cream triamcinolone and cloberasol have been tried for 1.5 weeks but not working. After second dose of vaccine I developed pain and redness to left hand 4th finger knuckle near where the previous lesion had been. And the cyst on my right hand middle finger is growing and taki bf on a weird shape, its surface area has increased and these creams are not helping.
48 2021-03-04 injection site warmth, injection site redness, injection site rash I have a large red, hot rash at my injection site that has developed 10 days after my dose. My arm i... Read more
I have a large red, hot rash at my injection site that has developed 10 days after my dose. My arm is slightly sore as well.
48 2021-03-04 injection site redness, rash with redness, injection site pruritus It started out as an itchy area under the band aid. I took the band aid off and the itching got wors... Read more
It started out as an itchy area under the band aid. I took the band aid off and the itching got worse and went down my arm. A minute left after waiting 15 minutes I let the nurse know the reaction I was having ( bad itching), she looked at it and was red. She said it could be a site reaction and gave me an ice pack. Another nurse came to check on, and I told her I was really thirsty. By the time she got back my lips were feeling very heavy, lips itching and difficult to swallow, then my whole chest was covered in a red rash. With in a couple minutes there was a paramedic there and was more difficult to swallow, they tried to give me Benadryl thru an IV and blew my vain. So he asked me for a IM shot of Benadryl, I said yes and took me to the ER. By the time got there the Benadryl wore off and my lips got itchy and they took me right to the room and Dr gave me IV Solumedrol and Benadryl. They watched me for two hour sin the ER , they released me with 3 days of prednisone, Epipen, Benadryl. I went to the pharmacy (15 minute drive from ER) and both my eyes starting swelling, so I took 50mg of Benadryl capsule and the next day I started the prednisone, I had to take Benadryl every 3 hours for the next couple days because my eyes would start swelling.
48 2021-03-04 injection site pain, injection site swelling, injection site redness Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injecti... Read more
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Error: Wrong Route (SC, IM, etc.)
48 2021-03-04 redness hot, dizzy, redness, headache
48 2021-03-05 itchy skin Mild headache, tired, itchy eyes and face, sneezing, congestion, heart racing
48 2021-03-07 rash I started having symptoms about an hour after receiving the shot. Bad pain, chills, swelling, heada... Read more
I started having symptoms about an hour after receiving the shot. Bad pain, chills, swelling, headache, tiredness and feeling unwell, etc. About Thursday, I noticed bumps starting to appear on me. IT was just a few and I was trying to deal with all of the other symptoms. By Friday, they started to appear more and more and are progressing as the days go on. I'm covered in bumps/rash.
48 2021-03-08 hives, injection site warmth Covid arm developed last night and is getting worse at the injection site. I have extreme dizziness... Read more
Covid arm developed last night and is getting worse at the injection site. I have extreme dizziness like vertigo, extreme fatigue, throwing up and nausea and my arm symptoms are huge welt that is burning hot at the injection site, cannot lift my arm without pain, numbness and nerve pain running down the arm down to the elbow. I feel faint. I am at home laying down with ice on it, Tylenol and Benadryl. I cannot make it to the doctor as I live alone and have epilepsy.
48 2021-03-08 injection site reaction at 6 am this morning I felt that the muscle on my left arm on the injection site is twitching and it... Read more
at 6 am this morning I felt that the muscle on my left arm on the injection site is twitching and it continues to twitch off and on up to the time I am writing this note at 2:20 pm
48 2021-03-09 itchy skin Generalized itching. Patient given diphenhydramine 50mg IM. Itching resolved.
48 2021-03-09 injection site tingling Patient felt tigling in left arm the injection arm. Patient has Anxiety issues . Anxious wanted to b... Read more
Patient felt tigling in left arm the injection arm. Patient has Anxiety issues . Anxious wanted to be checked.
48 2021-03-09 injection site rash, rash Rash around injection site Rash around neck Migraines Nausea Fever Ache
48 2021-03-10 injection site mass, injection site pruritus, hives It started with a few welts - raised - same color as rest of my skin (about 3 or 4 hours after vacci... Read more
It started with a few welts - raised - same color as rest of my skin (about 3 or 4 hours after vaccine) and then started red by that night and kept getting redder and broader. By second day, there was a solid lump under the injection site as well. It started getting itchy. I saw the doctor for it but I couldn't remember the day. Benadryl was recommended for me. (I took Tylenol that night of the vaccine.) I took Benadryl for four or five days and by then it wasn't growing anymore - it wasn't getting bigger. I took one pill each time. By second week, color was starting to fade. There is no longer a lump under the injection site.
48 2021-03-10 hives MINUTES AFTER VACCINATION PATIENT HAD TONGUE SWELLING, HIVES, AND THEN A SYSTEMIC ALLERGIC REACTION.... Read more
MINUTES AFTER VACCINATION PATIENT HAD TONGUE SWELLING, HIVES, AND THEN A SYSTEMIC ALLERGIC REACTION. EMS ON SITE. PATIENT TRANSPORTED TO ER. GIVEN BENADRYL AND SOLU-MEDROL ON SITE.
48 2021-03-10 rash papular, rash, rash with redness Nine days later, I got rash and it lasted less than a week. It was raised, it was red but it was no... Read more
Nine days later, I got rash and it lasted less than a week. It was raised, it was red but it was not itchy. It expanded to about 4 inches or so and then it stopped.
48 2021-03-11 pain of skin Achy-ness of muscles and skin; general feeling of being unwell; short episode of chills
48 2021-03-11 shingles, rash I woke up with a rash on chest tingling and burning. On Friday I had a Telehealth appt was diagnose... Read more
I woke up with a rash on chest tingling and burning. On Friday I had a Telehealth appt was diagnosed with Shingles.
48 2021-03-11 injection site pain Terrible pain and swelling under my left arm (arm pit area) with pain shooting into my left breast. ... Read more
Terrible pain and swelling under my left arm (arm pit area) with pain shooting into my left breast. Pain at the injection site that traveled through my arm to the joints in my wrist.
48 2021-03-13 injection site pain Day of vaccine: extreme muscle weakness and tenderness at injection site 24 hours later: chills, fev... Read more
Day of vaccine: extreme muscle weakness and tenderness at injection site 24 hours later: chills, fever of 100 degrees, body aches, extreme fatigue 48 hours later: low grade fever, normal menstruation turned into extremely painful menstruation, swollen lymph nodes, sweating like breaking a fever
48 2021-03-13 hives Fatigue & hives the next day & most days since. I?m not sure if it?s caused by my autoimmune disorde... Read more
Fatigue & hives the next day & most days since. I?m not sure if it?s caused by my autoimmune disorders or the vaccine. My nurse friend encouraged me to report the symptoms.
48 2021-03-13 itchy skin Headache w nausea started in 5 min. At about 15 min chest was tight. By 45 min neck muscles were e... Read more
Headache w nausea started in 5 min. At about 15 min chest was tight. By 45 min neck muscles were extremely tight. By about 90 min slight wheezing and all over joint pain. Skin itching in various places. Took Benadryl. At night my whole body was tight muscled. Felt much better next day other than continued fatigue , sore arm and mild flu feeling. No fever or rash. The form
48 2021-03-14 skin warm Chills, nausea , body aches , head aches, skin feels hot - bit no fever.
48 2021-03-14 injection site pain Fever, arm soreness at injection site, chills, muscle aches, and extremely swollen lymph nodes at le... Read more
Fever, arm soreness at injection site, chills, muscle aches, and extremely swollen lymph nodes at left clavicle
48 2021-03-14 itchy skin, rash Her symptoms included the development of a rash down her back, neck, chest, belly, and R forearm. T... Read more
Her symptoms included the development of a rash down her back, neck, chest, belly, and R forearm. The symptoms began within 4 hrs of receiving the vaccine and included intense itching. She described the itching similar to poison ivy. No fever, pain, aches, SOB, etc. was elicited. All symptoms have resolved at this time.
48 2021-03-14 itchy skin, hives, rash I started with bad rash day after shot.. 2 days later I started breaking out in hives.. as the day w... Read more
I started with bad rash day after shot.. 2 days later I started breaking out in hives.. as the day went on i started breaking out all over my body especially my face. my legs, back, face, stomach.. itchy everywhere.
48 2021-03-15 redness, hives, itchy skin Few minutes after 15 minute monitoring clearance, employee returned with itching on left lower back.... Read more
Few minutes after 15 minute monitoring clearance, employee returned with itching on left lower back. Upon examination, area reddened with bolder hives noted. Vaccination at 1447, left area at 1502, returned to clinic at 1524. Patient given 50 mg of oral Benadryl. Within 15 min of medication, noted improvement, hives gone only redness remained, patient reports itching improved. By 1604 redness, hives and itching gone.
48 2021-03-15 hives Hive on face
48 2021-03-15 redness Immediately after administration of the vaccine the patient experienced swelling and redness at the ... Read more
Immediately after administration of the vaccine the patient experienced swelling and redness at the administration site. An ice pack was applied and patient stayed for an additional 40 min for observation. After 40 min the redness and swelling was greatly improved. patient had no further complaints and was discharged.
48 2021-03-15 itchy skin tingling in mouth and lips, itchiness on neck, given Benadryl IM with improvement
48 2021-03-16 redness After receiving the first dose of the Pfizer vaccine, my face immediately went all red and got hot. ... Read more
After receiving the first dose of the Pfizer vaccine, my face immediately went all red and got hot. I stayed at the pharmacy for 30 minutes to ensure I didn't have an allergic reaction like a breathing issue. I had my epi pen with me just in case. It was loud in the pharmacy so I didn't notice it at first but once I got outside and was in the car, my ears were ringing. When we got to the restaurant to eat, we were the only family in there and it was pretty quiet. The ringing was really high pitched and loud. For the following two weeks it did not stop, day and night. I contacted my primary and had a telehealth appt and also went physically in to my ENT's office. I also tried acupuncture to see if that would take away the ringing. The acupuncture seemed to lower the pitch in my ear but it was still present. 2 hours after I left the office the pitch was back to a high pitch ring again. I cancelled my appointment today for 3/18 for the second dose because no one can assure me that this ear ringing will go away and the doctor's are unsure of whether the second dose will trigger a worse condition. I had a hearing test on 3/16 at my ENT's office and I couldn't hear some of the sounds because of the ear ringing but I did pass the test at the very line of baseline normal. My ENT is unsure if I will lose hearing due to this vaccine.
48 2021-03-16 redness Feet were red and hot, tingly No interventions other than monitoring reaction dissipated
48 2021-03-16 rash Shaky, felt faint, hyperventilated Rash on neck Emt checked vitals Heart racing all else good
48 2021-03-16 injection site pain at 2 am about 12 hrs after my second dose I woke up with a fever of 102.8, Rigors, muscle pain, pain... Read more
at 2 am about 12 hrs after my second dose I woke up with a fever of 102.8, Rigors, muscle pain, pain at the site of injection, headache, fatigue, chills. This last all day. I took 2 APAP 500mg at 2am, Advil at 8am, apap 1pm advil before bed at 7pm. I woke up the next night day 3 after injection 3/3/2021 sweating in bed a lot my legs even. I had no fever at that point but did at 9am 101.0 I took 2 APAP and was fine for the rest of the day. NO FEVER after that at all (I had no issues with my first injection on 2/8/2021 I just sneezed all day 8 days later then done)
48 2021-03-17 itchy skin 10 minutes after shot first noticed increased pulse, then lips and tongue tingling/slight swelling. ... Read more
10 minutes after shot first noticed increased pulse, then lips and tongue tingling/slight swelling. Throat tight. Some dizziness. Some chest pain. Some itching (especially scalp and sole of feet and then some on arms). Stayed where medical professionals could see me for about 2 hours. Took Benadryl about 3 hours later (after shot) and lingering symptoms mostly cleared up. 8 hours later still some itching and lips feel a little "off" still. Arm is normal vaccine sore. I have a strong history of repeated anaphylaxis (from MCAS) and this didn't get too serious compared to previous reactions I had to be hospitalized for.
48 2021-03-17 vaccination site pain Injection site soreness; body aches; fatigue; This is a spontaneous report from a contactable consum... Read more
Injection site soreness; body aches; fatigue; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration into the left arm on 17Feb2021 11:15 at a single dose for COVID-19 immunisation. Medical history included allergies. Patient was not pregnant. The patient was taking unspecified concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. On 18Feb2021, patient experienced injection site soreness, body aches and fatigue. The events were reported as non-serious and patient did not receive treatment. Outcome of events recovered on Feb2021. No follow up attempts are possible; information about lot/batch number cannot be obtained.
48 2021-03-17 rash Rash lasting 7 days so far
48 2021-03-17 blister Within 30 minutes of receiving the first dose of the COVID vaccine, I ban to feel tingling on the le... Read more
Within 30 minutes of receiving the first dose of the COVID vaccine, I ban to feel tingling on the left side of my face. Within another 30 minutes, I had multiple blisters in the same spot. Within another 2 hours, the lymph nodes on the left side of my neck were swollen.
48 2021-03-17 redness, itchy skin loss of appetite; spontaneous bleeding under skin by right eye; severe pain under arm in armpit with... Read more
loss of appetite; spontaneous bleeding under skin by right eye; severe pain under arm in armpit with swelling; severe pain under arm in armpit with swelling; hot feeling on skin; extreme fatigue; had some itchy skin and redness an hour after shot, especially on both arms; had some itchy skin and redness an hour after shot, especially on both arms; Extremely nausea/Often nauseous; insomnia; mild diarrhea; This is a spontaneous report from a contactable Other HCP (patient). A 48-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EM9809; expiration date not provided), via an unspecified route of administration (anatomical location: arm right) on 09Feb2021 18:00 at SINGLE DOSE for COVID-19 immunisation. Medical history included asthma and known allergies to sulfa drug both from unknown dates and unknown if ongoing. The patient has no COVID prior vaccination. Patient is not pregnant. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262; expiration date not provided) on 19Dec2020 02:30 pm (vaccination location: left arm) and experienced dizziness, extreme itchy skin, headache, and fatigue reported as 'After 1st shot had dizziness and extreme itchy skin 1 hour after shot for approx 2 hours before it ended, then headache and fatigue for 1-2 days. However, after 48 hours all effects from the 1st shot were gone'. The patient experienced spontaneous bleeding under skin by right eye on 14Feb2021. Patient's clinical course is as follows: After 2nd shot, patient had some itchy skin and redness an hour after shot, especially on both arms that lasted a couple hours (started at 7PM and stopped at 9PM). Patient also had extreme fatigue everyday since 11Feb2021, as well as insomnia especially during the first 48 hours. Also had total loss of appetite the past 8 days (17Feb2021), extremely nauseous and mild diarrhea everyday since immediately after 2nd shot until now (8 days later) with no improvement. Often nauseous until close to the point of vomiting. 2 days after 2nd shot started having severe pain under arm in armpit area with swelling and hot feeling on skin. Developed some spontaneous bleeding under skin by right eye about 5 days (14Feb2021) after shot which has now gone away. Fatigue and health is poor with no improvement; most effects seem to be getting worse instead of improving each day. Patient was not COVID tested post vaccination. It was reported that no treatment was provided for the events. Outcome of the event 'had some itchy skin and redness an hour after shot, especially on both arms' was recovered on 09Feb2021; outcome of the event 'spontaneous bleeding under skin by right eye' was recovered; outcome of the remaining events was not recovered.
48 2021-03-17 injection site pain sx started 5-10 min later-shoulder pain started in L shoulder, vaccine location, went across to othe... Read more
sx started 5-10 min later-shoulder pain started in L shoulder, vaccine location, went across to other shoulder. next day, walking to garage-could not breathe, chest pain, heartrate elevated, 104 fever. ED-chest xray, EKG, blood work. 3-4 hrs. waiting for heart rate to go down. sent her home 103 fever. felt bad for 4 days after that-heart rate, fever. no Rx. otc Tylenol for fever. Doctor told her she should not have had vaccine since she recently had Covid.
48 2021-03-18 rash macular As soon as I received my vaccine my face, specially cheeks felt very hot, I was wearing a face mask ... Read more
As soon as I received my vaccine my face, specially cheeks felt very hot, I was wearing a face mask so not sure f that had anything to do with that feeling. I sat down in the wait area for the required 15 minutes and left. while walking towards my car I was nauseous and drank some water to help ease my stomach. When I got home my stomach felt like if I had a nod at the top of it as well as it got a little upset. I noticed I had blotchy arms the following morning.
48 2021-03-18 hives Hives on arms, stomach and legs.
48 2021-03-18 injection site swelling, injection site redness Metallic taste after first vaccine and after second vaccine. Chills, aches, feverish after second va... Read more
Metallic taste after first vaccine and after second vaccine. Chills, aches, feverish after second vaccine. Hard lump under injection site. Minor redness.
48 2021-03-18 injection site warmth, injection site swelling, injection site redness Patient received first dose of vaccine 3 weeks prior with no issues. She returned today 24 hours aft... Read more
Patient received first dose of vaccine 3 weeks prior with no issues. She returned today 24 hours after 2nd dose and had a swollen, red, warm area at the site of injection that measured about 2 inches by 2 inches. She said she wasn't experiencing any other systemic symptoms.
48 2021-03-18 itchy skin Yesterday on March 17, I was supposed to get my 1st COVID Pfizer vaccine from facility but because o... Read more
Yesterday on March 17, I was supposed to get my 1st COVID Pfizer vaccine from facility but because of nurse negligence and human error she overdose me and injected two shots of vaccine one after the other at the same time. Right after the incident they shifted me to emergency and kept me under observation there for almost 10 hours. I am a healthy person of no underline issues but still went through physical and mental trauma. Right after the dose I got dizzy, disoriented, my BP shot up, my heart rate was on the lower side now I am moved to home but have severe body aches, headaches, ear pain and allergic rashes itch on both arms and neck . I am scared if this would affect my health in future.
48 2021-03-19 skin burning sensation 2/17/21: slight burning sensation on skin; itchy eyes 2/18/21: itchy eyes, sore deltoid, sore rt hip... Read more
2/17/21: slight burning sensation on skin; itchy eyes 2/18/21: itchy eyes, sore deltoid, sore rt hip, sore 1st rt finger 2/19/21, 2/20/21: sore under rt upper arm 2/21/21: greater pain under rt upper arm, took acetaminophen 2/22/21-3/7/21: pain extending from rt underarm to rt wrist upon extension/reaching 2/24/21-2/26-21: rt carpal tunnel ache 2/28/21: lymph nodes not as sore 2/28/21-3/11/21: puckered skin, rt upper arm
48 2021-03-19 injection site swelling, injection site pain Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain and swelling Tiredness Muscle pain Chills J... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain and swelling Tiredness Muscle pain Chills Joint pain Nausea Feeling unwell Tender lymph nodes areas Felt feverish, but didn't take temperature
48 2021-03-20 redness Continued extreme fatigue, fever, hypertension, bradycardia, severe facial redness and swelling. I a... Read more
Continued extreme fatigue, fever, hypertension, bradycardia, severe facial redness and swelling. I am unable to give a detailed report due to this website expiring in 20 minutes. I will be more than happy to submit a complete timeline if needed.
48 2021-03-20 injection site pain, injection site bruising, injection site hardening Fever, chills, agitated throat, very fatigue, sore shot area, hard for 4 days at the shot area, brui... Read more
Fever, chills, agitated throat, very fatigue, sore shot area, hard for 4 days at the shot area, bruised, headache for 4 days, eyes tired
48 2021-03-20 injection site pain Pain at injection site sore throat fatigue wheezimg
48 2021-03-21 rash, pain of skin, skin warm, shingles 3/18: Upon receiving the injection, nerve tingles began in my left arm, wrist and hand. My jaw and n... Read more
3/18: Upon receiving the injection, nerve tingles began in my left arm, wrist and hand. My jaw and neck became very sore and two small bumps appeared on the back of my neck. The bumps became very sore and my lymph nodes began to swell. All symptoms were on the left side of my body, which is the side I received the injection. 3/19: The two bumps multiplied and I had them behind my ear, in my hairline, on the back and front of my neck, trailing to my shoulder and a patch on my back. The bumps were painful and hot. I vomited 4 times that day, ran a 100 temp for a short period of time, had chills, body aches, very swollen lymph node, mild headache, and a very stiff, sore neck. All of this occurred on the left side of my body. 3/20: The bumps continued to increase in size, pain and number. The swollen glands, sore and stiff neck persisted. I was very tired and felt nausea at times. 3/21: I woke with an extremely sore and stiff neck, sore throat and new patches of bumps. I sought medical treatment and was diagnosed with Shingles. I was 100% healthy prior to the shot. I've never had Shingles before. I am now on medication to treat the outbreak.
48 2021-03-21 injection site tingling, injection site numbness Numbness/tingling in arm where injection occurred - lasting 10 min or so, then a feeling like the me... Read more
Numbness/tingling in arm where injection occurred - lasting 10 min or so, then a feeling like the medication was traveling across my upper chest to my other arm, brief metallic taste in mouth
48 2021-03-21 injection site pruritus, injection site redness, injection site swelling, injection site pain, injection site mass PAIN, SWELLING , ITCH & REDNESS AT INJECTION SITE. FEVER, CHILLS, BODY ACHES, MUSCLE PAIN BASICALLY... Read more
PAIN, SWELLING , ITCH & REDNESS AT INJECTION SITE. FEVER, CHILLS, BODY ACHES, MUSCLE PAIN BASICALLY FLU LIKE SYMPTOMS STILL LARGE SOFTBALL SIZED RED SPOT, ITCHING, TENDER TO TOUCH, LARGE LUMP AT INJECTION SITE 5 DAYS LATER
48 2021-03-21 shingles Shingles in the C3-C5 dermatome
48 2021-03-22 injection site redness The Day after the injection I had full body muscle aches, reddness at injection site. The 2nd Day... Read more
The Day after the injection I had full body muscle aches, reddness at injection site. The 2nd Day after the injection, my muscle aches are better but now my Lymph Node under my arm is very swollen and painful
48 2021-03-23 itchy skin About 25 minutes after 1st dose of Pfizer covid vaccination the patient noted facial itching and flu... Read more
About 25 minutes after 1st dose of Pfizer covid vaccination the patient noted facial itching and flushing and this was similar to previous anaphylaxis she had from allergy immunotherapy. No angioedema, throat swelling, tongue swelling, sob, wheezing, difficulty speaking or swallowing. She was brought to the medical tent and given benadryl 50mg po and observed x 1 hour. Symptoms completely resolved. She was discharged home with her husband.
48 2021-03-23 injection site redness, rash, injection site swelling Day after vaccine: Bad migraine, fever, chills, body aches Day 3: arm swollen/red at injection site... Read more
Day after vaccine: Bad migraine, fever, chills, body aches Day 3: arm swollen/red at injection site and armpit is sore. Day 4: went to the ED due to worsening symptoms from vaccine injection including a rash
48 2021-03-23 injection site pain Nausea, headache, fatigue. Started approximately 4 hours after shot, becoming worse as evening wore... Read more
Nausea, headache, fatigue. Started approximately 4 hours after shot, becoming worse as evening wore on. After sleeping, woke in morning with symptoms improved but present. Approximately 24 hours after onset of symptoms they had dissipated. Treated symptoms with rest. Soreness in injection site continues but 48 hours after injection is nearly gone.
48 2021-03-23 itchy skin Patient reported at about 25 minutes after 1st dose of pfizer covid vaccine she began to feel facia... Read more
Patient reported at about 25 minutes after 1st dose of pfizer covid vaccine she began to feel facial itching and flushing, similar to what she felt with previous anaphylaxis due to allergy immunotherapy. She was brought to the medical tent and given 50mg benadryl po and observed x 1 hour. No progression of symtpoms, vitals stable. No angioedema, throat or tongue swelling, difficulty breathing or speaking, sob, or wheezing. Symptoms had completely resolved prior to discharge. She was driven home by her husband.
48 2021-03-23 hives, itchy skin Within 10 minutes of receiving the vaccine, my skin broke out in hives, was itchy and hot. I took o... Read more
Within 10 minutes of receiving the vaccine, my skin broke out in hives, was itchy and hot. I took over the counter Benadryl about an hour later. The hives subsided but the itching lasted approximately 24 hours after injection. I called the clinic and spoke to a nurse who in turn recommended my primary physician contact me. My primary physician and I spoke by phone the next day. No office visit was scheduled.
48 2021-03-24 redness, hives, rash Client completed 15min observation after vaccine and went out to her car. She noticed a rash on ches... Read more
Client completed 15min observation after vaccine and went out to her car. She noticed a rash on chest, and a dull headache so she came back in. Client was given 50mg of Benadryl PO and was observed for another 15min. Nurse observed a rash on chest that looked like hives and some redness on her right arm. Client's rash decreased but she did complain of a feeling of thickness in her mouth. There was no difficulty swallowing or breathing. Client was released to leave clinic site at 4:06 pm by RN.
48 2021-03-24 itchy skin, skin tightness I feel itchy all over from head to toe. There is a slight warming sensation and tightness of my skin... Read more
I feel itchy all over from head to toe. There is a slight warming sensation and tightness of my skin. There are no bumps or rash. It feels like a similar reaction I have to penicillin before the hive appear.
48 2021-03-24 injection site pain, injection site swelling, injection site redness Injection site pain, injection site swelling, injection site redness, shaking, chills, tiredness, he... Read more
Injection site pain, injection site swelling, injection site redness, shaking, chills, tiredness, headache, muscle pain, joint pain, nausea, feeling unwell, fever of 103.6
48 2021-03-24 rash My arm was sore and the rash started. It has been present since 01/07/2021 and it is not going away.... Read more
My arm was sore and the rash started. It has been present since 01/07/2021 and it is not going away. The only thing different is the vaccine. I've had IV antibiotics twice that seems to help so that it's not quiet as bad. It has never gone away.
48 2021-03-24 itchy skin Pt reports: "feeling of itchiness across her entire body and 'burning on the inside.'" "Itchiness an... Read more
Pt reports: "feeling of itchiness across her entire body and 'burning on the inside.'" "Itchiness and a tightness in her throat"
48 2021-03-24 injection site pain Soreness at injection site, not much worse than flu shot. Lymph node in under arm area swollen and v... Read more
Soreness at injection site, not much worse than flu shot. Lymph node in under arm area swollen and very sore. Soreness goes down in to elbow.
48 2021-03-24 itchy skin, hives anaphylaxis; pounding of heart; tightness of chest; Itching; coughing; hives; swelling of throat and... Read more
anaphylaxis; pounding of heart; tightness of chest; Itching; coughing; hives; swelling of throat and ears; swelling of throat and ears; sudden drop in blood pressure; elevated blood pressure and heart rate; elevated blood pressure and heart rate; inability to breathe all within less than 30 minutes of injection during; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17Mar2021 10:00 (Batch/Lot Number: EN6208) as single dose for covid-19 immunisation at a clinic. Medical history included asthma, allergies, and previous history of anaphylaxis to oral sulfa (Sulfa- anaphylaxis). Concomitant medications in two weeks included diphenhydramine hydrochloride (BENADRYL); clarithromycin (CLARTIN); levosalbutamol hydrochloride (XOPENEX); and fluticasone propionate (FLOVENT). There was no other vaccine in four weeks. On 17Mar2021 10:15, the patient experienced pounding of heart, tightness of chest, itching, coughing, hives, swelling of throat and ears, elevated blood pressure and heart rate, sudden drop in blood pressure, and inability to breathe all within less than 30 minutes of injection during observation. Epipen was administered on site and care team called 911. Ambulance arrived, assessed and informed her that she was experiencing anaphylaxis and took her to ER. ER gave her steroids and prescription for epipen and steroids. The next day itching, swollen throat, ears, pounding of heart and tightness of chest came back and she self injected epipen. Went to her doctor and was prescribed more epi pens, singular, Pepcid AC, and refilled her inhalers. She is to her seen again tomorrow by doctor. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and were assessed by reporter as Life threatening illness (immediate risk of death from the event). Treatment for the events include Epipen, steroids, Pepcid AC, singular, inhalers. The outcome of the events was not recovered. The patient was not pregnant at the time of event onset or at the time of vaccination. Patient had no COVID prior vaccination and was not tested for COVID post vaccination.
48 2021-03-24 shingles early stages of pericarditis or the shingles; severe chest pain; early stages of pericarditis or the... Read more
early stages of pericarditis or the shingles; severe chest pain; early stages of pericarditis or the shingles; This is a spontaneous report from a contactable healthcare professional (patient). A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL1283, unknown expiration), via an unspecified route of administration in left arm on 13Jan2021 at 13:00 (01:00 PM; at the age of 48 years old) at a single dose for COVID-19 immunisation. Medical history reported as none. There were no concomitant medications. The patient has no known allergies. The patient also received first dose of BNT162B2 (Brand: Pfizer; Lot number: EJ1685, unknown expiration) on 23Dec2020 at 01:00 PM in left arm (at the age of 48 years old) for COVID-19 immunization. The patient went to the ER with severe chest pain. After many tests were run, doctors believed that the patient was in early stages of pericarditis or the shingles on 17Feb2021 at 04:00 AM. The patient confirmed that she never developed shingles but have had all symptoms of pericarditis. The events resulted in emergency room/department or urgent care visit. The patient received NSAIDs and pain meds as treatment for the events. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. The patient is recovering from the events. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information, the Company considers the reported event pericarditis is unrelated to BNT162B2 vaccine, but more likely an inter-current medical condition. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
48 2021-03-25 itchy skin, rash I have a headache, fever, chills, exhausted. Now I have covid arm. My arm is itchy, swollen, pain, a... Read more
I have a headache, fever, chills, exhausted. Now I have covid arm. My arm is itchy, swollen, pain, and have slight rash.
48 2021-03-25 itchy skin Itching and swelling on face with uncontrollable coughing
48 2021-03-25 injection site pain Low-grade fever, chills, aches, nauseous, fatigue, headache , tender and painful at injection site
48 2021-03-25 vaccination site swelling, injection site redness, injection site pruritus, injection site hives On 1/11/2021 I had itchiness, red, & swelling on the vaccine site I had hives. It lasted about 4 day... Read more
On 1/11/2021 I had itchiness, red, & swelling on the vaccine site I had hives. It lasted about 4 days.
48 2021-03-25 injection site pain, skin tightness Pain in upper left arm from shoulder to elbow, tightness in left hand
48 2021-03-25 itchy skin Pt felt with generalizet itching, started with SOB, and 1 dose of epipen 0.3 was administered. The ... Read more
Pt felt with generalizet itching, started with SOB, and 1 dose of epipen 0.3 was administered. The rescue took the patient to the hospital. The patient had normal vital signs and was breathing properly when the rescue arrived.
48 2021-03-25 rash, itchy rash Rash around the neck area that spread to chest and back of the neck later in the day. Very itchy and... Read more
Rash around the neck area that spread to chest and back of the neck later in the day. Very itchy and have a burning sensation. The lymph node in the left neck area where the rash is, feels swollen.
48 2021-03-25 hives Severe hives over entire body 2 hours after injection, especially bad on face and neck. Felt extrem... Read more
Severe hives over entire body 2 hours after injection, especially bad on face and neck. Felt extremely hot from the inside out. Seen at Urgent Care, given shot of Benedryl and a dose of Prednisone Symptoms continued into the next day and evening, took Benedryl every 4 hours Symptoms improved by 03/26, though not completely gone.
48 2021-03-26 injection site pruritus, injection site warmth 03/23/2021 - injection given and within 2-3 minutes after injection I had heart palpitations and flu... Read more
03/23/2021 - injection given and within 2-3 minutes after injection I had heart palpitations and flush of heat over my body. After about 3 minutes heartbeat regulated and flush of heat dissipated. About 45 minutes later I got a headache last about 15 minutes. Then came back about an hour later lasting same time before stopping. This occurred again about 3 hours later, same as before. 03/24/2021 - arm was sore and injection site was slightly itchy and hot but stopped by 03/25/2021, no hunger. 03/24/2021 - woke up feeling nauseous and overall crappy feeling (not achy, not in pain). nausea lasted throughout the day, but no vomiting. headache often throughout the day but not lasting more than 10-15 minutes, no hunger. 03/25/2021 - again woke up feeling nauseous lasting off/on thru day, no vomiting, no headache, feeling overall more energetic wanting to eat when nausea went away. 03/26/2021 - woke up NO nausea, not hungry so ate later in afternoon. Within 20 minutes of me eating I became extremely fatigued, dizzy and could barely stand up. I started to feel like I was going to faint and got to a couch and laid down. I started sweating and felt like my body was on fire. My scalp and face were wet with sweat, I felt dizzy and extremely nauseous before I vomited (3) times. After vomiting the dizziness, nausea and weakness dissipated. After about 30 minutes I just felt tired and my chest hurt from the convulsions of vomiting. After about 2 hours I felt better and just tired. 03/27/2021 - woke up no nausea, no headache and slightly fatigued.
48 2021-03-26 injection site pain, pain of skin I received Vaccine No. 2 at 5:45 p.m. on 03/19/21. Beginning at around 2:30 a.m. on 03/20/21, sympto... Read more
I received Vaccine No. 2 at 5:45 p.m. on 03/19/21. Beginning at around 2:30 a.m. on 03/20/21, symptoms started to gradually surface that progressed throughout the day, such as: - intense pain at the site of the injection that spread to my underarm and left side of ribcage/breast - chills - low grade fever - aching joints - painful skin surface on my whole body - headache - shortness of breath - neuropathy - nausea - loss of appetite - loss of taste - stuffy nose
48 2021-03-26 pain of skin, injection site pain Immediate pain at the injection site, less than with the first dose. 12 hours later at 4:30am 3/26/... Read more
Immediate pain at the injection site, less than with the first dose. 12 hours later at 4:30am 3/26/21. I woke up with a fever of 99.9, extreme body aches, skin hurt to touch, horrible headache, bad arm pain, wasn't able to sleep much after that due to all of the pain. Got up at 8am but in too much pain and went back to bed. Fever continued all day and fluctuated between 99.9 to 101.6. Headache, body aches, joint pain, arm pain was so intense I couldn't get comfortable lying down but could not stand very long and couldn't sit up due to extreme fatigue. Headache, body aches and joint pain started to diminish enough that I could sit up around 8:00pm 3/26/21. Showered at 8:00pm. Ate at 9:00pm. In bed again by 11:00pm with fever at last check 99.9. Woke up to fever breaking at 1:00am 3/27/21 Slept through the night without waking up due to pain. Woke up at 8am 3/27/21 some low grade fatigue but not in pain, no headache, and no fever. Feeling wiped out, arm still tender but not painful, feeling pretty great all things considered. Will likely have an autoimmune reaction/flare, but when I get sick or get a vaccine it usually comes a few days after.
48 2021-03-27 injection site pain March 8th. Almost 0 pain at injection site for first 3 hours then a little soreness Three hours lat... Read more
March 8th. Almost 0 pain at injection site for first 3 hours then a little soreness Three hours later a few minor sx began:- chills on my skin starting at hands, then pain across bottom of rib cage, then stabbing pains throughout torseau and legs-worsened at night time and joined by severe chills-shivering. All next day felt like I had flu-waking up most every hour-level 5-6 headache also developed. March 9th felt like I had the flu most of the day-flushing, then getting chills. still stabbing pains and indigestion-very tender around ribcage (tender to the touch). Took peptobismol tablet. Good 11-12 hour sleep 2nd night. Next morning:
48 2021-03-28 injection site numbness, injection site tingling Left arm is numb and tingles running from site of injection down to my wrist
48 2021-03-28 rash Rash on fingers around nailbeds and knuckles
48 2021-03-30 redness Date of start of drug 06Jan2021/ Date of start of drug 29Jan2021; 2nd dose Roof of mouth felt like i... Read more
Date of start of drug 06Jan2021/ Date of start of drug 29Jan2021; 2nd dose Roof of mouth felt like it was swelling; My tongue and lips started tingling; Both ears red and felt very warm; Both ears red and felt very warm; Slight headache; This is a spontaneous report from a contactable other hcp (patient). A 48-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: unknown; Expiration Date: unknown) via an unspecified route of administration in left arm on 29Jan2021 at 09:15 as a single dose for covid-19 immunization. Medical history included Allergies to medications, food, or other products: Penicillin, amoxicillin and codeine. Concomitant medications included esomeprazole magnesium (NEXIUM), ibuprofen (IBUPROFEN) and nature's bounty on unspecified date for unspecified indication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE). The patient experienced second dose roof of mouth felt like it was swelling, y tongue and lips started tingling and both ears red and felt very warm and slight headache for the second dose on 29 Jan2021 at 09:15 AM. The outcome of the events was recovered on an unspecified 2021. Information on the lot/batch number has been requested.
48 2021-03-30 rash, hives, itchy skin Developed hives rash itching and feeling of airway closure 30minutes after the vaccine
48 2021-03-30 hives, itchy skin I have developed hives on both arms that itch; I have developed hives on both arms that itch; This i... Read more
I have developed hives on both arms that itch; I have developed hives on both arms that itch; This is a spontaneous report from a contactable consumer (patient reported herself). A 48-year-old non-pregnant female patient received first dose of BNT162B2 (COVID 19, Formulation: Solution for injection) via an unspecified route of administration on 12Feb2021 02:00 PM at single dose for Covid-19 immunization. The patient's medical history included multiple sclerosis (MS) and allergic to COPAXONE (known allergies: Copaxone). Concomitant medications were not reported. Other medications in two weeks was reported none. Facility type vaccine: Workplace clinic. Covid was not tested prior or post vaccination. On 13Feb2021 06:00 PM, the patient developed hives on both arms that itch. The patient did not receive any treatment in response to the events. Outcome of the events was unknown. Information on the lot/batch number has been requested.
48 2021-03-30 itchy skin, rash With both injections I felt an almost immediate itching on my tricep and upper latissimus dorsi area... Read more
With both injections I felt an almost immediate itching on my tricep and upper latissimus dorsi area. The itching subsided on my tricep but I still have a red rash and discomfort to the lat area; With both injections I felt an almost immediate itching on my tricep and upper latissimus dorsi area. The itching subsided on my tricep but I still have a red rash and discomfort to the lat area; With both injections I felt an almost immediate itching on my tricep and upper latissimus dorsi area. The itching subsided on my tricep but I still have a red rash and discomfort to the lat area; This is a spontaneous report from a contactable nurse. This 48-year-old female nurse reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EH9899) intramuscularly from 18Dec2020 at 12:00 pm to 18Dec2020 at 12:00 pm at single dose (dose number; 1) on left arm, then second dose, lot number; EL1283 from 07Jan2020 to 07Jan2020 (dose number; 2) at single dose on right arm for covid-19 immunization. Patient was not pregnant at the time of vaccination. Vaccine facility type was reported as hospital. Patient's medical history (If covid prior vaccination, If covid tested post vaccination; no) was not reported. Past drug included allergy; sulfa. Other vaccine in four weeks was reported as no. Concomitant medications (other medications in two weeks) included ESTRADIOL (Estrogen), progesterone and multivits. Nurse reported that on 18Dec2020 at 12:00 pm with both injections I felt an almost immediate itching on my tricep and upper latissimus dorsi area. The itching subsided on my tricep but I still have a red rash and discomfort to the lat area. Treatment was not given for the AE. Outcome of event was not recovered.
48 2021-04-01 redness The day after receiving the shot I developed pain in my entire arm from armpit to fingers. Pain beca... Read more
The day after receiving the shot I developed pain in my entire arm from armpit to fingers. Pain became severe by day 3. Pain spread to my right breast, neck, back, and right scapular area. I have had numbness in my fingers on right side. Today is 16 days. The pain increased every day for about 10 days. Decreases slightly and is now holding. I'm am in terrible pain. I didn't sleep for 6 days when the pain was at is peak and still can barely sleep. It's the worst pain of my life. It feels like my arm is in fire and in a meat grinder. My arm and neck pain worsens when I use my arm or change positions. I am also getting flushed heat feelings on my face intermittently. Since this vaccine I have had allergic reactions to ibuprophen and prednisone which sent me to the ER. Two medications I have received before with no problem. I also felt I was reacting to gargling with listerine which I have used before without issue. I eat eggs regularly and got a small sensation of throat swelling with that too and have not eaten them again. My doctor is having trouble treating me since I am now having so many allergy symptoms to different things. I have been advised by my doctor not to continue with this vaccine or any vaccine in the future. I am still in terrible pain that is limiting me from participating i. my normal life activities. I did not develop any rashes or obvious swelling at the injection site. Twenty minutes after receiving the shot I did get a bit flush feeling and some redness in my face and my ears felt hot and then cold. That resolved within about 45 minutes.
48 2021-04-03 injection site swelling, redness, bruising, itchy skin Onset of symptoms was 24 hrs after vaccine. First symptoms were fatigue, abdominal discomfort, loss... Read more
Onset of symptoms was 24 hrs after vaccine. First symptoms were fatigue, abdominal discomfort, loss of appetite, mild dizziness, swollen injection site, arm soreness. Starting 48 hours after the vaccine: jaundice symptoms, including: itchiness on the feet and palms, large patchy bruises on the legs, clay-colored stools, extreme fatigue, yellowing of the eyes, dark-colored urine. Later, small, round, skin lesions emerged and spread , starting around March 11, 2021. By the 23, red, itchy, patches had expanded over the chest, abdomen and groin areas.
48 2021-04-07 redness About 15 minutes had urge to cough, tickling in throat, redness in throat and started to feel swelli... Read more
About 15 minutes had urge to cough, tickling in throat, redness in throat and started to feel swelling. Had my own kit of epic pen, steroids, Pepcid and Benadryl. Injected myself because the MA at site injected herself and not me, so had another. Did pen, 2 Benadryl, 2 20mg prednisone, I Prevacid. Drove to urgent care and had them monitor me. All the about seemed to work to relieve the swelling and not gonna watch myself for 24 hours. I have environmental allergies and have reacted to 3 allergy shots with similar symptoms listed above. Had to stop doing them. Please look at people with severe allergies as a group to not require these shots.
48 2021-04-07 redness Upon getting the dose in my left arm, my face immediate got bright red and my ears started ringing. ... Read more
Upon getting the dose in my left arm, my face immediate got bright red and my ears started ringing. It is a high pitched tone. Mostly my left ear. Hasn't stopped for six weeks now; Upon getting the dose in my left arm, my face immediate got bright red and my ears started ringing. It is a high pitched tone. Mostly my left ear. Hasn't stopped for six weeks now; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6203 and expiration date: Not available), via an unspecified route of administration in the left arm on 25Feb2021 at 04:15 PM as a single dose for COVID-19 immunisation. The patient was not pregnant. The patients medical history included Hashimotos Thyroiditis and Autoimmune Disorder. The patient had Latex, Zythromax, Remeron allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. The patient didn't receive other medication in two weeks. On 25Feb2021 at 04:30 PM, the patient experienced face immediate got bright red and my ears started ringing. The tone was reported to be high pitched mostly in the left ear and it has not stopped for six weeks. The patient received Lipo Flavonoid and acupuncture as treatment for the events. The patient underwent hearing test whose reports were not provided. The events resulted in a visit to Doctor or other healthcare professional office/clinic visit, disability, or permanent damage. The clinical outcome of events was not recovered.
48 2021-04-10 injection site pain My first on 03/19/2021 went smoothly, just sore area of shot. They had me wait 15 minutes after just... Read more
My first on 03/19/2021 went smoothly, just sore area of shot. They had me wait 15 minutes after just in case adverse reaction. On 04/09/2021 came back for second round. The nurse gave me my 2nd shot and said they don?t make patients wait after injections, I left the facility and by the time I reached my car my tongue had swollen up, went home and later that night my husband and kids asked what was wrong with my eyes - both my eyes were bloodshot red and swollen. On 4/10, my left eye was better but not my right. I have had brain fog, not being able to remember short memories all weekend. I plan to call my doctor in the morning. As a woman, I felt morally obligated to share my side effects.
48 2021-04-12 skin irritation Dermatitis; This is a spontaneous report received from a contactable consumer reporting for herself.... Read more
Dermatitis; This is a spontaneous report received from a contactable consumer reporting for herself. A 48-year-old female patient received 1 dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number # EN5318 via an unspecified route of administration, administered in Arm Left on 29Jan2021 12:30 at the age of 48 years as SINGLE DOSE for covid-19 immunisation. Vaccine administered facility type: Skill nursing facility(clinic). The patient medical history and concomitant medications were not reported. The patient experienced dermatitis on 29Jan2021 16:00 with outcome of recovered on unspecified date. Seriousness criteria: Important medical event. Therapeutic measures were taken as a result of the event.
48 2021-04-20 vaccination site pain, vaccination site itchiness became faint and passed out onto the floor; hit my chin and jaw so hard it was bleeding; hit my chin... Read more
became faint and passed out onto the floor; hit my chin and jaw so hard it was bleeding; hit my chin and jaw so hard it was bleeding and obviously very sore and swollen; hit my chin and jaw so hard it was bleeding and obviously very sore and swollen; nauseous; light headed; chills; flu like symptoms; arm felt sore/arm at site of injection remains sore; at site of injection remains sore and itchy; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (lot number: ER8733) first dose on 30Mar2021 12:30 PM on left arm at single dose for COVID-19 immunisation. Medical history included IDDM (Type 1 diabetes mellitus) and MS (Multiple sclerosis). Patient is not pregnant. No other vaccine in four weeks. No known allergies. Concomitant medications in two weeks included Insulin for IDDM, dimethyl fumarate (TECFIDERA) for MS. Had vaccine at 12:30pm. At 3am (31Mar2021), arm felt sore and felt both nauseous and light headed as well as having chills and flu like symptoms. Went to bathroom and on way back to bed, became faint and passed out onto the floor. Patient hit chin and jaw so hard it was bleeding and obviously very sore and swollen. It's been nearly a week since that incident and arm at site of injection remains sore and itchy. She still feel nauseous at times and her face is still swollen from falling onto the floor and passing out. She was now fearful of having the second dose on 20Apr2021 as due since her reaction to 1st dose was so severe. The outcome of the events was recovering. No treatment for the events. No Covid tested post vaccination.
48 2021-04-23 rash vesicular ulcers on the side of her tongue and on the inside of her lips; rash with blisters on her hand and b... Read more
ulcers on the side of her tongue and on the inside of her lips; rash with blisters on her hand and back; Blister of lip; Swollen lips; sore arm; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) on right arm on 12Jan2021 at single dose for covid-19 immunization (to not get symptoms from Covid). Medical history included typically had a strong local reaction to bees or insect bites. The patient's concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL) for Birth control 1 by daily (had been taking for 15 years and is ongoing). On 12Jan2021, the day patient received the vaccine, she had sore arm which resolved on 13Jan2021. Ten days later on 23Jan2021, she developed a rash with blisters on her hand and back, had blisters/ulcers on the side of her tongue inside her lips and her lips were also swollen and cracked. She states that she treated these symptoms with Benadryl and the rash and swelling resolved. She cannot attribute it to the vaccine. The ulcers in her mouth were better in about a week. She was calling to see if she should receive the second dose of the COVID-19 vaccine and would like to know how effective the Pfizer COVID-19 vaccine is after one dose. Everything that she had seen, this was not a typical reaction. She was wondering if it was safe to get the second dose. She went to the site where she received the vaccine and was unable to get any information. She does not have a physician. The rash has improved. Redness on her skin still can be seen. The blisters on her lips were white places like a canker sore but it was not a canker sore. Her lip was split like mouth ulcers. She took Benadryl and it helped. The outcome of the event ulcers on the side of her tongue was unknown. The outcome was recovered for the events sore arm on 13Jan2021, blister of lip on 31Jan2021 and swollen lips on 01Feb2021. The outcome of the event rash was recovering. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
48 2021-04-24 blister anaphylactic reaction; anaphylactic shock; my tongue first tingling; burning all over my tongue; mas... Read more
anaphylactic reaction; anaphylactic shock; my tongue first tingling; burning all over my tongue; massive and dangerous swelling of my tongue; an intense burning on the roof of my mouth; there were bumps forming all over the back of my tongue; blisters forming on the back of my throat; She has been very very sick; This is a spontaneous report from a contactable consumer (patient), other healthcare professional, and a physician. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6208), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 16:00 (at the age of 48years) as single dose for Covid-19 immunization. Medical history included known allergies: mild allergy to sulfa as a child that resulted in a rash; mild allergy to Crestor that resulted in extreme gas and bloating; other medical history: type 2 diabetic that has been controlled for 8 years with no A1C higher than 7.0. The patient is not pregnant at the time of vaccination. Concomitant medications included metformin, glipizide, bupropion hydrochloride (WELLBUTRIN), lovastatin, and other unspecified medication; all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that on 23Mar2021, she received her vaccine at 4 p.m. and experienced an anaphylactic reaction within 5 minutes, by 4:10 she was taken to the ER (emergency room) attached to the clinic due to her tongue first tingling, then burning all over her tongue, and then massive and dangerous swelling of her tongue and an intense burning on the roof of her mouth. The attending physician noted there were bumps forming all over the back of her tongue and blisters forming on the back of her throat. She was admitted for anaphylactic shock and kept at the ER for 2 hours before being transferred via ambulance to other hospital and she was admitted to the ICU (intensive case unit). She spent the next day in the ICU then 2 days in Cardiac Care, another day back in the ICU, with a 5th and final day back in the Cardiac care. All 5 days were spend trying to get her anaphylactic shock under control. She had numerous doses of EpiPen, steroids, Benadryl, and Pepcid. Her tongue never did completely stop swelling and the burning sensation has never stopped. The patient was hospitalized for 5 days. It was reported further reported that the patient was hospitalized for 6 days (also initially reported as 5 days-pending clarification) and was sent home with medications but was back in the hospital yesterday (unspecified date) because of another big blow up. She has had 2 stays in the ICU, 4 days in cardiac care and is now back in cardiac care again because of yesterday. It has been 2 weeks since she received the vaccine and it is now day 12 but it keeps coming back and she just cannot stop it. She has been very very sick, in a very severe, very rare, extreme, constant state of anaphylactic shock. She has had many Epi (Epinephrine) and is on strong steroids but it has not subsided. She mentioned that their lead pharmacist called last week but never heard any response back. Her doctor told her that they accessed a website from Pfizer which allowed them to search for adverse reactions and they mentioned to her that most of these reactions subside within 24-48 hours. She mentioned that she has no food allergies, no allergies to vaccines, and has only had minor drug reactions. This is the 1st time that this has happened to her and it is getting serious. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered. The reporter (consumer) assessed the events as non-serious. Information on lot/batch number was available. Additional information has been requested.
48 2021-04-26 shingles started having symptoms for Shingles approximately 2 weeks 3 days after receiving 1st vaccine. I was... Read more
started having symptoms for Shingles approximately 2 weeks 3 days after receiving 1st vaccine. I was diagnosed 4 days later; This is a spontaneous report from a contactable consumer (patient) reporting herself. A 48-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL9262) via an unspecified route of administration, administered in Arm Left on 28Jan2021 at 07:45 as SINGLE DOSE for covid-19 immunization. Medical history included colon cancer, hypothyroidism and hypertension. Concomitant medication in two weeks included thyroid (ARMOUR THYROID); sertraline (SERTRALINE) and hydrochlorothiazide (HYDROCHLOROTHIAZIDE). The patient did not receive any other vaccines in four weeks. The patient previously took Vicadine and experienced known allergies: Vicadine. On 14Feb2021, the patient experienced, started having symptoms for shingles approximately 2 weeks 3 days after receiving 1st vaccine and was diagnosed 4 days later. The patient not had covid prior vaccination; not tested covid post vaccination. Therapeutic measures were taken as a result of event and included treatment with Medication. The patient visited a Physician Office. The outcome of event is recovering.
48 2021-05-04 hives Broke out in hives; This is a spontaneous report from a non-contactable patient (other health care p... Read more
Broke out in hives; This is a spontaneous report from a non-contactable patient (other health care professional). A 48-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was El3246), intramuscular at arm left on 25Jan2021 19:30 as single dose for COVID-19 immunization. Previously patient received first dose of bnt162b2 as single dose for COVID-19 immunization. Patient did not receive any vaccine in 4 weeks. The patient did not take any medication in two weeks. The patient medical history was not reported. There were no concomitant medications reported. On 25Jan2021 the patient experienced broke out in hives. No treatment was received for the event. The patient did not have COVID prior to vaccination. On 25Jan 2021 the patient did COVID test as nasal swab, PCR test which results negative. Patient had no allergies. The outcome of event was recovered. No follow-up attempts are possible. No further information is expected.
48 2021-05-04 hives Red hives starting at neck and chest and radiating to arms and face; Light headed; Swollen tongue; T... Read more
Red hives starting at neck and chest and radiating to arms and face; Light headed; Swollen tongue; This is a spontaneous report received from a contactable other hcp. A 48-years-old female patient received first dose of (Solution for injection), via an unspecified route of administration, administered in Arm Left on 26 Jan 2021 18:30 as single dose for Covid-19 immunisation. The patient's medical history was not reported. Patient had no known allergies. Concomitant medications included Hydrochlorothiazide and Betahistine. It was reported that patient was not pregnant at the time event. On 26 Jan 2021, the patient experienced red hives starting at neck and chest and radiating to arms and face, lightheaded and swollen tongue. The events were non-serious. Patient received Benadryl as treatment for events. It was reported that patient was not taken any vaccine in four weeks nor had Covid and tested the same post to vaccination. Outcome of events was recovering. Follow-up attempts are completed. No further information is expected.
48 2021-05-09 itchy skin, hives, redness Severe anaphylaxis- Red on face and arm (hives/itching), severe shortness of breath, and severe swel... Read more
Severe anaphylaxis- Red on face and arm (hives/itching), severe shortness of breath, and severe swelling of face and under the arms.
49 2020-12-31 injection site pain mild dizziness (at time of injection); injection site soreness (12 hours after injection; duration 1... Read more
mild dizziness (at time of injection); injection site soreness (12 hours after injection; duration 1 day); 3 says after injection: nausea, dizziness and weakness, headache, tiredness, feeling unwell.
49 2021-01-01 itchy skin, redness 12 hrs after vaccination, had mild frontal headache and fatigue. 24 hours after, itching, burning , ... Read more
12 hrs after vaccination, had mild frontal headache and fatigue. 24 hours after, itching, burning , stinging sensation around eyes, itchy forehead with mild erythema including eyelids, mild circumoral numbness with occasional burning/stinging sensation.
49 2021-01-03 rash 10 min after initial injection, I experienced a brief flush of heat that resolved after a few minute... Read more
10 min after initial injection, I experienced a brief flush of heat that resolved after a few minutes. 6 hours later, I had a sudden onset of intense heat, diaphoresis, and a rash to my arms/legs, along with intense muscle tremors, nausea, vomiting and stomach cramps.
49 2021-01-03 injection site swelling, pain of skin, injection site redness 12/29 - Left arm - large painfull, swollen area at injection site. Pain radiated from neck, arm pit ... Read more
12/29 - Left arm - large painfull, swollen area at injection site. Pain radiated from neck, arm pit to wrist. All over fatigue, joint pain, brain fog, and temp of F. Nausea and headache. 12/30 - Pain in left worse, incressed pain, redness, and swelling at injecition site. Painful swollen area in left armpit. Pain with any movement of left arm. Headache, fatigue, nausea, and muscle weakness. 12/31 - Continued pain in left arm, but improved. Continue to have pain swollen area with warmth and redness size of an orange. Headache and fatigue. 1/1 - fatigue, arm sore. Bilateral arm weakness. 1/2 - headache throughout day, not responsive to Tylenol or Advil, fatigue 1/3 - Vertigo, fatigue 1/4 - Left arm slightly sore to touch, fatigue.
49 2021-01-03 injection site pain Four days after receiving vaccine, awoke at 3am to roll over in bed and had dizziness and nausea. S... Read more
Four days after receiving vaccine, awoke at 3am to roll over in bed and had dizziness and nausea. Symptoms are ongoing. Also, complaints of insomnia (ongoing), joint pain (day after vaccination), right lower quadrant pain (first night after vaccination), weakness (for 3 days after vaccination), moderate muscle pain at injection site (resolved after 48 hours), night sweats (ongoing).
49 2021-01-03 itchy skin, redness I had itching and redness and knots that formed in my left leg. The knots were at the site of a ver... Read more
I had itching and redness and knots that formed in my left leg. The knots were at the site of a vericose vein. I sought tx at an ER on 12/26 to ensure it was not a blod clot. I followed up with my family dr on 1/4/2021 (When her office reopend) and was diagnosed with Superficial Thrombophlebitis. The knots remain in my leg. The redness has mostly gone away. My PCP felt as I recenlty had covid, the vaccine likely flared up the inflamation in my body and caused this condition.
49 2021-01-03 vaccination site swelling, injection site redness I had lip swelling, flushing and coughing the day of the vaccine. I had swelling and redness around ... Read more
I had lip swelling, flushing and coughing the day of the vaccine. I had swelling and redness around the vaccine site. The next morning I had swelling of my hands, feet and legs.
49 2021-01-03 rash, itchy skin, redness Itching, rash and redness through out body.
49 2021-01-03 itchy rash, rash papular, rash vesicular, rash Right wrist rash, 4cm x 2.5cm, with vesicles that drained clear fluid after severe itching relieved ... Read more
Right wrist rash, 4cm x 2.5cm, with vesicles that drained clear fluid after severe itching relieved by scratching. Left hand rash, of the webbing between the thumb and forefinger, raised. Not as severe as the wrist. Numbness or tingling of the lips, intermittent, first occurred an hour after the vaccine and has been infrequent since then. Gradually reducing in frequency; described as an awkward sensation of tingling. Has contacted her PCP for an appointment. Local Pharmacy would not sell or recommend medications due to the patient's history of Pfizer vaccine without her having been diagnosed first.
49 2021-01-03 injection site swelling, injection site pain, injection site redness Started with pain at injection site the day after vaccine was given. The following day (2 days afte... Read more
Started with pain at injection site the day after vaccine was given. The following day (2 days after vaccine), there was a quarter size bump and it was tender when touched. At one week, the site was no longer tender but still erythema surrounding injection site, slightly larger. At 2 weeks, noticed bump was more diffuse had spread (~4-5 cm) with more noticeable erythema around the edges. Contacted employee health at this time who advised me to contact my PCP and submit VAERS report. No fever or other systemic reactions during this period. Unsure if 2nd vaccine should be given.
49 2021-01-03 injection site pain pain at injection site that radiated down left arm then turned into overall body aches on 1/3 at tim... Read more
pain at injection site that radiated down left arm then turned into overall body aches on 1/3 at time of injection. Nausea started on 1/4 around 930am. overall fatigue
49 2021-01-04 injection site swelling, injection site redness 9 days later had large red mark raised and bump at vaccine site.
49 2021-01-04 injection site nodule, injection site redness, injection site warmth I developed a small knot at the injection site the day after i received it. By the following evening... Read more
I developed a small knot at the injection site the day after i received it. By the following evening it had grown to the size of a baseball. It was red, warm, indurated and it itched. Though when I attempted to scratch it was very painful. I took Benadryl on the evening January 2nd and have taken cetirizine for the past two days. It has gotten slightly smaller and the itching has improved though not completely resolved.
49 2021-01-04 injection site pain I experienced my heart racing as I was driving back to my clinic. This happened about 45 minutes af... Read more
I experienced my heart racing as I was driving back to my clinic. This happened about 45 minutes after getting the vaccine. Twice while I drove back to work and twice while I was working. These episodes were brief. I also experienced numbness and tingling in my arm that received the injection. This feeling spread to my shoulder and traveled up my neck to my face. I had numbness and tingling on my left side of my face and lower lip. This lasted till about 3:30 pm and then went away. Tonight around 7:00 pm I am still experiencing some numbness and tingling on my face and lip which comes and goes. I am having soreness in my arm at the injection site.
49 2021-01-04 itchy rash, rash Itchy rash developed on extremities and buttocks.
49 2021-01-04 injection site pain Received Pfizer covid 19 vaccine 1/2/21(Saturday). Bed time Saturday injection site was and still is... Read more
Received Pfizer covid 19 vaccine 1/2/21(Saturday). Bed time Saturday injection site was and still is tender. Also notice mild body aches at this time. Sunday came home from work w fever chills headache and vomiting
49 2021-01-04 injection site pain, injection site swelling, pain of skin difficulty thinking; brain fog; Injection site pain and swelling; Injection site pain and swelling; ... Read more
difficulty thinking; brain fog; Injection site pain and swelling; Injection site pain and swelling; axillary lymph node swelling; wrist pain and swelling/joint pain; wrist pain and swelling; muscle and joint pain; skin pain; kidney and liver pain; kidney and liver pain; dizziness; nausea; weakness; fatigue; chilling; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient (not pregnant) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided), intramuscular in right arm on 22Dec2020 14:30 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included asthma. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR). The patient experienced Injection site pain and swelling, axillary lymph node swelling, wrist pain and swelling, muscle and joint pain, skin pain, kidney and liver pain, dizziness, nausea, weakness, fatigue, chilling, difficulty thinking, brain fog on 23Dec2020 01:15. Symptoms lasting x 6 days. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was reported as recovering. Information about lot/batch number are requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the difficulty thinking, brain fog and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
49 2021-01-04 redness swelling and redness in the face; swelling and redness in the face; Muscle and body aches; Muscle an... Read more
swelling and redness in the face; swelling and redness in the face; Muscle and body aches; Muscle and body aches; shortness of breath; headache/migraine; headache/migraine; runny nose; sneezing; soreness in upper and lower left arm; swelling in left arm and in both hands; This is a spontaneous report from a contactable Other HCP (patient). This 49-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EJ1685) at single dose on 28Dec2020 at 02:00 PM on left arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included fibromyalgia; skin lupus; sacroiliitis; chronic migraines; allergies to Latex, TB shot skin test, several foods, environmental things (trees, grass, pollen, cockroaches, etc.). Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication was not reported. Since the vaccination, the patient had not been tested for COVID-19. On 29Dec2020 at 06:15 AM, the patient experienced swelling and redness in the face, muscle and body aches, shortness of breath, fatigue, headache/migraine, runny nose, sneezing, swelling in left arm and in both hands. There was not treatment received for all the adverse events. All events considered non-serious as all not resulted in death, not life threatening, not caused/prolonged hospitalization, not disabling/incapacitating, not congenital anomaly/birth defect. The outcome of events was not resolved.
49 2021-01-04 vaccination site pain throat sore and pain in neck; her throat is sore, feels like it may be swelling; some neck pain; it ... Read more
throat sore and pain in neck; her throat is sore, feels like it may be swelling; some neck pain; it feels like muscle spasms; extremely tired; soreness in her arm; Chills; Nausea; felt weak/having some weakness; massive headache/mild headache; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) via an unspecified route of administration on 28Dec2020 11:00 on left arm at a single dose for COVID-19 immunization. The patient was positive for Covid back in Jun2020, it was a bad case that she was hospitalized for 6 days, that she did not have to go on respirator. She stated these days she still struggled with chest pains and still struggled with her taste, she went to the emergency room in Sep2020 with some issues from that. The patient concomitant medications were none. The patient stated she was retired who works security at a hospital that she got her first dose of the Pfizer Covid vaccine yesterday on 28Dec2020. She was calling to report some side effects from the vaccine. She was skeptical about shot but she went ahead and got the vaccine, she took it and waited the 15 minutes and everything was fine except some soreness in her arm, about an hour after the shot, she felt extremely tired, could not even read, by last night she was getting chills, nauseated and weak, all she wanted to do was sleep, she had a massive headache. She kept thinking she was going to have to go to the ER. She woke up this morning and her throat was sore, felt like it may be swelling, felt sick. She took two advil and her headache was better. She was taking tumeric and ginger root and honey with lemon for her throat. She knew she was not sick that it is just the vaccine and she would power through it but wanted to call. She was starting to feel better but still having some weakness, still tired, had pain in the arm of the injection site, a mild headache. She stated these side effects are still ongoing but are improved. She was also having some neck pain started this morning sometime, but does not know exact time, it feels like muscle spasms. Caller wanted to know if because she had Covid before her side effects are so bad. The patient did not do any relevant tests. The outcome of the events soreness in her arm, extremely tired, Headache was recovering, the outcome of the events Chills, Nausea was recovered in Dec2020 and the other events was not recovered.
49 2021-01-04 vaccination site swelling, hives, injection site redness, vaccination site warmth welts around body, buttocks, arm, legs. vaccine site redness, puffiness, warm to touch
49 2021-01-05 skin burning sensation, injection site pain, injection site redness After receiving the injection in the right arm, the patient began to feel pain and burning at the in... Read more
After receiving the injection in the right arm, the patient began to feel pain and burning at the injection site in the right deltoid with spreading down to her hand along with localized redness at the injection site. She was given 50 mg of diphenhydramine and subsequently developed facial flushing and a feeling of numbness/tingling in both arms and hands. At this time, about half an hour had elapsed after the injection, so she was referred to the hospital emergency department from the hospital vaccine pod for additional monitoring. No additional interventions were given in the emergency department, she was discharged home after 3 hours of monitoring. Symptoms had improved with time.
49 2021-01-05 bruising, injection site redness, injection site bruising Day of next day after vaccine administration-only had mild headache, thirst and fatigued. I did ha... Read more
Day of next day after vaccine administration-only had mild headache, thirst and fatigued. I did have a hematoma and bruising, No fever On Jan 1st, I started feeling fatigued again and noticed round reddening approximately 2 inch in diameter appear about a inch under vaccination location which is still bruised. There is no pain or itching at reddened site. Jan 2, 3 and 4th-Fatigue worsened and developed low grade temp never surpassing 100. My throat developed allergy reaction feeling, same reaction I get with nuts. Throat did not swell and benedryl managed the reaction on Jan 3rd. My eyes began swelling and I could not stop sneezing. Developed laryngitis from the post nasal drainage. I was up whole night but still went into work as normal on Jan 4th. Struggled through the days but swelling and itching subsided. I experienced the muscle aches on the 3rd and 4th. On Jan 5th, started feeling better and rested. Still have reddened reaction on arm but is fading. It is faintly visible today on Jan 6th, I feel better, just have the sneezing currently and a mild headache. Benedryl is the only medication besides daily meds I took during the past several days. I did not want to interrupt the immune system's work.
49 2021-01-05 vaccination site pain Eyes were red; Tiredness and needed to sleep extra; Tiredness and needed to sleep extra; Heartbeat w... Read more
Eyes were red; Tiredness and needed to sleep extra; Tiredness and needed to sleep extra; Heartbeat was fast; Felt like she had to throw up; Pain in right arm; Does not feel good; It felt like there was oil in her mouth; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received first dose of BNT162B2 via an unspecified route of administration on 30Dec2020 10:45 at single dose in right arm for COVID-19 immunization. The vaccination was given in hospital, not a military facility, at 10:45 and left hospital at 11:05 on 30Dec2020. Prior vaccinations within 4 weeks was none. Additional vaccines administered on same date of the Pfizer suspect was none. Medical history included ongoing migraine and family medical history included mother has high blood pressure and father has diabetes. Concomitant medication included verapamil from Oct2020 at 40 mg twice daily by mouth for migraine. Additional Information for concomitant products Verapamil included 1 for one week, 2 for second week 3rd week 3 and after 3 months, then came back down to 2. The patient experienced does not feel good at 11:30 on 30Dec2020. She was driving and did not feel good. She felt like she had to throw up at12:00 on 30Dec2020 and had it all night until she went to bed. Eyes were red when she woke up at 23:30 on 30Dec2020, that's when she first noticed. Heartbeat was fast around 12:30 on 30Dec2020. Tiredness and needed to sleep extra at 17:00 on 30Dec2020. Pain in right arm at 12:00 on 30Dec2020. When she went to drink something, she noticed her arm was painful. No ER or physician's office required. Received call from patient regarding the COVID vaccine. She received it on 30Dec2020 (yesterday) and was a healthcare worker. She later stated she works in patient transportation in a hospital. She did not feel good. Yesterday, she felt like she had to throw up. When she slept, she felt very tired and when she woke up, her eyes were red. She washed her face when she woke up around 11. Then she noticed her heart beat was kind of fast. She took another medication she takes all the time. Her doctor said that she can take it with it but she was not sure. She did not feel herself. Yesterday after she took it, she had to wait there for 15 minutes. It felt like there was oil in her mouth. She just drank water and came home. When she came home, her heart beat was fast. She had to sit down. She liked to eat spicy food, and she needed to sleep. Her kids said she never slept like this. Both eyes were red, red like blood. Her daughter told her to go look at them in the mirror. There was no pain or nothing in her eyes, they were just red and they improved today. If she goes to bed now, she can sleep, but she just wakes up and drinks tea and wants to wake up. She didn't want to sleep, but she felt like she could. Regarding the pain in her right arm, she had to hold her shoulder when she first woke up. It was worse then, but it's better now that she keeps moving it. She has 3 more weeks to get the next dose of the COVID Vaccine. Hopefully it will be this shot only and she can go back to work. She planned on going back to work on Saturday. She would like to know if she can continue to take Verapamil. She will call her pharmacy to find out. The outcome of the events does not feel good and tiredness and needed to sleep extra was not recovered. The outcome of the events felt like she had to throw up, eyes were red, heartbeat was fast and pain in right arm was recovering. The outcome of the other event was unknown. Information on Lot/Batch Number has been requested.
49 2021-01-05 hives Headache for 4 days following vaccine. On day 5 following vaccine developed hives on arms and chest.
49 2021-01-05 hives, itchy skin Hives, started in R Groin, traveled to R axila, back, neck, arms, leg and trunk; severe palm itching... Read more
Hives, started in R Groin, traveled to R axila, back, neck, arms, leg and trunk; severe palm itching, severe feet itching; This is a spontaneous report from a contactable nurse. A 49-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK5730), via an unspecified route of administration on 22Dec2020 16:00 at single dose at left arm for COVID-19 immunization. Medical history included allergies Ct contrast. The patient's concomitant medications were not reported. ON 23Dec2020 04:00, 12 hours post injection- the patient experienced Hives, started in R Groin, traveled to R axila, back, neck, arms, leg and trunk. 24 hours after the first incident, the patient experienced severe palm itching, another 24 hours later, the patient then experienced severe feet itching. The AE resulted in emergency room/department care. The patient received treatment for the events (Solumedrol). The events was assessed as non-serious. The outcome of the events was recovering.
49 2021-01-05 injection site reaction I did let the nurse know right after I got the vaccine It did feel like a huge water balloon was si... Read more
I did let the nurse know right after I got the vaccine It did feel like a huge water balloon was sitting on my arm and very heavy at the site. I went to the waiting area and the last 5 minutes and I started feeling weird, kind of getting dizzy and my heart started racing really fast. Am I can tell I was getting really hot and my face was flushed and my heart was racing and my hands started shaking, trembling almost like I couldn't control it. I've never experienced something like this. The part that really scared me was my heart racing like it was going to come out of my chest. They called a code, put me in a wheel chair and took me to the ER (where I work). They took my blood pressure which was really high, they did EKG, blood work and urine test. They kept me there for about five hours, while watching me. And the last weird thing that happened at one point I felt like liquid was running thru my body and my feet were really cold for several hours, It felt like someone was pouring liquid over me. I kept asking the nurse if this is normal and no one knew what to tell me. After everything started slowing back down and it had been a couple hours and the next day i felt like I had a slight head ache and felt out of it, kind of like I had a hangover and of course my arm was really sore. The Doctor in the ER did advise me not to get the second dose as it will be worse than the first one.
49 2021-01-05 itchy skin, hives UrticariaPruritus HOT flashes, prickly skin of jaw line to chest EMP was injected in the ER due to... Read more
UrticariaPruritus HOT flashes, prickly skin of jaw line to chest EMP was injected in the ER due to a previous flu vax reaction 2 years. She did consequently have a migraine headache upon awakening this AM which prevented her from working. Treated with Benadryl 25mg PO in the ER, monitored via cardiac monitor and then she was discharged with 25mg of Benadryl that she took when she got home at 1630.
49 2021-01-05 rash, hives, itchy skin coughing; Itching; chest tightening; large whelps all over body, face, eyes; high blood pressure and... Read more
coughing; Itching; chest tightening; large whelps all over body, face, eyes; high blood pressure and heart rate noted; high blood pressure and heart rate noted; 18 hrs after vaccine mild rash on back and arms and mild sob; 18 hrs after vaccine mild rash on back and arms and mild sob; This is a spontaneous report from a contactable nurse, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 9231), via an unspecified route of administration in the right arm on 23Dec2020 at 19:30 (at the age of 49-years-old) as a single dose for COVID-19 immunization. Medical history included asthma, kidney stones, and gastrooesophageal reflux disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethynylestradiol/norgestrel (OGESTREL-28), cetirizine hydrochloride (ZYRTEC), and cefdinir (OMNICEF). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took nicotinic acid (NIACIN) on unknown dates for an unknown indication and experienced drug allergy in the form of mild flushing. On 24Dec2020 at 13:30, 18 hours after the vaccine, the patient experienced mild rash on back and arms and mild shortness of breath (SOB). On 25Dec2020, the next day, the patient had a severe rash with large whelps all over body, face, eyes. She had extreme SOB, chest tightening, coughing and itching. The patient went to the hospital emergency room and high blood pressure and heart rate were noted. On 25Dec2020, the patient had a nasal swab done for COVID and it was negative. The patient was treated for the events with IV methyprednisolone (MANUFACTURER UNKNOWN), IV famotidine (MANUFACTURER UNKNOWN) and hydroxyzine pamoate (VISTARIL). The clinical outcomes of the rash, SOB, large whelps, chest tightening, couching, itching, high blood pressure, and high heart rate, were recovered in Dec2020.
49 2021-01-06 rash with redness, rash papular 9 x 5 cm area of raised redness and pain left arm starting on on day 8
49 2021-01-06 injection site hardening, injection site pruritus, injection site redness ?Pfizer-BioNTech COVID-19 Vaccine EUA Pfizer Covid 19 vaccine 30mcg/0.3ml Vaccine administered on 1... Read more
?Pfizer-BioNTech COVID-19 Vaccine EUA Pfizer Covid 19 vaccine 30mcg/0.3ml Vaccine administered on 12-31-20 at 3:38 pm. Pfizer vaccine Lot EL0142. 0.3ml IM, left deltoid. states felt dizzy after receiving injection. left arm soreness noted during night; 'knot' noted on left deltoid, when awoke on 1-1-21; knot grew to ~5x5 cm max size over 48 hrs. Itchy, but painful if tried to scratch. Took Benadryl 1-3-21, took Zyrtec 1-4-21. Evaluated at Employee Health on 1-5-21. Some dizziness with position change. Exam: No fever. No orthostatism to BP. Pulse 77-- >94 from lying to standing. Left lateral deltoid with 3.75 x 5 cm mildly tender, indurated area of erythema, with central erythematous punctum (presumed site of injection). Instructed to take OTC antihistamine (Zyrtec) daily until 7 days after symptoms resolve. PMH significant for Covid 19 infection (positive test Oct. 28, 2020). Hospitalized 11-4-20 for decreased O2 saturation. Treated with Remdesivir. Post-Covid infection shortness of breath/dizziness. A picture of the affected area is available if requested
49 2021-01-06 injection site pain About an hour after the injection I had pain and burning going down my left side and in the left sid... Read more
About an hour after the injection I had pain and burning going down my left side and in the left side of my chest that lasted about 45 min. I was fine for the next 12 hr. Around midnight I started with chills, joint pain body aches and a headache. I woke up around 2 am with a fever. All day on the 6th I felt horrible with body aches, joint pain and a severe headache. Around 10 pm on the 6th I started again with chills fever chest pain SOB Cough and vomiting (3 episodes throughout the night.) My lungs currently feel like they are on fire and I continue to have chest tightness, joint pain Severe headache and a cough. I am approximately 56 hr post second vaccination. I had no problems with the first vaccination
49 2021-01-06 hives, injection site hardening, skin warm DEVELOPED HIVES ON BACK, THAT THEN WENT DOWN THE RIGHT ARM. ARM GOT VERY HOT TO THE TOUCH AND INJECT... Read more
DEVELOPED HIVES ON BACK, THAT THEN WENT DOWN THE RIGHT ARM. ARM GOT VERY HOT TO THE TOUCH AND INJECTION SITE GOT HARD. LAST A FEW HOURS AND THEN HIVES WENT AWAY. NO MEDICINE WAS TAKEN TO HELP RESOLVE.
49 2021-01-06 injection site pain Dizziness, Headache, pins and needles injection site, one side shoulder, arm, neck pain, weakness, g... Read more
Dizziness, Headache, pins and needles injection site, one side shoulder, arm, neck pain, weakness, generalized weakness Narrative: employee considered response mild, needed a heat pack for pain relief, staying in bed on Jan 5. Taking 800 mgm ibuprofen every eight hours, has not recovered yet.
49 2021-01-06 hives Medical Imaging Associate - Received vaccine on 12/18/20 @ 0845hrs. Associate has developed neck/arm... Read more
Medical Imaging Associate - Received vaccine on 12/18/20 @ 0845hrs. Associate has developed neck/arm soreness, chills, and hives/welts on her face, neck, back, and thighs. The associate is taking Benadryl and self-monitoring her symptoms currently from home. The associate was instructed to seek medical attention if symptoms worsen.
49 2021-01-06 bruising Nausea, tick to mouth, headache, muscle aches, fatigue, bruising, chills and low grade fever of 99.4... Read more
Nausea, tick to mouth, headache, muscle aches, fatigue, bruising, chills and low grade fever of 99.4 beginning at 8PM on 1/6/2021. Vaccine given at 7:30 AM on 1/6/2021. Still experiencing body aches as of 10am on 1/7/2021 but all other symptoms have improved. No treatments given.
49 2021-01-06 rash SkinRash flushed face noted with rash around neck Narrative: @1348 noted face flushed and rashes aro... Read more
SkinRash flushed face noted with rash around neck Narrative: @1348 noted face flushed and rashes around neck. BP 132/80, P 96, R 18, O2 sat 100%, T 98.6 Given Cetirizine 10 mg po and observed for 30 minutes. @ 1405 BP 123/65, P 65, R 18. Resolved and d/c'd at 1410. Updated in employee record on database
49 2021-01-06 hives, rash, injection site pruritus, injection site redness Today was my second dose of the COVID vaccine and just a few short minutes after the injection the i... Read more
Today was my second dose of the COVID vaccine and just a few short minutes after the injection the injection site start itching. At just about the 15 min wait time after ionjection a nurse asked if i was feeling ok. I told her i was feeling gine but my arm was very itchy. She checked the site and I had redness all around the site and welt size hives around the site. She asked me to stay 15 min longer and I agreed. Shortly after that the hive started to spread to my neck and chest area and I became lightheaded and faint feeling. I became very hot. They gave me and injection of benadryl and since my BP was high and my syptoms were not going away completly I was taken to the ER for monitoring and IV fluids. There I was given more Benadryl, steroids, Pepcid and IV fluids and monitored. I felt much better and was released to go home with a RX for 4 days of steroids.
49 2021-01-06 redness cellulitis and lymphadenitis Narrative: emp developed redness and axillary lymphadenopathy in her l... Read more
cellulitis and lymphadenitis Narrative: emp developed redness and axillary lymphadenopathy in her lt axilla
49 2021-01-07 injection site pain 1/7/2021 I was extremely tired and could not raise left arm without assistance. I also, experience q... Read more
1/7/2021 I was extremely tired and could not raise left arm without assistance. I also, experience quit a bit of pain at the injection site. Arm pain decrease the next day and was able to raise arm without assistance. 1/8/2021 Tired and lightheaded. I felt like I would pass out if I did not sit down. Cannot stand on my feet longer than 30 minutes at a time. Also experience shortness of breath.
49 2021-01-07 vaccination site pain 100.7 temperature/her temperature and it was 101.7; she was up all night/she didn't sleep; It is ver... Read more
100.7 temperature/her temperature and it was 101.7; she was up all night/she didn't sleep; It is very painful; migraines; she felt warm; joint pain; dull headache; tenderness at the injection; chills; as had joint pain and fatigue ever since her COVID-19 diagnosis in October/the arthritis has flared from it; fatigue/joint pain and fatigue are getting worse; This is a spontaneous report from a contactable consumer. A 49-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on the left arm on 30Dec2020 10:40 at single dose for covid-19 immunisation. Medical history included from Feb2020 and ongoing she is currently a breast cancer patient/she had breast cancer, has lymphedema in the right due to breast cancer and on 31Oct2020, she tested positive for COVID and that ever since she was positive, her joints and skin, shins and upper arms and legs are really tender, and hips, wanted to know if that is normal. Had joint pain and fatigue ever since her COVID-19 diagnosis in October. There were no concomitant medications. The patient previously took H1N1 shot and her arm got really big and they watched for cellulitis discomfort. The patient stated on Dec2020, "received the COVID-19 vaccine on 30Dec2020 and is reporting 100.7 temperature, dull headache, tenderness at the injection, chills, joint pain and fatigue. She reported that she has had joint pain and fatigue ever since her COVID-19 diagnosis in October. The patient contacted COVID, she tested positive on 31Oct2020, and still has no taste or smell, and the biggest thing right now, that ever since she was positive, her joints and skin, shins and upper arms and legs are really tender, and hips, wanted to know if that is normal. She wants to know, where it has gone into the joint, the arthritis has flared from it, from her testing positive, it will be 9 weeks tomorrow since she had COVID, and she is not 100%, and yesterday she had the COVID vaccine, her first dose, and she was up all night, her joints and muscles were in a lot of pain, but she had been like that, and this morning she took her temperature and it was 101.7. Does it mean can't have the shot in 3 weeks? She has had health issues this year, she had breast cancer, and her oncologist wanted her to have the vaccine, but it concerns her with all the pain in her joints swelled, and wanted to know if it is a side effect due to COVID. States she is still coughing, she wants to know if Pfizer thought this was a side effect of COVID, since she tested positive in October, will she have to live like that? It is very painful. Her shot went fine at 10:40 yesterday morning, fine, but she has been experiencing stiffness and joint pain, and she contacted COVID in October, thinks this doesn't have to do with the shot, this has been this way since October, and her husband said to ask- will it be like this since she contacted COVID, and the only thing, this morning she had a headache, but she didn't sleep and she gets migraines it she doesn't sleep, and she took her temperature, she felt warm and it was 101.7. Her temperature was 101.7 about a half hour ago (31Dec2020), she takes her temperature now, states it is now 100.8. Stated that she probably needs to speak to her doctor for her questions. Got up a 1am and took Ibuprofen. Her joints were so sore from when having COVID and so she went back to sleep and slept off and on. Got up at 4am this morning with the dull headache, it was not enough to be considered a migraine, so she took another 800mg Ibuprofen. Headaches: states it is just a dull headache, she hasn't taken Ibuprofen yet this morning, she is not a big medicine person, she is trying to see if it will go away, but if it is worse she will take migraine medicine". The outcome of "as had joint pain and fatigue ever since her COVID-19 diagnosis in October/the arthritis has flared from it", "she was up all night/she didn't sleep", "It is very painful", "migraine" and "she felt warm" were unknown. Other events was not recovered.
49 2021-01-07 injection site pain, injection site swelling 12 hours after injection I acutely developed headache, chills, sweating, muscle aches, nausea, hand ... Read more
12 hours after injection I acutely developed headache, chills, sweating, muscle aches, nausea, hand and face swelling, swelling and tenderness around injection site, general flu-like symptoms making it difficult to sleep. I was able to go to work the next morning despite symptoms. Symptoms, other than mild soreness in arm where injected, resolved 36 hours after onset.
49 2021-01-07 itchy skin, redness Caregiver complained of a "heavy" throat and had redness and itching to her neck and chest area
49 2021-01-07 rash, redness EE received vaccine, waited in room for about 20 minutes. About 10 minutes after receiving vaccine, ... Read more
EE received vaccine, waited in room for about 20 minutes. About 10 minutes after receiving vaccine, she felt warm but she had a coat on and her eyes started to hurt and she felt tired but she works night shift. She felt this was normal for working the night before and having stayed up to get the vaccine. After her wait period she went to her car and remembers feeling warm for having to walk in the cold. Her right side of face became reddish purple and warm. She sat in car for a few minutes. As she drove her face started to swell and turn all red. When she arrived home she had heavy pressure middle of face-nose area. Her face continued to turn reddish purple with a rash on right side of face and down to her neck. She felt her sinuses and throat swell with irritation and in throat and wheezing. Her mom is a nurse and they waited to see if it worsen or got better. She decided since she could breath she would not go to hospital. After about 5 hours she felt much better. She continued to have a headache for 4 days. She had swelling and soreness of left arm for a couple of days. She continued to go to work.
49 2021-01-07 injection site pain Fever 102.3, severe headache and ears aching, chills, body aches, injection site soreness, nausea S... Read more
Fever 102.3, severe headache and ears aching, chills, body aches, injection site soreness, nausea Still present 33 hours later
49 2021-01-07 injection site pain, injection site inflammation I woke up the following morning with pain and inflammation in RT armpit.. by midday the swelling in ... Read more
I woke up the following morning with pain and inflammation in RT armpit.. by midday the swelling in armpit lymph nodes was the size of a very large egg. I couldn't comfortably put my arm down at my side. Pain radiated down arm to elbow, and up neck into ears. I had fever of 100.1, but took ibuprofen to try and alleviate pain. The symptoms lasted about 5 days.
49 2021-01-07 injection site pruritus, itchy skin Metallic taste in mouth after injection. Then 45 minutes later, had rapid heart rate and itching ove... Read more
Metallic taste in mouth after injection. Then 45 minutes later, had rapid heart rate and itching over the injection side. Later that night had itching throughout body. She has since had a HA.
49 2021-01-07 injection site pain Pain at site, shooting down the arm and unable to lift arm. Shoulder frozen.
49 2021-01-07 rash papular, itchy rash Some skin rashes as reaction when there is an allergen; Rash/They red bumps and itches; Rash/They re... Read more
Some skin rashes as reaction when there is an allergen; Rash/They red bumps and itches; Rash/They red bumps and itches; This is a spontaneous report from a contactable other hcp. A 49-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL0140), intramuscular (arm left) on 28Dec2020 12:00 at single dose (dose 1) for COVID-19 immunization. Medical history included psoriasis from an unknown date and allergies to medications, food, or other products (unspecified). The patient was taking unspecified concomitant medications including a vaccine within 2 weeks. Patient did not receive other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 with unknown results. On 29Dec2020 04:00, the patient had some skin rashes as a reaction when there is an allergen. After the vaccines, she has been having occasional rashes that pops at different places. They were red bumps and itches. She stated she needed to keep antihistamines CLARITIN/BENADRYL on the clock. Event outcome was not recovered. The patient underwent lab tests and procedures which included COVID test (Nasal swab): negative on 24Nov2020. Event outcome was not recovered. Patient considered the events as non-serious.
49 2021-01-07 hives Swollen lips/tongue, shortness of breath, cough, hives, nausea, headache Epi shot, Benadryl, Pepc... Read more
Swollen lips/tongue, shortness of breath, cough, hives, nausea, headache Epi shot, Benadryl, Pepcid, prednisone
49 2021-01-07 itchy skin, hives UrticariaPruritus
49 2021-01-08 injection site warmth Heat/flushing from injection site to neck to face to upper body x 20 minutes; sweating
49 2021-01-08 hives, itchy skin UrticariaPruritus, Diarrhea & NauseaVomiting
49 2021-01-08 itchy skin mouth itching, slight tongue swelling, tachycardia, coughing, feeling of impending doom, nausea, vo... Read more
mouth itching, slight tongue swelling, tachycardia, coughing, feeling of impending doom, nausea, vomiting, diarrhea, itching This started at minute 13 after the vaccine administration. I have had several infusion reactions before to biologics to treat my autoimmune disease and this is how it always starts. There was nothing available at the administration place so I left and took zyrtec, benadryl and pepcid. The symptoms stopped in about 25 minutes.
49 2021-01-09 injection site swelling, injection site redness, injection site mass, injection site pain Woke up with a severe migraine at 3:30 am, and again the following night another migraine. Also had... Read more
Woke up with a severe migraine at 3:30 am, and again the following night another migraine. Also had swelling and a red lump at site of injection, with pain and soreness around injection site.
49 2021-01-10 injection site pain, injection site warmth After the awcond vaccine: Woke up at 4 am the next morning with body aches, chills, nausea and a mi... Read more
After the awcond vaccine: Woke up at 4 am the next morning with body aches, chills, nausea and a mild headache that was intermittent. I had malaise and fatigue. I took some cold medicine 3 times in the course of 24 hours and woke up the next morning with none of those symptoms but did have lympadenopathy under my left arm that decreased through the course of the day. It was painful to touch and tender once the lymph node decreased in size. The only other reaction was the site pain and tenderness and warmth. That lasted a few days.
49 2021-01-10 itchy rash, rash with redness, rash EE sts COVID 19 vaccine #2 taken 1/9/21 approx. 2 hour later developed a red itchy rash to L foot fr... Read more
EE sts COVID 19 vaccine #2 taken 1/9/21 approx. 2 hour later developed a red itchy rash to L foot from toes to mid calf, R foot only to ankle, B/L ears and B/L dorsal hands. EE sts took 50 mg Benadryl and Melatonin and went to sleep. EE sts at appx 9pm took Benadryl 25 mg for itching. EE sts symptoms resolved and have not returned since 10pm 1-10-21
49 2021-01-10 injection site pain Pfizer-BioNTech COVID-19 Vaccine EUA headache injection site pain general malaise
49 2021-01-10 injection site hardening, injection site redness, injection site warmth Right armpit tender and swollen lymph nodes noted the next morning (01/10/2021) after 2nd IM injecti... Read more
Right armpit tender and swollen lymph nodes noted the next morning (01/10/2021) after 2nd IM injection administered. Fatigue and headache occurred by the same afternoon and low grade fever of 99.6° that evening at 8:30 PM. Right armpit tender and swollen lymph nodes remain present 2 days post 2nd IM injection and right arm injection site is warm to touch with redness and firmness to touch.
49 2021-01-10 rash, rash vesicular, itchy rash, rash with redness Stating many details to help determine whether or not this is not vaccine related: onset of red and ... Read more
Stating many details to help determine whether or not this is not vaccine related: onset of red and blistery rash, similar to a contact dermatitis with no known new contact substances; rash started on upper front torso, spread to folds under breasts and downward to abdomen and around to lower back; over several days spread to upper arms, elbow pits and below; next to shoulder areas and knee pits; 01/11/2021 the rash is still spreading slowly, itchy and inflamed, while parts of the original rash have begun to scab and heal. Due to holidays and level of inflammation and blistering, cosmetic surgeon recommended and PCP called-in 7-day round of Keflex to curb possible infection in breast creases beginning 12/26/2020. Taltz dose dates were 12/11/2020 and 01/08/2021. Breast augmentation 11/13/2020 (no adverse reaction to surgical tape, stitches or staples in this or prior procedures).
49 2021-01-10 rash, itchy skin Swelling to B/L hands, itching and rash to right hand. Patient advised to use OTC antihistamine and... Read more
Swelling to B/L hands, itching and rash to right hand. Patient advised to use OTC antihistamine and follow up with PCP.
49 2021-01-11 hives Hives started within 24 hours and have been ongoing for two weeks
49 2021-01-11 injection site swelling, injection site pain, injection site redness Mild chills the day after. Muscle aches day 2 (mild). Diarrhea day 3 (mild). Injection site swollen ... Read more
Mild chills the day after. Muscle aches day 2 (mild). Diarrhea day 3 (mild). Injection site swollen and red and sore (mild)
49 2021-01-11 redness painful swollen red arm shoulder to elbow joint and muscle pain sore throat low grade fever 99.5 nau... Read more
painful swollen red arm shoulder to elbow joint and muscle pain sore throat low grade fever 99.5 nausea vomiting shortness of breath headache some periods of confusion
49 2021-01-11 rash, itchy skin rash and diffuse itching
49 2021-01-12 hives, rash Dizzy, light headed, hives on left side of neck and chest.
49 2021-01-12 injection site pain, injection site swelling Injection site raised and sore Sore throat
49 2021-01-12 injection site pain Patient describes flu like symptoms, sore arm at injection site, congestion with no cough but feels ... Read more
Patient describes flu like symptoms, sore arm at injection site, congestion with no cough but feels "heavy in her chest".
49 2021-01-12 injection site pain chills which lead to shivers and putting on 3 layers, 2 down comforters and a throw blanket to go to... Read more
chills which lead to shivers and putting on 3 layers, 2 down comforters and a throw blanket to go to sleep, fever (I can't remember what it was), sweating (even after taking layers and blankets off), fatigue, arm swelling, and pain where the injection was, nausea, unable to stand for short periods of time, This lasted over 24 hours, the next day the same but on a lesser progression but included diarrhea and a swollen supraclavicular lymph node being swollen-- > 5"x2".
49 2021-01-12 injection site pain vaccine in am. That night had back pain. left hip pain and when walking felt like dragging left leg.... Read more
vaccine in am. That night had back pain. left hip pain and when walking felt like dragging left leg. Ice to injection site due to discomfort also.
49 2021-01-13 itchy skin 15 minutes after im shot, patient experienced itchy feeling and then flushed face patient was admin... Read more
15 minutes after im shot, patient experienced itchy feeling and then flushed face patient was administered diphenhydramine 25mg orally and observed . No additional side effects occurred
49 2021-01-13 injection site redness, injection site pruritus, injection site nodule, injection site warmth Developed itchiness, redness, and hard spot that was warm to touch at injection site and below as we... Read more
Developed itchiness, redness, and hard spot that was warm to touch at injection site and below as well as muscle pain in the arm as if she had been punched in the arm, first instance of this began over 1 week after injection. Seen in convenient care clinic and prescribed 7 day course of doxycyline for concern of possible abscess.
49 2021-01-13 injection site pain Left upper arm swelling Left facial swelling Neck pain Headache General fatigue Left leg ache Site p... Read more
Left upper arm swelling Left facial swelling Neck pain Headache General fatigue Left leg ache Site pain
49 2021-01-13 itchy rash, rash Patient developed rash approximately 24 hours after receiving the vaccine. Rash was on chest, face,... Read more
Patient developed rash approximately 24 hours after receiving the vaccine. Rash was on chest, face, and back. Lasted for about a week, but has improved. Itched the whole time.
49 2021-01-13 injection site numbness Right arm numbness occurred within the 15 minute waiting period. It did not start immediately with t... Read more
Right arm numbness occurred within the 15 minute waiting period. It did not start immediately with the injection but rather 5 minutes after. Lasted about 3 minutes before completely resolving. The right arm numbness returned on 01/01/2021 and persisted through 01/03/2021. Went away and returned on 01/06/2021 then migrated to the left arm. Waxes and wanes and added numbness to bilateral lower legs and feet. Improved with less frequency by 01/14/2021.
49 2021-01-13 injection site numbness c/o numbness at site of injection. Numbness from left deltoid distally to left hand. No other sympto... Read more
c/o numbness at site of injection. Numbness from left deltoid distally to left hand. No other symptoms noted. Monitored for 30 minutes.
49 2021-01-13 vaccination site redness, vaccination site hardening, vaccination site pain, vaccination site itchiness felt dizzy; left arm soreness; 'knot' noted on left deltoid Itchy, but painful/indurated area of ery... Read more
felt dizzy; left arm soreness; 'knot' noted on left deltoid Itchy, but painful/indurated area of erythema; 'knot' noted on left deltoid Itchy, but painful; pulse 77 to 94 from lying to standing; 'knot' noted on left deltoid Itchy, but painful/left lateral deltoid with 3.75 x 5 cm mildly tender; indurated area of erythema, with central erythematous punctum (presumed site of injection); indurated area of erythema, with central erythematous punctum (presumed site of injection); This is a spontaneous report from a contactable pharmacist. A 49-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142, 30mcg/0.3ml), intramuscular on 31Dec2020 15:38 (also reported as 08:30 am) at 0.3 mL, single at left deltoid for covid-19 immunization. Medical history included significant for Covid 19 infection (positive test 28Oct2020), shortness of breath, dizzy, hospitalized for decreased O2 saturation from 04Nov2020. Patient was treated with remdesivir for Covid 19 infection. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, it was unknown if patient had been tested for COVID-19. Patient felt dizzy after receiving injection on 01Jan2021, left arm soreness noted during night; 'knot' noted on left deltoid, when awoke on 01Jan2021; knot grew to 5x5 cm max size over 48 hours, itchy, but painful if tried to scratch. Some dizziness with position change. Examination: no fever, no orthostatism to BP, pulse 77 to 94 from lying to standing, left lateral deltoid with 3.75 x 5 cm mildly tender, indurated area of erythema, with central erythematous punctum (presumed site of injection). Patient took diphenhydramine hydrochloride (BENADRYL) 03Jan2021, and cetirizine hydrochloride (ZYRTEC) 04Jan2021 for events (Instructed to take OTC antihistamine (cetirizine hydrochloride) daily until 7 days after symptoms resolve). Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment diphenhydramine, certitizine for events. The report is considered as non-serious. Outcome of events was unknown.
49 2021-01-13 hives, itchy skin hives from neck to thighs, itchy, aches all over
49 2021-01-14 injection site pain 1/8/2021 3PM vaccination 1/9/2021 24 hours later, fever went up to 102.4. Tylenol @ 10pm. Body aches... Read more
1/8/2021 3PM vaccination 1/9/2021 24 hours later, fever went up to 102.4. Tylenol @ 10pm. Body aches, lump in armpit. *First dose; slight fever of 100 on day 3,4 and pain at injection site.
49 2021-01-14 redness, injection site pain, injection site pruritus Burning and itching at site, increased blood pressure, redness and burning down both arms, redness i... Read more
Burning and itching at site, increased blood pressure, redness and burning down both arms, redness in face, hot, sweaty, and cold
49 2021-01-14 injection site pain FOUR DAYS OF SINTOMES, DIZZINESS,WEAK, PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN, CHILLS, PAI... Read more
FOUR DAYS OF SINTOMES, DIZZINESS,WEAK, PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN, CHILLS, PAIN JOINTS,FEVER,NAUSEATE,FEELING BAD.
49 2021-01-14 hives Fever >101, nausea, urticaria. Treated for urticaria with steroids, H2 and H1 blockers
49 2021-01-14 vaccination site pain Soreness at injection sight; This is a spontaneous report from a contactable consumer. A 49-year-old... Read more
Soreness at injection sight; This is a spontaneous report from a contactable consumer. A 49-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 40113/ej1686), via an unspecified route of administration (anatomical location: left arm) from 04Jan2021 14:30 to 04Jan2021 14:30 at SINGLE DOSE for an COVID-19 immunisation. Medical history included diabetes, asthma and overweight. The patient's concomitant medications were not reported. On 04Jan2021, the patient experienced soreness at injection sight. Outcome of the event was unknown.
49 2021-01-14 vaccination site itchiness the skin overlying the injection site has an intense prickly "itchy" sensation; left side of my face... Read more
the skin overlying the injection site has an intense prickly "itchy" sensation; left side of my face felt heavy, stiff, and was palpably warmer than the right side of my face; left side of my face felt heavy, stiff, and was palpably warmer than the right side of my face; I had a short episode of disequilibrium; awoken by intense bilateral leg pain; my legs felt weak the following day; This is a spontaneous report from a contactable Physician who reported for herself. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EK9231) for COVID-19 immunisation on 07Jan2021 at 15:30 at single dose in Left arm. Medical history included allergy to penicillin , clindamycin, azathioprine (IMURAN) (known allergies: penicillin, clindamycin, Imuran) , allergy to glove powder and autoimmune disorder (unspecified). Concomitant medication (received within 2 weeks of vaccination) included hydroxychloroquine sulfate (PLAQUENIL), methotrexate, mycophenolate mofetil (CELLCEPT), folic acid and magnesium. On 07Jan2021 at 17:30 , approximately 2 hours after she received the vaccine, she had a short episode of disequilibrium, then an hour after that (at 18.30) the left side of her face felt heavy, stiff and was palpably warmer than the right side of her face. There were no visible changes to the appearance of her face, and she had normal motor control. This episode lasted for approximately 1-2 hours then gradually diminished. In Jan202, approximately 36 hours after the vaccine, patient was awoken by intense bilateral leg pain. The pain gradually diminished after approximately an hour, but her legs felt weak the following day. Legs were fine on 10Jan2021. In the evening of 09Jan2021 though 10Jan2021, the skin overlying the injection site had an intense prickly "itchy" sensation, there was no rash. Events were all non serious. No treatment administered and final outcome for all the events was reported as recovering.
49 2021-01-15 injection site redness, injection site swelling, injection site pain, injection site warmth Red arm, swollen, warm covered entire arm from shoulder to elbow itching and pain went away in about... Read more
Red arm, swollen, warm covered entire arm from shoulder to elbow itching and pain went away in about 4 days
49 2021-01-16 injection site pain Upon waking up on 1/13/21 had a headache and 99.8 F temperature. Arm with injection was quite sore. ... Read more
Upon waking up on 1/13/21 had a headache and 99.8 F temperature. Arm with injection was quite sore. Had a feeling of being in a fog and not quite myself. Taste and smell felt distorted and could not fully taste and smell my coffee. Took 2 max strength tylenol which helped bring temp down to 98.F and remained steady till the afternoon when temp went up to 102F. Had feeling of body aches and chills. Took a hot shower and another dose of tylenol and went to bed. Next morning felt much better with no fever symptoms. Left arm was sore but better than day before. Woke up with a vertigo feeling and hot flashes but not enough to interrupt daily activities. Treated with meclizine
49 2021-01-17 injection site pain 1. Tingling in left ring finger immediately 2. Left arm burning and soreness starting at injection ... Read more
1. Tingling in left ring finger immediately 2. Left arm burning and soreness starting at injection site and traveling down arm worse within 48 hours with continued pain left arm with on and off altered sensation left ring finger currently (3 weeks post injection) 3. Early fatigue left arm 4. Significant body/bone aches for 6 days
49 2021-01-17 redness, rash palms of my hands were bright red; very warm flush feeling; nausea; swelling of the throat; rash on ... Read more
palms of my hands were bright red; very warm flush feeling; nausea; swelling of the throat; rash on my arms and abdomen; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899 and expiration date not provided), intramuscular in the left arm on 06Jan2021 16:00 (at the age of 49 years old) at a single dose for COVID-19 immunization. Medical history included psoriasis, microscopic colitis, allergies to shellfish, and coconut. The patient's concomitant medications were not reported. The patient previously took estrogen patch, etanercept (ENBREL) and sulfamethoxazole, trimethoprim (BACTRIM) and experienced allergies to all. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine and did not take any other medications with 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 06Jan2021 16:15, the patient experienced a very warm flush feeling, nausea started and by 15 minutes, she had swelling of the throat and rash on her arms and abdomen and the palms of her hands were bright red. The events resulted in Emergency room/department or urgent care visit. The patient was treated with diphenhydramine hcl (BENADRYL), steroids (unspecified), famotidine (PEPCID) and ondansetron (ZOFRAN) in response to the events. The patient assessed the events as non-serious. The outcome of the events was recovered with sequel on an unspecified date in Jan2021. The patient has not been tested for COVID-19 since the vaccination.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
49 2021-01-17 redness, skin warm swelling, redness, warmth to touch, tenderness-this began later 1/15/2021 and continued throughout t... Read more
swelling, redness, warmth to touch, tenderness-this began later 1/15/2021 and continued throughout the weekend
49 2021-01-18 injection site pain Day 1 after injection: injection site soreness Day 2-4 after injection; headache, sleepiness, low g... Read more
Day 1 after injection: injection site soreness Day 2-4 after injection; headache, sleepiness, low grade nausea - No relieved by IBU 600mg tid for 3 days, sleep. Low grade nausea remains today 9 days post injection.
49 2021-01-18 injection site pain Deep tissue soreness that travels down left arm and to other muscles in body starting 18-20 hours af... Read more
Deep tissue soreness that travels down left arm and to other muscles in body starting 18-20 hours after injection. Soreness started to dissipate in grade around Day 4. Left arm deltoid still sore to touch today, Day 6. Fatigue also present Days 1-4.
49 2021-01-18 injection site vesicles Flu/cold symptoms (aches, pain, fatigue) and blister at injection sight
49 2021-01-18 itchy skin Patient reported having "itching" day after 1st dose, no hives or airway issues, no other s/s. Pati... Read more
Patient reported having "itching" day after 1st dose, no hives or airway issues, no other s/s. Patient self admitted to feeling anxious about 2nd dose, however wished to proceed. Approximately 20-25 minutes post vaccine, patient felt dizzy upon standing. VS checked, BP 130/80, HR 80s, SPO2 99% RA. Patient speaking in full sentences. Oriented. Felt fine otherwise. Patient held until 1615, symptoms did not improve, but did not worsen. Suggested patient go to Hospital for evaluation, or at the least have family pick her up. Patient met by family at 1700 and situation described as well as recommendations. F/u 1/18 - Patient had dizziness through the next day. Dizziness improved and she then had low grade symptoms from injection including fatigue / aches / HA that also went away and felt fine 1/18/21. She did not seek additional medical care.
49 2021-01-18 rash, itchy skin Rash whole body Itching
49 2021-01-18 rash Rash, Anxiety, Flushed
49 2021-01-18 hives Tachycardia; Itching hives on the trunk and bilateral arms with 15 minutes; Facial Flush; This is a ... Read more
Tachycardia; Itching hives on the trunk and bilateral arms with 15 minutes; Facial Flush; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration (Arm Right) first dose on 08Jan2021 at single dose for covid-19 immunisation. The patient's medical history included known allergies: Bee Venom, Coconut, and Shellfish. The patient's concomitant medication included vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]), metoprolol, zolpidem tartrate (AMBIEN), and dexmethylphenidate hydrochloride (FOCALIN [DEXMETHYLPHENIDATE HYDROCHLORIDE]). The patient previously took Fenofibrate and experienced allergies. On 08Jan2021, the patient experienced Itching hives on the trunk and bilateral arms with 15 minutes, Facial Flush, Tachycardia, Elevated. The patient was treated with Benadryl. The patient went Emergency room/department or urgent care due to the events. The outcome of the events was recovered in Jan2021. Facility where the most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination and was not been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.
49 2021-01-18 rash The same night of vaccination patient experienced rash in both arms, hands and face. She took Benadr... Read more
The same night of vaccination patient experienced rash in both arms, hands and face. She took Benadryl and topical cream he had at home for dermatitis and problem resolved by noon the next day.
49 2021-01-18 itchy skin, injection site pruritus, redness, rash, injection site rash Woke up January 18 with small rash and itching at injection site. By 1pm, I noticed a rash on my ne... Read more
Woke up January 18 with small rash and itching at injection site. By 1pm, I noticed a rash on my neck and chest. By 6 pm it was very itchy and spread over my back. It is reddened and extremely itchy. This morning, January 19, it continues to be extremely itchy and has spread down to my thighs. I took Benadryl 50 mg at midnight and it didn?t seem to help.
49 2021-01-18 injection site pain covid positive 1 week after 1st injection. chills fever cough loss of smell & taste body aches heada... Read more
covid positive 1 week after 1st injection. chills fever cough loss of smell & taste body aches headache & pain in left arm. some shortness of breath. 2nd injection headache w/ fever some aches still have headaches & a slight cough
49 2021-01-19 hardening : TM received a COVID 19 #1 vaccine on 1/11 to the left deltoid. She had arm soreness, headache and ... Read more
: TM received a COVID 19 #1 vaccine on 1/11 to the left deltoid. She had arm soreness, headache and fatigue following the vaccination. Those symptoms lasted a few days and resolved. On 1/17 she noticed a sore area under her left arm. she has a small firm painful lymph node under the left arm. She also noticed that she has a slight " fullness" in the neck area. She feels like her thyroid gland is more pronounced. than it was prior to the vaccine. She denies any dysphagia or odynophagia. No SOB or tachypnea. No fever or chills. No hx of thyroid dysfunction.
49 2021-01-19 injection site swelling Headache; fatigue; aches/soreness of the shot; shortness of breath; eyes hurting; swollen site; chil... Read more
Headache; fatigue; aches/soreness of the shot; shortness of breath; eyes hurting; swollen site; chills; fever; muscle pain; This is a spontaneous report from a contactable other HCP. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number=EL1284 via an unspecified route of administration on 06Jan2021 13:00 at SINGLE DOSE for covid-19 immunisation dose number=2 vaccine location=Left arm facility type vaccine: Military Base. Medical history included diabetes mellitus, asthma, dry eye, blood cholesterol increased, rubber sensitivity Known allergies: Latex, food allergy: Nuts. Concomitant medication included lactobacillus reuteri (BIOGAIA), rosuvastatin calcium (CRESTOR), celecoxib (CELEXA [CELECOXIB]), sambucus nigra fruit (ELDERBERRY [SAMBUCUS NIGRA FRUIT]), metformin hydrochloride (GLUCOPHAGE XR) , benazepril hydrochloride (LOTENSIN [BENAZEPRIL HYDROCHLORIDE]), magnesium oxide (MAG-OX), omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]), ciclosporin (RESTASIS), montelukast sodium (SINGULAIR) , liraglutide (VICTOZA), ascorbic acid, bioflavonoids nos (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS]), colecalciferol (VITAMIN D [COLECALCIFEROL]), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), zinc (ZINC). The patient previously took remeron and experienced drug hypersensitivity, amoxicillin and experienced drug hypersensitivity, percocet [oxycodone hydrochloride;paracetamol] and experienced drug hypersensitivity. The first dose of BNT162B2 vaccine for covid-19 immunisation was done on 16Dec2020 08:30 Intramuscular at single dose, Vaccine location Left arm Dose number 1 Lot number=EK5730. On 06Jan2021 13:00 the patient experienced headache outcome of recovered, fatigue outcome of recovered, aches/soreness of the shot outcome of recovered, shortness of breath on 06Jan2021 13:00 with outcome of recovered, eyes hurting on 06Jan2021 13:00 with outcome of recovered, swollen site outcome of recovered, chills outcome of recovered, fever outcome of recovered, muscle pain outcome of recovered. The patient underwent lab tests and procedures which included sars-cov-2 test negative: negative on 06Aug2020. The action taken was not applicable.
49 2021-01-19 injection site pain Patient reports acute pain at the injection site immediately after vaccination that lasted for an ho... Read more
Patient reports acute pain at the injection site immediately after vaccination that lasted for an hour and a half, she also had pain up and down her arm and into her neck. She reports numbing/tingling in both cheeks for half an hour after receiving the vaccine. 9 days later she continues to experience pain up and down the injected arm from wrist to shoulder and into her neck. The pain is somewhat relieved by NSAIDs.
49 2021-01-19 rash macular, redness Pt entered observation @ 1645. @ 1704 states prickles felt on back and arm. States s/s had been go... Read more
Pt entered observation @ 1645. @ 1704 states prickles felt on back and arm. States s/s had been going on about 10 mins before she said anything. Benadryl 25mg given @ 1705. Does have allergies to Flu Vaccine, MRI Dye, Vicodin, Buspar, Lisinopril, Suchycin. Celexa, Prev Pack, Lexapro, Penicillin, Hydrocodone, and Fluoxetine. Remains to voice s/s @ 1729. Red Blotchy areas noted to face and neck. Pt states this is normal for her when her anixety level is high. V/S were taken @ 1733 BP-193/105, P-74, R-18, 02-100% on L arm. V/S obtained on R arm @ 1731 BP-193/111, P-76, R-18, O2-100%. States that takes BP meds daily @ night, in which she hasn't taken her meds all day. Takes Amlodipine 5mg, Klonopin 0.5mg, Vit D 1000, MVI, Clartin 5mg, and Zantac 150mg. Stil continues to voice s/s @ 1739. BP remains elevated. Patient sent to ER @ 1740. Pt entered registration @ ER @ 1745. Pt continue to voice s/s of prickling noted to body. Denies SOB nor trouble w/ breathing.
49 2021-01-19 injection site pain chills, low-grade fever (99.6 F), injection site pain
49 2021-01-20 vaccination site warmth, vaccination site mass, vaccination site itchiness A lot of pain in arm; arm was completely swollen with hard ball underneath where the injection was g... Read more
A lot of pain in arm; arm was completely swollen with hard ball underneath where the injection was given. It's extremely hot and it's extremely itchy; arm was completely swollen with hard ball underneath where the injection was given. It's extremely hot and it's extremely itchy; arm was completely swollen with hard ball underneath where the injection was given. It's extremely hot and it's extremely itchy; arm was completely swollen with hard ball underneath where the injection was given. It's extremely hot and it's extremely itchy; This is a spontaneous report from a contactable other hcp (patient). A 49-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose bnt162b2 on 18Dec2020 for Covid-19 Immunization and experienced a lot of pain in arm which was normal. On 10Jan2021, the patient's arm was completely swollen with hard ball underneath where the injection was given. It's extremely hot and it's extremely itchy and on an unspecified date the patient had a lot of pain in arm. She had not taken anything other than acetaminophen (TYLENOL) 650 mg. The patient thought it was due to the vaccine (COVID-19 vaccine) she got the reaction. The outcome of the events was unknown.
49 2021-01-20 vaccination site pain Headache; Tired; Diarrhea; Sore nipples; Sore injection site; This is a spontaneous report from a co... Read more
Headache; Tired; Diarrhea; Sore nipples; Sore injection site; This is a spontaneous report from a contactable healthcare professional (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), intramuscularly on the left arm on 09Jan2021 (08:15) at a single dose for COVID-19 immunization at the hospital. The patient had no relevant medical history. The patient's concomitant medications were not reported. On 09Jan2021, the patient had headache; was tired; had diarrhea; sore nipples; and sore injection site. The patient did not receive any treatment for the reported events. The outcome of the events, 'headache', 'tired', 'diarrhea', 'sore nipples' and 'sore injection site', was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested post-vaccination. Information about lot and batch number was requested.
49 2021-01-20 itchy skin, redness, hives, rash macular Hives; legs were feeling itchy; red blotches to back of thighs/red blotches to both inner arms/red b... Read more
Hives; legs were feeling itchy; red blotches to back of thighs/red blotches to both inner arms/red blotches mostly to both calves; redness to right leg/redness to right thigh/she had redness, flushed and warmth of face; stated that all the flushed areas were hot to touch; redness to face (flushed)/she had redness, flushed and warmth of face; she had redness, flushed and warmth of face; moderate allergic reaction to the vaccine; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284; expiry date: unknown) via an unspecified route of administration in the right arm, on 07Jan2021 at a single dose, for COVID-19 immunization. Relevant medical history included right eye surgery on 06Jan2021, severe allergies, environmental and drug allergies. The patient has no concomitant medications. The patient stated that she had first dose of COVID vaccine on Thursday. Stated that she has sent V-safe reporting updates. Stated that she had a moderate allergic reaction to the vaccine on an unspecified date in Jan2021. She had noticed hives when she woke up on Friday morning (08Jan2021) that her legs were feeling itchy. She stated that she has hives, red blotches on back of thighs, arms and mostly on calves. The area was hot to touch. She then clarified that all the flushed areas were hot to touch. She was feeling a little better. She stated that they looked like they were trying to dry up and she has new ones. She had redness, flushed and warmth of face that started the day of vaccine that night (07Jan2021). She had red blotches to back of thighs Friday evening and they were starting to fade. Stated that the blotches to her left leg started Friday and that evening redness started to right leg and thighs. The blotches to both calves are still warm but starting to improve. The redness to her right thigh is more pink than red now. The patient was Benadryl around the clock and using Aveeno cream as treatment for the events. She has always had severe allergies but has not had an allergic reaction in over year. She also has history of environmental and drug allergies. Patient was trying to determine if should go back for second vaccine due to the reaction. She had asked for a consult from the immunization doctor before receiving the vaccine because she has history of severe allergies. Outcome of the events hives, and redness was not recovered, for events flushing, hot flushes, and red blotches was recovering, while for the remaining events was unknown.
49 2021-01-20 injection site pain, injection site warmth, injection site swelling Received Inj on 01-14-2021. That evening had chills, fever, muscle aches began. Took Tylenol and we... Read more
Received Inj on 01-14-2021. That evening had chills, fever, muscle aches began. Took Tylenol and went to bed. Awoke on 01-15-2021 with severe congestion, dyspnea, fever, chills, diarrhea, muscle aches, back pain, kidney pain, headache, felt exhausted all of which I had when I was Covid positive and to the same severity. Injection site extremely sore, swollen, warm, unable to lay on the injection site. Symptoms began to subside on 01-20-2021 and I returned to work on 01-21-2021. Employee Health representative advised me to complete this form.
49 2021-01-20 injection site swelling, injection site redness, injection site pain Swelling very red painful growing spot at injection site, beginning a few hours after injection, sor... Read more
Swelling very red painful growing spot at injection site, beginning a few hours after injection, soreness in entire arm beginning the morning after the injection more severe than with the flu vaccine, nausea two days past vaccination
49 2021-01-21 injection site pain CHILLS, BODY ACHE. INJECTION SITE SORENESS.
49 2021-01-21 injection site swelling, injection site redness, vaccination site mass Fever, chills, muscle and joint aches. Redness and large lump with swelling at injection site.
49 2021-01-21 hives Patient called for encounter: She received Pfizer COVID-19 Vaccine 07JAN2021. 08JAN2021 developed fl... Read more
Patient called for encounter: She received Pfizer COVID-19 Vaccine 07JAN2021. 08JAN2021 developed flushing on face, lower extremities and hives on left leg. Hives progressed to both legs and arms. She then developed swelling on the left side of the roof of her mouth. She started taking benadryl every 4-5 hours for 7 days. She did not use the EpiPen. Simultaneously patient developed vasculitis flare - pain involving ankles and lower legs. No hx of allergy to polyethylene glycol. Prior to vaccine - no changes in exposure other than eye surgery the day before vaccine which utilized the same medications that have been used for prior eye surgeries
49 2021-01-22 redness, injection site pain, injection site redness Received first COVID vaccine 12/18/20. and just had soreness at the site. She received the second do... Read more
Received first COVID vaccine 12/18/20. and just had soreness at the site. She received the second dose 1/8/21 and had soreness at site that day. Soreness and redness worsened every day after injection. She began having trouble moving her arm 1/10/21 which continued on 1/11/21. Redness is traveling into axillary region, pain is also in this area now. Went to urgent care at 1:30pm on 1/11/2021.
49 2021-01-22 skin warm, itchy skin The night I had the Covid vaccine, ~ 12 hrs later, I had a sudden onset of intense itching in my rig... Read more
The night I had the Covid vaccine, ~ 12 hrs later, I had a sudden onset of intense itching in my right ear, that extended deep into region of Eustachian tube. This lasted ~ 1 hr and finally subsided just before I was getting ready to take a Benadryl. The itching returned intermittently over the next 3 weeks, and was bothersome. This was accompanied by the feeling of warmth about the ear occasionally. One incidence of tiny pains in the ear occurred. After ~ 18 days, a gradual onset of ringing in the ears began. This worsened on day 19 , becoming twice as loud. At this point , I deferred the second vaccine dose which was scheduled for day 19, 1/22/21.
49 2021-01-23 rash Rash on upper right shoulder.
49 2021-01-24 redness I had the first dose on Friday afternoon and on Monday morning when I woke up it feels like my face ... Read more
I had the first dose on Friday afternoon and on Monday morning when I woke up it feels like my face has been sunburned. It is red and slightly puffy. No new skin products or foods. No difficulty breathing or other symptoms. I am also a nurse practitioner.
49 2021-01-24 injection site redness, injection site swelling I received my second Pfizer covid vaccine at 4:00 p.m. on 1/14/2021 from a co-worker. At 2:30 a.m. ... Read more
I received my second Pfizer covid vaccine at 4:00 p.m. on 1/14/2021 from a co-worker. At 2:30 a.m. on 1/15/2021 I woke up with severe rigors that lasted 2 hours. Over the course of the day 1/15/2021 I had a second 2 hour episode of rigors. They were almost violent and seizure-like. In addition, I had severe nausea, dizziness, decreased vision, fever, myalgia, and exhaustion. My temperature reached 103.4 and lasted over 24 hours. Ibuprofen would bring the fever down 1 degree and helped decrease rigors, but did not help the headache. On 1/16/2021 I developed redness and swelling of entire upper left arm, and edema in arm pit. I spent three days unable to work or sit up in a chair. Symptoms began to decrease after three days, but I was unable to resume full work days until 1/22/2021. Vision returned to 100%, and nausea resolved, on 1/23/2021. Decreased appetite and fatigue are still an issue as of 1/25/2021.
49 2021-01-24 rash Rash on face that looked like she broke out in pimples; Rash on face that looked like she broke out ... Read more
Rash on face that looked like she broke out in pimples; Rash on face that looked like she broke out in pimples; This is a spontaneous report from a contactable nurse (patient). A 49-year-old non pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EH9899) in the left arm, on 22Dec2020 at 09:00, at single dose, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included hypothyroidism. No known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID) and bupropion hydrochloride (WELLBUTRIN). On 24Dec2020, the patient experienced rash on face that looked like she broke out in pimples. No treatment was received. The patient recovered from the adverse event on an unspecified date. The patient had not experienced Covid-19 prior vaccination. Post the vaccination, the patient has not been tested for COVID-19.
49 2021-01-25 injection site hives, hives 12/21/2021 HIVES AT THIGHS WITH ITCHING AT SITE ITCHING -RT SAME DAY 01/12/2021 HIVES AND ITCHING TO... Read more
12/21/2021 HIVES AT THIGHS WITH ITCHING AT SITE ITCHING -RT SAME DAY 01/12/2021 HIVES AND ITCHING TORSO AND THIGHS- SITE OF ARM- LT SAME DAY UP TO 4TH DAY-WORST OM 1/16/2021 WITH RESTLESS NIGHT WAKING UP EYE MATTED-WAKING UP ITCHYAT SITE/TORSO/THIGHS/LT EYE SWELLING AND RT EYE WITH WATERY LUNG FEELING SEEN AT THE ER AND ORAL STEROIDS CAUSE SOME SWELLING AT OTHER EYE BUT BETTER AFTER 30 MIN.AFTER A NAP RT EYE WAS SWELLING W/O ITCHING PRETTY BAD.AND ORAL MEDROL PACK LAST DOSE 1/19/2021 AND FORGOT THE DOSE ON 1/21/2021 AT WORK HAD EYE SWELLING LT EYE FIRST THEN WENT TOOK A DOSE THEN HAD ON THE RT EYE. SWELLING WITH TORSO AND SITE ITCHING TOO SO TOOK ANOTHER STEROID GETTING BETTER WITH PO BENADRYL 50 MG- FATIGUE BUT PRETTY GOOD.YESTERDAY TIRED TOWARDS THE END OF SHIFT AND THIS AM AFTER 9 HRS WAS FEELING TIRED-FATIGUE- STARTED LATE AND THIS PM SWELLING ON THE LT AND THEN RT (SAW CHIROPRACTOR 1/23/2020). IM DEXAMETHASONE 8 mg IM NOW BETTER AFTER 30 MINUTES BETTER.
49 2021-01-25 cellulitis Fever, cellulitis on the 2nd dose administration arm, inflammation and nodes in axilla, dizziness.
49 2021-01-25 vaccination site pain Injection site pain; joint pain; mild fever; headache; nausea; diarrhea; This is a spontaneous repor... Read more
Injection site pain; joint pain; mild fever; headache; nausea; diarrhea; This is a spontaneous report from a non-contactable nurse (patient). A 49-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E13248), via an unspecified route of administration on right arm on 11Jan2021 08:30AM at a single dose for COVID-19 immunization at workplace clinic. Medical history included hypertension and obesity. The patient had no known allergies. Concomitant medication included zinc and melatonin in two weeks. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) on right arm on 23Dec2020 7:45AM. The patient did not receive other vaccine in four weeks. The patient was not pregnant and was not diagnosed with COVID-19 prior to vaccination. The patient experienced injection site pain, joint pain, mild fever, headache, nausea and diarrhea on 12Jan2021 10:00AM. The events were reported as non-serious. The patient did not receive treatment for the adverse events. The outcome of events was recovering. The patient had not been tested for COVID-19 since the vaccination. No follow-up attempts are possible. No further information is expected.
49 2021-01-25 vaccination site pain migraine; vertigo; diarrhea; sore arm injection site; dizzy; This is a spontaneous report from a con... Read more
migraine; vertigo; diarrhea; sore arm injection site; dizzy; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0142 and expiry date unknown) via unspecified route of administration at the left arm on 08Jan2021 13:45 at single dose for Covid-19 immunization in a hospital. Medical history included vestibular migraines, allergies to ragweed, and allergies to PCN (penicillin). The patient was not pregnant. The patient has no covid prior vaccination. Concomitant medications included amitriptyline hydrochloride (ELAVIL), propranolol hydrochloride (INDERAL), bifidobacterium infantis, lactobacillus acidophilus (PROBIOTIC), riboflavin (VIT B2), and colecalciferol (D3) and multivitamins; all from unspecified date for unspecified indication. The patient has no other vaccine in four weeks. On day 1 (08Jan2021), the patient experienced sore arm injection site. On day 2 (09Jan2021), the patient experienced diarrhea once. On day 3 (10Jan2021), the patient experienced migraine, vertigo attack. On day 4 (11Jan2021) and 5 (12Jan2021), the patient was still little dizzy. The patient did not receive treatment due to the events. The outcome of the events sore arm injection site, diarrhea, migraine and vertigo was recovering, while dizzy was not recovered.
49 2021-01-26 rash RASH ON THE SKIN, DIARRHEA
49 2021-01-27 injection site pain Everyday-fatigue 25th Jan 2021-HA @1500, pain at injection site 26th Jan-0930-shaking uncontrollable... Read more
Everyday-fatigue 25th Jan 2021-HA @1500, pain at injection site 26th Jan-0930-shaking uncontrollable-she states, COLD, body aches, HA, nauseated, sweating, muscular & joint pain 27th Jan-decreased symptoms some, intermittent SOB, chest pain, rt & left sides 28th Jan-SOB-continues, -she has a history of seasonal allergies, Told to go to the ER if her SOB & chest pain gets worse. Took Tylenol & Motrin for the body aches, HA, joint pain and discomforts Can't walk-gets fatigued-even short distances
49 2021-01-27 pain of skin Headache; body aches; fever; dizziness; sore arm; drowsiness; loss of balance; agitation; skin ach; ... Read more
Headache; body aches; fever; dizziness; sore arm; drowsiness; loss of balance; agitation; skin ach; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231 and expiration date not provided), via an unspecified route of administration in the left arm on 15Jan2021 13:30 at a single dose for COVID-19 immunization. Medical history included osteoarthritis, guttate psoriasis, degenerative disc disease, fibromyalgia, COVID, and allergies (unspecified). The patient did not receive any other vaccine in 4 weeks. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medication included unspecified medication. The patient experienced headache, body aches, fever, dizziness, sore arm, drowsiness, loss of balance, agitation, and "skin ach" on 15Jan2021 21:00. Treatment was not provided in response to the events. The patient has not undergone COVID test post vaccination. The outcome of the events was recovered with sequel on an unspecified date in Jan2021.
49 2021-01-27 rash, redness Patient presented to the ED approximately 2 days after receiving the 2nd dose of the COVID 19 vaccin... Read more
Patient presented to the ED approximately 2 days after receiving the 2nd dose of the COVID 19 vaccine. It is unknown where the patient received the vaccine, since it was outside our facility. The ED report states the patient woke up with eye swelling (bilateral). red rash on trunk. After contacting the patient, on 25 January 2021, the patient stated that she also began using a Lotus flower facial cream that she believes may have been the cause of the reaction.
49 2021-01-27 redness Pt was up and caregiver noticed she didn't look right. she stated to caregiver she felt like she was... Read more
Pt was up and caregiver noticed she didn't look right. she stated to caregiver she felt like she was having a reaction. pt was assisted to the floor. RN assessed pt and noticed her tonge swelling and patient getting red and neck swelling. RN ran to get emergency kit EPI PEN. EPI Pen administered Right thigh. EMS arrived. took patient to the ED for further treatment.
49 2021-01-27 injection site pruritus, itchy skin Site: Itching at Injection Site-Severe, Systemic: Exhaustion-Mild, Systemic: Other- Itching,Swollen ... Read more
Site: Itching at Injection Site-Severe, Systemic: Exhaustion-Mild, Systemic: Other- Itching,Swollen tongue, Difficulty in breathing
49 2021-01-27 vaccination site pain Swollen axillary lymph node on same side as injection; fatigue; body aches; headache; injection site... Read more
Swollen axillary lymph node on same side as injection; fatigue; body aches; headache; injection site soreness; This is a spontaneous report from a contactable nurse. A 49-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302), via an unspecified route of administration in left arm on 13Jan2021 00:15 at a single dose for COVID-19 immunization. Vaccination was done in a hospital. Medical history included asthma, anxiety and penicillin allergy. The patient did not have COVID prior to vaccination. Concomitant medication included escitalopram oxalate (LEXAPRO), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), zinc (ZINC), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), and montelukast sodium (SINGULAIR). The patient previously received the first dose of bnt162b2 (lot number EL1284) on 23Dec2020 12:00 PM in left arm for COVID-19 immunization. The patient experienced swollen axillary lymph node on same side as injection, fatigue, body aches, headache, injection site soreness on 13Jan2021 20:00. The outcome of the events was recovering. No treatment was received for the events. The patient was not tested for COVID-19 post vaccination.
49 2021-01-27 rash c/o receiving her second vaccine today and notice there was now a rash on her chest and she states s... Read more
c/o receiving her second vaccine today and notice there was now a rash on her chest and she states she is starting to feel tingling in her throat and bilateral arms Transferred to ED. Treated with epinephrine, solumedrol, benadryl and pepcid with resolution of symptoms
49 2021-01-27 hives diffuse urticarial rash. facial swelling.
49 2021-01-27 hives patient developed hives on her left arm which continue to right arm and both feet. Stated her thro... Read more
patient developed hives on her left arm which continue to right arm and both feet. Stated her throat was tight and lung sounds coarse. Pulse oximetry range 91-98%. Given 50 mg of diphenhydramine. Became hypotensive when standing up. First response team called and taken to the ED for further observation.
49 2021-01-28 injection site pain, injection site pruritus, injection site warmth, injection site redness 2nd day after 2nd vaccine, my injection arm turned bright red, sore, hot and itchy. The area is abou... Read more
2nd day after 2nd vaccine, my injection arm turned bright red, sore, hot and itchy. The area is about 5 inches in length and width. 4 days after the vaccine, the area is not getting better, symptoms are the same. With the 1st and 2nd vaccines I had bad back pain in my spine within 6-7 hours of injection lasting 1 day after 1st injection and 3 days after 2nd vaccine.
49 2021-01-28 injection site pain Day 1: mild headache, dizziness and loopy, tired. Day2: soreness at the injection site and my enti... Read more
Day 1: mild headache, dizziness and loopy, tired. Day2: soreness at the injection site and my entire right arm. I was only able to lift my arm up to my shoulder. Very fatigue, body aches, dizziness and drunken feeling. Day 3: less arm soreness. Very fatigued and dizzy. Body aches, joint and muscle pain. Pain in my body. Day4: muscle and joint pain, still very fatigued and my vision began to become blurry. Day 5: fatigue, joint pain, headache and blurred vision has worsened. Day 6: fatigue joint pain, sever headache, dizzy, vision is still bad. I contacted the ophthalmologist and Optometry to schedule an appointment.
49 2021-01-28 shingles Developed shingles 2 weeks after second injection
49 2021-01-28 injection site pain Vaccine received at 10 AM on 1/28/21. No symptoms that day, but upon awakening at 8 am on 1/29/21, ... Read more
Vaccine received at 10 AM on 1/28/21. No symptoms that day, but upon awakening at 8 am on 1/29/21, I was experiencing chills, fever of 100.9, pain at the injection site, body aches and fatigue. It literally feels exactly like I did when I had COVID.
49 2021-01-28 hives left arm is "double swollen"; broke out in hives; Have troubles trying to swallow; feels like "somet... Read more
left arm is "double swollen"; broke out in hives; Have troubles trying to swallow; feels like "something is cutting" through her throat; This is a spontaneous report from a non-contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown), via an unspecified route of administration on 15Jan2021 10:30 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the vaccine at 10:30 and then started experiencing "bad side effects" almost 10 hours later. She said her left arm is "double swollen", she broke out in hives, have troubles trying to swallow, and she feels like "something is cutting" through her throat. With this, she wanted to know what temperature should the vaccines be stored in since she noticed that the place where she got the vaccine was "kind of warm". The outcome of the events was unknown. No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
49 2021-01-28 vaccination site pain pain at the injection site; fatigue; muscle/joint pain; muscle/joint pain; chills; headache; This is... Read more
pain at the injection site; fatigue; muscle/joint pain; muscle/joint pain; chills; headache; This is a spontaneous report from a contactable nurse (patient). A 49-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular at left arm on 22Dec2020 13:00 at single dose for covid-19 immunization. Medical history included fibromyalgia, depression, anxiety, migraines, gastrooesophageal reflux disease (GERD), menopause, allergy to sulfa. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included other medications within 2 weeks of vaccination. The patient experienced pain at the injection site, fatigue, muscle/joint pain, chills and headache on 22Dec2020 14:00 with outcome of recovered on an unspecified date. No treatment received for the adverse events. The patient received the second dose of BNT162B2 (lot number: EK9231) at left arm on 10Jan2021. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious.
49 2021-01-28 skin discolouration, hardening, redness pain/mildly achy; small SQ bump; red and swollen 2x3cm, firm; red and swollen 2x3cm, firm; red and s... Read more
pain/mildly achy; small SQ bump; red and swollen 2x3cm, firm; red and swollen 2x3cm, firm; red and swollen 2x3cm, firm; gray discoloration; muscle atrophy; Indentation; This is a spontaneous report from a contactable 49-year-old female physician reported for herself. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1685), via an unspecified route of administration on 23Dec2020 07:30 at single dose at left arm for covid-19 immunisation. Medical history included allergy: walnuts. Concomitant medication within 2 weeks of vaccination included medroxyprogesterone acetate (DEPO PROVERA). Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced initial pain and small SQ bump. After 1 week, red and swollen 2x3cm, firm. No pain, no warmth. About 2 weeks after, swelling gone, but gray discoloration on 2x3 cm area. Now after 3 weeks, same area with muscle atrophy. Indentation and mildly achy. Adverse event start date was reported as 30Dec2020. Patient was not pregnant at the time of vaccination. The patient underwent lab tests and procedures which included nasal swab, SARS-CoV2, NAAT: negative on 05Jan2021. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Patient didn't receive treatment for events. Outcome of event swelling was recovered, and outcome of other events was not recovered. The report is considered as non-serious.
49 2021-01-30 rash Five minutes after vaccination patient complained of scratchy throat and difficulty breathing with l... Read more
Five minutes after vaccination patient complained of scratchy throat and difficulty breathing with lots of coughing at the throat. Patient took 2 inhalations with her Proventil inhaler. However, this did not stop the issue. Rash spreading across face and chest started as well. Patient was given 2 doses of Benadryl. This did not stop coughing or rash. 911 was called and patient was taken to Hospital for further observation
49 2021-01-30 injection site swelling HEADACHE AND BODY ACHE, took ibuprofen and kept moving. Bump size of marbel where shot was given, as... Read more
HEADACHE AND BODY ACHE, took ibuprofen and kept moving. Bump size of marbel where shot was given, as of 1/31/2021 did shrink in size but still present.
49 2021-01-31 skin irritation . In addition I felt a retrosternal chest discomfort/scratchiness/tightness that has been intermitte... Read more
. In addition I felt a retrosternal chest discomfort/scratchiness/tightness that has been intermittent; . In addition I felt a retrosternal chest discomfort/scratchiness/tightness that has been intermittent; . In addition I felt a retrosternal chest discomfort/scratchiness/tightness that has been intermittent; local pain/bodyache; Fatigue; feverish feeling; dry cough; This is a spontaneous report from a contactable Physician (patient). A 49-years-old female patient (no pregnant) received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , intramuscular on 08Jan2021 11:00 at single dose at left arm for covid-19 immunisation . Medical history included bee sting. There were no concomitant medications. The patient previously received the first dose bnt162b2 on 18Dec2020 10:30 AM at Left arm. The patient experienced a retrosternal chest discomfort, scratchiness, tightness that has been intermittent, local pain, bodyache, fatigue, feverish feeling, dry cough on 08Jan2021. The patient did not received any treatment for the events. The patient underwent lab tests and procedures which included nasal swab: negative on 26Aug2020. The outcome of events was not recovered. No other vaccine in four weeks; No covid prior vaccination; Information on the Batch/Lot number has been requested.
49 2021-01-31 sensitive skin I started out feeling light headed with a little bit of a headache. As the day went on my legs and m... Read more
I started out feeling light headed with a little bit of a headache. As the day went on my legs and my back started to ache. My legs were so bad that you could not touch the back of them. I had a low grade fever. I also had the shakes and a runny nose. This lasted 24 hours. The fever and headache lasted 36 hours. After that all I was left with was a runny nose. My job all made me get a COVID test and that came out Negative.
49 2021-01-31 rash Systemic rash over my entire body- evaluate BP.
49 2021-01-31 sensitive skin woke up writhing in pain; had chills so bad my teeth were chattering; had fevers through night; head... Read more
woke up writhing in pain; had chills so bad my teeth were chattering; had fevers through night; headache 6/10 /My head hurt so bad 10/10; thought I would throw up; My arm was dead weight, I couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch; My arm was dead weight, I couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch; My arm was dead weight, I couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch; My arm was dead weight, I couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch; muscle and bone aches; muscle and bone aches; I was just crying; This is a spontaneous report from a contactable nurse, the patient. A 49-year-old non-pregnant female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3302, intramuscular in the left arm on 18Jan2021 at 12:45 (at the age of 49-years-old) as a single dose for COVID-19 vaccination. Medical history included hyperthyroidism from an unknown date. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included Levothyroxine, Liothyronine, CoQ10, McIntyre Vit D, and Probiotics all from unspecified dates for unspecified indication. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL1284, intramuscular in the left arm on 28Dec2020 at 09:00 as a single dose for COVID-19 vaccination. It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine. On 19Jan2021 at 12:30, the patient experienced writhing in pain and had chills so bad her teeth were chattering. She had fevers through night. From 12:30-4 am. Her head hurt so bad 10/10 she was just crying and thought she would throw up. Her arm was dead weight, she couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch. This morning just muscle and bone aches and headache 6/10. The patient did not receive treatment for the events. The clinical outcome of the events writhing in pain and had chills so bad her teeth were chattering. She had fevers through night. From 12:30-4 am. Her head hurt so bad 10/10 she was just crying and thought she would throw up. Her arm was dead weight, she couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
49 2021-02-01 injection site pain Arm sore at injection site, nausea
49 2021-02-01 injection site bruising, injection site nodule COULD NOT LIFT LEGS TO GET INTO BED, OR HARDLY WALK IT WAS SO PAINFUL AND LOW BACK PAIN, MIGRAINE, F... Read more
COULD NOT LIFT LEGS TO GET INTO BED, OR HARDLY WALK IT WAS SO PAINFUL AND LOW BACK PAIN, MIGRAINE, FUZZY HEAD, DIZZY, LACK OF APPETITE, FATIGUED (SLEPT ALL DAY STARTING AT 3 PM DAY OF VACCINE TO ALL WAY NEXT DAY AND NIGHT), VERY ACHEY, COULD NOT LIFT MY RIGHT ARM, BRUISE WHERE INJECTION WAS GIVEN ALONG WITH A KNOT. TODAY IS 2.2.21 AND STILL FEEL FUZZY HEAD AND ACHEY.
49 2021-02-01 hives, rash, rash macular, injection site pain, itchy skin I had the Pfizer COVID vaccine on 1/28/21, I had no side effects at all, left arm, site of injection... Read more
I had the Pfizer COVID vaccine on 1/28/21, I had no side effects at all, left arm, site of injection was a tad sore, nothing out of the ordinary. Sunday morning my husband noticed I had a rash on my throat/neck and around my eyes. They were not itchy at all or bothering me. My inside of my throat was a little scratchy, but not closing at all. I put hydrocortisone cream on neck & throat Sunday night, Monday, rash, hives, scratchy throat were the same, Monday night after my shower, they were extremely itchy, I again put hydrocortisone cream on my neck and around eyes, it was still itchy and getting onto my eyelid, Monday my face was very blotchy and itchy, I called my doctor, who saw me right away, the doctor told me NOT to get the 2nd vaccine, he is concerned about an anaphylactic reaction and to take Benadryl. Doctor told me he would be researching if I could get another brand, ie. the Johnson & Johnson 2nd dose? Now, I am very nervous to get a 2nd dose and do not know if I should cancel my 2nd dose or not? I do not know who else to talk to about it?
49 2021-02-01 vaccination site pain Pain at site; shortness of breath; palpitations; elevated blood pressure; positive D-dimer; tachycar... Read more
Pain at site; shortness of breath; palpitations; elevated blood pressure; positive D-dimer; tachycardia; abnormal ekg; headache; chest pain; achy; fatigue; fever; chills; Covid/Flu like symptoms; This is a spontaneous report from a contactable Other HCP (patient). A 49-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 11Jan2021 at 13:00 at single dose in left arm for covid-19 immunization. Medical history included hypothyroidism, known allergies: penicillin and dexamethasone. Concomitant medication included thyroid (ARMOUR THYROID), lisdexamfetamine mesilate (VYVANSE), amitriptyline, zolpidem. The patient previously received the first dose bnt162b2 (lot number: EK5730) on 21Dec2020 at 13:00 in left arm for covid-19 immunization. The patient experienced pain at site, shortness of breath, palpitations, elevated blood pressure, positive D-dimer, tachycardia, abnormal EKG, headache, chest pain, achy, fatigue, fever, chills and Covid/Flu like symptoms; all on 12Jan2021 at 18:00. The events resulted on doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient received treatment for the events with Sodium Chloride and Dulera Inhaler. The patient did not have COVID prior vaccination, the patient had been tested for COVID post vaccination, which included SARS-CoV-2 (Nasal Swab): negative on 15Jan2021, and Novel Coronovirus PCR (Blood test): negative on 15Jan2021. The outcome of all events was not resolved.
49 2021-02-01 injection site hives Patient with one solidary hive over injection site, given vaccine 7 days ago. ER visit 1/16/2021. di... Read more
Patient with one solidary hive over injection site, given vaccine 7 days ago. ER visit 1/16/2021. discharge home with Benadryl
49 2021-02-01 shingles, rash, rash vesicular Vaccination day was Sunday. Sunday evening developed chills and malaise which lasted thru Monday mid... Read more
Vaccination day was Sunday. Sunday evening developed chills and malaise which lasted thru Monday mid-day. Monday night noticed canker sore on the gums in the mouth which gradually resolved over the course of the next few days. On Thursday I noticed a small rash on the left side of my upper back. Within next 48-72 hrs multiple blistery patchy rashes developed on the left lower back, hip and groin. The rash is painful and tingly. Dr. visit on Tuesday (2/2/21) diagnosed/confirmed shingles. Valacyclovir was prescribed by MD.
49 2021-02-01 pain of skin, injection site pain, injection site nodule a knot in her arm; sore to the touch; Exhibiting flu-like symptoms; Fever; Severe body aches; Runny ... Read more
a knot in her arm; sore to the touch; Exhibiting flu-like symptoms; Fever; Severe body aches; Runny nose; Cough; Anaphylaxis; This is a spontaneous report from a contactable consumer(patient). A 49-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3246), intramuscular in right bicep(arm) on 13Jan2021 around 16:15 at single dose for preventative. Medical history included high blood pressure from 2016 and ongoing. Concomitant medication included ongoing chlortalidone for high blood pressure. She received first dose of covid vaccine BNT162B2 (Lot: EL0140) on 23Dec2020 around 13:00., in right bicep(arm), a little above where she received this second dose for covid-19 immunization, she previously received flu shot for immunization and had a knot in her arm where it is tender to the touch and sore. She had an anaphylaxis event directly after her shot on 13Jan2021, she was kind of knocked out for the anaphylaxis event and her body was hurting. She was not sure if it was from the shot or from the trauma anaphylaxis event. She received an epi shot in the clinic, diphenhydramine (BENADRYL)into her arm. She was taken to the ER(Emergency Room) where she stayed till about 9:30pm. She was not admitted. Anaphylaxis recovered on 13Jan2021. She also stated that she got sick after the shot, she was exhibiting flu-like symptoms, she never lost her taste or smell, she had a fever, severe body aches, runny nose, and a cough. These symptoms started the next day on the 14Jan2021 and got worse on the 15Jan2021, on 17Jan2021, She feeling better morning and recovered completely by the time she went to bed in regards to her flu-like symptoms, she felt like herself and normal. She felt rested. This morning she felt good. Treatment included paracetamol (TYLENOL) and she was taking diphenhydramine every night since the anaphylaxis occurred. She still had a knot in her arm that it was very sore to the touch which she stated was pretty common even with flu shot(not know the name of the flu shot or have lot, NDC, or expiration date) where it was tender to the touch and sore. There was no relevant test. Outcome of anaphylaxis was recovered on 13Jan2021, of a knot in her arm, sore to the touch was unknown, of other events was recovered on 17Jan2021.
49 2021-02-01 itchy skin, itchy rash, rash, rash macular blotchy, itchy rash over much of body including face
49 2021-02-01 vaccination site pain dizziness; extreme fatigue/fatigue; Sore arm at injection site; dull headache; This is a spontaneous... Read more
dizziness; extreme fatigue/fatigue; Sore arm at injection site; dull headache; This is a spontaneous report from a contactable Other-HCP reporting for self. A 49-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), intramuscular on 14Jan2021 08:30 at single dose for COVID-19 immunization. Medical history was not reported. There were no concomitant medications. The patient experienced on 14Jan2021 09:00 Sore arm at injection site, dull headache day of injection, 2 days later extreme fatigue. 4 days later dizziness and fatigue that lasted 2 days. Outcome of events was recovered.
49 2021-02-02 injection site pain Fatigue, injection site soreness, difficulty concentrating (foggy feeling) for 36 hours
49 2021-02-02 itchy skin, redness Red itchy spots on neck and chest. Took antihistamine for 2 days. Tongue blisters on both side an... Read more
Red itchy spots on neck and chest. Took antihistamine for 2 days. Tongue blisters on both side and felt like it was burned. Resolved in 3 -4 days Dry mouth. Resolved in 3-4 days
49 2021-02-03 pain of skin 103.0 fever; Severe swelling of nodes in left armpit; severe muscle, joint, skin aches; severe muscl... Read more
103.0 fever; Severe swelling of nodes in left armpit; severe muscle, joint, skin aches; severe muscle, joint, skin aches; severe muscle, joint, skin aches; headache; lethargy; This is a spontaneous report from a contactable healthcare professional (patient). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231), intramuscularly in the right arm, on 08Jan2021 at 10:30 (at the age of 49-years-old) at a single dose for COVID-19 immunization. Medical history included interstitial cystitis, anxiety, and shellfish allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications, taken within two weeks of vaccination, included mirabegron (MYRBETRIQ), escitalopram (MANUFACTURER UNKNOWN), doxycycline (MANUFACTURER UNKNOWN), bisoprolol (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), nortriptyline (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN), and colecalciferol (VIT D3). Other concomitant medications included an unspecified multivitamin. The patient previously took iodine (MANUFACTURER UNKNOWN) and experienced allergy. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EJ1685), intramuscularly in the left arm, in Dec2020 at 13:30 (at the age of 49-years-old) for COVID-19 immunization. The patient experienced 103.0 fever, severe swelling of nodes in left armpit, severe muscle, joint, skin aches, headache, and lethargy on 08Jan2021 22:45. The events were reported as non-serious. It was reported that the severe swelling of nodes in left armpit lasted less than 3 days. The patient underwent lab tests and procedures which included body temperature: 103.0 on 08Jan2021. The patient did not receive any treatment for the events. The clinical outcome of 103.0 fever, severe swelling of nodes in left armpit, severe muscle, joint, skin aches, headache, and lethargy was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
49 2021-02-03 injection site pain Diarrhea, fever, pain at injection site with swelling
49 2021-02-03 rash Difficulty swallowing, swollen uvula, rash in ~15-20 minutes Benadryl (self administered), Epinephri... Read more
Difficulty swallowing, swollen uvula, rash in ~15-20 minutes Benadryl (self administered), Epinephrine & steroids (ED) 4 hours post epinephrine observation Headache, arm pain and lethargy the following day
49 2021-02-03 rash, itchy skin, hives Employee reported hives, chest tightness, rash, pruritus and lip tingling 2 hours post injection. S... Read more
Employee reported hives, chest tightness, rash, pruritus and lip tingling 2 hours post injection. She was given Benadryl 50 mg IM at 1117
49 2021-02-03 redness She had chills at 5pm, by 8pm she had heart palpitations, beat red face, nausea and swollen glands i... Read more
She had chills at 5pm, by 8pm she had heart palpitations, beat red face, nausea and swollen glands in throat. She then went to bed. She woke up around 10pm and felt fatigued but better.
49 2021-02-03 itchy skin Weakness; fatigue; small breathes like slightly short of breath; body aches/ severe tender and painf... Read more
Weakness; fatigue; small breathes like slightly short of breath; body aches/ severe tender and painful lymph nodes-to neck and groin and around sides; low grade fever; abdominal pain one day; all days lymph nodes pain /neck lymph node aches/ severe tender and painful lymph nodes-to neck and groin and around sides, under ribs; tenderness, especially around the side rib cage and waist area; tenderness especially around the side rib cage and waist area/ severe tender and painful lymph nodes-to neck and groin and around sides; feeling really bad like i want to cry; slight headache; night sweats; rapid heart rate; increased blood pressure; severe tender and painful lymph nodes-to neck and groin and around sides, under ribs; severe tender and painful lymph nodes-to neck and groin and around sides, under ribs; tenderness to flank area; difficult to turn in bed and lie on right side; Itchiness but no visible rash; first dose of bnt162b2 on 28Dec2020 and second dose on 12Jan2021; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), via an unspecified route of administration at the right arm on 12Jan2021 at a single dose for COVID-19 immunization. Medical history included taking medication for focus (adult adhd?); perimenopausal. She also has known allergies: sulfa; shrimp, strawberry/raspberry flavored foods or candies. The patient was not pregnant at the time of vaccination. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) for focus, perimenopausal. The patient previously received the first dose of bnt162b2 intramuscularly at the right arm on 28Dec2020 at 2:30 PM at the age of 49 years for COVID-19 immunization (Lot number: EL3249). On 15Jan2021, the patient experienced weakness, fatigue, small breathes like slightly short of breath/ short of breath, body aches, low grade fever, abdominal pain one day, all days lymph nodes pain and tenderness especially around the side rib cage and waist area, more on right side then left, neck lymph node aches, feeling really bad like the patient wanted to cry, slight headache, night sweats. Lymph node pain and tenderness is the worse along with body aches and weakness. Also, on 15Jan2021, patient experienced rapid heart rate, increased blood pressure, severe tender and painful lymph nodes-to neck and groin and around sides, under ribs and tenderness to flank area. Mainly right below right ribs and right waist, right flank painful and difficult to turn in bed and lie on right side. There were also Itchiness but no visible rash. According to the reporter the events started on 15Jan2021 at 1AM. The patient received the first dose of bnt162b2 on 28Dec2020 and second dose on 12Jan2021. The patient had nasal swab, rapid on18Jan2021 result was negative and nasal swab on 20Jan2021 result was negative. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovering except for abdominal pain one day which recovered on 16Jan2021.
49 2021-02-03 hives, rash feel prickly; both arms broke out in raised hives and rash; both arms broke out in raised hives and ... Read more
feel prickly; both arms broke out in raised hives and rash; both arms broke out in raised hives and rash; This is a spontaneous report from a contactable consumer (patient). A 49-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on the left arm on 14Jan2021 at 13:00 at a single dose for COVID-19 Immunization. Medical history included severe asthma, depression, anxiety, sinus problems, and known allergies with Penicillin and intravenous (IV) iodine. Concomitant medications included duloxetine hydrochloride (CYMBALTA) and aripiprazole (ABILIFY). The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. About 15 minutes after the shot, on 14Jan2021 at 1330 hours, the patient started to feel prickly and both arms broke out in raised hives and rash. Treatment for the events included intramuscular (IM) 50mg Benadryl. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included nasal swab: negative on 14Nov2020. The events resolved in Jan2021. Information on the lot/batch number has been requested.
49 2021-02-03 vaccination site pain non-swollen cord like lymph nodes; burning sensation and joint pain in injection arm; burning sensat... Read more
non-swollen cord like lymph nodes; burning sensation and joint pain in injection arm; burning sensation and joint pain in injection arm; 19Dec2020 she received the 1st dose. 2nd dose received 11Jan2021; This is a spontaneous report from a non-contactable consumer. A 49-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: not provided), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose on 19Dec2020 and experienced numbness for an hour, and subsequently burning sensation and joint pain which subsided with Tylenol use. Patient's 2nd dose was received on 11Jan2021 and since 15Jan2021 she mentioned non-swollen cord like lymph nodes, burning sensation and joint pain in injection arm which transcends to the left arm. Tylenol helps sometimes. Outcome of the events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
49 2021-02-04 rash macular Aching joints; severe headache; blotchy skin on arms; This is a spontaneous report from a contactabl... Read more
Aching joints; severe headache; blotchy skin on arms; This is a spontaneous report from a contactable other hcp reported for herself. A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1282), via an unspecified route of administration on the left arm on 21Jan2021 11:15 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included sertraline (SERTRALINE). The patient previously took the first dose of bnt162b2 (lot number: EL0142) for covid-19 immunization on 31Dec2020 and diflucan and experienced drug hypersensitivity. The patient experienced aching joints, severe headache, blotchy skin on arms on 22Jan2021 04:00 AM . The patient underwent lab tests and procedures which included sars-cov-1 test: negative on 22Jan2021. No treatment was received for the events. The outcome of the events was not recovered.
49 2021-02-04 itchy skin, rash, injection site rash, injection site swelling Immediate rash and swelling. Was given 50ml Benadryl I he injection in same arm. Rash continues ... Read more
Immediate rash and swelling. Was given 50ml Benadryl I he injection in same arm. Rash continues to spread. Very itchy. All over. Legs back stomach neck chest arms hips buttocks. Still spreading and uncontrollably itchy. Have seen PCP and was given steroid ointment. Doesn?t help at all. Seeing doctor again next Monday
49 2021-02-04 rash, vaccination site rash Rash; Fever of 101; Anxiety; more anxiety each day after the shot; Anxiety was reported as worsened;... Read more
Rash; Fever of 101; Anxiety; more anxiety each day after the shot; Anxiety was reported as worsened; Rash at injection site; This is a spontaneous report from a contactable consumer, the patient. This 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EJ1685), single dose via intramuscular route of administration in the left arm between 5:30-6pm on 15Jan2021 (at the age of 49 years-old) for COVID-19 vaccination. Relevant medical history includes ongoing nervous bad anxiety attacks, spinal stenosis (diagnosed 2-3 years ago), two stomach surgeries, so she had problems going to the bathroom and experienced bloody discharge, hiatal hernia surgeries (one surgery was 4 years ago and the other was 3 years ago), appendix taken out 3 years ago, ongoing insomnia diagnosed 10-11 years ago, shellfish allergy to lobster, pinched nerve and nerve issues and took Krill pills and had an allergic reaction. Relevant drug event included increased anxiety and her hands would fall asleep when she took trazodone and quetiapine (SEROQUEL). The patient did not receive any concomitant medications. On 17Jan2021, the patient experienced rash at the injection site. On 18Jan2021, the patient experienced a fever of 101 and more anxiety each day after the shot. Anxiety was reported as worsened. On an unknown date the patient experienced rash. The patient was treated for rash with diphendydramine (BENADRYL). The clinical outcome of fever was recovered on 19Jan2021, recovering for rash at injection site, unknown for rash and not recovered for anxiety.
49 2021-02-04 injection site pain Shot received approx. 11:45 am on 2/3/2021. No I?ll effects besides slight injection site pain in ev... Read more
Shot received approx. 11:45 am on 2/3/2021. No I?ll effects besides slight injection site pain in evening. 6am on 2/4/2021, slight headache, muscle ache, and dizziness. 11am, increased dizziness. 2pm, tiredness, dizziness, increased muscle pain. (2/4/21) 6pm, tiredness, no appetite, fell asleep in chair. 10pm, awoke chilled and with dizziness and went to bed. Woke from sleep with difficulty breathing/catching a breath (2/5/21) and nauseous. 8am, chills, minor breathing issues, elevated temp (98.1) and headache. Slept upright until 1:30pm.
49 2021-02-04 hives Welt on arm next to site where shot was given. Headache, stomach, achy, tired
49 2021-02-04 injection site reaction swollen lymph nodes under left injection arm
49 2021-02-05 hives Started with hives on 1/30, still with hives 2/6. went to my primary care on 2/3 and was given a pr... Read more
Started with hives on 1/30, still with hives 2/6. went to my primary care on 2/3 and was given a prednisone taper
49 2021-02-05 rash pt was vaccinated at work with her 2nd dose on 1/20/21 and began having symptoms on 1/22. pt prese... Read more
pt was vaccinated at work with her 2nd dose on 1/20/21 and began having symptoms on 1/22. pt presented to my office on 1/25/21 she had confusion, memory loss, labial bp, relative hypotension, bradycardia, severe fatigue, muscle pain and weakness, barely able to rise from a chair or walk, also reported HA, diarrhea, hiccups,decreased O2 sat to a low of 91%-her baseline is 98-100%, she developed a rash after her appointment with me.
49 2021-02-06 injection site pain I got the 2nd vaccination for Pfizer-BioNTech Covid-19 Vaccine EUA and after i have a Fever, chill, ... Read more
I got the 2nd vaccination for Pfizer-BioNTech Covid-19 Vaccine EUA and after i have a Fever, chill, headache, nauseos and muscle pain where injection is and chest.
49 2021-02-06 itchy skin, redness Within 48 hours had 4 red cyst type spots that grew in size. One on right side front, two on back r... Read more
Within 48 hours had 4 red cyst type spots that grew in size. One on right side front, two on back ride side. Irregular shape. Itch, very sore and painful.
49 2021-02-08 hives, itchy skin As reported by patient on 2/6/21: Within 10 minutes of receiving vaccine patient developed pruritis... Read more
As reported by patient on 2/6/21: Within 10 minutes of receiving vaccine patient developed pruritis, urticaria on chest, tongue tingling and thickness in throat. P118 BP 180/100 Treated with diphenhydramine 50mg PO, observed for 40 min, discharged home, told not to get a second COVID vaccine and with the instruction to go to ER if anything else developed. Subsequently she was told by an allergist she could not get a second dose unless there are specialized facilities. She did NOT recieve a second dose. FYI - under our protocol she should have recieved epinephrine
49 2021-02-08 injection site pain, injection site swelling Pain in arm at injection site. Pain and swelling in armpit on same arm. Lethargy and slight fever.
49 2021-02-09 rash vesicular, rash Mild Headache and a rash that started on my lip and spread to my cheek, my eye and forehead. The ras... Read more
Mild Headache and a rash that started on my lip and spread to my cheek, my eye and forehead. The rash it blistery kind of looking, little bit blister and they would open and bleed and then close back up. It was also burning. It start continually spread more. I went yesterday 02/09/2021to a Dermatologist he treated me for a contact kind of dermatitis as if he was unsure if it was linked to vaccine or not. He gave me two steroid injections in the office and prescribed a cream Elidel 1% . The medications seem to be clearing up my face today.
49 2021-02-09 vaccination site pain Very Flush; hot/cold flashes; hot/cold flashes; mild headache; sore at injection site; This is a spo... Read more
Very Flush; hot/cold flashes; hot/cold flashes; mild headache; sore at injection site; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, lot number=EL9261), via an unspecified route of administration on 23Jan2021 14:45 at single dose at left arm for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. No other vaccines within 4 weeks prior to the COVID vaccine. Medical history included allergies to sulfa, mold, asthma, multiple sclerosis, anemia. Concomitant medication included dimethyl fumarate, chorionic gonadotrophin (PROVIGIL), clonazepam, modafinil and Fl. The patient previously took Wellbutrin and experienced allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. The patient experienced very flush, hot/cold flashes, mild headache, sore at injection site on 23Jan2021 17:00. The outcome of the events was recovered in Jan2021. No treatment received for the adverse events.
49 2021-02-10 injection site discomfort, injection site pain Discomfort/Pain at injection site
49 2021-02-14 skin spots, rash papular, rash with redness, injection site rash 1. rash below the vaccine site covering lower upper arm , erythematous and mild elevated 2. petechi... Read more
1. rash below the vaccine site covering lower upper arm , erythematous and mild elevated 2. petechial spots over left 4th and 5th finger
49 2021-02-14 injection site pruritus, injection site swelling Delayed onset (post vax +2D) rubor, calor, mild dolor surrounding injection site accompanied with it... Read more
Delayed onset (post vax +2D) rubor, calor, mild dolor surrounding injection site accompanied with itching. Notable raised red area is approximately 3 cm x 6 cm below injection site. Tx: topical hydrocortisone
49 2021-02-15 rash macular, injection site pruritus, injection site warmth Started itching at injection site, feels warm,red blotches on neck, chest. Think from mask. Switched... Read more
Started itching at injection site, feels warm,red blotches on neck, chest. Think from mask. Switched out mask. Will sit 10 more minutes per EMS. Take benadryl at home
49 2021-02-16 hives, itchy skin Hives and it progressed to an anaphylactic reaction; Hives and it progressed to an anaphylactic reac... Read more
Hives and it progressed to an anaphylactic reaction; Hives and it progressed to an anaphylactic reaction; hives itch; slight swelling around her eyes; This is a spontaneous report from a contactable nurse (patient) via Pfizer Sales Representative. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 at single dose for COVID-19 immunization. Medical history included anaphylaxis (Patient does have a history of anaphylaxis to bee stings), Hysterectomy, Gallbladder surgery, Mastectomy partial/ lumpectomy, Alcohol use: Yes (Comment: socially rare, Drug use: Never), Shellfish-derived products, Seasonal allergies (J30.21), HX: breast cancer (Z85.31), smoker stopped on 01Jan2000 (Former Smoker, Years since quitting: 21, Smokeless tobacco: Never Used), Hot flashes, Axillary Node Dissection. Allergie to Bee venom, Shellfish-derived products, Coconut, Codeine, and Other The patient's allergies have been reviewed. Family History included Cancer oral of Mother; Lung cancer of Father and Maternal Grandfather and Paternal Grandmother; Uterine cancer of Paternal Grandmother. Concomitant medication included ongoing cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ongoing dexmethylphenidate hydrochloride (FOCALIN [DEXMETHYLPHENIDATE HYDROCHLORIDE]), epinephrine (EPIPEN), ongoing lisinopril dihydrate (PRINIVIL), lisinopril (ZESTRIL), ongoing metoprolol succinate (TOPROL XL), valaciclovir hydrochloride (VALTREX), zolpidem tartrate (AMBIEN) from 30Apr2020 and ongoing, promethazine (PHENERGAN [PROMETHAZINE]) from 13Sep2019. Patient previously took Codeine and had vomiting and allergy to it. Patient had an anaphylactic reaction to our vaccine. it started as hives and it progressed to an anaphylactic reaction on 08Jan2021. they gave patient Benadryl afterwards for her anaphylactic reaction because they do not want to interfere with the efficacy of the vaccine that she was able to breathe so she did not have to have any Epipen or anything. She was sent to an ER within hospital to get that. She was in the hospital getting the shot and then they sent her to the ER and she started having the reaction. Emergency department summary of care: Chief complaint: Allergic reaction. ED Diagnosis: Diagnosis Final diagnosis. Allergic reaction to vaccine: Allergic reaction to vaccine. ED Vitals: Date/Time: 08Jan2021 14:00. Pulse: 79. Resp.: 18. BP: 144/86. SpO2: 96%. Date/Time: 08Jan2021 12:54. Pulse: 90. Resp.: 16. BP: 147/98. SpO2: 96%. Weight: 72. 06 kg (160 lb). Date/Time: 08Jan2021. Temp.: 97.6 F (36.4 C). Pulse: 121. Resp.: 16. SpO2: 97%. Result: None. Imaging result: None. ECG result: None. Emergency Department Encounter: Patient was placed in face mask in first look and the following protective measures were taken unless additional measures were taken and documented below in the ED course. Patient was wearing facemask when nurse entered the room and throughout our encounter. nurse wore full protective equipment throughout this patient encounter including a face mask, and gloves. Hand hygiene was performed before donning protective equipment and after removal when leaving the room. Date of encounter: 08Jan2021. Last ED provide Note: patient is a 49 y.o. female who presents to the ED c/o chief complaint of allergic reaction. Patient reports that she just received her first Covid immunization approximately 30 minutes ago, immediately broke out into hives. Patient reports she had hives on bilateral arms as well as her back, hives itch. Patient complains of slight swelling around her eyes. No swelling of her tongue slipped or throat, no difficulty swallowing, no difficulty breathing, no nausea or vomiting. Patient reports that prior to the vaccination she was at baseline without complaint. Patient does have a history of anaphylaxis to bee stings, no other history of anaphylactic reactions, does have history of allergic reactions with hives. Patient received 50 mg oral Benadryl prior to arrival. Patient reports that the hives on her arm have since resolved, continues complain of itching on her back. No active ambulatory problem. No resolved ambulatory problem. All systems reviewed and negative except for those discussed in HPI. PHYSICAL EXAM nurse have reviewed the triage vital signs and nursing notes. ED Triage Vitals (08Jan2021 1229): Temp: 97.6 F (36.4 C), Heart Rate: 121, Resp.: 16, SpO2: 97%. General: No acute distress. HENT: NCAT, PERRL, Nares patent, no swelling of the lips tongue, no posterior oropharyngeal swelling, Voice is normal, no difficulty handling secretions Eyes: no scleral icterus. Neck: trachea midline, no ROM limitations, no stridor. CV: regular rhythm, regular rate. Respiratory: normal effort, CTAB, no wheezing rales or rhonchi Abdomen: soft, nondistended, nontender to palpation, no rebound tenderness, no guarding or rigidity. GU: deferred. Musculoskeletal; no deformity. Neuro: alert, moves all extremities, follows commands. Skin: warm, dry, bilateral arms are normal in appearance, no hives, No rash. Patient has several scattered Hives on her back. Lab Results: No results found for this or any previous visit (from the past 24 hour(s)). Nurse ordered the above labs and reviewed the results. Radiology: No Radiology Exams Resulted Within Past 24 Hours. Nurse ordered the above noted radiological studies. Nurse reviewed the images and results. Nurse agree with the radiologist interpretation. Procedures: Medications - No data to display. PROGRESS DATA. A complete history and physical exam have been performed. All available laboratory and imaging results have been reviewed by nurseself prior to disposition. After the initial H&P, Nurse discussed pertinent information from history and physical exam with patient/family. Discussed differential diagnosis. Discussed plan for ED evaluation/work up treatment. All questions answered. Patient/family is agreeable with plan. ED Course: Patient complaining of allergic reaction, hives seems to be resolving, no symptoms consistent with anaphylaxis. Symptoms seem to be improving after oral Benadryl, no further medication at this time, will monitor closely. Patient reassessed, reports rash has resolved, itchiness has resolved. Patient continues to deny any swelling of lips tongue or throat, no difficulty breathing, no nausea or vomiting. Discussed at length with the patient that Nurse do not advise her to get the second dose of the vaccination as it can cause repeat allergic reaction, possibly worse allergic reaction. Discussed possibility of obtaining the mother no vaccine once it becomes available. Patient understands. Discussed need for close follow- up with primary care physician, Extensive discussion return precautions. Discharging. The patient was reexamined. They have had symptomatic improvement during their ED stay. nurse discussed today's findings with the patient, explaining the pertinent positives and negatives from today's visit, and the plan of used plan for discharge as there is care. No emergent indication for admission. Discussed limitation of the ED work-up and that this is to rule out life-threatening emergencies but that they could require further testing as determined by their primary care and or any referred specialist patient is agreeable and understands need for follow-up and repeat exam/testing. Patient is aware that discharge does not mean there is nothing wrong. Indicates no emergency is present, and that they must continue their care with their primary care physician and/or any referred specialist. They were given appropriate follow-up with their primary care physician and/or specialist. nurse had an extensive discussion on the expected clinical course and return precautions. Patient understands to return to the emergency department for continuation, worsening, or new symptoms. Nurse answered any of the patient's questions. Patient was discharged home in a stable condition. As of 14:11 EST Vitals: BP - 144/86, HR -79, Temp - 97.6 OF (36.4 (Tympanic) 02 SATS - 96%. DISPOSITION: DISCHARGE: Patient discharged in stable condition. Reviewed implications of results, diagnosis, meds, responsibility to follow up, warning signs and symptoms of possible worsening, potential complications and reasons to return to ER. Patient/Family voiced understanding of above instructions. Discussed plan for discharge, as there is no emergent indication for admission. Patient referred to primary care provider for BP management due to today' BP. Pt/family is agreeable and understands need for follow up and repeat testing. Pt is aware that discharge does not mean that nothing is wrong but it indicates no emergency is present that requires admission and they must continue care with follow-up as given below or physician of their choice. Schedule an appointment as soon as possible for a visit in 2 days. Medication List NO changes were made to your prescriptions during this visit. ED Treatment Team. Previous ED Visit: None. ED Arrival Information: Arrival: 08Jan2021 12:27 PM. Means of Arrival: Car. Escorted By: Self. Service: Emergency Medicine Acuity: Emergent. Admission Type: Emergency. ED deposition: Discharged: condition stable. Triage sepsis screen: Row name: Sepsis screen. Documented or Suspected Infection: 0. Documented or Suspected Infection. Indications: None. Acutely Altered Mental Status:0. Temp <96.8 OR > 100.9: 0. Heart Rate >90): 0. Respiratory Rate > 20: SBP < 90:0 MAP < 65:0 Blood Glucose >140(mg/dL)- Not diabetic: WBC <4 or>12 (10*3/mmm3: Unknown Bands >10%. Result of current screen is: Negative. Medication administration from 08Jan2021 12:27 to 09Jan2021 02:02: None. ED Prescription: None. Discharge Orders (From admission, onward): None. Allergies (Reviewed on: 08Jan2021) Agent Bee Venom Severity: High, Shellfish-derived Products, Severity: High Comments: Anaphylaxis. Coconut Comments: Facial swelling. Codeine Comments: Vomiting. Other Severity: Phenofibrates cause Skin hives. Immunizations Administered Name: COVID-19 (PFIZER) Tetanus Up TO Date: None. ED LDA Documentation (to) Patient Lines/Drains/Airways Status Active Airway / Central Venous Catheter Line / Drain / Epidural Line / Intraosseous Line / Peripherally Inserted Central Catheter Line / Peripheral Intravenous Line / Arterial Line: None. Weight: 72.6 kg (160 1b). Height: 157.5 cm (62"). Oxygen Therapy from 07Jan2021 14:02 to 08Jan2021 14:02. Oxygen Therapy from 07Jan2021 14:02 to 08Jan2021 14:02 (continued) Date and Time 08Jan2021 14:00 (also reported 14: 11) sp02: 96 %. Date and Time 08Jan2021 12:58 Device (Oxygen Therapy: Room air. Date and Time: 08Jan2021 12:54 sp02: 96 % Device (Oxygen Therapy: Room air. Date and Time 08Jan2021 12:29 sp02: 97%. Breathing Date and Time: 08Jan2021 14:00, Date and Time: 08Jan2021, 12:54 Date and Time: 08Jan2021 12:29 were sp02:96 %, sp02:96 % and sp02:99 %. 08Jan2021 14:00 Departure Condition: Stable, Mobility at Departure: Ambulatory Patient Teaching Discharge instructions reviewed; Follow-up care reviewed; Medications discussed; Patient verbalized understanding. ED Events: Date/Time 08Jan2021 12:27 Patient arrival, Arrival info file, 08Jan2021 12:29 Triage Started, Patient roomed in ED, 08Jan2021 12:32 Assign Attending, Assign Provider, First Provider, Evaluation of Patient, 08Jan2021 12:52 Registration Completed 08Jan2021 12:56 Triage Completed, 08Jan2021 14:02 Patient discharged, ED Tracking End. Follow-up Information: Details Schedule an appointrnent as soon as possible for a visit in 2 days. Specialty: Family medicine Discharge Instructions: You have been given emergency department evaluation. This evaluation is intended to rule out life-threatening conditions. Is not a complete evaluation. You could require further testing as determined by your primary care physician or any referred specialist. Please follow-up with all doctors that you are referred to. Please be sure to take your prescribed medications and follow any specific instructions in the discharge instructions. Please follow-up with your primary care physician within 48 hours. Please have your primary care provider recheck your blood pressure. Please return to the emergency department if you experience chest pain, shortness of breath. abdominal pain, fever greater than 102, intractable vomiting. Please return to the emergency department if your symptoms continue or worsen, or if you begin to experience any other concerning symptom.Discharge References/Attachments: Hives Easy-to-Read AVS Reports: Date/Time: 08Jan2021: Report: COVID-19: Overview & Impact. Date/Time: 08Jan2021 Report: ED after Visit Summary. Chart Review Routing History No routing history on file. Case Management registry, Status: Active, First included on: 08Jan2021 2:20 PM, Emergency Encounter Documentation Registry, Status: Active, First included on: 09Jan2021 12:06 AM, Emergency Encounters Registry Status: Active, First included on: 08Jan2021 12:36 PM. Patient was recovering from the events. Information on the Lot/Batch number has been requested.; Sender's Comments: A causal association between administration of BNT162B2 and the onset of Anaphylactic reaction, hives, itching and Eye swelling cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
49 2021-02-18 itchy rash Developed 6 days after vaccine RUQ abd pain that woke her from sleep. Seen later that day by PCP in... Read more
Developed 6 days after vaccine RUQ abd pain that woke her from sleep. Seen later that day by PCP in another facility and had labs done: t..bili 1.6, GGT 472, alb 4.2, alkaline phos 257 (upper nl 150), AST 276 (upper normal 33), ALT 512 (upper normal 33) HepB surf ag - non-reactive, hep B core Igm - non-reactive, IgA non-reactive, hepC non-reactive CBC wbc-9.8 rbc 5.26 hgb 17.1 hct 49.7, MCV 94.6 MCH 32.5, MCHC 34.3, plt 229 mpv 10.3 RDW 14.2 Lipids - Tot-218, TRG-138, HDL - 65 LDL-125 non-HDL 153paLiver US (2.12.2021) - liver diffusely coarsened and increased in echogenicity that can be seen in fatty infiltration or other diffuse hepatocellular process. This limits the sensitivities for the detection of hepatic masses. Cholecystectomy. dilatation of th ecommon duct due to postcholecystectomy state.
49 2021-02-18 injection site pain Fever, chills, body aches, injection site pain. Recovered from COVID in 12/2020.
49 2021-02-18 rash Rash on back of right arm, left arm, left thigh, right thigh, both feet and arms.
49 2021-02-18 hair loss Severe hair loss
49 2021-02-19 injection site pain, injection site redness Patient complained of redness at injection site, and that the injection site grew from a quarter siz... Read more
Patient complained of redness at injection site, and that the injection site grew from a quarter sized redness, to a half dollar sized redness over the course of a couple days. Pharmacist on duty advised patient to ice the location, take Benadryl and contact PCP if it gets any worse. Followed up with patients a couple days later, and reported redness had not got any worse, but was still off and on painful.
49 2021-02-22 redness, injection site discomfort Redness, soreness at the site of the smallpox vaccine scar. Smallpox was administered in childhood i... Read more
Redness, soreness at the site of the smallpox vaccine scar. Smallpox was administered in childhood in the country. COVID vaccine injection site is about two inches away from the smallpox scar.
49 2021-02-22 hives hives; facial swelling; throat swelling; throat itching; nausea; anaphylactic reaction/ Anaphylaxis;... Read more
hives; facial swelling; throat swelling; throat itching; nausea; anaphylactic reaction/ Anaphylaxis; This is a spontaneous report from a contactable physician via FDA. A 49-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in the arm on 17Dec2020 at 13:30 at 0.3 ml, single dose for covid-19 immunization. Medical history included ongoing essential hypertension, ongoing protein c deficiency, ongoing lumbosacral radiculopathy, ongoing type 2 diabetes mellitus, ongoing pulmonary embolism, Strep pharyngitis from 29Nov2020 and resolved at the time of vaccination, serious allergic reaction, allergy to iodonated contrast media and Cardiac Arrest after IV contrast. Concomitant medication included apixaban (unknown manufacturer) for Protein C Deficiency, metformin hydrochloride (unknown manufacturer) for Type 2 Diabetes, chlorthalidone (unknown manufacturer) for hypertension, metoprolol (unknown manufacturer), clonidine hydrochloride (unknown manufacturer) for hypertension, atorvastatin (unknown manufacturer), magnesium oxide heavy;tocopheryl acetate (unknown manufacturer), tramadol hydrochloride (unknown manufacturer), diphenhydramine hcl (unknown manufacturer), epinephrine bitartrate (unknown manufacturer) for serious allergic reaction and anaphylaxis. On 17Dec2020 at 13:48, approximately 13min after vaccination while in observation the patient experienced hives, facial swelling, throat swelling/itching, and nausea. Patient was immediately taken to Emergency Department where epinephrine was given 1M in the left thigh followed by 125mg IV solumedrol, 50mg IV benadryl, 1000mL NS, and 20mg IV famotidine. Hemodynamically stable throughout ED course. The events were considered serious as per hospitalization. Medical Tests and Laboratory results related to the adverse event included: CRP: 11.0, Glucose-182, BRN-29, INR-1.1, Remained of CMP and CBC were WNL. The physician stated that anaphylactic reaction onset 6min after vaccination symptoms improved - 20min after epipen administration, Resolved 60 min later. The signs and symptoms of anaphylactic reaction included Diffuse rash, Itching, throat/lip swelling, shortness of breath, cough, BP 128/72, Spon-97% HR-71. The patient rushed to ED from vaccination PoD. Received EpiPen approximately 8 min post vaccination. Then received steroid, antihistamines, IVF. Sx improved in 20 min resolved 60 min. The patient was not hospitalized and not admitted to an intensive care unit for anaphylactic reaction. The physician stated that multiorgan involvement included respiratory, dermatological/mucosal. Also reported as Respiratory: Yes; Upper airway swelling: Yes; Respiratory distress: Yes; Tachypnoea: Yes; Dry cough: Yes; Difficulty breathing (without wheeze or stridor):Yes; Dermatological/Mucosal: Yes; Generalized urticarial: Yes; Angioedema (not hereditary): Yes; Generalized pruritus with skin rash: Yes. The following laboratory tests or diagnostic studies performed included Hematology on 17Dec2020 showed: results with units, if applicable: 8/13/299/41; Clinical chemistry on 17Dec2020 showed: results with units, if applicable: 137,103,29/36,22,07 (Less than sign) 182; CRP on 17Dec2020 showed: results with units, if applicable: 11.0. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient had not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient had anaphylaxis on 17Dec2020 at 13:36. The patient was not deceased and received treatment. Treated in emergency room/ epinephrine IM IV steroids, antihistamines, IV fluids. The physician considered the Pfizer product had a causal effect to the adverse event. The outcome of the event anaphylactic reaction/ anaphylaxis was recovered on 17Dec2020, while other events were recovered on 17Dec2020 at 13:48. Information on the lot/batch number has been requested. Follow-up (08Feb2021): New information received from the contactable Physician included: additional medical history and lab data, concomitant medications details, suspect drug information (lot number, dosage regimen details), event information (new event "anaphylactic reaction/ Anaphylaxis") and other clinical courses.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events anaphylactic reaction/Anaphylaxis urticaria, swelling face, pharyngeal swelling, throat irritation and nausea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
49 2021-02-23 rash Pfizer-BioNTech COVID-19 Vaccine I received my injection on 2/6/21. On 2/9/21 or 2/10/21, I began t... Read more
Pfizer-BioNTech COVID-19 Vaccine I received my injection on 2/6/21. On 2/9/21 or 2/10/21, I began to feel swollen nodes under my left arm (injection arm) and developed a mild rash on my left arm. The rash worsened and spread to my torso, right arm, and both legs. I saw a teledoc on 2/16/21 who told me to take benedryl every 6 hours and pre-treat prior to getting the second shot. I took benedryl for two days, but then switched to Allegra, to reduce fatigue. Rash did not improve. I saw an urgent care provider on 2/23/21 who prescribed antihistimine, anti-itch med, and steroid pac.
49 2021-02-23 injection site warmth, injection site pain, injection site redness redness warmth & soreness to injection site
49 2021-02-24 rash, redness, skin swelling, skin burning sensation 12/22 vaccination 4pm. 4:05 PM, my HR went way up. I broke out on neck, chest, face; fire engine red... Read more
12/22 vaccination 4pm. 4:05 PM, my HR went way up. I broke out on neck, chest, face; fire engine red. Felt like burning from the inside, out. Lightheaded and dizzy. Got puffy. Was NOT anaphylactic. 2 Benadryl. I didn't feel good for a couple weeks. 14-20 days, same experience with redness/burning. I took pictures. That happened every day for 4-5 more days. I went to doctor after doctor; ER after ER. About 6-7 times I have been to the ER; SOB, dizzy all the time, panic attack/anxiety, Stomach is not emptying correctly (NOT diabetic), eye keeps twitching, hurting behind my eyes, all my muscles are shrunken now. Blood panel, stress test; gastroparesis; positive; ringing in my ears; SOB; *COVID; negative.
49 2021-02-24 itchy skin Initially, tingling tongue and gums. Tongue felt ?big?. All over body itching. Excessive coughing... Read more
Initially, tingling tongue and gums. Tongue felt ?big?. All over body itching. Excessive coughing. Could not clear throat. It felt as if I was put inside a CS chamber. Went to ER. Treated with steroid and antihistamine. Coughing stopped with residual tightness in chest. Tingly stopped and reduced itchiness.
49 2021-02-24 skin discolouration, injection site pain Sun 2/21 - fever (101.1), site of injection soreness, body aches, joint aches, headache, fatigue, lo... Read more
Sun 2/21 - fever (101.1), site of injection soreness, body aches, joint aches, headache, fatigue, loss of appetite. Mon 2/22 - same as Sunday 2/21 but fever came down to 100.1 and symptoms were generally milder Tues 2/23 - better in general and fever broke during early hours of morning. Most symptoms still present but milder Wed 2/24 11:30am mild breathing difficulty began and at 1 pm inhaler was used. Breathing difficulty subsided (but not fully restored)until @7pm and 1st nebulizer treatment was done. Breathing difficulty subsided (but not fully restored) until @10:45pm and 2nd nebulizer treatment was done. Hands were noticed to have purple coloring prior this nebulizer treatment. Thurs 2/25 7:00am breathing was labored and became difficult by 8:30am and was taken to emergency room for evaluation and treatment.
49 2021-02-25 itchy skin, hives Hives, pruritus, and sensation of tongue swelling developed within 10 minutes of receiving 2nd COVID... Read more
Hives, pruritus, and sensation of tongue swelling developed within 10 minutes of receiving 2nd COVID. Transferred to the ED as by rapid response. Diphenhydramine 50 mg IV and prednisone 60 mg PO administered. Monitored for approximately 1 hr 20 minutes in ED. Symptoms improved. Patient released with prescription to continue prednisone 60 mg/day x 5 days and cetirizine 10 mg/day prn at home.
49 2021-02-25 skin tightness Over a week ago I started feeling a tightness in my right cheek and neck. I wasn't sure what it was ... Read more
Over a week ago I started feeling a tightness in my right cheek and neck. I wasn't sure what it was but it went away. I received my second vaccination 3 days ago and the tightness is back. Accompanied by sore throat. I felt the area and the lymph node in front of my right ear and the one in my neck on ther right side are swollen. :
49 2021-02-26 injection site pain Mild fever, tiredness and loose bowel which cleared up after 12 hours. Vaccine also seemed to provok... Read more
Mild fever, tiredness and loose bowel which cleared up after 12 hours. Vaccine also seemed to provoke an MS-related response with pain in back, leg spasms and difficulty walking. Symptoms began to clear about 24 hours after onset (36 hours after vaccine injection). First vaccine was tolerated well with only mild and normal side effects (mild cough, soreness at injection site, etc.).
49 2021-02-26 itchy skin, rash with redness came to the vaccination appointment with no current illness or cough. Within less than 5 minutes af... Read more
came to the vaccination appointment with no current illness or cough. Within less than 5 minutes after the injection started with a cough that is similar to asthma attack onset. As talking with the nursing staff on site after waving them over I began to get worse very quickly. Within minutes I heard one of the staff say "she's crashing, move it". At that point I could not breathe, audible wheezing, shortness of breath, throat was closing, entire body felt like it was on fire, extreme itching on back (especially upper back), shaking/convulsing, incoherent. Paramedic staff was put into place and i was ambulanced to the hospital across the street from the vaccination site. Everything is a whirlwind at this point and treatment from what I can remember was albuterol svn, atrovent svn, use of cpap, epipen administration in the parking lot, benadryl via iv, solumedril, oxygen and pepcid. Once arrived at E.R. I was aggressively treated. Once stabalized began to wheen off the oxygen onto room air. I am a rare asthmatic and my oxygen sats usually do not drop, although I am in distress. At one point I heard oxygen sats were at 96, which is low for me. I was discharged from the hospital to my husband's care. In the next days now I am expriencing fever (100), itching, red rashy skin, severe headaches, joint pain, body ache, diarehha and extreme fatigue
49 2021-02-27 rash 5 min after the shot, throat and chest began to feel slightly tight; nurse monitored for 45 min; no ... Read more
5 min after the shot, throat and chest began to feel slightly tight; nurse monitored for 45 min; no other symptom changes or treatments given; 65 hours later woke up with a swollen face and generalized rash on throat - this is current state at time of submission so final outcome unknown at this time
49 2021-02-27 injection site pain I received the first dose of my vaccine at 4:20 pm. My left arm was sore at the injection site prett... Read more
I received the first dose of my vaccine at 4:20 pm. My left arm was sore at the injection site pretty quickly as I would have expected. At about 9:30 pm, I noticed that both of my hands were painful and achy (I assumed the cause was flu-like symptoms from the vaccine). Upon examination of my hands, I noticed that my veins were significantly enlarged and bulging from partway down my forearms through my hands. When I raised my hands in the air, the veins became smaller and the pain subsided. I took 2 advil and went to bed with my hands slightly elevated. When I woke up in the morning, the veins were back to normal.
49 2021-02-28 vaccination site warmth 2 blisters around the injection site in her left arm. Blisters were approximately the size of pencil... Read more
2 blisters around the injection site in her left arm. Blisters were approximately the size of pencil eraser; it feels warm at the injection site; arm was initially sore and that was all/a sharp pain in her arm/it was very sore/arm hurt; I didn't realize if a 'lesion' (not clear over the call) kind of formed overnight; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown, Expiry Date: Unknown), via an unspecified route of administration in left arm on 25Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were none. It was reported that patient had her 1st Pfizer vaccine dose on Monday, 25Jan2021, her arm was initially sore and that was all. Then sometime today (on 28Jan2021) she has developed 2 blisters around the injection site in her left arm. Blisters were approximately the size of pencil eraser. She was driving home from work and felt a sharp pain in her arm. She pulled her car over because it was "very sore". "she was glad that she was close to home when this happened. It was kind of freaked her out." Patient also stated that she got the vaccine on Monday and today (on 28Jan2021) she was driving home. She hadn't had any issues other than her arm hurt but it feels warm at the injection site and she just got in to her house, she wanted to stretch, she didn't realize if a 'lesion' (not clear over the call) kind of formed overnight in Jan2021, it hurts, her arm hurts." No lab work was done. No treatment was received for the events. The outcome of the events was unknown. Information on the batch/lot number has been requested.
49 2021-02-28 rash, itchy skin All of these symptoms happened within a few hours of getting the vaccine. MolkMetallic taste in my m... Read more
All of these symptoms happened within a few hours of getting the vaccine. MolkMetallic taste in my mouth, headache, sore arm, itchiness on legs and back, rash on inner thigh
49 2021-02-28 rash macular, skin discolouration Brown and orange spots about 2 inches in diameter,
49 2021-02-28 itchy skin, injection site pain Fever 103.0 F, Chills, Muscle Pain, Headache, Night Sweats, Dizziness/near-syncope, tachycardia (120... Read more
Fever 103.0 F, Chills, Muscle Pain, Headache, Night Sweats, Dizziness/near-syncope, tachycardia (120's bpm), nausea, severe fatigue, severe soreness at injection site (but mild swelling, mild itching). Starting from 3:30 am on 02/21/21 until about 3 pm on 02/22/21. Milder headache and fatigue throughout rest of that week. Back to normal now.
49 2021-02-28 vaccination site pain Painful site Weakness and shaking Tingling sensation in mouth EMS called and recommended transport t... Read more
Painful site Weakness and shaking Tingling sensation in mouth EMS called and recommended transport to the hospital - patient declined
49 2021-02-28 itchy skin Patient began to feel "itchy" on her Left leg. Patient stated she has had this same reaction to sul... Read more
Patient began to feel "itchy" on her Left leg. Patient stated she has had this same reaction to sulfa drugs. Vital signs within normal limits after 30min observation patient felt "better" and comfortable going home.
49 2021-02-28 injection site pain The side effects after the first of the two vaccinations (01/23/21) resulted in the side effects sta... Read more
The side effects after the first of the two vaccinations (01/23/21) resulted in the side effects starting same night and resolving by 01/25/21 of headache, fatigue and localized soreness at vaccine injection site. The side effects from tge 2nd vaccination administered on 02/13/21 resulted in the side effects beginning later the same night of moderate site soreness, severe fatigue, headache, feeling hot and cold, loss of appetite and pain in muscles. All of the side effects resolved by 02/18/21 except the fever and chills which has happened every night since the second vaccination and had not been experienced prior to tge vaccination.
49 2021-02-28 injection site redness, injection site pain, injection site pruritus, injection site warmth Vaccine was given in left arm. She is having pain, redness, itching and fever to top of left arm.
49 2021-02-28 itchy skin Waited 30 min in vaccine clinic with no problems. Approx 2 hours after vaccination, experienced di... Read more
Waited 30 min in vaccine clinic with no problems. Approx 2 hours after vaccination, experienced diffuse itching with oral paresthesia and cough. No globus or SOB. Seen in Urgent Care. No hives or other rash recorded. Vital signs stable. Treated with oral decadron and benadryl and released after >1 hour observation with resolution of sxms.
49 2021-02-28 vaccination site pain arm hurt with first dose; This is a spontaneous report from a contactable consumer (patient herself)... Read more
arm hurt with first dose; This is a spontaneous report from a contactable consumer (patient herself). A 49-year-old female patient received her first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via intramuscular route of administration in the left arm on 29Dec2020 at a single dose because "a coworker came down with Covid." Medical history included migraine and headache. The patient's concomitant medications were not reported. The patient had no additional vaccines administered on same date of the Pfizer suspect. The patient reported that her arm hurt with first dose on an unspecified date. There were no relevant tests conducted. The outcome of the event was recovering.
49 2021-03-01 itchy skin Intensely itchy blisters on inside of upper and lower right lips. Upper roof of mouth as well. Nev... Read more
Intensely itchy blisters on inside of upper and lower right lips. Upper roof of mouth as well. Never had this symptom prior. Took Zyrtec in case it was allergic reaction, but did not get better.
49 2021-03-02 bruising, itchy skin I have a silver dollar size bruise at the base of my thumb. It was initially itchy, then just bruise... Read more
I have a silver dollar size bruise at the base of my thumb. It was initially itchy, then just bruised. Appeared about 1 hour after vaccine was administered. It is not painful to touch.
49 2021-03-02 vaccination site warmth, vaccination site redness, vaccination site pain The site is still red, painful and hot to the touch; The site is still red, painful and hot to the t... Read more
The site is still red, painful and hot to the touch; The site is still red, painful and hot to the touch; The site is still red, painful and hot to the touch; This is a spontaneous report from a contactable consumer (reported for herself). A 49-year-old female patient (not pregnant at the time of vaccination) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 13Feb2021 08:15 at single dose in left arm for COVID-19 immunisation. Medical history included diabetes type 2; no Allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included sertraline; acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE). The patient previously took the first dose of bnt162b2 on 19Jan2021 07:15 (at the age of 39 years old) in left arm for Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It has been over 72 hours since the vaccination. The site was still red, painful and hot to the touch which started from 13Feb2021 08:15. Not sure if this was normal for this to continue so long. No treatment received for the adverse events. The events were non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
49 2021-03-02 redness received Pfizer vaccine through on 2/19/2021. Pt woke on 2/26/2021 with a bad headache on left side... Read more
received Pfizer vaccine through on 2/19/2021. Pt woke on 2/26/2021 with a bad headache on left side of her head, left side of her neck was sore & there was a lump on her left clavicle. She went to her PCP's walk-in clinic on 2/26/2021. Diagnosed with a bright red left ear, swollen lymph nodes on the left side of her neck, clavicle & left arm pit. She was prescribed Amoxicillin for 10 days.
49 2021-03-03 itchy skin patient experienced pruritis of face and arms as well as throat tightness. no perioral swelling, ton... Read more
patient experienced pruritis of face and arms as well as throat tightness. no perioral swelling, tongue swelling, or respiratory distress
49 2021-03-04 skin warm 1435 received vaccine. 1445 warmness to arm and dry mouth, anxiety. 124/80, hr-114, 02 sat 94%ra. Wa... Read more
1435 received vaccine. 1445 warmness to arm and dry mouth, anxiety. 124/80, hr-114, 02 sat 94%ra. Warmness to arm resolved 1500. anxiouness resolved 1505. throat cont to be dry able to drink water w/o difficulty. drank one full bottle of water. Report sensitive and has many allergies. Pt husband is in car and informed of pt condition. 1520 pt condition dryness in needs to take mask off.. went outside totake off and get fresh air. 1540 128/89-hr-122-02 sat 96%ra r-18. Pt instructed to f/u with MD has appointment on tuesday. upon discharge reports tired and dry throat.
49 2021-03-04 itchy skin Itching. Benadryl 25 mg given. BP 127/97 (pulse 101), 99% O2 sat. BP 127/92 (pulse 87), O2 sat 97%.
49 2021-03-04 rash, rash with redness Patient arrived to obversation area stating she felt hot and ?not normal.? She was guided to observa... Read more
Patient arrived to obversation area stating she felt hot and ?not normal.? She was guided to observation by field ops and received by nurse. Nurses alerted immediately and made available to patient. Patient stated she went to the restroom because she ?felt hot and I needed to cool off? but returned to be observed. Vitals taken @ 1:56 pm BP 177/96, Pulse 104, O2 Sat 95%, Temp 99.4 F. Red Rash noted on bilateral arms and chest. Nurses made available to patient. At 2:16 pm vitals reassessed with patient positioned on the floor. BP 144/90, Pulse 78, Temp 97.1, Respirations 20. At 2:19 patient continued to state she felt ?hot?, nauseous, dry mouth and some tightness in the chest. Nurse offered additional help to the patient by calling EMS, but patient refused. Nurses continued to monitor patient. Vitals reassessed with patient upright on chair @ 2:30 156/82, 97.4 Temp, 95% O2 Sat, Pulse 85, Respirations 18. At 2:38 patient stated she is starting to feel less hot and it is easier to breath. Patient requested to use the restroom to refresh herself. Patient accompanied by Nurse. At 2:48 patient states she is feeling better and only feels slightly nauseous. No reports of chest tightness. Rash on arms cleared. Rash on chest significantly improved. Patient refused to stay for additional observation. Patient educated to consult with health care provider prior to receiving second dose. Earlier, patient stated she has had instances where she had to take Benadryl when taking NSAIDS, and also carries EPI Pen. Patient also educated to call 911 if ?chest tightness,? respiratory issues occur. Patient accompanied out by brother-in-law.
49 2021-03-04 vaccination site swelling She is worried it might be Bell's Palsy; had a knot at the injection site of her left arm; Tingling ... Read more
She is worried it might be Bell's Palsy; had a knot at the injection site of her left arm; Tingling sensation on her upper back which went up to her neck and head/tingling in my neck, face, lips and eyes; Burning and tingling in my neck and in my face and in my lips and in my eyes; Burning and tingling in my neck and in my face and in my lips and in my eyes; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no: EH9899, Expiration date: not provided), intramuscular on the left arm on 19Jan2021 at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 49-year-old for COVID-19 immunization. The patient was worried it might be bell's palsy (medically significant) on an unspecified date. she experienced side effects on 22Jan2021 after receiving the vaccine on 19Jan2021. She had a knot at the injection site of her left arm on the first day. After 3 days, she experienced a tingling sensation on her upper back which went up to her neck and head. It was not excruciating pain but had presence to be noticed. It had been there since that day and was not going away. She had been feeling it around her eyes and on her lips. She was worried it might be Bell's Palsy. She was asking for advice and if this had been reported. As soon as she get the second Covid Shot at the 19Jan it was about 2-3 days afterwards, it was on the Friday and it was about 2' O'clock, well she had the knot in my arm, her left arm where she received the IM (Intramuscular) vaccination (Covid Shot) and she had started having the symptoms of like burning and tingling in my neck and in my face and in my lips and in my eyes and that is not gone away and I still have that knot in my arm, I still have the burning and tingling. she had some blood work done like last Thursday to see if she had any kind of like rheumatoid problems to see arthritis or something but other than that no. Consumer stated, "Well I work in the doctor office and the Physician the one he told me to get the blood work and it goes to the doctor office because I work in one. For treatment consumer stated, she had only been taking an Advil and it did not seem to help her. The outcome of the events was not recovered. Comments/Narrative: Patient will follow up with Physician next week. She is currently on vacations.
49 2021-03-04 rash, itchy skin, redness itchy and red on her chest just below her neck shot at 7:08pm 7:20 said itchy on neck. Said wasn't i... Read more
itchy and red on her chest just below her neck shot at 7:08pm 7:20 said itchy on neck. Said wasn't itchy until the sanitizer was on her hands and she rubbed her neck. Her arm opposite of her vaccine arm also started to get a rash. We gave her 50mg of benadryl. We are observing her for 30 minutes. Not on blood pressure medicine currently. Current bp 125/91 pulse 67 118/89 pulse 68
49 2021-03-05 rash 24 hr post vaccine: fever, headache, chest pain 48 hr post vaccination: tingling sensation in arms a... Read more
24 hr post vaccine: fever, headache, chest pain 48 hr post vaccination: tingling sensation in arms and legs (bilateral), rash on chest, face, back
49 2021-03-05 injection site pain Pain at injection site, soreness in right arm, Abdominal cramps and diarrhea lasting throughout the ... Read more
Pain at injection site, soreness in right arm, Abdominal cramps and diarrhea lasting throughout the night
49 2021-03-05 skin warm, itchy skin warm itchy hands approx 15mins post-vaccine - patient give a cetirizine 10mg tab
49 2021-03-07 itchy skin, rash Adverse reaction began 20 minutes of receiving injection. Began with a rash on throat and neck. Foll... Read more
Adverse reaction began 20 minutes of receiving injection. Began with a rash on throat and neck. Followed by swelling of throat, trouble breathing, O2 levels dropped, itching began, selling in face, watery eyes, and other.
49 2021-03-07 injection site pain Second vax, vax burned when going into arm this time, started feeling tired three hours later. Had a... Read more
Second vax, vax burned when going into arm this time, started feeling tired three hours later. Had a full dinner, went to bed at 10:00. Woke at 4:00 am feeling very achy. Went to kitchen for ibuprofen, took two. Started feeling very nauseated. Went to master bathroom to urinate, and started feeling like I was going to faint. Tried to make it three steps to my small sofa outside bathroom door. That?s the last thing I remember. My husband heard me fall. I had fallen chin first on hardwood floor. He found me lying in a pool of blood. Before going to ER in the next 15 minutes, i had an extreme bout of diarrhea. At ER, I learned that I had Broken both my condyals in jaw and fractured lower mandible. At ER and hospital on 2/2, threw up multiple (about 7-8) times, even with anti-nausea drugs in IV. Doctor put an anti-nausea patch behind my ear but not sure if it helped. Had surgery to set it on 2/3/21.
49 2021-03-07 hives facial hives, left arm numbness and tingling, facial flushing w/ parenthesis. Evaluated by EMS-Clea... Read more
facial hives, left arm numbness and tingling, facial flushing w/ parenthesis. Evaluated by EMS-Cleared
49 2021-03-08 injection site swelling, injection site pruritus, injection site pain, injection site redness 12-24 hours after vaccination, I experienced moderate body aches, joint pain, headache, and fatigue... Read more
12-24 hours after vaccination, I experienced moderate body aches, joint pain, headache, and fatigue. Recovered after 48 hours. 3 days after vaccination, I?m experiencing pain, redness, swelling, and itching just below the vaccination site on my left arm. Still experiencing these symptoms.
49 2021-03-08 injection site tingling, injection site discolouration, injection site pain Second dose of Pfizer vaccine was given on 1/8/21 and on 3/8/21 I noticed a hypopigmented circular ... Read more
Second dose of Pfizer vaccine was given on 1/8/21 and on 3/8/21 I noticed a hypopigmented circular area approximately 1.25 inches in diameter on my left arm where the vaccine was given. It has a slight tenderness/parasthesia to the touch. It has been winter time so I have been wearing long sleeves when outdoors and have not had that area exposed to sun any more or less than the rest of the left arm. Also, after second dose did not even have a bandaid applied in Jan.
49 2021-03-08 skin discolouration hypertensive crisis; mental fog; I had systemic reaction with numbness; tingling; extreme nausea; he... Read more
hypertensive crisis; mental fog; I had systemic reaction with numbness; tingling; extreme nausea; headache; thirst; palpitations; changes to color of extremities; cold/heat intolerance; diuresis; inability to eat; inability to eat or sleep; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female (not pregnant) patient received BNT162B2 (lot number: ek9231) second dose on 06Jan2021 on left arm at single dose for covid-19 immunization. Medical history included hypothyroidism and allergies to penicillin. Concomitant medications in two weeks included levothyroxine sodium (SYNTHROID), liothyronine, magnesium carbonate (MAG 2), trimebutine maleate (MOTRI), zinc, curcuma longa (CURCUMA). The patient previously took BNT162B2 (lot number: ek5730) first dose on 17Dec2020 10:00 AM (age of vaccination was 49-year-old) on left arm for covid-19 immunization. Facility type vaccine was Hospital. No other vaccine in four weeks. On 10Feb2021 07:00 (also reported as 08Feb2021), approximately one month after 2nd vaccine, patient received a steroid epidural with contrast and a day after she had systemic reaction with numbness, tingling, extreme nausea, headache, thirst, palpitations, hypertensive crisis, changes to color of extremities, cold/heat intolerance, extreme thirst, mental fog, diuresis, inability to eat or sleep. Not sure if related to vaccine. No COVID prior vaccination. COVID tested post vaccination (Nasal Swab, PCR) on 17Feb2021 and result was Negative. The outcome of the event was recovering. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization]. Hospitalization for 2 days. Patient received symptomatic management as treatment.; Sender's Comments: It is unclear what was the indication for the mentioned 'steroid epidural with contrast ' performed one month after the second dose of BNT162B2. The reported systemic reaction with numbness, tingling, extreme nausea, headache, thirst, palpitations, hypertensive crisis, changes to color of extremities, cold/heat intolerance, extreme thirst, mental fog, diuresis, inability to eat or sleep seems attributable to the reported procedure, or the unspecified indication for the procedure, rather than BNT162B2 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
49 2021-03-09 rash macular, redness 24 hours after vaccination patient complains of arthralgias, fatigue, headache. 36 hours after vacc... Read more
24 hours after vaccination patient complains of arthralgias, fatigue, headache. 36 hours after vaccination complained of macular rash on the left breast above the areola. Seen in clinic on March 10, macular confluent erythema 9 x 5 cm, no induration, no pruritis, mild swelling, c/ pain in left axillary area. No nipple discharge. Afebrile. No adenopathy. BP 121/78, pulse 72, Resp. 17, T 36.1 C, Sat 91%. z
49 2021-03-09 rash I started with a rash on my chest which spread to my abdominal area and very top part of my thighs
49 2021-03-09 hives, itchy skin No current pregnancy. Hives, itching, shortness of breath, light headed, numbness/tingling in extrem... Read more
No current pregnancy. Hives, itching, shortness of breath, light headed, numbness/tingling in extremities, thick/numb feeling in tongue, coughing. taken to ED and given IV Benadryl and oral prednisone. Given prescription of for prednisone and Zyrtec for home use. At home, shortness of breath with coughing, lightheadedness, numbness/tingling in extremities, itching persisted for the next 5days. Took prednisone as prescribed for 3 days. Did not take allergy medication. Three days later on Thursday 2/22, I fell while going down stairs and suffered a badly sprained ankle. I feel the fall is a result of lingering symptoms of the vaccine.
49 2021-03-09 vaccination site warmth, vaccination site pain right arm was feverish, painful and difficult to move; right arm was feverish, painful and difficult... Read more
right arm was feverish, painful and difficult to move; right arm was feverish, painful and difficult to move; right arm was feverish, painful and difficult to move; fatigued; developed a fever/reached 101.3 and was steady at 100 F for the duration of day/fever broke; piercing headache; sleepiness; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 49-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262, Expiry date: unknown), via an unspecified route of administration on 30Jan2021 at 09:15 am (Age at the time of vaccination was 49-years-old) at single dose on right arm for covid-19 immunisation. Medical history included hypertension an obesity. The patient did not have allergies to medications, food, or other products. Concomitant medication patient received within 2 weeks of vaccination included propranolol, triamterene, bupropion, valaciclovir hydrochloride. The patient reported that, within 4 hours of injection, on 31Jan2021 at 08:00 my right arm was feverish, painful and difficult to move. Within 8 hours, I became fatigued and developed a fever the next day at 8 am that reached 101.3 and was steady at 100 F for the duration of day. I also developed a piercing headache and sleepiness. At 1:45 am on 02Feb2021, my fever broke. My headache remained until 02Feb2021. The events were considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. The patient recovered from the event headache on 02Feb2021 and recovered from other events on an unspecified date in 2021.
49 2021-03-11 injection site numbness, injection site tingling Patient stated that starting 1 week post vaccine, she experienced numbness & tingling starting at in... Read more
Patient stated that starting 1 week post vaccine, she experienced numbness & tingling starting at injection site, and went down to thumb.
49 2021-03-11 shingles Three days after my vaccination, I got shingles. I?m currently undergoing treatment.
49 2021-03-12 injection site pain 02/12/2021- 12:36am woke up with chills that went on for about 1 hour. About 7am woke up went to the... Read more
02/12/2021- 12:36am woke up with chills that went on for about 1 hour. About 7am woke up went to the restroom and almost fainted (lightheaded, nausea, black vision, cold sweat). Blood pressure was 84 over 44. In the afternoon had muscular pain and a low grade fever of 100F for about 2 hours. A little sore at the injection site but all symptoms disappeared on day two 03/13/2021
49 2021-03-12 itchy skin, rash 1628 ? Patient received first dose of Pfizer vaccine. She reported a history of allergic reactions ... Read more
1628 ? Patient received first dose of Pfizer vaccine. She reported a history of allergic reactions in the past and was thus observed for 30 minutes following her injection time. 1704 ? Vitals: 99% sp02, 192/101 BP. Patient reported symptoms of itching of face, scalp, eyes, and hands. 25 mg Benadryl given by Observer. Patient placed on continuous sp02 monitor. No SOB, cough, or wheezing at this time. 1710 ? Observers called ED Nurse to let them know we would likely be sending a patient their way. 1715 - Observer was advising patient?s husband to take her to the ED when Coordinators were alerted to situation. contacting ED and allowing patient to transport themselves is not our protocol and Coordinators took control of the situation at this time. 1717 ? 1720 ? Patient moved by wheelchair to private area in the library for further evaluation. Vitals: 99% sp02, 200/119, BP, 90 HR. assessed patient. Rash but not hives are present on her chest. There is mild end-expiratory wheezing consistent with asthma history. No airway edema. No trouble speaking or swallowing. She is mildly diaphoretic but neurologically intact. 1720 ? Rapid response called for transport to ED. Sp02 98 ? 99. 1722 - Patient is starting to have increased wheezing with sp02 holding at 98%. She doesn?t have her inhaler. 1727 ? Rapid response called to say transport is 5 ? 10 minutes away. Patient still on monitor. No visible airway edema. Starting to cough and bilateral upper extremities mildly edematous. She notes her back is itching in addition to chest. 1728 ? After briefly explaining procedure to patient and obtaining verbal consent, 0.3 mg Epi Pen injection given to right lateral thigh. Vitals 192/133 BP, 91 HR, 99% 02. 1731 ? EMS arrives. Itching, wheezing, and cough have improved. Report given to EMS. Patient transported by stretcher to ED. Report had previously been given to ED and updates since then were given to EMS.
49 2021-03-12 itchy skin 5:05pm chest pain, itching, paresthesia, sweating. gave patient 50mg benadryl. chest pain resolved... Read more
5:05pm chest pain, itching, paresthesia, sweating. gave patient 50mg benadryl. chest pain resolved and itching and paresthesia decreased. bp = 124/64. patient reports resolution of symptoms. Monistored until 5:30pm and allowed to leave.
49 2021-03-12 injection site redness At around 1:30 I started feeling achy and tired. Overnight and the following day, I couldn't get out... Read more
At around 1:30 I started feeling achy and tired. Overnight and the following day, I couldn't get out of bed. I had an increase in hot flashes, which lasted through the 2nd day and I was back at work. On the 2nd day, the arm pain and swelling worsened. I had a 2 in x 2 in area of redness by the injection site. With the 1st one I had a lot of hot flashes, but nothing to where I was unable to work.
49 2021-03-12 sensitive skin, redness, blister Bilateral swelling of big toe, 2nd toe, and 3rd toe on left/right feet. began with swelling. blist... Read more
Bilateral swelling of big toe, 2nd toe, and 3rd toe on left/right feet. began with swelling. blisters, then developed. inflammation, heat, and pain also present. became difficult and painful to wear socks. shoes were also uncomfortable. swelling and sensitivity were present all day, but flare ups occured in evening which included further swelling, pain, redness, and tingling sensation. PCP diagnosed anti-fungal and said would improve. after 7 days on anti-fungal ointment, no improvement. Referred to dermatologist. Dermatologist diagnosed Pernio/Chilblain, likely related to 2nd Vaccine. prescribed topical steriod and suggested keeping toes and feet warm at all times.
49 2021-03-12 injection site hives, itchy skin, hives, rash, blister I broke out in hives 5 days after on my arms and on the back of my legs. Then on the 7th day I start... Read more
I broke out in hives 5 days after on my arms and on the back of my legs. Then on the 7th day I started getting, I guess more hives on my left hand (the same arm I got the injection). The bumps have turned into what looks like blood blisters the morning after. They are EXTREMELY itchy.
49 2021-03-12 rash with redness, itchy skin, rash Patient felt itchy and developed a rash. Rash was red skin discoloration. Rash was not consistent wi... Read more
Patient felt itchy and developed a rash. Rash was red skin discoloration. Rash was not consistent with hives. Patient was given benadryl and offered transport to the hospital. Rash improved with benadryl within 10 minutes. Patient refused transport to hospital.
49 2021-03-13 rash, itchy skin Headache and back pain within an hour of getting the second dose of the vaccine. Fever within 3 hour... Read more
Headache and back pain within an hour of getting the second dose of the vaccine. Fever within 3 hours of getting the vaccine. Fever lasted for 13 days in a row despite round the clock tylenol and ibuprofen. Then I would get a fever for a few hours about every other day. Dizziness, lightheadedness, severe headaches, nausea, exhaustion, rash, extreme itchiness, heaviness on my head that radiated down both arms
49 2021-03-13 injection site hives, itchy skin Itchy and hives around injection 2 days
49 2021-03-14 injection site pain Pain & stiffness: injection site within an hour of dose 3/12. The next morning, (3/13) 9:30 am, I w... Read more
Pain & stiffness: injection site within an hour of dose 3/12. The next morning, (3/13) 9:30 am, I woke with severe pain all over my body. The worst pain was left arm, neck, back, buttocks, calves. Moderate pain throughout the rest of my body, notably my torso and my jaw. I had terrible headaches throughout the day. I was fatigued/exhausted and slept for several hours intermittently throughout the day. By 9PM I started to feel less fatigued, but the pain was very bad in most of my muscles. I felt like my muscles were battered and beaten, bruised and weak. The next day (3/14) I started to have energy, but not a lot, around 11am, and was still very sore, but the pain had subsided, and no more headaches. Today is 3/15, I am still very tired, but wouldn't call it fatigue, rather less energy than I am used to. I have noticed that my back is still very sore, especially the intercostal muscles. My legs and buttocks are still very sore today. I would not call it pain, but definitely notable and uncomfortable soreness.
49 2021-03-15 rash, redness, itchy skin, skin discolouration I went to get vaccinated at clinic on March 4, and I wait my 20 minutes at the time of leaving I got... Read more
I went to get vaccinated at clinic on March 4, and I wait my 20 minutes at the time of leaving I got itchy all over my body, my face turned red and with many outbreaks, I went back to clinic and the doctor gave me an injection, I got better a little but it gave me a lot of hyperactivity, when I arrived at home I couldn't handle the itch in the body and I felt my throat closing my husband took me to emergency, I couldn't breathe well, and I was itchy from head to toe. I stayed in emergency and I got some green discoloration very big on my legs, I have to go to the allergist because I still had itchy in the body
49 2021-03-15 injection site pain numbness and tingling in both hands, pain in muscle at injection site, worse at night, unable to sle... Read more
numbness and tingling in both hands, pain in muscle at injection site, worse at night, unable to sleep
49 2021-03-17 hives After 7 minutes, the patient developed difficulty breathing, scratchy throat, cough, hives, chest ti... Read more
After 7 minutes, the patient developed difficulty breathing, scratchy throat, cough, hives, chest tightness, nausea and lightheadedness. She was transferred to the Emergency Department within 5 minutes and was treated with Benadryl, Pepcid, Methylprednisolone, and another medication that she is not able to remember.
49 2021-03-17 shingles, rash with redness, sensitive skin, rash On day 6, Hyper sensitivity on skin of lower back, which progressed to upper back and then down righ... Read more
On day 6, Hyper sensitivity on skin of lower back, which progressed to upper back and then down right leg to knee. On day seven red bumps appeared on lower back. On day eight more red bumps appeared on the center of the back. On day nine, I was diagnosed with shingles. On day 10 the shingles had spread to the right torso. I do not believe I ever had chickenpox as a child.
49 2021-03-17 injection site pain Patient states she received COVID-19 vaccine on 3/5/21 and "it seemed high up" and describes site as... Read more
Patient states she received COVID-19 vaccine on 3/5/21 and "it seemed high up" and describes site as "one finger width down from the top of the shoulder bone". Denies immediate pain with injection. Reports she went home and "kept trying to move it around" to minimize soreness at injection site. States she and her husband put together a treadmill, although she "just unwrapped the parts and did not do any heavy lifting". Reports pain worsened that night and rated it 7-8/10. Reports she used ibuprofen and ice without effectiveness. Reports she "did not sleep at all Friday night". Reports she couldn't get dressed or undressed and could not wash her hair.
49 2021-03-17 rash vesicular Small blister- like rash around my right eye. It has been there since approximately 10 days after I ... Read more
Small blister- like rash around my right eye. It has been there since approximately 10 days after I received the 2nd dose of my vaccine
49 2021-03-17 injection site pain Soreness at injection site, sleepiness, headache
49 2021-03-17 bruising severe arm bruising -black over one inch long and wide , arm pain . I received the vaccine since Mar... Read more
severe arm bruising -black over one inch long and wide , arm pain . I received the vaccine since March 5th and still have those issues
49 2021-03-18 rash Broke out in a rash on my thighs on 3-7-21, continued to spread down my legs & across my stomach 3-8... Read more
Broke out in a rash on my thighs on 3-7-21, continued to spread down my legs & across my stomach 3-8-21. Went to Urgent Care on 3-9-21, was give a steroid shot & topical cream. Rash continued to spread to my feet and arms. Topical cream & steroid shot did not seem to help. Rash was worse on 3-11-21. Rash cleared up by 3-17-21.
49 2021-03-18 redness, hives, skin swelling, itchy skin Itching on my legs. no welts or hives. just itchy skin overnight. when I woke up I did have welts an... Read more
Itching on my legs. no welts or hives. just itchy skin overnight. when I woke up I did have welts and where any pressure is applied to my skin a welt forms and swells and itches. (example, I held my purse strap on my shoulder and when I put my purse down there was itchy redness and a welt where the strap applied pressure.) These welts are all over my body. Back, under my breasts, legs, arms etc. and one on my face.
49 2021-03-18 rash papular raised rash to neck, torso, back and upper arms; This is a spontaneous Report from a contactable Nur... Read more
raised rash to neck, torso, back and upper arms; This is a spontaneous Report from a contactable Nurse (patient). A currently 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EM9810), via an unspecified route of administration, administered in left arm on 09Feb2021, at 12:45pm (at the age of 49 years old) as single dose, for COVID-19 immunization. The patient did not have any medical history. The patient did not have any known allergies. The patient did not experience COVID-19 prior to vaccination nor was tested for COVID-19 post vaccination. The patient received vitamins (not specified) within two weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to vaccination. The patient experienced raised rash to neck, torso, back and upper arms on 15Feb2021 at 08:00 AM. The event resulted in a Doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the event. The clinical outcome of the event raised rash to neck, torso, back and upper arms was not recovered.
49 2021-03-19 skin warm Immediately after vaccine, felt tingly through arm and down leg (L side both). A few minutes later, ... Read more
Immediately after vaccine, felt tingly through arm and down leg (L side both). A few minutes later, she got hot on l side of face, like a hot flash.
49 2021-03-19 itchy rash, injection site rash, injection site warmth Pfizer-BioNTech COVID-19 Vaccine EUA. Baseball size rash on injection area - just a rash with heat ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA. Baseball size rash on injection area - just a rash with heat and inching - no other irritations. Was totally gone within three days.
49 2021-03-20 blister, rash, shingles I received my first Pfizer shot on March 3rd. No reactions at all. About 13 days later on Tuesday, M... Read more
I received my first Pfizer shot on March 3rd. No reactions at all. About 13 days later on Tuesday, March 15th, I noticed a small rash on my right side upper eye lid and the side of my eye but thought it may just be an allergic reaction to something. No pain or itching. I had a couple of similar spots on my scalp but didn?t think much of it. On Thursday, I had a headache but I do get headaches now and then. When I woke up on Friday morning, March 19th, I found my eye lid completely swollen and saw the rash had turned to blisters, and there was a new one by the inner corner of my eye and a very faint rash on my forehead. Still no fever, pain or fatigue but had a lingering headache and a burning sensation on the rash. Saw my opthalmologist right away who diagnosed it as shingles and did a complete eye exam. Luckily no shingles in the eye as that can lead to glaucoma or even blindness in severe cases. I was prescribed Valtrex (1000 mg x 7 days) and prednisone (60 mg x 5 days) by my PCP. Hoping that I was still in the 72 hour window when the antiviral med is effective, I started on the meds immediately. Today is the third day of treatment and the blisters seem to be crusting away and healing faster. Luckily, no new blisters as of now. The prednisone caused my eye area to swell up further so I am gradually tapering off the dosage from 60 mg prescribed to 40-30-20 mg. Keeping a watch for any complications such as ear pain or numbness in the face. Have a follow up appointment with ophthalmologist who will be dilating my eyes for further checks. I was glad to have found the Reddit board and see that there are over 50 cases of people reporting shingles after the first or second covid vaccine. I plan to delay or skip my second Pfizer vaccine for now.
49 2021-03-21 rash 3/20 rash on abdomen/chest (vaccine was on 3/18)
49 2021-03-21 itchy skin she experienced throat swelling, difficulty breathing, itching, flushing. she self-administered Epi... Read more
she experienced throat swelling, difficulty breathing, itching, flushing. she self-administered Epi-Pen which she brought with her. EMS was called.
49 2021-03-21 rash macular, redness, itchy skin, rash, skin warm, hives skin red and some white blotchiness. small raised ares( hives) warm to touch. exceptionally itchy ... Read more
skin red and some white blotchiness. small raised ares( hives) warm to touch. exceptionally itchy legs,back, abdomen, arms, armpit,elbow, behind knee - all affected.
49 2021-03-22 redness, itchy skin, hives Approximately 8 minutes after receiving the first dose of the Pfizer-BioNTech COVID-19 vaccine, the ... Read more
Approximately 8 minutes after receiving the first dose of the Pfizer-BioNTech COVID-19 vaccine, the patient reported feeling ?funny?. She described symptoms including itching/tingling, sweating and increased heart rate. She was immediately ushered into the counseling room of the pharmacy and a blood pressure monitor was attached to her arm. At 2:09 p.m. her blood pressure was 166/78 and heart rate was 98 BPM. At this time 25mg of diphenhydramine was given to the patient orally. In addition to the subjective symptoms, the patient?s complexion had turned from neutral to red, and her face was covered in what appeared to be hives. EMS was called, and while on the phone with a dispatcher, a subsequent reading found the patient to have a BP of 140/122 and HR 121 BPM (2:15p.m.). As instructed by the EMS dispatcher, 0.3mg was administered to the patient via auto-injector into the left thigh. Paramedics arrived several minutes later and the patient was helped onto a stretched and subsequently escorted from the building for further observation and treatment.
49 2021-03-22 injection site pain I had an "off" taste when eating & drinking , plus a funny smell when being in our truck. However, I... Read more
I had an "off" taste when eating & drinking , plus a funny smell when being in our truck. However, I was the only person that could smell it. It was like an antiseptic smell & if you could imagine what that might taste like, that is the best way to describe the strange test I got while eating & drinking. This lasted about a week. Plus, my left arm where I received the injection was sore for about 2 - 3 days, but I suppose that's to be expected.
49 2021-03-22 itchy skin, hives, rash I noticed a small section of a rash/hive on my right hip in the morning. Later that day, after the v... Read more
I noticed a small section of a rash/hive on my right hip in the morning. Later that day, after the vaccine, there was a spot on my right hand, between my fingers that started to itch. Then from that time until this morning (3-22-21), I have had more locations and more intense itchiness with the hives.
49 2021-03-22 injection site pain, injection site redness, injection site warmth Within one hour of injection: tingle in tongue (resolved in 24 hours), headache, low-grade fever, fa... Read more
Within one hour of injection: tingle in tongue (resolved in 24 hours), headache, low-grade fever, fatigue (on and off for 3 days), injection site pain, red and hot injection site (resolved after 3 days). Within 12 hours of injection: lip swelling (occurred 10 hours after injection, resolved within 24 hours, note: no lip fillers). Within 48 hours of injection: swollen lypmh nodes in left armpit (resolved within 12 hours).
49 2021-03-22 redness bumps in mouth on first day, face turned read on second day and bumps went away, third day lips beca... Read more
bumps in mouth on first day, face turned read on second day and bumps went away, third day lips became raw and almost wind burned and chapped then fourth and fifth day lips swelled up very large as well as chin and lower face and cheeks. Benadryl, claritin given together as well as epi pen for emergency use.
49 2021-03-22 rash rash, sob
49 2021-03-23 hives Symptoms include airway itching and warmth, subjective eyelid closing, eye itching, and localized hi... Read more
Symptoms include airway itching and warmth, subjective eyelid closing, eye itching, and localized hives on left thumb within 30 minutes of dose.
49 2021-03-24 itchy skin, rash, rash with redness 9 days after vaccination (3/18/21), extreme itchiness from neck through trunk of body. 11 days after... Read more
9 days after vaccination (3/18/21), extreme itchiness from neck through trunk of body. 11 days after vaccination (3/20/21) rash from neck through trunk of body with extreme itchiness. Went to urgent care on Monday (3/22/21) and was told unsure of how vaccine is effecting people as it is too new. Was given steroid cream for the rash. Recommended see dermatologist. Saw dermatologist on Tuesday (3/23/21) with a similar comment and was advised to report and try to get some direction. Said to continue on steroid cream. Bumps are improving but red rash and itching still persists and continues to spread to new spots. Overall feeling tired. working to get a doctor that will test for internal adverse effects.
49 2021-03-24 skin irritation, itchy skin Knot under left breast, Entire neck and left foot Irritated and itchy
49 2021-03-24 itchy skin Tingling in throat @ 20 minutes after shot. Then lips felt very tingly but not swollen. Then my enti... Read more
Tingling in throat @ 20 minutes after shot. Then lips felt very tingly but not swollen. Then my entire body (different parts) itched on and off for two days. I contacted my primary doctor who had me take zyrtec to alleviate the itch. Walgreens staff DID NOT make anyone stay for 15 minutes after their shots to make sure there were no reactions. They are also NOT giving the second dose until FOUR WEEKS LATER not the recommended THREE. I wish I had known this before I went there - there are so many other facilities that are doing a wonderful job.
49 2021-03-24 injection site swelling pt states that developed a red bump the size of a quarter on her left arm around the injection site.... Read more
pt states that developed a red bump the size of a quarter on her left arm around the injection site. Lymph nodes are inflamed. she has cough, and headache. Pt still as these symptoms but has not taken any medication. She will contact her PCP.
49 2021-03-25 injection site bleeding After withdrawing the syringe from the patients arm, she had blood run down her arm resulting in abo... Read more
After withdrawing the syringe from the patients arm, she had blood run down her arm resulting in about 3 dime size drops on the chair and a few pin point drops on the floor. The technician, that gave the shot didn't know what to do so she ran for help. Another technician came out and held a cotton swab over the injection site until the puncture stopped bleeding, between 30-60 seconds later.
49 2021-03-25 shingles Diagnosed with Shingles 3/23/2021
49 2021-03-25 redness I received the vaccine at 9:15a and was told to wait 30 min instead of 15 due to my anaphylactic all... Read more
I received the vaccine at 9:15a and was told to wait 30 min instead of 15 due to my anaphylactic allergy history. At 9:21a, while in the waiting area, I felt a flushing sensation through my body and felt my face grow hot. I got very light-headed even though I was sitting down and thought I was going to be sick, and my heart rate as noted on my watch became elevated. It went from low 70's to high 90's. My throat did not close up and I did take my regular allergy medicine and inhalers prior to the vaccine. After 30 minutes, I went to the facility restroom and noted my face was still red. I called my sister (a hospital doctor) who told me to immediately take Benedryl. After taking Benedryl, I was feeling better after about another hour and the nausea and light-headedness subsided. In total, the symptoms lasted about an hour and 45 minutes. I did not notify staff at Med.Centerl at that time as my throat didn't close but did contact my PCP and now have an appointment scheduled with an allergist at Med. Center for next week and have put my 2nd vaccine on hold until I see the allergist.
49 2021-03-25 skin warm On same side as vaccination I experienced burning knuckles on middle finger and ring finger, warmth ... Read more
On same side as vaccination I experienced burning knuckles on middle finger and ring finger, warmth on side of neck, the cheek on the left side of my face was numb, my lips tingled, and my heart rate increased to 105 bpm. The facial numbness went away after a few hours and felt like I had received Novicane for dental work. The burning knuckles took 8 days to go away. I called my doctor's office and spoke to the on call nurse who said the reaction was likely due to the vaccine.
49 2021-03-25 rash Pt arrives to ED w/ c/o of SOB, rash (flat, blanchable, over trunk and scalp), cough, body aches and... Read more
Pt arrives to ED w/ c/o of SOB, rash (flat, blanchable, over trunk and scalp), cough, body aches and fatigue. She got her second covid vaccine Monday, felt poor yesterday but today sx are worse. She is alert, oriented, and ambulatory. Electronically Signed by RN on 01/20/21 1628
49 2021-03-25 injection site pruritus, itchy skin, rash Site: Itching at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Me... Read more
Site: Itching at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Medium, Additional Details: bp 175/110 hr 76 and bp 15 min later 158/100 hr 72 and on bp meds
49 2021-03-25 rash Started having a small red area on on the neck a week after the vaccine and since then the rash has ... Read more
Started having a small red area on on the neck a week after the vaccine and since then the rash has expanded to entire neck. chest, armpits. thighs. Throat feels ticklish. has body aches.
49 2021-03-26 injection site pain Arm pain I pain around midnight the night of injection continuing through next day. Night sweats ... Read more
Arm pain I pain around midnight the night of injection continuing through next day. Night sweats Fever and chills March 27th all day StIff and painful joints and muscles everywhere Slight headache Energy drain was almost immediate and ongoing.
49 2021-03-26 redness, itchy skin, skin reaction, injection site reaction Delayed skin reaction at injection site in upper left arm. Pfizer vaccine administered on 3/18/21,... Read more
Delayed skin reaction at injection site in upper left arm. Pfizer vaccine administered on 3/18/21, however skin reaction did not present until 3/26/21. Developed a circular red and itchy patch about 2 inches in diameter.
49 2021-03-26 itchy skin Itchiness starting in my shoulders then moving both up my neck and down my back until I was very itc... Read more
Itchiness starting in my shoulders then moving both up my neck and down my back until I was very itchy from head to toe. Fever of 99.5. Felt like an allergy attack with runny watery eyes and itchy ears. Throat felt itchy and dry.
49 2021-03-26 injection site reaction Muscle soreness down left arm from injection site to elbow over first 36 hours. Then the soreness de... Read more
Muscle soreness down left arm from injection site to elbow over first 36 hours. Then the soreness decreased into the next 12 hours. 49 hours post-injection, soreness was gone.
49 2021-03-27 skin warm Headache, chills, body aches, hot to touch, joint pain,
49 2021-03-27 injection site pain Minor injection site pain followed by chills, high fever, SOB, dizziness, weakness, blurred vision, ... Read more
Minor injection site pain followed by chills, high fever, SOB, dizziness, weakness, blurred vision, severe muscle pain, and large swollen lymph node (size of golf ball under left arm/near injection site) 12 hours after second shot. Adverse events diminished 12 to 48 hours later.
49 2021-03-27 rash, itchy rash Small bumpy, itchy rash on lower back
49 2021-03-28 rash with redness, itchy skin, rash Adverse reaction to dose 1 of Pfizer COVID-19 vaccine (lot# EN6207). Pt was vaccinated at 1735 and r... Read more
Adverse reaction to dose 1 of Pfizer COVID-19 vaccine (lot# EN6207). Pt was vaccinated at 1735 and reported itchiness on arms, chest, and scalp at 1800. Immediate area around the vaccination (right deltoid) was not erythematous but PT's arms and chest had flat, erythematous patches. PT has a Hx of formaldehyde allergy (hives and itchiness). Denied SOB, swelling, or tingling in lips/tongue/mouth. Denied lightheadedness or racing heartbeat. Monitored PT for the remainder of her 30-minute observation period. Recommended that she call 911 if she experiences any of the aforementioned symptoms, and that she can take Benadryl when she returns home.
49 2021-03-28 injection site numbness, injection site tingling After receiving vaccine client states she has tingling and numbness in the arm which she received th... Read more
After receiving vaccine client states she has tingling and numbness in the arm which she received the vaccine. Client states she feels better. Client discharged home
49 2021-03-28 injection site pruritus itchy arm at injection area
49 2021-03-30 skin discolouration her heart was racing; nose bled; felt dizzy; green mark just below her arm near the veins; Heartburn... Read more
her heart was racing; nose bled; felt dizzy; green mark just below her arm near the veins; Heartburn; This is a spontaneous report from a Pfizer-sponsored program. A 49-year-old female patient reported that she received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9262), intramuscular in righ arm ton 09Mar2021 (at the age of 49-years-old) at single dose for covid-19 immunisation. The subject had a history of cholesterol (she mentions she takes a cholesterol medication as well but she doesn't have it with her at the time), fibromyalgia, blood pressure and muscle relaxant. Relevant concomitant medications included naproxen for fibromyalgia, lisinopril for blood pressure and methocarbamol for muscle relaxant therapy. The first day after the vaccine, the patient felt nothing, except heartburn. She clarifies further she felt fine the first day, completely fine. The next day, she noticed on her arm, not in the place where they put the vaccine (injection site), but lower down the arm, near her hands, there was a big circle where her vein was. patient may have mentioned the color green, but could not clarify these details further after multiple attempts. She confirmed that 2 days later, this disappeared. The patient also reported that her nose bled as well and felt dizzy and her heart was racing. The reported events were palpitations with unknown outcome, skin discolouration on 10Mar2021 with outcome of recovered, epistaxis on 12Mar2021 with unknown outcome, dizziness on 12Mar2021 with unknown outcome and dyspepsia on 09Mar2021 with unknown outcome.
49 2021-04-03 vaccination site pain Sore at inj site for 3 days; This is a spontaneous report from a contactable Nurse (patient). A 49-y... Read more
Sore at inj site for 3 days; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration, in left deltoid on 01Feb2021 as single dose for covid-19 immunisation. Medical history included vestibular migraine from 24May2017 and ongoing, PCN allergy from 01Jun2012 and ongoing, ragweed allergy from 10Oct2017 and ongoing. Concomitant medications included allopurinol (ELAVIL) via oral from unknown date in 2017 and ongoing at 10 mg, daily for vestibular migraines and propranolol via oral from 12Aug2020 and ongoing at 60 mg, daily for Vestibular migraine. The patient historical medication included first dose of BNT162B2 (at the age of 49-year-old) Lot number: EL0142, (IM injection) time vaccination was given: 12:50 (24-hour clock) on 08Jan2021 for covid-19 immunisation and experienced Sore arm inj site, diarrhea (event onset date and time of onset (24 hr clock): 09Jan2021; 22:00), Migraine, vertigo (event onset date and time of onset (24 hr clock): 10Jan2021; 14:30) and dizziness (After vertigo attack, increase dizziness persisted resulting in EMLA/LOA from work) and acetaminophen (Most recent dose: x 1 dose 1000mg oral) for Premedicated before vaccine. The patient experienced sore at inj site for 3 days on Feb2021. The outcome of the event was unknown. Reporter considered that the Pfizer product had a casual effect to the adverse event. Information on the lot/batch number has been requested.
49 2021-04-05 redness Pt scheduled for 2nd COVID vaccination (pfizer). While in observation after vaccine administration,... Read more
Pt scheduled for 2nd COVID vaccination (pfizer). While in observation after vaccine administration, pt reported not feeling well. Clinic caregivers monitored vitals and eventually moved patient from chair to bed located behind curtain in observation room. Pt started to become increasingly disoriented and experiencing shortness of breath. Pt condition rapidly concerning as was visibly and audibly struggling to inhale and exhale with significant facial redness. Epinephrine 0.3mg auto injection given once. Med team called after dose of epi. Rescue breathing using bag was applied as patient appeared apneic. Upon med team arrival RN administered another 0.3mg epi and brought pt to ED for further treatment and monitoring. Pt was discharged from ED in stable condition.
49 2021-04-08 itchy skin, bruising, rash After 1st shot (Feb 11) - 5 days after, I started vomitting and running a fever for 2 days, my stoma... Read more
After 1st shot (Feb 11) - 5 days after, I started vomitting and running a fever for 2 days, my stomach was upset until the second shot After 2nd shot (March 4) - 2 days post shot, I started excessive itching - after 11 days, and trying various antihistamines - the bruising and rashing from itching covered my entire body. I started jaundice on March 17, this continued to worsen and is still present.
49 2021-04-13 rash Anaphylactic Reation. everything swelled and rash appeared, couldn't swallow, throat constricting. ... Read more
Anaphylactic Reation. everything swelled and rash appeared, couldn't swallow, throat constricting. Epinephrine injection, Racepinephrine, diphenhydramine methlprednisolone, famotidine Day after feel like run over by a truck and nausea, feel sick, headache, joint pain not sure how long everything will last or if more will appear
49 2021-04-22 rash All this on the right side of the body. Injection site was on the right arm. Dizziness and weaknes... Read more
All this on the right side of the body. Injection site was on the right arm. Dizziness and weakness, swollen/painful lymph nodes (axillary, cervical, epitrochlear, under jawline and chin). Parotid gland swollen and painful. Entire right arm swollen with rash, Right check swelled. Right ear pain.
49 2021-04-24 vaccination site pain she thought she had a blood clot; maybe it is MS (multiple sclerosis); possible septal infarct; weak... Read more
she thought she had a blood clot; maybe it is MS (multiple sclerosis); possible septal infarct; weakness in her left arm; losing her balance; vaccine was given up high on her arm, not 2 fingers down. She thought they had hit bone; less range of movement in her left foot; trouble walking; like someone who had a stroke; numbness; legs felt heavy climbing stairs; immediate pain when needle went all the way in and worse when vaccine went in; pain in shoulder joint; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Ep6955), dose 1 via an unspecified route of administration, administered in Arm Left on 25Mar2021 18:00 (at the age of 49years) as single dose for Covid-19 immunization. The patient is not pregnant at the time of vaccination. Medical history included anemia that is treated, living kidney donor, gastric bypass in 1999, gallbladder removal, hysterectomy, intussusception x2, migraines, high heart rate, and smoking. Concomitant medications included omeprazole (OMEPRAZOLE), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), and albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]); all taken for an unspecified indication, start and stop date were not reported. The patient previously received Flu vaccine and Tetanus vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. She got the shot on 25Mar2021 on Thursday evening at 1800. She is 49 years old and has had all the flu shots and tetanus shots. She has never had one hurt so bad. She stated that the vaccine was given up high on her arm, not 2 fingers down. She thought they had hit bone. It was reported that the patient experienced immediate pain when needle went all the way in and worse when vaccine went in. The whole time it hurt really bad and her arm hurt severely for 2 days from 25Mar2021. She still has pain in shoulder joint. That aside wasn't a big deal, it went away even though the joint is sore. The following Monday 29Mar2021 in the evening, her legs felt heavy and she had trouble going up the stairs. Then she had complete numbness of her left leg, from her hip or butt crack to the tip of her toes. It was on the same side she had the shot. It was further reported that the patient's legs felt heavy climbing stairs then she woke Thursday morning with her left leg numb. She couldn't feel herself starting to have a bowel movement because the numbness went all the way up to that area. She went to the ER (emergency room) on Saturday night (03Apr2021) because she was afraid of a blood clot. An ultrasound was done on her left leg, CT of head and neck, and blood work with nothing found. She has numbness and less range of movement in her left foot with trouble walking and have had no improvement with calf being numb. It was further clarified that when she was Easter shopping, there was numbness in her foot was causing her to drag her foot around the store. It was like someone who had a stroke, with slight impairment on one side. Her foot slaps the floor. She doesn't have control of it, she can't flex her foot up and down at all and she has little movement in her toes, even now. When she went to the emergency room, she thought she had a blood clot. She is a kidney donor and is healthy over all except for anemia that gives her tingly toes since she was 30, off and on. She never had a body part felt so numb, other than when she sits on her leg wrong. They did a bunch of tests there. They did a doppler, CT scan, and an EKG (unspecified date) which was abnormal. Her EKG has never been abnormal before. It said possible septal infarct undetermined time. The doppler showed no deep or superficial blockages noted from her groin down to her toes/ankle. The doppler was to check for blood clots. They referred her to her primary care provider who said that she will do a neurological exam. She has weakness in her left arm as well. The weakness in her left arm was only told by the neuro touch test. The patient further clarified that she doesn't have less range of motion, it is really just pain (arm). She can still move her arm all the way. Her left side is weaker or less sensitive as far as the neuro test. She wasn't aware she had less feeling on her arm until the nurse said she did. Her arm pain is nothing significant, it can hurt when moving her arm. She had no leg pain or anything like that until later in the week. She still had symptoms of losing her balance. Getting in and out of the chair she almost fell down. She didn't realize the numbness. Monday, she felt heaviness going up the stairs. For 2 days she had the worst pain ever in her arm. She had the tetanus shot and didn't have anything like that. It went away, when she raises her arm off from the side, she still has pain in the joint. She has migraines, it is nothing that is causing difficulty. She is more concerned something else happened. Patient thought maybe it is MS (multiple sclerosis) and asked if it is peripheral artery disease. She did smoke half a pack every other day. She is 49 but didn't start smoking till she was 36. It is a terrible habit and her doctor is aware. She also had her good and bad cholesterol which was just over 100. She is just reporting it because it happened on only the left side and she is a healthy person. She never had high blood pressure and never been treated for it, but she has had high heart rate before. It is not something that has ever caused any issue. She doesn't have something like peripheral artery disease, when she (software company name withheld) that is said plaque in the arteries. The doppler showed no signs of blockage superficial or deep on that side. She doesn't have an appointment until 29Apr2021. She doesn't know what to do to get more urgent care. The pain in her arm was better after the first 2 days. It is like a tooth ache, a dull ache. It is not all the time, just when moving her arm. Her legs were worse to where Thursday, she woke, and she was numb from the top of her leg to the tip of her toe. She can still lift her leg, but when she walks the tip of her second toe which is longer will drag on the ground. When she walks it is hard to hold her shoe on the left foot or put her shoe on. She can't maneuver her foot. When her foot hits the ground, the ball area of her foot smacks the floor because she doesn't have control over it. It is laboring to walk and is hard. She was kind of limping and pulling that leg on the left side. Her laboratory tests were BMP, CBC auto diff, CBC with diff, CT, angiogram of the head and neck, EKG 12 lead, and they did a venous doppler of the left lower extremity. It all came back good except the EKG which says septal infarct undetermined date, which has never come up on any tests before. The events resulted in Emergency room/department or urgent care, Disability or permanent damage. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered.
49 2021-04-26 rash About 3 to 4 days after injection,I noticed swollen nodes under my left(injection arm); Rash on left... Read more
About 3 to 4 days after injection,I noticed swollen nodes under my left(injection arm); Rash on left,Rash worsened on my left arm expanded to my torso, right arm and legs; This is a spontaneous report from a contactable Other health care professional. A 49-year-old female non-pregnant patient (Other HCP) received first dose BNT162B2 (Pfizer Covid vaccine, Solution for injection, Lot number: EN5318) via an unspecified route of administration in arm left on 06Feb2021 11:00 AM at single dose for COVID-19 immunisation. Medical history included Hashimoto's thyroiditis. Concomitant medications included Levothyroxine, vitamin D (COLECALCIFEROL). No covid prior vaccination and no covid tested post vaccination. On 10Feb2021, the patient reported that about 3 to 4 days after injection, patient noticed swollen lymph nodes under her left arm (injection arm) and rash on left arm. Rash worsened on patient left arm, expanded to her torso, right arm, and legs. The patient received treatment for the events via unspecified treatment medications as anti-itch meds, antihistamine and steroid pack. The outcome for the events was not recovered.
49 2021-04-26 shingles, sensitive skin, rash, itchy skin Around 4/20/2021 developed itching along left jawline. Progressed to rash and bumps along left jawl... Read more
Around 4/20/2021 developed itching along left jawline. Progressed to rash and bumps along left jawline/chin and rash and bumps above left temple near left eye (this area was sensitive). Itching continued and worsened. 4/23/2021 had telehealth visit - suspected shingles and was started on Valtrex 1,000mg three times daily. By 4/25/2021, rash had mostly resolved along left jaw/chin and above temple near left eye ..still some slight itching (but improved). By 4/26/2021, rash, bumps and itching nearly completely resolved.
49 2021-04-28 injection site warmth, injection site redness, injection site nodule, injection site pruritus, injection site swelling 04/24/21 FIRST DOSE , SHE NOTICED A SM NODULE A THE SITE OF VACCINE ON L UPPER ARM... on 4/25/21 IT ... Read more
04/24/21 FIRST DOSE , SHE NOTICED A SM NODULE A THE SITE OF VACCINE ON L UPPER ARM... on 4/25/21 IT WAS A SIZE OF A SM GOLF BALL, IT IS RED, WARM AND ITCHY. 04/26- The size has grown to nearly a tennis ball and its puffy. She has taken Advil - 200 MG ( 2 tabs ) and Benadryl cream.
49 2021-04-28 itchy skin This is a spontaneous report from a contactable consumer reporting for a patient. A 49-years-old fem... Read more
This is a spontaneous report from a contactable consumer reporting for a patient. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 11:00 (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation, at 49 years old at other facility type. The patient is not pregnant at time of vaccination. Medical history included allergies to Rosemary from an unknown date. No other vaccine in four weeks were noted. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC); propranolol hydrochloride (INDERAL); lorazepam (ATIVAN); hctz; quetiapine fumarate (SEROQUEL); gabapentin taken for an unspecified indication, start and stop date were not reported. The patient previously took macrobid [nitrofurantoin] and experienced allergies. The patient previously received the first dose of BNT162B2 (Lot number: ER8727) on 17Mar2021 13:00 (left arm) for COVID-19 immunisation. On 10 Apr2021, the patient experienced Itchy palms (reported as within hours), tachycardia, tightness in chest, difficulty breathing, tingling tongue and fingers, vomiting, confusion, dizzy, fainting, abdominal pain, severe pain everywhere, too fatigued to move. Patient tried to call ambulance but could not get phone or unlock the door. She stated she tried from 1 AM to 07:30 AM. After 07:30 AM she had expected effects of fever as well as fatigue and pain. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment was not given. Outcome of the events was recovered on an unspecified date.
49 2021-04-30 itchy skin, redness, rash macular, rash Allergic reaction; itching from head to toe; rash; broken vessels in cheeks, turned red; difficulty ... Read more
Allergic reaction; itching from head to toe; rash; broken vessels in cheeks, turned red; difficulty breathing; arm went numb; was not feeling good; blotchy; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in right arm on 25Mar2021 14:30 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were none. No prior vaccinations within 4 weeks. The patient experienced itching from head to toe on 25Mar2021 with outcome of not recovered, rash on 25Mar2021 with outcome of not recovered, broken vessels in cheeks, turned red on 25Mar2021 with outcome of not recovered, difficulty breathing on 25Mar2021 with outcome of recovering, allergic reaction, arm went numb, was not feeling good and blotchy on 25Mar2021 with outcome of unknown. The events itching from head to toe, rash, broken blood vessels in cheeks and difficulty breathing require a visit to Emergency Room. No relevant tests. Clincial course reported as follow: Patient received her first dose 25Mar2021 and within 3 hours she was in the Emergency Department. She had an allergic reaction. She has had itching and rash since receiving the shot. The allergic reaction wasn't even 5 minutes of getting the shot her arm went numb and she thought she's in trouble and was this normal. She asked people running the clinic and asked if this was normal and they said no never heard of that. After that itching started. Itching started at her head and moved to her face and then her entire body. She had a rash on her face, neck and chest. The blood vessels broke in her cheeks. She knew she should have some diphenhydramine hydrochloride (BENADRYL) and the emergency department didn't have any there. The staff made her wait for 30 minutes after her injection. She was not feeling good. It was hard for her to take a deep breath, and to catch her breath after 30 minutes of waiting there. Then she drove herself to store and got diphenhydramine hydrochloride, and drove herself home, she was not feeling any better and took the diphenhydramine hydrochloride. She called her doctor's office. It was like an hour after the shot and she told them at the doctor's office she was blotchy, itchy, and having trouble breathing. She talked to the nurse and was advised she must got to the Emergency Department. The nurse told her that the staff should not have let her leave the facility where had shot administered and should have called an ambulance and did not. The staff did not even have diphenhydramine hydrochloride. She went to the Emergency Department and she was still itchy. It had been since 25Mar2021. The rash was mainly on both sides of her neck and under her ears. It comes and goes. She confirmed outcome as persisting. The broken vessels, turned red, under her eyes were no better. She would get spells of difficulty breathing. She couldn't get a deep breath for about a week after the shot and it has gotten better. No follow-up attempts are needed. No further information is expected.
49 2021-04-30 vaccination site pain, pain of skin Felt weakness and lethargic all day long; developed neck pain on the same side as injection. Day aft... Read more
Felt weakness and lethargic all day long; developed neck pain on the same side as injection. Day after injection (Saturday), neck pain was severe; severe major joint pain; Also, muscle and skin pain all over my body; Also, muscle and skin pain all over my body; Overall feeling of malaise; Felt weakness and lethargic all day long; Sites of previous injuries from years earlier that had healed and presented no pain prior to injection, hurt more than other joints did; The day of the injection (Friday), pain at sight was very strong.; That night, developed deep cough that sounded and felt like someone with fluid in the lungs (although had no prior symptoms); That night, developed deep cough that sounded and felt like someone with fluid in the lungs (although had no prior symptoms); This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 26Mar2021 (Batch/Lot Number: ER8732) as single dose in left arm at the age of 49-year-old for COVID-19 immunisation, administered at healthcare facility. Medical history included Heterozygous Factor 5 Leiden, narcolepsy, total knee replacement 13 months before in 2020, arthritis, chronic low vitamin D levels, sites of previous injuries from years earlier that had healed. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously received Effexor and experienced drug hypersensitivity. The past vaccination history included the 1st dose of bnt162b2 (Lot number EN6199) as single dose in left arm on 05Mar2021 for COVID-19 immunisation. No other vaccine in four weeks. On 26Mar2021 03:45 PM, the day of the injection, pain at sight was very strong. That night (26Mar2021), developed deep cough that sounded and felt like someone with fluid in the lungs (although had no prior symptoms), and also developed neck pain on the same side as injection. On 27Mar2021, day after injection, neck pain was severe, and developed severe major joint pain throughout body. Also, muscle and skin pain all over my body. Overall feeling of malaise. Sites of previous injuries from years earlier that had healed and presented no pain prior to injection, hurt more than other joints did. Felt weakness and lethargic all day long. All of these symptoms were gone by 28Mar2021 except for the neck pain which remained sever for 10 days, but has subsided slightly more for the last 5 days leading up to today (still suffering from neck pain today). No treatment received. Covid was not tested post vaccination. The outcome of pulmonary edema, cough, vaccination site pain, lethargic, joint pain, muscle pain, skin pain, malaise and weakness was recovered on 28Mar2021, of neck pain was not recovered. No follow-up attempts are needed. No further information is expected.
49 2021-04-30 vaccination site rash, itchy rash, rash her symptoms started as a couple of dots at the injection site; The rash started growing all over he... Read more
her symptoms started as a couple of dots at the injection site; The rash started growing all over her body; Rash growing all over body was worsened; It is still burning and itching; It is still burning and itching; Neither of them can sleep; This is a spontaneous report from a contactable consumer (Patient husband) via Medical Information Team. A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot# unknown), via an unspecified route of administration on 01Apr2021 (at the age of 49-years) as single dose for COVID-19 immunisation. It was reported that the patient received vaccine 22 days ago. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, patient experienced symptoms that started as a couple of dots at the injection site that got worsen and started growing all over her body, it is still burning and itching, neither of them can sleep. There is no relief for her rash even after ten days. Patient visited the emergency room four times and has been to her primary doctor and her pain management doctor where she received six different prescriptions, of which three are from a hospital which prescribed over-the-counter medicine and asked to come back after seven days. But nothing helped and the rash is still growing like poison ivy. Reporter described that patient back looks like the surface of Mars as seen on a television channel. Nothing else was different in her diet or medications outside of the vaccine. Later, patient visited another hospital where she was prescribed with another medication. Patient received treatment with an unspecified intravenous (IV) medication which helped her to sleep. Reporter stated that none of the medication helped except the IV medication, considered so because it helped her sleep. Reporter was upset and thought that Pfizer vaccine gave the patient that rash. The outcome of the event insomnia was recovered and the outcome of the event condition aggravated was unknown while for all the other events, it was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
49 2021-05-02 rash macular, injection site redness Saturday 4/1: Extremely tired around 1:00 pm quarter-size redness around shot site Sunday 4/2: lime... Read more
Saturday 4/1: Extremely tired around 1:00 pm quarter-size redness around shot site Sunday 4/2: lime size redness around shot site, spotty rash down inside of arms, torso, groin, headache in the afternoon
49 2021-05-03 injection site pain 1st Vaccine shot-FRI APR 23, 0900 9hrs later, shot area sore, next morning SAT approx 330am woke up ... Read more
1st Vaccine shot-FRI APR 23, 0900 9hrs later, shot area sore, next morning SAT approx 330am woke up to migraine that lasted till noon SAT. Afternoon fatigue /tired / dizzy; *started weezing , nose felt stuffy-took 1 puff inhaler. Sun 25- breathing normal, no inhaler, but by mid day both hands-ALL fingers tight / stiff/ bones sore - pain lasted approx 1 day, stiffness in joints lingering. Mon 26- bone joint / stiffness somewhat subsides, constant Left hip bone pain, intermittent heat sensation / like hot flashes- ongoing until current. May 2-3-weezing is back, stuffy nose - 1 puff inhaler per day. May 3- approx. 0500am bright red blood found in stool. Stool normal size / color, blood in feces, no blood when I wipe. No odd smell, no difficulty in moving bowls, no stomach pain. Appetite & sleep pattern is normal, no fever.
49 2021-05-03 rash, redness, dry skin, skin peeling I have ha-mrsa and the skin had a rash; Left arm swollen and red; Left arm swollen and red; I have h... Read more
I have ha-mrsa and the skin had a rash; Left arm swollen and red; Left arm swollen and red; I have ha-mrsa and the skin had a rash; Cellulite looking swelling and now skin extremely flaky and dry; Cellulite looking swelling and now skin extremely flaky and dry; Cellulite looking swelling and now skin extremely flaky and dry; This is a spontaneous report from a contactable consumer reporting for herself. A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 09Apr2021 at 17:30 (at the age of 49 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 17Mar2021 at 04:30 PM (at the age of 49 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included HA-MRSA/asthma, and had known allergies: sulfa. The patient was not pregnant at the time of vaccination. Concomitant medication included amoxicillin and doxycycline. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Apr2021 at 08:00, the patient reported she has ha-mrsa and the skin had a rash, Left arm swollen and red, Cellulite looking swelling and now skin extremely flaky and dry. The patient did not receive treatment for these events. The outcome of the events was not recovered. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
49 2021-05-04 skin burning sensation Developed unilateral neuropathic pain in one thigh, progressing to both thighs; posterior arm numbne... Read more
Developed unilateral neuropathic pain in one thigh, progressing to both thighs; posterior arm numbness; skin feels sunburned but no skin findings; lower abdominal burning sensation; This is a spontaneous report from a contactable physician. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 11Jan2021 (Batch/Lot Number: EL3248) as single dose for COVID-19 immunisation. Medical history included diabetes, hypertension, allergies: shellfish. Historical vaccine included 1st dose of BNT162B2 (lot number=59267-1000-1 Lot EJ1685) via intramuscular on left arm on 21Dec2020 for COVID-19 immunization. Concomitant medications included semaglutide (OZEMPIC), atorvastatin, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) and enalapril, all taken for an unspecified indication, start and stop date were not reported. Patient developed unilateral neuropathic pain in one thigh, progressing to both thighs. Patient also had posterior arm numbness, skin feels sunburned but no skin findings, also now with lower abdominal burning sensation. The events onset on 22Jan2021. Patient received treatment for the events included prednisone. The events result in doctor or other healthcare professional office/clinic visit. Outcome of the events was not resolved. Follow-up attempts are completed. No further information is expected.
49 2021-05-04 hives I was pretty much covered in hives; This is a spontaneous report from a contactable consumer (patien... Read more
I was pretty much covered in hives; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/Lot Number: EL9264) via an unspecified route of administration on 02Feb2021 as single dose for covid-19 immunization. The patient was 49-years-old at the time of vaccination. The past medical history and concomitant medications were not reported. On 05Feb2021 the patient experienced i was pretty much covered in hives, therapeutic measures (took Benadryl) were taken as a result of i was pretty much covered in hives. The patient wondering, she got the vaccine on Tuesday night and she was doing fine and last night at 2 o' clock or 2:30 in the morning, she woke up and she was pretty much covered in hives, when she looked on her paperwork, said that, that could happen but like usually within an hour of vaccine. So, she was wondering if that could still be the side effect of the vaccine." When paraphrased the concern, consumer stated, "No, not two nights later, it was last night." (clarified as 5Feb2021). The outcome of event was recovering. Follow-up attempts are completed. No further information is expected.
49 2021-05-07 redness 2 weeks after vaccine noticed pain; Swelling; Tenderness; redness; lump on left leg; Superficial clo... Read more
2 weeks after vaccine noticed pain; Swelling; Tenderness; redness; lump on left leg; Superficial clot and other DVT clot found; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female consumer received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), from lot ew0153 as single dose via unknown route at the left arm on 06Apr2021 11:30, at the age of 49 years, for COVID-19 immunization. The patient was not pregnant. Medical history included, in 1996 while on oral contraceptives had a blood clot in left leg. Prescribed Coumadin for year. Went off, bad leg swelling occurred. Prescribed compression stocking. Genetic test discovered Factor V Leiden mutation heterozygous. Since 1996-1998, have had bad swelling in left leg but no further clotting. Last time ultrasound was needed to confirm leg was just bad swelling was approximately 2007. No other clotting since around 1996-1998. Concomitant medications were not reported. On evening 20Apr2021, 2 weeks after vaccine, noticed pain, swelling, tenderness, redness and lump on left leg. Went to doctor on 21Apr2021. Ultrasound performed. Superficial clot and other DVT clot found. Prescribed Xarelto. The outcome of the events was reported as recovering. No covid prior vaccination and the patient was not tested for covid post vaccination.
49 2021-05-11 bruising, redness bruising with blood under the skin; scratched right leg and it bled profusely; scratched right leg a... Read more
bruising with blood under the skin; scratched right leg and it bled profusely; scratched right leg and it bled profusely; Low grade fever; Face, Neck and Ears turned bright red; headaches; fatigue; This is a spontaneous report from a contactable healthcare professional. A non-pregnant 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 intramuscular, administered on right arm on 22Apr2021 10:30 (Batch/Lot Number: EW0169) as 2nd dose, single (at the the age of 49 years old) for covid-19 immunisation. The patient medical history was not reported. allergies: Tetanus, metronidazole. Concomitant medications included levonorgestrel (I PILL) taken for an unspecified indication, start and stop date were not reported. The patient previously took tetanus (TETANUS TOXOID) and metronidazole and experienced known allergies; BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered on right arm on 01Apr2021 12:00 PM (Batch/Lot Number: R8733) (at the the age of 49 years old) for covid-19 immunisation and no reaction on previous exposure to drug. The patient experienced low grade fever on 27Apr2021. Face, Neck and Ears turned bright red, headaches and fatigue on 23Apr2021. Day 4 after injection (26Apr2021), scratched right leg and it bled profusely, with difficulty stopping the bleeding. Day 5 after injection (27Apr2021), had blood drawn from left hand with butterfly needle. When it was removed immediate bruising with blood under the skin, larger then a half dollar coin. Hospital added to check platelet count specimen order. The patient stated that this is very abnormal for her. Prior to vaccination, was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. It was unknown if the patient received treatment for the events. The outcome of the events was unknown. No follow up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
49 2021-05-13 rash papular, vaccination site itchiness site of where she got injected got infected and she was diagnosed with Cellulitis/ arm pain; rash is... Read more
site of where she got injected got infected and she was diagnosed with Cellulitis/ arm pain; rash is mostly on her shin, on that part of her body, and goes up her leg. It is like little raised bumps; injection site itchy; scratching so much like she would scratch her skin off; scratching so much like she would scratch her skin off; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration (at the age of 49-years-old), administered in Arm Left on 06Apr2021 12:00 (Batch/Lot Number: Unknown) as 1st dose, single for COVID-19 immunization. Medical history included cellulitis from a bug bite in a different location. The patient's concomitant medications were not reported. The patient initially stated she had an allergic reaction, then clarified to reaction. She had this reaction three weeks to the date of the first shot. She had to go Urgent Care. The site of where she got injected got infected and she was diagnosed with Cellulitis. Her injection site is all red and infected, it is like a rash there. She further explained she is unsure if this is an allergic reaction, but she has a rash, it is itchy. Her injection site is tender, itchy, warm, and red. She was given antibiotics to take. She does not have her primary care doctors address to provide at time of call. She further clarified today is like the 3rd or 4th day of having a rash, later clarified the start as 24Apr2021. The rash is mostly on her shin, on that part of her body, and goes up her leg. It is like little raised bumps. In the middle of the night she found herself scratching so much like she would scratch her skin off. The rash on her arm feels different. There is site pain there, but it also itches. It feels hard like she just got the shot in the arm. She feels like she wants to scratch and there are bumps there. Time of onset of rash in arm was started mid-afternoon. The arm pain started as clarified 26Apr2021. She confirmed she still feels the arm pain. It is bothersome. She wants to itch it. She does not think it is has gotten worse. However, she just started the antibiotics. Time of onset of arm pain was middle of the night. She went to urgent care yesterday and was officially diagnosed with cellulitis yesterday, 27Apr2021. Treatment included an antibiotic and antihistamine, but she does not have the name to provide. She scheduled an appointment to see the doctor when she gets back home. Sure he will do testing/blood work. The outcome of the events was unknown. The event "site of where she got injected got infected and she was diagnosed with Cellulitis" was considered as serious (medically significant). No history of all previous immunizations with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. She was supposed to get the second shot yesterday, but she did not due to everything going on. She wants to know if she should see her doctor before getting the second vaccination. She stated she is not comfortable with getting the second dose. If she wanted to get the second dose wanted to know what the window of opportunity was to get the second dose. Information on the lot/batch number has been requested.
50 2020-12-31 injection site pain Extreme tiredness started 30 minutes after vaccination into the day after. Chills, pain at the injec... Read more
Extreme tiredness started 30 minutes after vaccination into the day after. Chills, pain at the injection site, headache, tiredness day after vaccination. Took Motrin 600 mg which relieve headache.
50 2020-12-31 rash with redness, rash, hives, itchy skin I did immediately feel some slight dizziness but I also ad worked all night and was exhausted. I was... Read more
I did immediately feel some slight dizziness but I also ad worked all night and was exhausted. I was driving home and did become itchy and developed a couple of small hives that quickly went away. The main event that I am reporting is a severe outbreak of eczema. I used to get it on my hands as a child and it was caused by citrus. On the morning of 12/24, I noticed itching and a red rash starting on my right wrist and my left hand. I thought perhaps it was from over washing or not rinsing all of the soap off. The rash became worse and I noticed a small area above my lip on the left side, I then developed a large area on the right side of my lower face. There were also a few spots elsewhere but these were the worst.
50 2021-01-03 itchy skin 35 minutes after administration of vaccine, patient started to experience itching on the right palm ... Read more
35 minutes after administration of vaccine, patient started to experience itching on the right palm and shortly after the left palm which was resolved by taking 25 mg of benadryl
50 2021-01-03 skin discolouration, rash After receiving the vaccine, my arm was in a lot of pain. Then that night and the next day, it was e... Read more
After receiving the vaccine, my arm was in a lot of pain. Then that night and the next day, it was extreme pain, I couldnt lay on it. Then about 3-4 days later, the color is blue and black. Then I started having cold symptoms. Like a head cold. On my left side, my arm and my leg is sore. In addition, my face broke out too. I did not go to the ER. I let Employee health examine my arm . No ER visit
50 2021-01-03 itchy skin Approximately 35 minutes after administration of vaccine, patient experienced itching on right palm ... Read more
Approximately 35 minutes after administration of vaccine, patient experienced itching on right palm then after a while to the left palm which resolved by taking 25 mg Benadryl
50 2021-01-03 injection site pain Constant and severe Pain from injection site traveling all the way up my arm and into my neck.
50 2021-01-03 skin warm Pfizer-BioNTech COVID-19 Vaccine EUA. Vaccine received at 11:40 AM. At approximately 9pm I began to ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA. Vaccine received at 11:40 AM. At approximately 9pm I began to experience whole body chills, teeth chattering, and extreme fatigue. I took Ibuprofen and went to sleep. I experienced chills until approx 3 AM. My watch alerted my heart rate rose above 120 bpm three separate times during the night in the 1, 2 and 3:00 hours. Upon review of the summary it appears to have been sustained at just over 120 for that entire time. I awoke at noon, with a temp of approx 99.5 F, I felt extreme fatigue and a sense of cold but body was warm to touch and I was very sweaty this entire time. I slept most of the day and at 5 pm awoke with a temp of 102.4F. I contacted my physician who directed me to use tylenol and Benadryl. I took a dose at 5 pm, anther at 9 PM. Upon waking the next morning I was afebrile. At that time I felt slightly dizzy and lightheaded but also dehydrated. Forcing fluids relieved symptoms. I experienced a very mild headache and very mild queasiness as well.
50 2021-01-03 hives Pt developed urticaria on both arms 4 hours after COVID vaccine administration. Pt received dexameth... Read more
Pt developed urticaria on both arms 4 hours after COVID vaccine administration. Pt received dexamethasone 10mg IM for treatment and diphenhydramine PO 25 mg. Symptoms subsequently resolved.
50 2021-01-03 itchy skin, hives dizziness, itching/small hives on forearm (not at injection site) , 30 minutes after vaccine given. ... Read more
dizziness, itching/small hives on forearm (not at injection site) , 30 minutes after vaccine given. Vitals monitored, were normal, sent home and advised to take Benadryl. More hives on upper lip/chin appeared 36 hours after vaccine given. Patient was at home, self-treated with benadryl, zyrtec, famotidine and ice pack applied to area.
50 2021-01-04 bruising 2 days later, noted patches of bruising in the right lower leg near ankle, posterior calf, lateral c... Read more
2 days later, noted patches of bruising in the right lower leg near ankle, posterior calf, lateral calf, left lower leg in the medial aspect, right tibial tubercle area, left medial knee, right distal forearm, left wrist underneath her watch, posterior olecranon processes, posterior proximal humerus bilaterally. No bruises in the trunk, back, face or neck. She started Plavix treatment with Cardiologist 12/28/20. Cardiologist, Hospital physician.approved her to get the COVID vaccine. She will call her Cardiologist and let us know what course of action resulted. She could just be bruising from mild trauma that she is unaware of since Plavix is a new med for her. States she does cross her legs when she sits and leans on her elbows. Shoulder bruising seems to be where she lays when in bed.
50 2021-01-04 itchy skin 8:31 Reported to us increased heart rate and tingling lips. Stated she had several allergies and bro... Read more
8:31 Reported to us increased heart rate and tingling lips. Stated she had several allergies and brought her epi pen with her. Brought her to EMS station. 8:32 Gave epi 8:35 HR126 SPO2 100% 8:38 IV placed 8:39 POC 108 8:39 Benadryl 50mg IV push 8:40 Solumedrol 125 mg IV push Continued tongue/throat/ head itching 8:42 second epi given 8:46 136/64 HR 125 8:48 Transported to Medical Center via EMS
50 2021-01-04 vaccination site pain Chills; Muscle ache; Headache; Did not feel well in general; Right arm soreness in the same arm that... Read more
Chills; Muscle ache; Headache; Did not feel well in general; Right arm soreness in the same arm that the COVID vaccine was given; It was hard to lift her arm and woke her up when she was sleeping; It was hard to lift her arm and woke her up when she was sleeping; This is a spontaneous report from a contactable consumer (patient, occupation: Respiratory Therapist). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on 22Dec2020 11:00 (reported as Approximately 11am in the morning) at single dose to help stop the spread of COVID. Location of the COVID Vaccine: Right arm. There was no additional Vaccines Administered on Same Date of the Pfizer Suspect. There were no prior Vaccinations with 4 weeks. Medical history included she had tested positive for COVID on 02Oct2020. The patient did not have any illness at time of vaccination. Family Medical History Relevant to adverse event also reported as none. There were no concomitant medications. The patient previously had flu vaccine given at the hospital she works at and She had mild arm soreness after the Flu vaccine. The patient experienced Right arm soreness in the same arm that the COVID vaccine was given on 22Dec2020, Chills on 23Dec2020, Muscle ache on 23Dec2020, Headache on 23Dec2020, did not feel well in general on 23Dec2020. Caller reported that she experienced right arm soreness, in the arm she received the vaccine, that was unlike any other vaccine she had ever had. The arm soreness began the same evening as the day she received the COVID vaccine. It was hard to lift her arm and woke her up when she was sleeping in Dec2020. The remainder of the side effects began the following morning after she had received the COVID Vaccine. Other side effects included chills, which lasted until the 24th or 25Dec2020. Muscle aches, which lasted until the 24th or 25th Dec2020. Headaches, which she is still getting off and on, but it is hard to say if the headaches that she is still getting is still from the COVID vaccine. The headaches are coming less often. She has had to take something for the headaches. Caller stated that she did not feel well, in general. Asked caller what other vaccines she had received and had experienced arm soreness but not to the extent she had after the COVID Vaccine and caller stated that she had mild arm soreness after the Flu vaccine. Previous flu vaccines had been given to her at the hospital she works at; therefore, she did not have any lot number information for these flu vaccines. The reported adverse events did not require a visit to Emergency Room and Physician's office. The patient was not hospitalized. The outcome of event Right arm soreness in the same arm that the COVID vaccine was given was recovered on 26Dec2020, the outcome of the event Chills, Muscle ache was recovered in Dec2020, the outcome of the event did not feel well in general was recovered on 25Dec2020. The outcome of the event Headache was recovering. The outcome of the other events was unknown. The causality assessment for events Right arm soreness in the same arm that the COVID vaccine was given, Chills, Muscle ache, Headache, did not feel well in general with suspect COVID vaccine was assessed as related by Primary Source Reporter via Method of assessment Global Introspection. Information on the lot/batch number has been requested.
50 2021-01-04 rash with redness, rash Red face rash morning of 2 days following vaccine Dull headache, day of vaccine
50 2021-01-04 rash allergic reaction; had been a little sick since she had it; she really felt bad; weak; rash on her l... Read more
allergic reaction; had been a little sick since she had it; she really felt bad; weak; rash on her legs/ rash all over her; Fever/ feverish; a fast heart rate that comes and goes; Hasn't felt good; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm on 21Dec2020 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were reported as none. She indicated she received vaccine on 21Dec2020 and noticed a rash on her legs in the shower on 24Dec2020. She hadn't felt good since done on 21Dec2020. She had a rash all over her, didn't realize when went back and read a paper, said a bad rash all over body, what should she do, take a Benadryl. She stated the health department gave the vaccine. She had been a little sick since she had it. Tuesday was really bad, all day on Tuesday, she really felt bad. She woke up with a rash at the time of the report on 24Dec2020, she thought she had a fever, but didn't check, that was last night and this morning, but at the time of the report she didn't think she had a fever. The rash, she was covered in a fine rash all over her body, she had thought it had happened with an allergic reaction immediately. When asked for outcome of not feeling good, stated she felt ok, it was just the rash, that was what she was most concerned about, stated she did have a fast heart rate that comes and goes on 21Dec2020. When she awoke this morning, she was just weak, and feverish, she didn't take her temperature, she should have, but she took a shower a few minutes and saw the rash, thought it was probably all combined. Stated her card said on 11Jan2021, she should take the second dose, and wanted to known should she take it if this is all connected. The patient had tested positive for COVID antibodies on an unspecified date. The outcome of the events "rash on her legs/ rash all over her" and "Fast heart rate" was not recovered, while other events were unknown.
50 2021-01-04 rash body aches; decreased appetite; cotton mouth; everything tastes metallic and it's kind of hard to ex... Read more
body aches; decreased appetite; cotton mouth; everything tastes metallic and it's kind of hard to explain it very well; change of sense of taste; loss of taste; body rash on upper torso only described as "not bad" and "not itchy" or bothersome; low grade fever 100.3; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of BNT162B2 (lot number: EH9899), via an unspecified route of administration in left upper arm, on 21Dec2020 06:30 AM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital.The patient's weight was 67.13 kg and height was 173 cm. The patient's medical history included nausea and flu like symptoms. Concomitant medications included omeprazole(PROTONIX) from Dec2020 at 40mg once a day for nausea. The patient stated that a week before she received the vaccine she had flu like symptoms and she was tested for COVID-19 and the test result was negative in Dec2020. The patient experienced low grade fever 100.3 which started in the evening of the vaccine(21Dec2020) and she took Tylenol and went to sleep and the next day felt better, which resolved by the next day(22Dec2020). The patient experienced body aches on an unknown date, body rash on upper torso only described as "not bad" and "not itchy" or bothersome which started on 21Dec2020(a few hours after receiving vaccine) and resolved on 23Dec2020. The patient experienced change of sense of taste, "everything tastes metallic and it's kind of hard to explain it very well" on 24Dec2020. The patient experienced loss of tastewhich started on either 23Dec2020 or 24Dec2020. She was starting to be able to taste. She has anything it is bland. She can taste some saltiness. That started coming back on approximately Saturday, 26Dec2020. The patient experienced decreased appetite, "cotton mouth" on an unknown date. The outcome of the events "low grade fever 100.3", "body rash on upper torso only described as "not bad" and "not itchy" or bothersome", "loss of taste" was recovered and of other events was unknown.
50 2021-01-04 rash, redness day of vaccine: dull headache for the majority of the day (I don't typically get headaches) 2 days ... Read more
day of vaccine: dull headache for the majority of the day (I don't typically get headaches) 2 days after vaccine: minor bilateral rash on face - both cheeks red, slightly raised bumps, no itching or pain, lasted for about 24-36 hrs
50 2021-01-04 bruising fair amount of bleeding after the needle was removed; good size bruise; This is a spontaneous report... Read more
fair amount of bleeding after the needle was removed; good size bruise; This is a spontaneous report from a contactable physician (patient). A 50-year-old female patient started to received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. Other products, patient history and investigation assessment was No. There were no concomitant medications.She provided her weight as 140, 142, or 143 lbs. After administration of the COVID 19 vaccine there was a fair amount of bleeding after the needle was removed. It could have been the administration process. Another resident here had the same experience, but she was unsure if the resident received the Pfizer of Moderna vaccine. This was day 5 and the caller still had a bruise. The current caller said she developed a good size bruise, and she didn't bruise easily. She didn't have a prescribing doctor. She got it at the city hospital, where she worked. She was not on anticoagulants. She had not taken aspirin or Motrin. The outcome of the event bruise was not recovered, of other event was unknown.
50 2021-01-04 itchy skin, hives hives in her chest and neck; Her neck and chest were itchy; had a headache and was tired; had a head... Read more
hives in her chest and neck; Her neck and chest were itchy; had a headache and was tired; had a headache and was tired; This is a spontaneous report from a contactable Other HCP reporting for herself. A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EJ1685), via an unspecified route of administration in the right arm on 23Dec2020 12:00 at single dose for COVID-19 immunisation. Medical history included seasonal allergies to: Ragweed, bees, mold, trees, lots of seasonal things. The patient's concomitant medications were none. On 23Dec2020 the patient had a headache and was tired with outcome of unknown, the patient attributed it to having a stressful day. On 24Dec2020 (between 00:00 and 06:00), she had hives across her neck and part of chest. Her neck and chest were itchy and she had hives the next morning. The patient took diphenhydramine hydrochloride (BENADRYL) for 2 days for hives and was all better. She would like to know if she should get the second dose.
50 2021-01-05 pain of skin . Woke up in the middle of the night with acute facial pain on the left side. From the scalp to the... Read more
. Woke up in the middle of the night with acute facial pain on the left side. From the scalp to the jaw line including the roof of my mouth. I took 3 Advil at the time and the woke again a couple hours later and took 2 more. In the morning it seemed fine. I have noticed a very slight change to my lower left eye - it seems lower.
50 2021-01-05 skin warm, itchy skin, rash, hives Approximately 2 hours post injection, my left arm started to feel warm and itchy. I was wearing a t... Read more
Approximately 2 hours post injection, my left arm started to feel warm and itchy. I was wearing a thick hoodie and when I pulled my sleeve up, it was covered with hives and welts. My lower lip started to feel full and nose started to feel runny. I was close to a pharmacy when I discovered the hives so I went and bought Tylenol and Benadryl and took it immediately. After that, I headed to the emergency room of the facility where I got my covid 19 -Pfizer injection. When I got there, my right arm started to feel itchy as well and I also broke out in a rash on my left upper chest. They gave me a steroid injection and steroid taper prescription. When I got home that night, my right forearm broke out in hives. The next couple of days, my left arm intermittently had hives.
50 2021-01-05 injection site redness, injection site warmth, injection site pain, injection site pruritus, injection site reaction, hives Had welt at injection site the size of golf ball with redness spreading from site out about the size... Read more
Had welt at injection site the size of golf ball with redness spreading from site out about the size of a baseball. Site itched, redness with heat coming out of site for several days. Arm soreness for 5-6 days afterwards. Injection give on 12/22/2020 and today 1/6/2021 there still is soreness at injection site and slight redness of the area.
50 2021-01-05 injection site swelling, injection site pruritus, injection site redness The evening of the vaccine around the injection site exp redness, swelling lasted 3 days went away.... Read more
The evening of the vaccine around the injection site exp redness, swelling lasted 3 days went away. After 10 days the injection site it appeared 3 inches was deep, red and exp itching. I took Benadryl the redness, swelling went away.
50 2021-01-05 injection site pain swelling and tingling in face after waiting 40 minutes of injection. left side of tongue swelling/ w... Read more
swelling and tingling in face after waiting 40 minutes of injection. left side of tongue swelling/ went down chills/fatigues soreness to injection site( which was excepted)
50 2021-01-06 injection site pain, injection site swelling Day after vaccine: Upper back and neck stiffness and ache; injection site swollen/ache; eyes stingin... Read more
Day after vaccine: Upper back and neck stiffness and ache; injection site swollen/ache; eyes stinging; extreme lethargy
50 2021-01-06 injection site swelling, injection site pain MIGRAINE HEADACHE BEGAN ABOUT 2 HOURS POST INJECTION, BODY ACHES BEGAN ABOUT 3:30PM, THROBING PAIN A... Read more
MIGRAINE HEADACHE BEGAN ABOUT 2 HOURS POST INJECTION, BODY ACHES BEGAN ABOUT 3:30PM, THROBING PAIN AND SWELLING TO INJECTION SITE BEGAN AT APPROXIMATELY 10:00 PM. TOOK TYLENOL 500MG AT 1:45pm THEN AGAIN AT 10:30 pm, also applied ice to injection site.
50 2021-01-06 skin swelling, skin irritation, skin burning sensation, redness The patient is a 50 yo female with a history of IBS who reports concerns about Covid vaccine AE. (Pf... Read more
The patient is a 50 yo female with a history of IBS who reports concerns about Covid vaccine AE. (Pfizer EK5730) receipt 16 DEC 2020. She reports no immediate reaction except experienced a dry throat which she noted after her 30 minute wait, but no urticaria, SOB, wheezing, oral/face/throat/tongue edema, flushing, pruritic, CP n/v/d. She states about 3 hours later she developed a dermatitis initially to her legs. The lesions were raised, pink, initially nonpruritic, fixed but no vesicles, pustules or bruising. She took a shower which exacerbated the symptoms with erythematous patches and severe burning sensation. She reports she was seen in ER and her spouse noted lesions to her neck and ears. Her eyes felt swollen. She left ER due to the wait and obtained Benadryl OTC. She saw her PCP in the morning. She received IM dexamethasone and oral prednisone dose pack. She continued to not feel well. She experienced heart palpitations, feeling hot and flushed, fatigue and headache which she treated with Tylenol. She treated the dermatitis with Zyrtec 10-20 mgs q1-2 x daily, but sometimes took Benadryl. Last dose was Benadryl at midnight, Zyrtec 10 at 0600 and has one day of prednisone left. She also experienced bilat tingling in her feet starting day 5. which the left resolved but her right foot continued. She has no paresis, paralysis, altered gait, tripping or fall, difficulty emptying her bladder. She saw PCP on 05 January. ESR was normal . Overall symptoms improved but continued r foot numbness, pain to her legs. She reports PCP ordered CXR and abdominal series which were normal.
50 2021-01-07 injection site pain 01/08/2020 2:00AM extreme pain in arm at injection site ; 11:00AM chills, jaw pain, fever 103. 2, Ty... Read more
01/08/2020 2:00AM extreme pain in arm at injection site ; 11:00AM chills, jaw pain, fever 103. 2, Tylenol reduced fever to 100.8, body aches and joints, slight cough
50 2021-01-07 rash macular 20 minutes after vaccine, cold chills sweat. 30 minutes after shortness of breath blochy rash neck/... Read more
20 minutes after vaccine, cold chills sweat. 30 minutes after shortness of breath blochy rash neck/ torso. went to urgent care, wouldnt let me enter becuase didnt have a phone on to call. Went home, took 50 mg benadryl pepcid PO. took albuterol inhaler due to tachypnea. tried to wait it out at home. apporox 0200, rigors/ seizure tachypnea continued with respirations ranging 32-38/min. took 600 mg ibuprofen and albuterol inhaler, additional 50 mg benadryl. continued blocky rash. next day, called urgent care asking for appointment, thought needed steroid, they instructed to go to ED to check for covid. explained to them not covid, but allergic reaction. afraid to go to ED in thinking may need to get intubated. approx 1030 am, had 2 addtional episodes of rigors/ seizure. temp never above 99.0 F. found epi pen in house and used it. no further rigors, no further tachypnea, rash disappeared.
50 2021-01-07 itchy skin, hives Anaphylaxis with a hives, itching, and airway involvement
50 2021-01-07 itchy skin Mild itching that started within 20 minutes of injection that I thought was a result of my sweater m... Read more
Mild itching that started within 20 minutes of injection that I thought was a result of my sweater material. But itching increased over a couple hours of time even after changing clothes. No rash on body. Just itching all over. Benadryl helped calm itching and it finally started subsiding around 4 hours later.
50 2021-01-07 injection site hives, redness Patient had local reaction. Hives at site, redness on neck and face. Benadryl 25mg given po. Pati... Read more
Patient had local reaction. Hives at site, redness on neck and face. Benadryl 25mg given po. Patient monitored about30 minutes.
50 2021-01-07 rash, rash with redness approx 20 after injection 1420, started getting chills, cold sweat, elevated heart rate, shortness o... Read more
approx 20 after injection 1420, started getting chills, cold sweat, elevated heart rate, shortness of breath and blocky red rash on neck and torso. immediately drove to urgent care, was not allowed in for treatment due to did not have phone on med to call for appointment. went home, took 50 mg benadryl and pepcid po. had tachypnea and continued blocky rash on neck and torso with chest tightness. took albuterol inhaler. approx 0200 had rigors/ seizure. with continued prior symptoms. took additional 50 mg benadryl and albuterol inhaler. temp 99.0. in am 1/6 called urgent care to make appointment thought neded steroid. they said to go to ED. was afraid to go to ED in fear would be intubated as had before for allergic reaction. took additonal 50 mg benadryl, pepcid and zyrtec along with a shot of epi pen. within minutes, all symptoms ressolved. will be calling place where I got vaccinated today to report. 1/8/21
50 2021-01-07 itchy skin, hives dizziness; itching/small hives on forearm (same side as injection but not at injection site); hives ... Read more
dizziness; itching/small hives on forearm (same side as injection but not at injection site); hives on chin/upper lip; This is a spontaneous report from a contactable pharmacist (patient). A 50-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration (arm right) on 02Jan2021 08:15 at single dose for Covid-19 immunization. Medical history included asthma, hypothyroidism, and migraines. Concomitant medications included cetirizine hydrochloride (ZYRTEC), famotidine, salbutamol (ALBUTEROL), fluticasone propionate (FLOVENT), and fluticasone propionate (FLONASE). The patient previously took Keflex [cefalexin] and experienced drug allergies: hives, angioedema. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that 30 minutes after the injection on 02Jan2021 (08:45 AM), the patient experienced dizziness and itching/small hives on forearm (same side as injection but not at injection site). Vital signs were measured, all was normal. It was also reported that 36 hours after the injection, the patient got hives on chin/upper lip. The patient was treated with Benadryl, Pepcid, and Zyrtec to stop itching and resolve the hives. Benadryl was taken at home, upon advice from nurse. The outcome of events was recovered on an unspecified date in Jan2021. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.
50 2021-01-07 injection site pain inject site soreness, dizziness, headache, chills
50 2021-01-07 hives, itchy skin itching, welp
50 2021-01-07 itchy skin sores and redness at the back of throat and tongue; sores and redness at the back of throat and tong... Read more
sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; numbness; tingling; burning sensation in throat and the back of tongue; burning sensation in throat and the back of tongue; mild nausea; allergic reaction; dizzy, light-headed; ashen pale; head felt heavy; Burning and itchiness on chin persists; Burning and itchiness on chin persists; This is a spontaneous report from a contactable nurse (patient). A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration in left arm on 29Dec2020 12:00 at first single dose for COVID-19 immunization. Medical history reported as none. No known allergies. Concomitant medication the patient received within 2 weeks of vaccination included ergocalciferol (VIT D), linum usitatissimum seed oil (FLAX SEED OIL), cyanocobalamin (VITAMIN B12) and multi-vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 2 min after shot the patient was dizzy, light-headed, ashen pale, and head felt heavy. After sitting and lying down about 45 min, the patient felt numbness, tingling, and a burning sensation in throat and the back of tongue. MD took O2 sat (99%) and heart rate (72). The patient felt mild nausea for 5 min. MD gave her Pepcid 20 mg as antihistamine. About 30 min later, the patient noticed sores and redness at the back of throat and tongue. The patient consulted MD and she advised the patient to go to employee health clinic. The clinic MD stated the patient was probably having some kind of allergic reaction to vaccine. The patient was given steroid shot and Benadryl 25 mg PO (per oral) and observed for 90 min. The patient left and was given Medrol Dose pack if symptoms persisted after 2 days. The patient was told to take Benadryl 25 mg PO (per oral) 4-6 hours and Pepcid 20 mg PO (per oral) BID (twice a day) for 1-2 days. Redness, sores at back of throat and tongue persist. Burning and itchiness on chin persists. The patient had no difficulty breathing at any time. Adverse event start date was reported as 29Dec2020 12:15 PM. Events were non-serious. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included: Benadryl 25 mg PO and a steroid shot IM. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events sores and redness at the back of throat and tongue, burning and itchiness on chin persists not recovered, of other events was recovered with sequel.
50 2021-01-08 pain of skin 01/08/21 03:30am Body Aches, 04:00am Chills, 05:00am hands and feet swollen and headache, nausea and... Read more
01/08/21 03:30am Body Aches, 04:00am Chills, 05:00am hands and feet swollen and headache, nausea and head congestion/sinus congestion, eyes hurt and bright red. 07:00am temp 99, took Tylenol 1000mg. 10:00am weakness and severe body aches and difficulty getting out of bed and almost fell several times and reported skin hurt. 2:57PM temp 102.7, took Tylenol 1000mg and Motrin 800mg , 06:00pm temp 100.4 took another 1000mg Tylenol and continued with symtpoms through the night and woke up around 3:30am 01/09/2021 soaking wet with sweat. 01/09/21 1:50pm continues with mild body aches and moderate headache.
50 2021-01-08 injection site pain About 15 min after injection my heart started racing and I got lightheaded. Heart rate was 95+ and B... Read more
About 15 min after injection my heart started racing and I got lightheaded. Heart rate was 95+ and BP was 190/90 something. My resting HR is 56 and BP is usually around 120/80. Began to drop after about another 15 minutes. Followed by migraine for the rest of the day. Felt okay when I woke up, but had one episode during the day today in which my heart rate shot up again and was a little short of breath even though I was not exerting myself. Lasted about 10 minutes. Injection site hurts to the touch, but otherwise is painful. Throat hurts a little and a little congested, but probably unrelated.
50 2021-01-08 injection site swelling, injection site pain Arm pain and injection site that worsened over 24 hours. I developed swelling of entire upper left a... Read more
Arm pain and injection site that worsened over 24 hours. I developed swelling of entire upper left arm and severe headache 12/19/20
50 2021-01-08 shingles, rash Developed severe right leg pain, small rash on my right buttocks, tenderness at the LS joint, subseq... Read more
Developed severe right leg pain, small rash on my right buttocks, tenderness at the LS joint, subsequently diagnosed with shingles on 1/7/21
50 2021-01-08 injection site pain Swelling and pain under arms - no treatment (seemed to mostly subside when Celebrex was taken) Spot ... Read more
Swelling and pain under arms - no treatment (seemed to mostly subside when Celebrex was taken) Spot on tongue-no treatment still visible but no pain or irritation Other symptoms were expected and include injection site pain, heat rash likely from fever during the night but never had a recorded fever-subsided through day, fatigue, mild headache, overall just feeling like I was fighting a cold. (Viewed as immune response to me)
50 2021-01-08 itchy skin, hives UrticariaPruritus Narrative: 12/19-12/21 hives to R wrist, chest, back, neck
50 2021-01-09 skin laceration, injection site pain Chills/shivers, injection site pain, back pain/body aches, nausea, syncope, low blood pressure Start... Read more
Chills/shivers, injection site pain, back pain/body aches, nausea, syncope, low blood pressure Started getting chills at 0300, back pain started and injection arm became very painful. at 0430, got out of bed, nausea became severe and I passed out for 2 minutes. Subsequently fractured my nose from the fall after passing out and ended up in the ER for 6 hours with low blood pressure.
50 2021-01-09 hardening Low grade fever, large hard painful lump in right arm, achy joints
50 2021-01-09 rash swollen lips and tongue and rash I woke at 8 am with swollen lips and my tongue felt funny. I took 5... Read more
swollen lips and tongue and rash I woke at 8 am with swollen lips and my tongue felt funny. I took 50 mg of benadryl at 815, at 830 I took zyrtec 10 mg and went to the ER. At 945 they gave me a shot of decahedron and discharged me at 10 30 with prescription for oral steroids, epi pen and instructions to take pepcid, zyrtec twice daily and benadryl as needed.
50 2021-01-10 injection site vesicles Blister formed at the injection site 24 hrs after the second vaccine off Pfizer Covid Vaccine. Reso... Read more
Blister formed at the injection site 24 hrs after the second vaccine off Pfizer Covid Vaccine. Resolving when presented
50 2021-01-10 injection site pain Dose 1: Chills and upset stomach by 11:00am (4hours after vaccination) until bed rest same day, pain... Read more
Dose 1: Chills and upset stomach by 11:00am (4hours after vaccination) until bed rest same day, pain in the site of injection making arm unable to rise more than 30 degrees from 11:00am day of vaccination until 12/20/2020
50 2021-01-10 injection site pain Dose 2: Chills, body ache, headache by 10:00pm (13.5hrs after vaccination 01/07/2021), severe body... Read more
Dose 2: Chills, body ache, headache by 10:00pm (13.5hrs after vaccination 01/07/2021), severe body ache, nausea, pain on the site of injection but mild compared to first dose, tiredness, fever from 9:00 am until bedtime on 01/08/2021
50 2021-01-10 cellulitis, injection site swelling, injection site redness, injection site hardening Later same night 1/8//21 my arm was red swollen with hard lump at injection site. Not sure if injec... Read more
Later same night 1/8//21 my arm was red swollen with hard lump at injection site. Not sure if injection might have been given subcutaneous instead of intramuscular. The redness and swelling has increased each day. Have been marking borders abs each morning the redness has expanded and is bigger. It does not hurt or itch. The lump is not as hard but can still feel hard area surrounding injection site. clinic called in antibiotics to treat cellulitis.
50 2021-01-10 bruising While getting ready for work after showering on 1/11/2021 before 0630 this morning, I noticed a pre... Read more
While getting ready for work after showering on 1/11/2021 before 0630 this morning, I noticed a pretty large bruise on the inner left thigh of my left leg. I was shocked to see it. This bruise wasn't present prior to the vaccination. I also didn't injure my leg which would've caused the bruise. It isn't painful, but surprised to see it there. I'm sure the bruise will heal in a few days. I took a photograph if it and will monitor it.
50 2021-01-11 hives, itchy skin 1/11/21 developed itching and hives to ears, neck, chest, trunk and arms.
50 2021-01-11 injection site pain GIVEN ON 12/23. SORENESS FELT ON LEFT ARM SITE THE NEXT DAY, WITH DECREASED MOBILITY AND STRENGTH DU... Read more
GIVEN ON 12/23. SORENESS FELT ON LEFT ARM SITE THE NEXT DAY, WITH DECREASED MOBILITY AND STRENGTH DUE TO SEVERE SORENESS AND PAIN. PAIN PROGRESSIVELY LESSENED BUT THE SORENESS STILL VERY APPARENT. ON 1/5, SPOKE TO PRIMARY MD, XRAY ON LEFT SHOULDER DONE ON 1/6. ON 1/7, STIFFNESS WITH SEVERE PAIN UPON MOVEMENT NOTED ESP IN THE MORNING. ULTRASOUND WAS DONE ON 1/8, NOTED BICEPS TENOSYNOVITIS. ORTHOPEDIC SURGEON SEEN ON 1/11, W DX OF ADHESIVE CAPSULITIS, SUGGESTED FOR PT FOR NOW, AND OFF WORK, AND TO BE FOLLOWED UP ON 2/1 BY SAME ORTHO SURGEON. WILL NOT OFFER CORTISONE SHOT FOR NOW AS IT MAY COMPROMISED OR WEAKEN IMMUNE RESPONSE, IN WHICH MY SECOND COVID SHOT DUE ON THE 15TH OF JANUARY. FIRST APPT FOR PT ON 1/15
50 2021-01-11 injection site pain INFLAMATION OF THROAT,PAIN INJECTION SITE , HEADACHE,TIRED,MUSCULAR PAIN CHILLS,JOINT PAIN,FEVER,PAR... Read more
INFLAMATION OF THROAT,PAIN INJECTION SITE , HEADACHE,TIRED,MUSCULAR PAIN CHILLS,JOINT PAIN,FEVER,PARNASAL INFLAMATION AND HOARSLY.
50 2021-01-11 injection site reaction INJECTION SITE, HEADACHE TIRED, CHILLS,FEVER,NAUSES,MODERATE COUGH
50 2021-01-11 hives, rash, itchy skin, redness On 1/11/21 developed itching, redness, hives to ears, neck, chest, trunk and arms.
50 2021-01-11 injection site pain Pain at injection site, eventually inability to move/rise left arm. Same day at 7pm temp started to ... Read more
Pain at injection site, eventually inability to move/rise left arm. Same day at 7pm temp started to rise, all night fever as high as 104.2 despite multiple doses of Tylenol, chills, severe headaches
50 2021-01-11 injection site swelling, injection site redness, injection site warmth, injection site pain Post vaccination, HCW reports she sustained Right arm swelling, pain, warmness to touch. Red spots... Read more
Post vaccination, HCW reports she sustained Right arm swelling, pain, warmness to touch. Red spots were noted at injection site and was warm to touch. HCW reported staggering Motrin 800mg and Tylenol 1000mg around the clock for a period of 3 days. Also used cold compress to to right arm. On 01/12/2021, 5 days post vaccination, HCW reports some relief in pain , decrease in arm swelling and improvement in redness at the injection site. The HCW sought evaluation at the facility's Occupational Health Center and was instructed to continue Motrin and cold compress and report back if symptoms worsens.
50 2021-01-11 rash, hives Rash, hives, throat discomfort, treated with 1 dose of IM epinephrine, benadryl, pepcid, solumedrol,... Read more
Rash, hives, throat discomfort, treated with 1 dose of IM epinephrine, benadryl, pepcid, solumedrol, and albuterol
50 2021-01-11 injection site vesicles, injection site pain, injection site redness Received her COVID-19 vaccine. Patient stated "within 10 mins of receiving the vaccine, I started f... Read more
Received her COVID-19 vaccine. Patient stated "within 10 mins of receiving the vaccine, I started feeling like I'm going to have an asthma attack." She reported having headache, chills, her heart racing, "I feel like my airway is closing that I had to cough". Vital signs were taken by staff at the clinic. Patient reported BP was elevated, HR elevated, but O2 Sat was 100%. Within 15 mins symptoms resolved. Patient returned to her work area in the ED that same morning. During her shift she took Motrin for a headache. On 1/8/21, @ 2330 started feeling burning sensation on the injection site, noticed that there was a blister and redness on the area. . 1/11/2021, she reported redness at the injection. All other symptoms resolved on its own.
50 2021-01-11 vaccination site pain Severe nausea; headache; sore throat; sweating with chills; sweating with chills; chest pain; inject... Read more
Severe nausea; headache; sore throat; sweating with chills; sweating with chills; chest pain; injection site soreness; shaking hands; This is a spontaneous report from a contactable other HCP reported for herself. A 50-year-old female patient received first dose of BNT162B2 (lot number: ej1686), via intramuscular in right arm, on 05Jan2021 06:30 AM at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient hasn't been tested for COVID-19. Medical history included Known allergies: sulfa antibiotics, avascular necrosis, multiple joint replacements, anticoagulation, chronic pain, multiple hospitalizations in 2020 for diverticulitis. Facility where the most recent COVID-19 vaccine was administered was hospital. No other vaccines was received within 4 weeks prior to the COVID vaccine. Concomitant medications which patient received within 2 weeks of vaccination included warfarin, oxycodone, linaclotide (LINZESS), cyanocobalamin (VIT B12), ergocalciferol (VIT D) and iron. The patient experienced severe nausea, headache, sore throat, sweating with chills, chest pain, injection site soreness, shaking hands on 05Jan2021 07:00 AM. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The outcome of the events was recovering.
50 2021-01-11 vaccination site pain, redness both ears felt hot; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; both ... Read more
both ears felt hot; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; tongue & mouth felt slightly tingly with a metallic taste; tongue & mouth felt slightly tingly with a metallic taste; tongue & mouth felt slightly tingly with a metallic taste; felt tired most of the day; felt soreness at injection site; joint pain; This is a spontaneous report from a non-contactable nurse (patient). A 50-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EJ1685), via an unspecified route of administration on left arm at 13:45 on 21Dec2020 at single dose for Covid-19 immunization. Medical history included hypertension, central serous retinopathy, known allergies to penicillin and Nickel. Concomitant medication included losartan, hydrochlorothiazide, cetirizine hydrochloride (ZIRTEC) and multivitamin. The patient previously took clindamycin, Septra and Keflex and experienced drug allergy. Within 30 min on 21Dec2020 started at 02:30 PM, both ears felt hot, mildly itchy, slightly puffy, and bright red in color. The patient's tongue and mouth felt slightly tingly with a metallic taste. She felt tired most of the day. Next day felt soreness at injection site and joint pain. Soreness at injection site lasted several more days. Events resulted in Doctor or other healthcare professional office/clinic visit, events were reported as non-serious. The patient received Benadryl 50 mg & additional dose of Zyrtec as treatment. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovered on unknown date. No follow up attempts are possible. No further information is expected.
50 2021-01-11 injection site pain, rash, rash macular, rash with redness day 1: injection site pain, left neck/jaw area painful lymph node. After 24 hours: swollen lymph nod... Read more
day 1: injection site pain, left neck/jaw area painful lymph node. After 24 hours: swollen lymph nodes. At approximately 30 hours after injection - on face, neck, scalp - burning, blotchy, red rash (item 20 - recovered? yes to rash bcz I took Benadryl. lymph nodes still swollen)
50 2021-01-12 rash, hives Hives diffusely involving arm back eye and chin. No anaphylaxis.
50 2021-01-12 hives, itchy skin Hives/itching - Benadryl taken and is being taken every 4-6 hrs
50 2021-01-12 itchy skin Itching- mild different areas Palms of hands
50 2021-01-12 injection site pain Lt arm injection site soreness, body malaise, low grade temp, chills, fatigue
50 2021-01-12 injection site pain Pain at injection site, extreme fatigue, general body ache, temperature 102 F
50 2021-01-12 rash Systemic: Rash (other than injection site)-Medium
50 2021-01-12 hives, itchy skin, vaccination site itchiness Vaccine received at 10:10. Mild pruritus occurred at vaccination site at 10:25. Quickly progressed t... Read more
Vaccine received at 10:10. Mild pruritus occurred at vaccination site at 10:25. Quickly progressed to upper body widespread hives and itching/ Received 0.3mg epi in Right thigh at 10:35 and 25 mg Benadryl. All hives resolved by 10:40 and itching resolved by 11:00
50 2021-01-13 redness "I have had a headache and been fatigued for about 4 days along with what feels like cramps in my ar... Read more
"I have had a headache and been fatigued for about 4 days along with what feels like cramps in my arms and legs. My arm is red and lumped up but not as bad as it was second day. Also having cold chills as well."
50 2021-01-13 itchy skin Shortness of breath, chest tightness, throat itching, ear closing and itching developed 4 hours afte... Read more
Shortness of breath, chest tightness, throat itching, ear closing and itching developed 4 hours after vaccine dose. Treated with inhaler, Claritin, Zyrtec and Benadryl. Symptoms reoccurred every 4 hours x3 and then resolved.
50 2021-01-14 injection site pain, injection site nodule 1/12/2021 @ 1045hrs - Received vaccine in left arm. 1/12/2021 @ 2200hrs - Vaccination site tendernes... Read more
1/12/2021 @ 1045hrs - Received vaccine in left arm. 1/12/2021 @ 2200hrs - Vaccination site tenderness, body/muscle aches. 1/12/2021 @ 2300hrs - Body/muscle aches, chills. 1/13/2021 @ 0300hrs - Body/muscle aches, chills, fever 99.0, general malaise. 1/13/2021 @ 0600hrs - Body/muscle aches, chills, general malaise, no energy. Did not report to work. 1/13/2021 @ 1000hrs - Symptoms continued. Took Advil 600mg PO. Slept from 1030-1230hrs. 1/13/2021 @ 1230hrs - No energy, very tired, rested the entire day. Took Advil 600mg every 4 to 6 hours. 1/13 to 1/15/2021 - Left arm site tenderness with raised, hard area at injection site. Left armpit soft tissue swelling, possibly lymphadenopathy. 1/15/2021 - Reported symptoms to provider, awaiting appointment.
50 2021-01-14 itchy skin Approximately 10 minutes after receiving the second dose of the Pfizer Covid-19 vaccine, patient beg... Read more
Approximately 10 minutes after receiving the second dose of the Pfizer Covid-19 vaccine, patient began coughing. Patient reported throat tingling and itching that spread to her face as well. Patient reported a severe headache as well.
50 2021-01-14 itchy skin Swelling around both eyes, itching around eyes, progressing to general facial itching. Swelling wors... Read more
Swelling around both eyes, itching around eyes, progressing to general facial itching. Swelling worsening over the 5 days after injection leading to Urgent Care visit.
50 2021-01-14 injection site pain Sx - mild wheezing, mild headache, mild nausea, muscular pain injection site. Tx- self administered ... Read more
Sx - mild wheezing, mild headache, mild nausea, muscular pain injection site. Tx- self administered inhaler
50 2021-01-14 injection site redness, injection site discolouration, injection site pruritus, injection site pain old scar that I forgot that I have there, it just swelled up really bad; The injection site looked l... Read more
old scar that I forgot that I have there, it just swelled up really bad; The injection site looked like "a small pox vaccine," in which appear red and scabby with a blue dot in the middle; The injection site looked like "a small pox vaccine," in which appear red and scabby with a blue dot in the middle; The injection site looked like "a small pox vaccine," in which appear red and scabby with a blue dot in the middle; The injection site looked like "a small pox vaccine," in which appear red and scabby with a blue dot in the middle; Injection site began to itch; Injection site soreness; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142 (also reported as EL0140, pending clarification), expiry date: 03Mar2021 (also reported as 31Mar2021, pending clarification), intramuscular on the right arm on 08Jan2021 06:30 at a single dose for covid-19 immunisation. Medical history included heartburn, hot flashes, Grave's disease (father also has Grave's disease), had a thyroidectomy in Dec2015, menopause, weight loss, and appetite control, allergies, compromised immune status (brother and father side with autoimmune), respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity, and diabetes type 2 diagnosed in 2019 (both parents and brother also with diabetes). Concomitant medications included levothyroxine sodium (SYNTHROID) in Dec2015 for Grave's disease and had a thyroidectomy, esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) on 02Jan2021 for heartburn, phentermine for weight loss and appetite control, estradiol on 02Jan2021 for hot flashes and menopause, medroxyprogesterone acetate (PROVERA) on 02Jan2021 for hot flashes and menopause, prednisone for unexplained whelps (pending clarification), and cimicifuga racemosa (also reported as black cohosh) for hot flashes. The patient previously took metformin and experienced GI upset (she quit taking metformin/it was causing GI upset because they increased dose/current dose is 1,000mg twice daily increased from 500 mg twice daily) and generic levothyroxine sodium and experienced feels like crap. The patient had no previous history of immunization with the Pfizer vaccine. No additional vaccines administered on same date of the bnt162b2. No prior vaccinations within four weeks. The patient wanted to know if she can receive the second dose of the Covid vaccine after experiencing adverse events. On 08Jan2021, the patient experienced some injection site soreness, in which she took TYLENOL for. Around 14:30, she noticed that the injection site began to itch. Around 16:00, the injection site looked like "a small pox vaccine," in which appear red and scabby with a blue dot in the middle. The patient also reported, "scar that I have on my arm, it is not a reaction, it is an old scar that I forgot that I have there, it just swelled up really bad." Event injection site looked like a smallpox vaccine was assessed as serious-other medically important condition. No emergency room or physician's office required. Therapeutic measure was taken as a result of injection site soreness. Outcome of the event injection site looked like a smallpox vaccine was not recovered. Outcome of the events injection site soreness, injection site began to itch, vaccination site erythema, vaccination site scab, vaccination site discoloration, and old scar that I forgot that I have there, it just swelled up really bad was unknown.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the event vaccination site discomfort cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
50 2021-01-15 itchy skin, hives Body aches for 24 hours. Itching and welts in areas 42 hours after injection.
50 2021-01-15 injection site mass Fever, chills, vomiting, cough, diarrhea, painful lump at injection site, fatigue
50 2021-01-15 injection site pain Sore deltoid lasting approximately 12 hours.
50 2021-01-15 injection site swelling, injection site pain nausea, swollen around injection site, arm very painful for 2 days, persistent headache, and extreme... Read more
nausea, swollen around injection site, arm very painful for 2 days, persistent headache, and extreme exhaustion. I had to leave work early and take the next day off. I slept 14 hours on that day off.
50 2021-01-16 rash papular, injection site pain, injection site redness At 2AM, woke up with a fever of 103.6 and had a fever till Tuesday 1/12/21. Temp stayed between 102... Read more
At 2AM, woke up with a fever of 103.6 and had a fever till Tuesday 1/12/21. Temp stayed between 102-103 till 1/10/21 and on 1/11/21, temp stayed in the 100?s. I had redness from above the injection site down to my elbow x 4 days. The area was raised 1/2 inch. I had to take Benadryl to help with the reaction. On 1/10/21, my lymph node in my axilla on the same arm where the injection was administered started swelling and had redness and had redness and tenderness that extended to the left breast. Had a severe headache x 4 days with neck stiffness. The swelling in my axilla improved by 1/15/21. The redness and swelling in the arm resolved by 1/15/21. Headache still lingered till 1/16/21. Was out of work x 4 days
50 2021-01-16 itchy skin, injection site pain itchy toes both feet similar to symptoms experienced with possible covid infection in past sore arm... Read more
itchy toes both feet similar to symptoms experienced with possible covid infection in past sore arm at injection site no treatment
50 2021-01-17 rash with redness, itchy skin Friday January the 15 2021, at 5:00 PM, patient stated to have itchiness on left arm, Saturday 16, p... Read more
Friday January the 15 2021, at 5:00 PM, patient stated to have itchiness on left arm, Saturday 16, patient stated to have red little balls on left arm, PT states that she used hydrocortisone, and that calmed the itching.
50 2021-01-17 vaccination site pain I felt tingling like kind of about 10 minutes after having the vaccine as I was standing there, I fe... Read more
I felt tingling like kind of about 10 minutes after having the vaccine as I was standing there, I felt a little tingly.; little zingy feeling in my left pinky and ring finger; Pain injection site; This is a spontaneous report from a contactable physician (patient). A 50-year-old female patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration at left arm on 06Jan2021 at single dose for COVID-19 immunization. The patient medical history included was none. The patient's concomitant medications were not reported. The patient reported: " pain injection site" and "I felt tingling like kind of about 10 minutes after having the vaccine as I was standing there, I felt a little tingly. I had the vaccine in my left arm in my right hand I had a little tingly feeling and I was like well maybe because I am holding my pocket book on that side I shifted over, at work I am getting like just a little zingy feeling in my left pinky and ring finger". The patient outcome of the events was unknown.
50 2021-01-17 injection site pain I got a fever 101 the day after shot , I had chills , my bones hurt the pain was very intense in rel... Read more
I got a fever 101 the day after shot , I had chills , my bones hurt the pain was very intense in relived by Motrin and Tylenol , intense pain at injection site my underarms hurt very badly / nausea/ intense fatigue all about 20 hours after injection hit me hard like a wall - this went on for 24 hrs then I felt better but felt very weak for 2 more day s- to day is 6 days after injection first day I feel normal again
50 2021-01-17 redness SEVERE SWELLING OF LEFT EYE LID AND MILD SWELLING LEFT SIDE OF HER FACE. REDNESS.
50 2021-01-17 itchy skin, redness redness and itchy
50 2021-01-18 itchy skin 1736-First dose of COVID Pfizer Vaccine received ; 1740-Patient c/o itching all over and was active... Read more
1736-First dose of COVID Pfizer Vaccine received ; 1740-Patient c/o itching all over and was actively scratching her self. Patient related she took a Zyrtec prior to arrival in anticipation of a reaction; 1745-Increased work of breathing by patient, reports feeling like she "just climbed a flight of stairs" 1748-Patient arrived in ED for further evaluation from clinic.
50 2021-01-18 injection site pain, skin tightness Got vaccine at 11:30am. At 1:30p not feeling right, sweating, anxiousL hand swollen and tight, inj... Read more
Got vaccine at 11:30am. At 1:30p not feeling right, sweating, anxiousL hand swollen and tight, injection site looked normal. Assessed and was given Benadryl 50mg PO and lay down for an hour. Went home at 2:30p. Returned to work the next day and at noon felt feverish (100.0F), SOB, overall muscles ached and sore, injection site sore. My blood pressure was taken x 2 at 200/100 by nursing. I was driven to local ER and worked up. They could not determine if symptoms r/t to vaccine or not. My BP returned to normal. I was given a diagnosis of hypertension and a script for Lisinopril 5mg PO qd. I continue to have fluctuating high BP readings. My left hand swelling resolved. I plan to see my PCP as I have now s
50 2021-01-18 hives, redness Patient reported an allergic reaction including hives and redness occurring 2 hours after receiving ... Read more
Patient reported an allergic reaction including hives and redness occurring 2 hours after receiving the vaccine. Patient reported face swelling, throat tightness, and slight difficulty of breathing later that same evening. Patient self treated with benadryl and her symptoms resolved.
50 2021-01-18 injection site pain Received vaccine at 11:30am. At 1:30p didn't feel well, noted that my left hand was swelling and fe... Read more
Received vaccine at 11:30am. At 1:30p didn't feel well, noted that my left hand was swelling and felt tight. The injection site looked OK. I was sweating and face was flushed. I was given Benadryl 50mg PO and lay down for an hour at work. I went home at 2:30p. The following day I went to work but at 12:00noon I was feverish (100.0F), dizzy, SOB, all-over sore muscles and my blood pressure was 200/100 taken twice by nurses at the facility. I was taken to the ER by car and had labs and work up in the ER. They were unable to determine if symptoms were vaccine related or not. I had taken first dose of hypothyroid medication on 1/14/21. They diagnosed hypertension and wrote me a script for Lisinopril 5mg PO daily. I continue to have high BP readings. My left arm at injection site is sore. The edema in my hand resolved the first day after the Benadryl dose.
50 2021-01-18 redness, skin warm There is a knot on my left arm. It is warm to the touch and red. Additionally, I am unable to lay on... Read more
There is a knot on my left arm. It is warm to the touch and red. Additionally, I am unable to lay on that side. I have also lost range of motion
50 2021-01-18 injection site swelling swelling pain in arm on injection site body aches fever diarrhea
50 2021-01-19 hives, redness Delayed Localized allergic reaction. Approximately 24 hours after shot, I developed hives and swell... Read more
Delayed Localized allergic reaction. Approximately 24 hours after shot, I developed hives and swelling on cheeks, chin and swelling of lips. Immediately took 25mg of Benadryl. Sought treatment at an UTC for evaluation. I did not have trouble breathing and oxygen saturation was good, always above 97%. Upon reaching clinic 1 hour later, swelling and redness had gone down. Doctor diagnosed it as a localized allergic reaction to vaccine. I was given another 25mg of Benadryl and prescribed prednisone 20mg for 3 days. Swelling and redness has been intermittent since yesterday. All swelling and hives are confined to the face. I have been taking 50mg pf Benadry every 6-8 hours continuing this evening. It should be noted that I pre medicated with Benadryl the 2 nights before vaccination, the morning of, 1 hour after the shot and late evening the day I received the vaccine. I knew with my history of allergies I was at higher risk of allergic reaction. Please note the facial, eye and lip swelling began the following morning, 12 hours AFTER my last dose of Benadryl.
50 2021-01-19 injection site pain Palpitation, shortness of breath, dizzy, nausea, headache, pain on injection site
50 2021-01-19 injection site pain, injection site reaction, injection site swelling Swelling, deep muscle ache/spasm at injection site. Tylenol taken and ice pack at site
50 2021-01-20 injection site pain #1 Pfizer 12/24/20 w/ chest tightness, DOE starting 4 hrs post vaccine. DOE resolved after 24hrs. Em... Read more
#1 Pfizer 12/24/20 w/ chest tightness, DOE starting 4 hrs post vaccine. DOE resolved after 24hrs. Employee contacted company, who in consult with CDC recommended #2 Pfizer 1/14/21 administered at an allergist's office. Instructed to take Claritin 10mg 1hr prior to appt. At 2hrs post vaccine, patient developed similar sxs of chest tightness, DOE, palpitations, O2 sat 87%. Given Albuterol via nebulizer, additional dose of Claritin10mg. Patient felt better 5-10min after neb. D/c'd home after total 3hr observation. Had mild DOE 1/15 that resolved w/in 24hrs. Also severe HA, BA, fatigue, injx site pain. Felt much better on1/16. Denies hx asthma or atopic dermatitis.
50 2021-01-20 rash At approximately 3:21pm, patient developed a small rash on both of the lower halves of her upper arm... Read more
At approximately 3:21pm, patient developed a small rash on both of the lower halves of her upper arms. RN contacted the PA who agreed the patient should be given diphenhydramine 50mg p.o. She was given the dose and stayed 1/2 hr and then left as she was feeling fine. Had a similar reaction with the first dose received. She had already discussed this with her MD and he was fine with her receiving the second dose. She was driven home by a family member and is feeling fine, when I called her at home.
50 2021-01-20 injection site swelling, injection site redness Chills and fever up to 102.5 reduced with advil. Fever started about 24 hours after vaccine was admi... Read more
Chills and fever up to 102.5 reduced with advil. Fever started about 24 hours after vaccine was administered. Gone around 48 hours after. Swelling and redness at injection site. No stealing.
50 2021-01-20 vaccination site pain Nasal congestion/congestion; Runny nose; I ran a fever starting at about 9 PM that evening of 99.6 w... Read more
Nasal congestion/congestion; Runny nose; I ran a fever starting at about 9 PM that evening of 99.6 which increased to 101.4; Arm pain from the injection site; Headache; Extreme fatigue; I just felt very tired; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 11Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report received from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: Apr2021), via an unspecified route of administration in arm, on 07Jan2021, at single dose, for COVID-19 immunization. There were no medical history and concomitant medications. The patient stated, "I received the vaccination on Thursday of last week (07Jan2021) and I would say by 9 PM, of course I had the usual arm pain from the injection site, no big deal there. I had little bit of headache (07Jan2021) nothing serious. I had extreme fatigue, I just felt very tired when I went to work after that and then I ran a fever starting at about 9 PM that evening (07Jan2021) of 99.6 which increased to 101.4 by 1:00 in the morning (08Jan2021) and then Friday (08Jan2021), I started with some nasal congestion, runny nose, had congestion and that kind of things." The patient had COVID-19 test on 10Jan2021 and when probed about the results, she stated, "No" (Unknown results, pending clarification). Treatment for the events included Tylenol. The outcome of the events was unknown.
50 2021-01-20 rash Rash on torso, face and legs starting 2 days after injection. Prn Zyrtec as antihistamine
50 2021-01-20 itchy rash, rash Woke up the morning after vaccination with itching rash on neck, face, chest; chills but no fever; b... Read more
Woke up the morning after vaccination with itching rash on neck, face, chest; chills but no fever; body aches; rhinorrhea.
50 2021-01-20 vaccination site swelling, vaccination site redness, itchy skin a redness and swelling appeared around the injection spot; a redness and swelling appeared around th... Read more
a redness and swelling appeared around the injection spot; a redness and swelling appeared around the injection spot; itchy; This is a spontaneous report from a contactable healthcare professional (patient herself) and consumer. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 02Jan2021 10:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant and had not tested positive for COVID prior vaccination. On 11Jan2021 07:30AM, 9th day after the vaccination, a redness and swelling appeared around the injection spot, as a round region of 2.5'' in diameter. One spot inside this round region was very itchy. A much smaller region of redness was seen during the first two days but disappeared on the 3rd day and reappeared as described above. No treatment was received for the events and the outcome was not recovered. Information about lot/batch number has been requested.
50 2021-01-20 injection site reaction, injection site swelling chills fever exhaustion nausea red and swollen at the injection site
50 2021-01-20 rash inappropriate schedule of vaccine administered (first dose on 18Dec2020, second dose on 07Jan2021); ... Read more
inappropriate schedule of vaccine administered (first dose on 18Dec2020, second dose on 07Jan2021); Temp 102; body aches; chills; lymph node in right armpit swelling sz golf ball; vertigo all lasted 2.5 days; migraine pain >10 on pain scale; rash on hands and arms; nausea; blurred vision; Ongoing headache and body aches 5 days now; This is a spontaneous report from a contactable Nurse (patient). A 50-year-old Female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 07Jan2020 at 09:00 a.m. intramuscular on right arm at single dose for COVID-19 immunization. Relevant medical history included hypothyroidism, post-traumatic stress disorder, anxiety and allergy to tetracycline. Concomitant medications included escitalopram oxalate (LEXAPRO), celecoxib (CELEBREX), levothyroxine, esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]), colecalciferol (VITAMIN D [COLECALCIFEROL]) and paracetamol (TYLENOL). The patient received first dose of BNT162B2 on 18Dec2020 at 04:00p.m. intramuscular on right arm. On 07Jan2021 at 11:00 a.m. the patient experienced pyrexia with temperature of 102, body aches, chills, lymph node in right armpit swelling sz golf ball (as reported), nausea, migraine pain >10 on pain scale (as reported), rash on hands and arms, blurred vision and headache. On 08Jan2021 the patient underwent Nasal Swab SARS-CoV-2 test (Abbott) which resulted negative. No Treatment received for events. The patient recovered from vertigo on 09Jan2021. At the time of the reporting the patient had not yet recovered from headache and body aches, while was recovering from other reported events. Information about Lot/Batch number has been requested.
50 2021-01-21 itchy skin, redness, hardening 3x2, red, hard, swollen, painful, itchy patch in arm
50 2021-01-21 injection site pain Approximately 15 hours after vaccine, she noticed chills, fever up to 100.6, severe headache, fatigu... Read more
Approximately 15 hours after vaccine, she noticed chills, fever up to 100.6, severe headache, fatigue and nausea. About a day later she noted lightheadedness. About 1 days later she noticed soreness at the injection site and sensitivity to cold.
50 2021-01-21 skin discolouration Changes on skin pigmentation on hands, and superior lip.
50 2021-01-21 rash I felt tired and then after 5 days I had a rash on my breast and it lasted for almost 3 weeks. I we... Read more
I felt tired and then after 5 days I had a rash on my breast and it lasted for almost 3 weeks. I went to Urgent Care.
50 2021-01-21 rash I had fatigue, fever, body aches and constant headaches. I had a rash that showed up after four or f... Read more
I had fatigue, fever, body aches and constant headaches. I had a rash that showed up after four or five days.
50 2021-01-21 injection site pain Moderate Site pain, generalized body ache, fatigue, chills, headaches
50 2021-01-21 pain of skin On day 2 post vaccine severe body aches, joint pain, skin felt like a very painful sunburn , dizzine... Read more
On day 2 post vaccine severe body aches, joint pain, skin felt like a very painful sunburn , dizziness, fatigue and headache, Difficult to get out of bed. Took Acetaminophen 500 mg 1-2 tabs a couple of doses. Missed several shift of work. Symptoms fully resolved by 1/17/21- back to work. Telehealth appt.
50 2021-01-21 rash with redness On the 20th, had significant nausea that improved with zofran, and on the 21st, my ears started burn... Read more
On the 20th, had significant nausea that improved with zofran, and on the 21st, my ears started burning and when I looked in the mirror saw that they were extremely red, and then saw that my neck was red, pulled my long sleeves up and noticed a rash forming and within 5 minutes had a full blown body rash and redness; I was given a Benadryl and then I drove to the Urgent Care Clinic and was treated with Dexamethasone, and a Pepcid which resolved the rash within 20 minutes .
50 2021-01-21 skin burning sensation Skin burning, severe joint pain, dizziness, headache, fatigue lasted for 5 days. Missed several shi... Read more
Skin burning, severe joint pain, dizziness, headache, fatigue lasted for 5 days. Missed several shifts.
50 2021-01-22 itchy skin I had a reaction to the vaccine and wanted to make sure you were aware. I had a very similar reactio... Read more
I had a reaction to the vaccine and wanted to make sure you were aware. I had a very similar reaction to Kenalog about 4 years ago. Within minutes of receiving the vaccine, I started to feel like my body was racing a little. My foot started tapping and I felt hyperactive. At the end of my 15 minute wait time, I spoke to the physician that was in the room. I told him I was having a mild reaction and asked him if it was still okay for me to get the 2nd dose. He said yes, but he also took me over to another person to give me some Benadryl, just in case it got worse. They gave me 50mg of Benadryl and asked me to wait another 15 minutes to give it a little time to kick in. My reaction kept getting worse. I started itching all over and the hyperactive feeling became worse. She offered to use an epipen. I declined and asked to wait another 15 minutes. At the 30 minute mark after taking the Benadryl, they called their EMT team because I continued to get worse. The team took me over to the ER. While they were pushing me there, my breathing started coming faster like I was panting. As if I had just gone for a run. Once I was in the ER, a physician saw me pretty quickly but it took a while until he came back to see me. I do not know how long it was. I would guess about 45 minutes to 1 hour. While waiting for the doctor the second time, it felt like my body started slowing down. Within 10 minutes, I felt like i had no energy left. I couldn't lift my arms. I was wide awake and could understand everything. But, all I could do was lay there. The ER doctor ordered oral Prednisone, IV Pepcid & IV Benadryl to be given immediately. He sent me home with prescriptions for the Prednisone and Pepcid since I already have Benadryl. He also recommended I not get the second dose and follow up with my PCP.
50 2021-01-23 injection site pain, injection site swelling Injection site began to hurt about 9 hours after my second shot and was very tender. It was slightl... Read more
Injection site began to hurt about 9 hours after my second shot and was very tender. It was slightly swollen. I have treated it with ibuprofen but today (1/24/21) my upper arm , shoulder and left scapula are aching and have not responded to analgesics.
50 2021-01-24 skin warm 1st 15 minutes, top lips getting warm, tingle legs on legs , coolness after 15 more minutes, patient... Read more
1st 15 minutes, top lips getting warm, tingle legs on legs , coolness after 15 more minutes, patient felt numbness of lips -- > sent to ER
50 2021-01-24 hives HIVE LIKE RASH SPREADING FROM LOWER EXTREAMITYS TO HEAD AND NECK, ON GOING FOR A MONTH SEFT TREAT W... Read more
HIVE LIKE RASH SPREADING FROM LOWER EXTREAMITYS TO HEAD AND NECK, ON GOING FOR A MONTH SEFT TREAT WITH ANTIHISTAMINE WITH SOME IMPROVEMENT. SCHEDULED FOR DERMATOLOGIST VIIST
50 2021-01-24 redness, itchy skin Itching and redness on head, itching on arms and torso.; Itching and redness on head, itching on arm... Read more
Itching and redness on head, itching on arms and torso.; Itching and redness on head, itching on arms and torso.; This is a spontaneous report from a contactable Other HCP (patient). A 50-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 09:00 at SINGLE DOSE at Left arm for COVID-19 vaccination. The patient was not pregnant. Medical history included hypertension. Concomitant medication in two weeks included omeprazole (PRILOSEC [OMEPRAZOLE]), doxycycline and otc vitamins. The patient previously took oxycodone hydrochloride/oxycodone terephthalate/paracetamol (PERCOCET) and experienced drug allergies. On 12Jan2021 10:00, the patient experienced itching and redness on head, itching on arms and torso. No treatment received for the events. No covid prior vaccination and no covid tested post vaccination. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
50 2021-01-24 itchy skin Itchy face, tongue swelling, face swelling
50 2021-01-25 injection site swelling, itchy skin, injection site redness, hives, rash with redness, rash macular 5-10 minutes after shot had a metallic taste in mouth, no adverse reactions. Next 2 days the injecti... Read more
5-10 minutes after shot had a metallic taste in mouth, no adverse reactions. Next 2 days the injection site became red, swollen (knot under skin) and grew in size to a silver dollar. My left arm was sore. Redness and swelling dissipated on 4th day and looked like a bruise. About 6pm on 4th day, I was itchy on my stomach. I didn't think twice as had a neoprene/spandex brace around stomach/back from exercise. When I finally took a shower at 8pm, I noticed my torso was completely red. I immediately took 2 Benadryl. Throughout the evening the rash/hives spread to my shoulders. Took 2 more Benadryl at 1am. By morning rash around torso was almost gone, but some spread slightly to wrists, shoulders, breasts and knees. Took 2 more Benadryl at 8 am. Applied Benadryl cream to few spots on body throughout today. Itching mostly gone but splotches on legs, neck and few on back. Will take more Benadryl about 6pm.
50 2021-01-25 itchy skin Itching all over; This is a spontaneous report from a contactable nurse (reported for herself). A 50... Read more
Itching all over; This is a spontaneous report from a contactable nurse (reported for herself). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3246; expiry date: not known), via an unspecified route of administration in the left arm on 11Jan2021 11:00 at single dose for COVID-19 immunization, administered in hospital. There was no medical history. The patient is not pregnant. The patient's concomitant medications were not reported. No other vaccines received within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced itching all over on 15Jan2021 08:00. The reported event is considered non-serious. Therapeutic measures were taken as a result of itching all over with diphenhydramine. The outcome of the event was unknown.
50 2021-01-25 itchy skin Itching: neck, arm, torso; no hives, no angioedema/wheezing Given po beandryl 25mg and cold water bo... Read more
Itching: neck, arm, torso; no hives, no angioedema/wheezing Given po beandryl 25mg and cold water bottle Much improved within 20 minutes; resolved
50 2021-01-25 itchy skin pt stated she was feverish, had headache and fatigue for about 1 1/2 days after covid vax. Pt state... Read more
pt stated she was feverish, had headache and fatigue for about 1 1/2 days after covid vax. Pt stated she started having diarrhea and developed a itchy nodule on the left side of her neck about a week later along w/ fatigue. Pt has an appt w/ ENT Dr. tomorrow 1/27/2021.
50 2021-01-26 skin tightness " Pt c/o left arm tighten shortly after receiving vaccine. BP taken. Pt found to be hypertensive 194... Read more
" Pt c/o left arm tighten shortly after receiving vaccine. BP taken. Pt found to be hypertensive 194/91. RRT called @ 1510. Pt BP still high 191/100 HR 100. Pt then taken to ED [1518] to be monitored. "
50 2021-01-26 pain of skin Arm became sore mid-afternoon, about 8pm in the evening developed aches/tenderness on all skin surfa... Read more
Arm became sore mid-afternoon, about 8pm in the evening developed aches/tenderness on all skin surface areas. About 10pm developed headache, facial flushing, painful eyes, fever 101.3, rigors, and muscle cramps in feet and legs.
50 2021-01-26 itchy skin Patient returned to the vaccine clinic a couple of hours after receiving vaccine with complaints of ... Read more
Patient returned to the vaccine clinic a couple of hours after receiving vaccine with complaints of itching of hands, face, and neck. Patient refused diphenhydramine and stated it was the end of her shift and she was going home.
50 2021-01-26 sensitive skin involuntary muscle contractions in her diaphragm; chills; cold; severe body aches; Involuntary muscl... Read more
involuntary muscle contractions in her diaphragm; chills; cold; severe body aches; Involuntary muscle cramping; chest pain; Feels bad; severe joint aches; tremor; nausea; severe body pain in her back and knees; severe body pain in her back and knees; Weakness; Headache; This is a spontaneous report from a contactable Other HCP reported for self. This 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 07:00 on Deltoid Left at single dose (Lot # EK9231) for covid-19 immunisation. Concomitant medications were none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 via Intramuscular at age of 50 years old on Deltoid, Left at single dose (Lot # EH9899) for covid-19 immunisation, experienced Tingling lips, Swollen lips, and the Benadryl took away the lip tingling and swelling, Tachypnea, Myalgia, Joint pain, severe headache, Weakness generalized, Nausea, she said she was really pale, so much so, that her husband was scared for her. She said the symptoms lasted for about 3 days, but the weakness lasted longer. Reported she took some Zofran disintegrating tablets for her nausea. Clarified she did have a PCR COVID-19 Virus test after she developed symptoms from receiving the first COVID-19 Vaccine dose. She said she had the PCR COVID-19 Virus test about 3 weeks ago and the test was negative. She said she thought she had the COVID-19 Virus after receiving the first COVID19 Vaccine dose because no one else she knew who had the COVID-19 Vaccine had any issues. Reported she received the second COVID-19 Vaccine dose on 12Jan2021 at 7:00AM in the left Deltoid. She said the adverse reaction she experienced after the second vaccine dose was slightly different from what she experienced with the first dose. She said about 10 hours after the COVID-19 Vaccine was administered, clarifying at around 17:00PM 12Jan2021, she started having severe body aches(disability), and involuntary muscle cramping (disability), like tetanus. She said even her diaphragm was cramping. She said she had chest pain on 12Jan2021(disability), tremors on 12Jan2021 (medically significant), and body aches, but doesn't think she had fever. She said the symptoms are still going on like with the first COVID-19 Vaccine dose, but she has more severe joint aching on 12Jan2021 (disability), weakness on 12Jan2021 (disability), and nausea on 12Jan2021 (medically significant). She said her knees feel like she was beaten severely. She said she aches so bad, it hurts having pants on. She said she does not have a headache or tremors now, but did have a headache on 12Jan2021 (medically significant) and tremors in the beginning. She said she feels the most pain in her back and knees. She said she feels really bad on 12Jan2021(disability). After the second dose on 12Jan2021, she reports severe body pain in her back and knees (disability). She reports almost feeling like she has tetanus- involuntary muscle contractions in her diaphragm on unknown date(disability), tremor, cold, chills, nausea, muscle cramps/chest pain. 'Felt like a heart attack. It was out of this world'. She still has nausea, severe pain all over my body, she can't be touched, and even wearing pants hurts. She said she is a healthy person with no chronic disease. She said she had nothing wrong with her prior to getting the COVID-19 Vaccine. Reported she hurts so bad, she can't even lift her arm. She completed a covid 19 PCR test after the first dose in Dec2020, which was negative. Treatment were received for the events severe body pain in her back and knees, involuntary muscle contractions in her diaphragm, tremor, nausea, muscle cramping, chest pain, Feels bad, more severe joint aching, severe body aches, Weakness, headache, chills, cold. Reported she has taken 1500mg of Motrin. Outcome of the severe body aches, Involuntary muscle cramping, Chest pain, severe joint aches, weakness, Nausea, Back pain, Knee pain, Feels bad was not recovered. Outcome of the event Tremor was recovered in Jan2021, Headache was recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the reported events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
50 2021-01-26 hives, itchy skin, rash macular itchy, red splotches, hives, prickly sensation on skin on date of injection, then came back on Satur... Read more
itchy, red splotches, hives, prickly sensation on skin on date of injection, then came back on Saturday evening 1/23
50 2021-01-26 injection site pain nausea, joint pain, muscle pain, headache, chills, insomnia, tiredness, injection pain, don't feel w... Read more
nausea, joint pain, muscle pain, headache, chills, insomnia, tiredness, injection pain, don't feel well
50 2021-01-26 injection site pain soreness to injection site, mild headache, mild bodyache
50 2021-01-27 hives, rash Started with rash/ hives on face Tuesday 1/26/21, 7 days after receiving vaccine. Have taken Benadry... Read more
Started with rash/ hives on face Tuesday 1/26/21, 7 days after receiving vaccine. Have taken Benadryl and is not getting better. Rash/hives are spreading . Have scheduled a doctors appointment today to be seen,
50 2021-01-27 rash, itchy rash papular itchy rash on lower back area. Treated with prednisone 50 mg daily x 5 days, TAC ointment b... Read more
papular itchy rash on lower back area. Treated with prednisone 50 mg daily x 5 days, TAC ointment bid, cetirizine 10 mg qd, diphenhydramine 50 mg qhs.
50 2021-01-28 vaccination site pain Heart palpitations; sore throat; hurt when vaccination was injected; This is a spontaneous report re... Read more
Heart palpitations; sore throat; hurt when vaccination was injected; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: unknown), intramuscular in the left arm, on 15Jan2021 16:15, at single dose, for COVID-19 immunization, in a public health clinic. The patient medical history and concomitant medications were not reported. Past drug included sulfamethoxazole, trimethoprim (BACTRIM) which the patient has allergies to. The patient did not have COVID-19 prior to vaccination and is not pregnant. The patient did not receive other vaccines in four weeks. The patient experienced heart palpitations, sore throat, and hurt when vaccination was injected on 15Jan2021 at 16:15. No treatment was given for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events was recovered on an unspecified date.
50 2021-01-28 redness, rash Vaccine admin at 12:00 pm. At 12:20 pm, patient developed redness-rash to chest, neck area. 12:25 ... Read more
Vaccine admin at 12:00 pm. At 12:20 pm, patient developed redness-rash to chest, neck area. 12:25 pm oral Benadryl admin. 12:45 Patient feeling ok. Left vaccination facility with instructions to seek medical services if symptoms re -appear, worsen.
50 2021-01-28 vaccination site itchiness, vaccination site swelling itchiness at injection site which then became swollen/looks like a huge mosquito bite, large horizon... Read more
itchiness at injection site which then became swollen/looks like a huge mosquito bite, large horizontal oval shape; Itchiness at injection site; This is a spontaneous report from a contactable healthcare professional (patient). A 51-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 50-year-old, intramuscular in the right arm on 08Jan2021 at 14:00 at a single dose in the hospital for covid-19 immunization. Medical history included sulfa allergies. The patient is not pregnant at the time of vaccination. Concomitant medication included escitalopram oxalate (LEXAPRO) and celecoxib (CELEBREX). 8 days after vaccine (16Jan2021 at 13:00), patient developed itchiness at injection site which then became swollen by 9th day after vaccine (17Jan2021). Itchy and looks like a huge mosquito bite, large horizontal oval shape. The patient did not receive treatment for the events. Outcome of the events was recovering. Information on the lot/batch number has been requested.
50 2021-01-28 vaccination site pain my temperature was 101.5f to 100 f 24hrs. and 100-99.5f neck and head heaviness another 8hrs; neck t... Read more
my temperature was 101.5f to 100 f 24hrs. and 100-99.5f neck and head heaviness another 8hrs; neck to shoulder, chill; head heaviness; neck and head heaviness another 8hrs; still felt the pain on the injection site but not too much; fatigue; shoulder pain; sleepy; sleepy; This is a spontaneous report from a contactable nurse (patient). A 50-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4176), via an unspecified route of administration on 08Jan2021 11:00, at left arm, at single dose for covid-19 immunization. Medical history included Hx of hypothyroidism. not now, known allergies was none. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), via an unspecified route of administration on 18Dec2020 14:00, at left arm, at single dose for covid-19 immunization and after the first dose, the patient had a pain from left side neck to elbow at next day but it was gone, she felt little sleepy the day she got vaccine. The patient received the second dose on 08Jan2021, and the patient was little sleepy so she went to sleep 8pm (20:00), from 11pm (23:00) 100f she woke up due to neck to shoulder, chill, 11:30pm (23:30) 101.3f after that she had same symptoms and her temperature was 101.5f to 100 f 24hrs, and 100-99.5f neck and head heaviness another 8hrs, she took Advil 200mg x4 in the 32hrs. She still felt the pain on the injection site but not too much. She went back to work 12Jan2021 but feel fatigue until yesterday (16Jan2021) but no more shoulder pain. No treatment was received for all events except fever. The outcome of the event fatigue was not recovered, the outcome of the event pain on the injection site was recovering, the outcome of the other events was recovered in Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
50 2021-01-28 skin warm pt states that within 10 minutes after vax that she experienced cool tingling sensation down both le... Read more
pt states that within 10 minutes after vax that she experienced cool tingling sensation down both legs below knees and had a rapid heart beat. Pt discussed her symptoms w/ medic at facility when she noticed a tingling at the top of her head and her top lip that was numb and hot. They checked her blood pressure and it was high at that time 153/? Pt was from out of town so transported to Urgent Care via ambulance. Her blood pressure was 170/? at this time. They did an EKG which was normal. Pt was given Benadryl. Dr. told her she had a Panic Attack and issued Hydroxyzine 25mg. Pt. said she has had panic attack before and it wasn't the same but she thinks it may have been from anxiety but is trying to determine what went wrong. Pt is waiting for her PCP to do tele visit for a FU.
50 2021-01-29 hives Patient received COVID vaccine at 10:45 while in patient observation they began to have hives so a B... Read more
Patient received COVID vaccine at 10:45 while in patient observation they began to have hives so a Benadryl was given at 10:50 and was held for further observation. While waiting the patient began to have difficulty breathing, swallowing and was short of breath at 11:07 and 911 was called immediately and an epipen was given. The firemen came to the location to assess the patient and paramedics shortly came after to take the patient to Kaiser Fontana.
50 2021-01-31 injection site mass, injection site swelling Fever, chills, large red circle with lump at injection site. Low grade fever for 2 1/2 days, felt b... Read more
Fever, chills, large red circle with lump at injection site. Low grade fever for 2 1/2 days, felt bad, still able to work from home though.
50 2021-01-31 shingles I had a shingles outbreak which started 6 days after receiving the 2nd COVID-19 vaccine.
50 2021-02-01 injection site pain Around 6 hrs after vaccine felt fatigue. I also exp tenderness at injection site and 9 days shortnes... Read more
Around 6 hrs after vaccine felt fatigue. I also exp tenderness at injection site and 9 days shortness of breath with diarrhea/mild headache.I went to urgent care for Covid, PCR test (results negative). I had symptoms approximately 10 days before shortness of breath resolved.
50 2021-02-01 rash, itchy rash Developed rash & pruritus on neck w/ external swelling. Swelling & rash became worse, developed head... Read more
Developed rash & pruritus on neck w/ external swelling. Swelling & rash became worse, developed headache & neck pain. Took benadryl then saw MD. Started prednisone & hydrocortisone cream on 2/1/21.
50 2021-02-01 hives, itchy skin Elevated heart rate, hives, itching
50 2021-02-01 hardening Extreme body aches (muscles), Chills, tired, swollen and hard lymphoids, headache, nausea, pain in l... Read more
Extreme body aches (muscles), Chills, tired, swollen and hard lymphoids, headache, nausea, pain in lungs when breathing.
50 2021-02-01 itchy skin, hives Immediate flushing of face. Itchy hands and arms. Ears and face red/hot. C/O hives on back. Hyperten... Read more
Immediate flushing of face. Itchy hands and arms. Ears and face red/hot. C/O hives on back. Hypertensive
50 2021-02-01 vaccination site pain Tenderness at injection sight, severe enough to awaken during the night; Tenderness at injection sig... Read more
Tenderness at injection sight, severe enough to awaken during the night; Tenderness at injection sight, severe enough to awaken during the night; The day after the injection, I broke out in sweats to the point that my shirt was wet; This is a spontaneous report from a non-contactable nurse reported for herself. A currently 50-year-old (reported age at vaccination was 50) female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on 11Jan2021 at single dose for covid-19 immunization in Hospital. Medical history was not reported. Patient is not pregnant at the time of vaccination. Not allergies to medications, food, or other products. Concomitant medications were not reported. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously took first dose of bnt162b2 on 22Dec2020 via Intramuscular at left arm at single dose for covid-19 immunization. Patient experienced tenderness at injection sight, severe enough to awaken during the night (12Jan2021); relieved with ibuprofen. Lasted about one week. The day after the injection, patient broke out in sweats to the point that my shirt was wet. This occurred multiple times but resolved about 24 hours post injection. the patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. treatment received for the events included OTC med. Patient was recovered from the events tenderness at injection sight, severe enough to awaken during the night in Jan2021 and recovered from sweats on 13Jan2021. It was non-serious, Seriousness criteria of Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect were all no. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
50 2021-02-02 injection site tingling Tingling, Numbness Narrative: 5 min after vaccine administered IM to L deltoid she developed L arm ... Read more
Tingling, Numbness Narrative: 5 min after vaccine administered IM to L deltoid she developed L arm and L trunk tingling. Tingling these locations resolved. Developed mild perioral tingling. At 1149 mild numbness tongue and lips. At 1155 resolving perioral tingling and numbness.
50 2021-02-03 injection site redness, rash, itchy skin, injection site pain 1st dose of COVID19 (Pfizer) vaccine received on 12/29/2020. Day #1 (12/30/2020) following 1st vacc... Read more
1st dose of COVID19 (Pfizer) vaccine received on 12/29/2020. Day #1 (12/30/2020) following 1st vaccine individual developed arm soreness and redness at injection site. On Day #5 (1/2/2021), body ache, fatigue, and headache, plus development of skin eruptions on tops (anterior) of hands and arms (bilateral). Skin eruptions associated with significant pruritus and pain. Individual thought reaction was related to eczema (past medical history) and treatment initiated with topical steroid and hydroxyzine without relief. Received 2nd dose of COVID19 (Pfizer) vaccine on 1/19/2021. Following receipt of 2nd dose, skin eruptions progressed to involvement of back (posterior/dorsal) of arms/wrist, chest, face, and scalp. Currently 2 weeks post-2nd vaccine, individual continues to have skin eruptions present with persistent pruritus and pain.
50 2021-02-03 injection site pain, injection site swelling Early morning 3 am chills , muscle aches and pain. fatigue, mild pain and swelling on Inj site. Pa... Read more
Early morning 3 am chills , muscle aches and pain. fatigue, mild pain and swelling on Inj site. Pain and swelling ion Inj site still tender
50 2021-02-03 injection site swelling SWOLLEN AXILLARY LYMPH NODE IN RIGHT ARM WHERE INJECTION WAS GIVEN
50 2021-02-03 hives, itchy skin Swelling of forearm; trouble with movement in right hand; heaviness in same arm; Hives; itching; hea... Read more
Swelling of forearm; trouble with movement in right hand; heaviness in same arm; Hives; itching; headache that has turned into migraine.; headache that has turned into migraine.; This is a spontaneous report from a contactable other Healthcare Professional. A 50-years-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), intramuscular at right arm on 14Jan2021 13:00 at single dose for covid-19 immunization. Medical history included allergies to penicillin and sulfa. Concomitant medication included bupropion, propranolol, topiramate, sertraline, montelukast, alprazolam. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The historical vaccine included the first dose of BNT162B2 (lot number: EL1284) on 27Dec2020 02:30 PM intramuscularly at right arm for covid-19 immunization. The patient experienced swelling of forearm, trouble with movement in right hand and heaviness in same arm. Hives, itching, headache that had turned into migraine. The symptoms started the day after the injection (15Jan2021). No treatment received for the adverse events. The events outcome was recovering. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.
50 2021-02-03 skin discolouration That day just felt sick and then next day could hardly lift arm and felt very sick, sat I looked lik... Read more
That day just felt sick and then next day could hardly lift arm and felt very sick, sat I looked like someone beat me . The pictures look like I was beat to death my skin was all purple went to urgicare they sent me hime , went Er Sunday and the Dilantin wouldn?t kill the pain, dehydrated Gabe me fluids and did a Doppler, then sent me hime on oxi which did nothing but dull pain went from Sunday since so tired and still in pain and sick , he send mye for labs on Friday. It came back iron was low. My arms are both blotchy and sore and black n blue .
50 2021-02-03 vaccination site swelling, vaccination site redness, vaccination site warmth her right hand is slightly swollen; Where she got the shot is a little red, warm, and swollen; Where... Read more
her right hand is slightly swollen; Where she got the shot is a little red, warm, and swollen; Where she got the shot is a little red, warm, and swollen; Where she got the shot is a little red, warm, and swollen; a little sore; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: 3248), via an unspecified route of administration in the right arm on 18Jan2021 at 08:40 A.M. (at the age of 50 -years-old) as a single dose, dose 2 for COVID-19 vaccination. Medical history was unknown. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), single dose, dose 1 in the left arm on 28Dec2020 and a flu vaccine on 29Aug2020. There were no concomitant medications. On 19Jan2021, the patient's right hand is slightly swollen. It was still mobile. She can move all digits. It was puffy and a little sore and where she got the shot was a little red, warm, and swollen. There were no relevant tests done. The patient had no emergency room or physician office visits. The clinical outcome of right hand is slightly swollen, puffy and a little sore and where she got the shot was a little red, warm, and swollen was not recovered.
50 2021-02-03 rash rash broke out all over my neck; This is a spontaneous report from a contactable physician (patient)... Read more
rash broke out all over my neck; This is a spontaneous report from a contactable physician (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231; expiration date not provided), via an unspecified route of administration in the left arm on 04Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included Mild anxiety, Sjogrens, Perimenopausal, and Allergies to tree nuts. The patient is not pregnant. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram and estradiol (ESTROGEN). On 10Jan2021 06:00, 6 days after injection, the patient had rash broke out all over her neck which has not fully resolved after treatment with oral prednisone 20 mg for 10 days. The outcome of the event was not recovered. The patient has not been tested for COVID post vaccination.
50 2021-02-04 itchy skin I had an area on my right wrist that was almost healed from eczema that started after the first vacc... Read more
I had an area on my right wrist that was almost healed from eczema that started after the first vaccine as I previously reported. That area became inflamed and itchy. My lower right arm became covered with eczema as a couple of days progressed. I have since ended up with it on the left side of my face.
50 2021-02-04 skin discolouration I started running a fever 101.8 and after 48 hours fever was gone. Swelling to my arm and my arm wa... Read more
I started running a fever 101.8 and after 48 hours fever was gone. Swelling to my arm and my arm was pink.
50 2021-02-04 injection site warmth, injection site pain, injection site swelling, injection site redness Injection site pain, Fever, chills, tiredness, injection site swelling, injection site redness, inj... Read more
Injection site pain, Fever, chills, tiredness, injection site swelling, injection site redness, injection site warm/hot to touch. Tylenol and Motrin for fever. Contacting Dr today to see if I need to be seen for cellulitis.
50 2021-02-04 injection site tingling, injection site pruritus Left arm injection site, itcy and tingling on down both arms, flushed throughout body, 140/80 BP, HR... Read more
Left arm injection site, itcy and tingling on down both arms, flushed throughout body, 140/80 BP, HR 71 and RR 18. Headache later that night, with chills and fever for 2 days. Took Tylenol.
50 2021-02-04 injection site swelling, injection site redness, injection site warmth Redness, swelling and warmth at injection site. Lasted 4 days and then went away. No other reaction... Read more
Redness, swelling and warmth at injection site. Lasted 4 days and then went away. No other reactions.
50 2021-02-04 injection site pain Sore arm at injection site, body aches, fatigue, chills
50 2021-02-04 injection site pain Within 4-5 hours, muscle soreness on shoulder at injection site. Within 12-13 hours, migraine, feve... Read more
Within 4-5 hours, muscle soreness on shoulder at injection site. Within 12-13 hours, migraine, fever, chills, body aches, nausea, and vomiting. Symptoms lasted 36-38 hours from the time of vaccination
50 2021-02-04 itchy skin, redness itchiness/redness of hands and face; given benadryl 50mg po with improvement in symptoms after 30-mi... Read more
itchiness/redness of hands and face; given benadryl 50mg po with improvement in symptoms after 30-min
50 2021-02-04 pain of skin skin on her face feels burnt and sore to touch; skin on her face feels burnt and sore to touch; Bad ... Read more
skin on her face feels burnt and sore to touch; skin on her face feels burnt and sore to touch; Bad headache; medical history: lupus anticoagulant positive; medical history: lupus anticoagulant positive; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248), via intramuscular route of administration on 19Jan2021 at 12:00 at a single dose in the arm left for COVID-19 immunization. The patient's medical history included high blood pressure, hypothyroidism, depression, lupus anticoagulant positive, and anemia. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), verapamil, apixaban (ELIQUIS), montelukast sodium (SINGULAIR), levothyroxine sodium (SYNTHROID) , ergocalciferol (VIT D), cetirizine hydrochloride (ZYRTEC), hydrocodone bitartrate, paracetamol (NORCO). The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and acetylsalicylic acid (ASPIRIN) and experienced allergies. The patient also previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140 ) on 29Dec2020 at 08:00 pm, via intramuscular route in the left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. On 19Jan2021 at 19:00, the patient stated that her skin on her face feels burnt and sore to touch without any redness or signs of injury and had a bad headache. The patient did not receive any treatment for the reported events skin on her face feels burnt and sore to touch and bad headache. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient has not recovered from the events.
50 2021-02-05 redness, rash Bumps on finger, some swelling with pinkness around.
50 2021-02-05 redness patient received covid vaccination. developed pain and redness and edema
50 2021-02-06 injection site pain Immediately after 2nd injection, sensitivity to light & color. Hot and sweaty for 24 hours, then col... Read more
Immediately after 2nd injection, sensitivity to light & color. Hot and sweaty for 24 hours, then cold & clammy, jumbled though and speech. Soreness at injection site. Extreme tiredness. 2-days after injection, swelling of piriformis muscle in hip, extreme pain, bedridden, unable to walk, fever, for going on 36 hours. Taking 800 mg ibuprofen to sleep. Muscle cream, Epson salt baths to reduce pain.
50 2021-02-06 injection site pain, skin spots Severe stomach cramping and diarrhea: Began at 4:30 pm 02.03.2021 - 02.07.2021 required hospital ER... Read more
Severe stomach cramping and diarrhea: Began at 4:30 pm 02.03.2021 - 02.07.2021 required hospital ER visit for iv fluids to treat stomach pain, nausea and dehydration from diarrhea. Sent home with prescription for Dicyclomine 20 mg tablet anti spasm medication. Petechiae on back of both hands, wrists and fingers: Began at 4:15 pm 02.05.2021 required hospital ER visit for multiple blood testing to evaluate platelets, etc. Testing clear and ER Dr. noted condition is associated with vaccination reaction and advised to closely monitor for any change and seek immediate return if continued progression and if so follow-up with hematologist. Foot cramps: Began overnight 02.04.2021, increased fluids and subsided. 99.8 Temperature: Began 02.04.2021 at 9:30 pm - to 11:30 pm and treated with extra strength Tylenol and subsided. Began 02.03.2021 at 10:30 pm -11:30 pm and treated with extra strength Tylenol and subsided. Soreness at injection site: Began 02.04.2021 ongoing treating with extra strength Tylenol.
50 2021-02-07 hives, rash Hives, rash, headache, itchy swollen eyes
50 2021-02-07 redness Redness on arm and legs onset 2hr after dose.
50 2021-02-07 itchy skin itching scalp; arms; patient took own benadryl; denies sob; no problems with throat; 17:15 feels bet... Read more
itching scalp; arms; patient took own benadryl; denies sob; no problems with throat; 17:15 feels better but still itchy; no respiratory issues; no other problems.
50 2021-02-08 skin warm, redness Pain, swelling, formation of large, red, warm, lump, and unable to lift arm. Took over the counter p... Read more
Pain, swelling, formation of large, red, warm, lump, and unable to lift arm. Took over the counter pain relievers, tried cold and warm compresses. Redness, warmth, and lump resolved after 3 weeks. Still will left arm pain. Painful to lift and abduct arm.
50 2021-02-09 vaccination site pain Sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 50-year-old fema... Read more
Sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 50-year-old female patient started to received first dose of BNT162B2 (COVID-19, Pfizer, Solution for injection, lot number: EL3247), via an unspecified route of administration at left arm on 29Jan2021 14:00 at single dose for covid-19 immunisation. Medical history included scleroderma. The patient's concomitant medications were not reported. No other vaccine administration reported within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. No Allergies to medications, food, or other products were reported. The patient was not pregnant at the time of vaccination. On 29Jan2021 at 19:00 the patient experienced sore arm. No treatment was received for the event. The patient underwent lab tests and procedures which included sars-cov-2 test: COVID-19 virus test was negative prior to vaccination. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.
50 2021-02-10 rash APPROXIMATELY THREE DAYS POST VACCINATION; DEVELOPED SPOTS; LESIONS; AND SORES ON RIGHT MIDDLE FINGE... Read more
APPROXIMATELY THREE DAYS POST VACCINATION; DEVELOPED SPOTS; LESIONS; AND SORES ON RIGHT MIDDLE FINGER; RIGHT INDEX FINGER; TOP OF RIGHT FOOT; AND GROIN; WHICH SPREAD TO LEFT THIGH. WENT TO URGENT CARE ON 2/1/21. HAD MD FOLLOW UP ON 2/8/21. BIOPSY OF LEFT THIGHT DOWN AND LABS DRAWN. ACCORDING TO HER, THE DOCTOR THINKS IT MAY BE RELATED TO UNDERLYING LIVER DISEASE. AS OF THIS TIME IT IS NOT RESOLVED.
50 2021-02-10 injection site pain Arm burned from the inside out from injection site to finger immediately , walk to seat for obs sat ... Read more
Arm burned from the inside out from injection site to finger immediately , walk to seat for obs sat down immediately headache lump in throat then: tingling fingers , dizziness, swelling hands feet and face, flushed, turn bright & lump in throat bigger within 10 mins to the ER for treatment
50 2021-02-10 injection site pain Bell's palsy on left side; soreness at the injection site; This is a spontaneous report from a conta... Read more
Bell's palsy on left side; soreness at the injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number EV1685, expiry date unknown) via an unspecified route of administration on the left deltoid, left arm, on 05Jan2021 08:15 AM at a single dose for COVID-19 immunization. The patient's medical history included allergies to Penicillin and Sulfa from an unknown date and unknown if ongoing. The patient had no current Illness and no family medical history. The patient is not pregnant. Concomitant medications included metoprolol tartrate, Vitamin C [ascorbic acid], Vitamin D3, and Multivitamins; patient received these medications within two weeks prior to the COVID vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. Patient had a routine Physical Examination on Nov2020 and underwent lab tests and procedures on 24Jan2021 which included unknown BW and negative Lyme Disease Test. On 23Jan2021 18:30, the patient developed bell's palsy on left side which was reported as getting a little worse every day. The event required Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care; the event resulted in Disability or permanent damage. Since 24Jan2021, patient received Prednisone 60 mg, daily for 7days and Valtrex 1g, 3x/day (TID) for 7days as treatment for the event. The patient did not recover from the event Bell's palsy on left side.' It was further reported that patient experienced soreness at the injection site on an unspecified date with outcome of unknown.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product BNT162B2 to reported event Facial paralysis cannot totally be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
50 2021-02-10 vaccination site pain Chills; lymph nodes swollen on chest; lump in throat; muscle aches pain at injection site; nightmare... Read more
Chills; lymph nodes swollen on chest; lump in throat; muscle aches pain at injection site; nightmares; euphoria; insomnia; waking up often red eye; Nasal Swab positive; Nasal Swab positive; This is a spontaneous report from a contactable nurse reported for herself. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot#Ek5730, on 28Dec2020 04:00 PM at single dose for COVID-19 immunization. Medical history included hypothyroidism. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No COVID prior vaccination. On 31Dec2020 the patient tested positive for the SARS-COV-2 virus (via nasal swab). The outcome of the event was unknown. On 27Jan2021 the patent experienced chills, lymph nodes swollen on chest, lump in throat, muscle aches pain at injection site, nightmares, euphoria, insomnia and waking up often red eye. The outcome of these events was reported as recovered and no treatment received. Lab data included Polymerase chain reaction: Positive on 31Dec2020.; Sender's Comments: Based on the current available information, the events Drug ineffective and COVID-19 are unlikely related to BNT162B2 vaccine. The events occurred 3 days after vaccination, when vaccine was not expected to achieve the effect. The case will be reassessed if additional information becomes available.
50 2021-02-10 injection site swelling, injection site pain Low grade fever began about 21 hours after shot. Very achy all over about 24 hours after shot. 36 ho... Read more
Low grade fever began about 21 hours after shot. Very achy all over about 24 hours after shot. 36 hours after shit the lymph nodes under my left arm began to swell and hurt. Over the course of the next 2-3 days after that, the nodes continued to swell and hurt down my arm past the elbow. A week after the shot it was all resolved
50 2021-02-10 rash papular, rash with redness Red raised rash from top of thighs to just under breasts all the way around my body. Started taking... Read more
Red raised rash from top of thighs to just under breasts all the way around my body. Started taking Benadryl 50mg at 9:00pm 2/9/21 . Unable to take every six hours per nurse hot line instructions been doing 2x during the day. As of 3:21 pm on 2/11/21 still some raised red rash but not completely covered.
50 2021-02-10 rash with redness on first day felt vertigo and headache second day felt chillscold sore, fatigue, headache continued,... Read more
on first day felt vertigo and headache second day felt chillscold sore, fatigue, headache continued, joint pain. These symptoms lasted 5 days. skin felt sunburned all over and hurt to touch which lasted 2 days
50 2021-02-11 rash Systemic rash - face, neck, arms - I took 4 zyrtec which finally stopped it from spreading
50 2021-02-11 blister reports fever blister within 1 hour that resolved and didn't require immediate treatment. next day d... Read more
reports fever blister within 1 hour that resolved and didn't require immediate treatment. next day developed myalgias but then came into the ED due to a feeling of tongue swelling and swelling of the neck, no n/v/d, no sob/wheezing/stridor
50 2021-02-14 rash, itchy skin ABOUT TWO DAYS AFTER THE VACCINATION, I NOTICE SMALL ITCHING SPOT ALL OVER MY BODY. TOP LIP WAS THE ... Read more
ABOUT TWO DAYS AFTER THE VACCINATION, I NOTICE SMALL ITCHING SPOT ALL OVER MY BODY. TOP LIP WAS THE MOST BOTHERSOME. BOTH MY FEET FELT LIKE NEEDLES FOR ABOUT 2HOURS. BUT EVEN TODAY, 2/14/2021, THE ITCHING HAS CONTINUED. DOES NOT ITCH TO THE POINT THAT MAKES ME WANT TO SCRATCH; BUT NOTICEABLE. BOTH ARMS AND LEGS MOSTLY. I HAVE NOT NOTICED A RASH. I HAVE NOT TAKEN ANY MEDICATIONS FOR THIS ITCHING. I AM HOWEVER WORRIED ABOUT TAKING THE 2ND DOSE. AS A MATTER OF FACT, I AM LEANING AGAINST TAKING THE SECOND DOSE.
50 2021-02-14 redness Headache Low grade fever Arm redness and soreness Fatigue
50 2021-02-14 itchy skin, hives She received her 1st vaccine without any adverse or side effects. Within 30 seconds of her 2nd vacc... Read more
She received her 1st vaccine without any adverse or side effects. Within 30 seconds of her 2nd vaccine she became flushed, within minutes she developed hives starting on her hands and then becoming more generalized, as well as itchy palms. She also was hypertensive. The COVID vaccine clinic administered epinephrine and transfer her to the emergency department where she was given prednisone, Benadryl, and famotidine. ED notes do indicate she had some mild expiratory wheezing but on further discussion with her today this is a consistent finding after being diagnosed with asthma last year (more on this below). She was monitored for over 3 hours and discharged home. Her itching resolved in the ED, hives resolved about 3 hours after discharge and other symptoms resolved around 24 hours post vaccine. She did have labs drawn in the ED: troponin and C4 WNL. CBC showed leukocytosis with lymphocytosis and eosinophilia. No personal history of seasonal, perennial, food, or bee sting allergies; asthma history as below. She did have an episode of bilateral eye swelling in December that was evaluated by her PCP; she was treated with benadryl & prednisone and this took 3 days to resolve. She has no other history of anaphylaxis, hives or angioedema. She was able to show me pictures of this today.
50 2021-02-14 hair loss, hives swelling in L axilla hair loss swelling under L breast hives (happened after eating eggs, but never ... Read more
swelling in L axilla hair loss swelling under L breast hives (happened after eating eggs, but never had any history of egg allergy in the past)
50 2021-02-15 itchy skin From occupational health note: patient was asked by her supervisor to call. Received vaccine on 1/1... Read more
From occupational health note: patient was asked by her supervisor to call. Received vaccine on 1/14, had dizziness, seeing spots in her eyes, lethargy and was sent to to ED and discharged. Generalized itching the next day. All sxs have resolved since yesterday. Scheduled to work on Friday, 1/22. From ED note: 50 yo f c/o mild dizziness and light-headedness today, worse with standing up. No n/v/d/f/c. Describes sx as typical early flu like sx today but slightly worse that her usual feeling from flu vaccines. Received the covid vaccine yesterday and friend experienced same symptoms. Felt "difficulty concentrating at work", which was very busy. No weakness, pre-syncope, numbness, cp, sob. No unsteady gait, vision changes. occ vision spots assoc with standing up. H/o anemia, h/o gastric bypass 2005. Often gets routine labs q 6 months but has not had any yet since COVID.
50 2021-02-15 redness I had the usual arm soreness. Foot pain started on 22nd and worse on 23rd. Left foot hurt the most. ... Read more
I had the usual arm soreness. Foot pain started on 22nd and worse on 23rd. Left foot hurt the most. This foot was the one that hurt a little before vaccine. It was in the center of my foot where the arch is but inside the foot - an achy pain. It would shoot through my foot with pain if I stepped a certain a way. I was limping a bit. I tried to stay off my feet as much as I could. It continued through Christmas holidays. December 28 -(my PCP) - she thought it was tendonitis - could see a red circle and swelling where most of the pain was. Dec 28 - x-ray of foot was done. There was no fractures Meloxicam - anti-inflammatory 15 mg daily starting 12/28/2020. Pain continued - trouble walking and started having hip pain and left leg pain maybe from compensating. I saw Dr. on January 7th. He said it was posterior tibialis tendonitis. He gave me a foot brace to wear - around ankle and foot. It helped but I was still having pain. I was still taking Meloxicam every day. A chiropractor and a physical therapist -they gave me foot exercises and leg exercises and that has been helpful - I see them once a week still. Dr check-up on February 9 and he ordered an MRI and I had that done on February 11th. Report says Tendinopathy and not tendonitis. I got the second dose on January 8th.
50 2021-02-15 injection site warmth, injection site swelling, injection site redness Night of vaccine (2/13) headache and body ache; Morning after (2/14 am) site injection swollen, red,... Read more
Night of vaccine (2/13) headache and body ache; Morning after (2/14 am) site injection swollen, red, and hot. body was weak, headache; Night after (2/14 pm) nausea, headache, injection site swollen, hot to the touch, and red. lymph nodes swollen (right armpit); Two mornings after (2/15 am) throwing up (4 times), injection site more swollen, hot, swollen lymph nodes (right armpit), body was clammy; Two evenings after (2/15 pm) injection site swollen, hot, swollen lymph nodes (right armpit), body was clammy; Three mornings after (2/16 am) injection site swelling increased, red, hot, swollen lymph nodes (right armpit), redness line from site to right armpit into a red circle
50 2021-02-15 hives Trouble breathing and extremely severe hives. Acute on chronic urticaria, improved over 5 days with ... Read more
Trouble breathing and extremely severe hives. Acute on chronic urticaria, improved over 5 days with high dose steroids. Breathing also improved slowly over same period.
50 2021-02-16 redness, itchy skin, rash Several minutes after vaccine administration, patient was in monitoring area and reported to EMS sta... Read more
Several minutes after vaccine administration, patient was in monitoring area and reported to EMS staff having a scratchy throat and a rash. Pt was scratching chest, redness present. No facial swelling noted, no signs of respiratory distress. An IV was started by EMS, and IV Benadryl was administered. Pt was monitored by EMS, symptoms improved. Patient denied wanting transport to the hospital for further monitoring and had a friend give her a ride home. She was informed to not receive the second dose.
50 2021-02-17 vaccination site pain 6 hrs post vax and 48 hours post vax: injection site pain; 6 hrs post vax: headache/ 48 hours post ... Read more
6 hrs post vax and 48 hours post vax: injection site pain; 6 hrs post vax: headache/ 48 hours post vax: remaining symptoms headache; 24 hours post vax: as above plus extreme fatigue/ 48 hours post vax: extreme fatigue; 24 hours post vax: chills/inability to feel warm; 24 hours post vax: inability to feel warm; 28 hours post vax: hot and cold flashes/ 48 hours post vax: remaining symptoms hot and cold flashes; 28 hours post vax: as the above plus nausea; 32 hours post vax: as above plus vomiting/ 38 hours post vax: vomiting ended; 38 hours post vax: otherwise as above with simultaneous hot sweats at upper body and cold sweats at lower body; 38 hours post vax: otherwise as above with simultaneous hot sweats at upper body and cold sweats at lower body; 48 hours post vax: general physical weakness and malaise; 48 hours post vax: general physical weakness and malaise; This is a spontaneous report from a contactable other Health professional (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9261), via an unspecified route of administration on 28Jan2021 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at Workplace clinic. Age at vaccination was 50-years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL0142) administered on 07Jan2021 (at the age of 50 years), at single dose in left arm. Medical history included anxiety, depression, obesity. The patient has allergies to certain unspecified antibiotics. Concomitant medications included citalopram, linum usitatissimum seed oil (FLAX SEED OIL), daily multivitamin 50+. It was reported that 6 hrs post vax on 29Jan2021 the patient experienced injection site pain, headache, 24 hours post vax: as above plus extreme fatigue, chills/inability to feel warm, 28 hours post vax: as the above plus nausea, hot and cold flashes, 32 hours post vax: as above plus vomiting, 38 hours post vax: vomiting ended, otherwise as above with simultaneous hot sweats at upper body and cold sweats at lower body, 48 hours post vax: remaining symptoms headache, injection site pain, hot and cold flashes, ex-treme fatigue, general physical weakness and malaise. The events were reported as non serious. No treatment was received for the events. The events resolved on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.
50 2021-02-21 itchy skin Within one minute of vaccination, patient was flushed, light-headed, dizzy, itching, and tingling do... Read more
Within one minute of vaccination, patient was flushed, light-headed, dizzy, itching, and tingling down right side. Also had mild muscle aches and a headache. Had a similar reaction on her first dose. Oxygen: 97% on room air, BP109/57 and HR 54. Pt declined Benadryl and was taken to ED for further evaluation,
50 2021-02-22 redness, vaccination site pain Arm burning from the inside out from injection site right after injection; headache; tingling hand a... Read more
Arm burning from the inside out from injection site right after injection; headache; tingling hand and feet; swelling hands feet and face; swelling face; flushed; red all over wheel down to ED; lump in throat; Low blood pressure; high resting heart rate; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: e10140), via an unspecified route of administration at the left arm on 11Jan2021 09:15 at single dose for COVID-19 immunization. Medical history included psoriatic arthritis, and allergies to shellfish, sulfa, bees, and, kiwi. The patient was not pregnant at the time of vaccination. Concomitant medication included naproxen sodium (ALEVE) and estradiol (ESTROGEN). The patient previously took naproxen (NAPROSYN) and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced arm burning from the inside out from injection site right after injection on 11Jan2021 9:15. Seconds later the patient experienced headache, lump in throat, tingling hand and feet, swelling hands, feet, and face, flushed, red all over wheel down to Ed, low blood pressure, and high resting heart rate all on 11Jan2021. The events resulted in emergency room/department or urgent care. Treatment was received for the all the events reported as IV with added therapy. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.; Sender's Comments: Based on the information currently available and due to a plausible temporal relationship, a possible contribution of the suspect product administration to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
50 2021-02-22 rash, rash with redness C/O feeling warm all over and developed a red lacy rash on trunk and extremities. Benadryl 25 mg ta... Read more
C/O feeling warm all over and developed a red lacy rash on trunk and extremities. Benadryl 25 mg tablet PO was given. BP taken.
50 2021-02-22 shingles Pt got vaccine 12/23/2020- then herpes zoster 1/7/2021 so started Valtrex. Started bleeding 1/10/21 ... Read more
Pt got vaccine 12/23/2020- then herpes zoster 1/7/2021 so started Valtrex. Started bleeding 1/10/21 and was admitted with platelet count of zero 1/11/2021. Diagnosed with ITP and is responding to prednisone. Also got IVIG. Of note- her dad has a h/o ITP as well and was on Rituxan and also developed low platelet count with each of his COVID vaccines.
50 2021-02-22 hives, itchy skin, injection site swelling Swelling at injection site leaving round circle that itches. Swelling under arm and tenderness in gl... Read more
Swelling at injection site leaving round circle that itches. Swelling under arm and tenderness in glands under arm. Muscle spasms in arms and chest. Slight nausea.
50 2021-02-23 injection site pain Adverse reactions started approximately after 14h -- Headache for 12 hours, pain to left arm/should... Read more
Adverse reactions started approximately after 14h -- Headache for 12 hours, pain to left arm/shoulder for 16 days; malaise and extreme fatigue for 5 days.
50 2021-02-23 injection site pain Side effects emerged approximately 12 hours after vaccinated. 1) temp that fluctuates from regula... Read more
Side effects emerged approximately 12 hours after vaccinated. 1) temp that fluctuates from regular to 101F. 20 hrs after vaccination, T100.7F, then persisted up and down for about a week. 2) Musculoskeletal pain to Left side of body: Mainly left upper body. -- 17 hrs after, woke up with severe pain to Lt shoulder and clavicle (thought it was broken somewhere.) The injected site was sore but mild. The Musculoskeletal pain still continues, and the pain comes in various sites, various forms, and in various level. It can be at Left shoulder, scapula, armpit, rib, lumber, hip, knee, and foot. Once in a while, Left ear pain. Mostly Lt shoulder, scapula, armpit, rib lately (today is 0224/2021.) Level changes depends on how it hurts; severe-moderate/shooting and needle pain, moderate/radiating pain, moderate-mild/dull pain, mild/annoying persistent uncomfortable pain. 3) neck and jaw joint stiffness only on left side. Current. 4) Extreme fatigue and brain fog--Extreme fatigue started on the next day and persisted for 3 days, then it became randomly daily. No warning signs given, suddenly feels extremely tired. This fatigue often comes with intermittent confusion. When severe, unable to move while laying. Today is 3rd week from vaccinated and unresolved completely.
50 2021-02-24 injection site pain, injection site swelling I waited the recommended 15 minutes after my vaccine and felt okay. When I got to my car, my face f... Read more
I waited the recommended 15 minutes after my vaccine and felt okay. When I got to my car, my face felt very hot and was flushed and the right side of my tongue felt thick for a day or more. Yesterday was one week ago from my vaccine and my tongue intermittently still feels thick. My tongue feels like it does when novocaine starts to wears off from the dentist. My right arm also felt sore and puffy; however, there was no skin reaction. The next day or so the right side of my neck was sore. As to be expected, my arm was also sore.
50 2021-02-24 injection site pain Sore arm, fever started on the day of vaccine 1/19/2021,body aches started on the day of vaccine un... Read more
Sore arm, fever started on the day of vaccine 1/19/2021,body aches started on the day of vaccine until today 02/25/2021, joint ache started at the time of vaccine up to now 02/25/2021, lingering fever 99.9 to 100 mostly at night .lingering headache, fatigue easily, short of breath on exertion started 2/02/2021 until now.
50 2021-02-25 injection site discomfort, injection site pain Received first covid vaccine 1/17/21 to the right deltoid (Pfizer, lot #EL3248). On 1/27/21 seen by ... Read more
Received first covid vaccine 1/17/21 to the right deltoid (Pfizer, lot #EL3248). On 1/27/21 seen by an APNP for right arm pain and decreased mobility. Presented to EHS on 1/29/21 with pain and concern that vaccine was give posterior to the deltoid. Pt did not take pictures or get seen around the time of her vaccine. So, 12 days later, unable to verify exact placement of the vaccine back on 1/17/21. Per the APNP's report on 1/27/21, the pt developed sharp shooting pain into the right trap/scapular area and radiation to lower arm. The pain started within a few seconds after the covid-19 vaccine was given. Feels soreness and tension in the shoulder/scapular area which has not resolved since vaccine. Pt advised continue supportive cares, trial diclofenac gel, use oral NSAIDs cautiously, apply heat. Follow up with EMG (scheduled for 4/14/21). Pt was also given a prescription for cyclobenzaprine. Per documented telephone encounters, as of 2/26/21 pt continues to have significant pain. Note: Pt received her second covid-19 vaccine on 2/13/21 in her left deltoid and there has been no mention of issues with pain in the left arm (Pfizer, lot #EN5318)
50 2021-02-25 itchy skin the room was spinning/whole room was spinning; dizzy spells/more of when she is in a certain positio... Read more
the room was spinning/whole room was spinning; dizzy spells/more of when she is in a certain position like when she is reaching up to get something or bending down, or at night when she reclines or is switching from side to side; her scalp was itching and her back and stomach was itching; This is a spontaneous report received from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm, on 21Jan2021 15:00, at single dose, for COVID-19 immunization. There were no medical history and concomitant medications. On 21Jan2021 at 15:00 (last Thursday), the patient received the first dose. On 22Jan2021 (the day after the vaccine) at 07:00, her scalp was itching and her back and stomach was itching and that went away the same day. In the morning of 23Jan2021 (also reported as "either 22Jan2021 or 23Jan202"), the patient had dizzy spells, more of when she is in a certain position like when she is reaching up to get something or bending down, or at night when she reclines or is switching from side to side. She stated that it usually happens when bending over, reaching up high, in a recline position or when switching sides on the pillow. She reported that she is still experiencing this symptom with no improvement and reported that dizziness worsened. In the morning of 26Jan2021, the patient reported that it was worst, the whole room was spinning but that spell went away after a few seconds. The patient reported her second dose was scheduled on 11Feb2021 and asked if the side effects after the second dose will be worse. The patient did not visit the emergency room and physician office. The outcome of the event "dizzy spells/more of when she is in a certain position like when she is reaching up to get something or bending down, or at night when she reclines or is switching from side to side" was not recovered; "the room was spinning/whole room was spinning" was recovered on 26Jan2021 (reported as "went away after a few seconds"); and "her scalp was itching and her back and stomach was itching" was recovered on 22Jan2021 (also reported as recovered on 23Jan2021). Information on lot/batch number has been requested.
50 2021-02-26 injection site pain 2/24/21 Injection Site arm soreness (8 hours) 2/25/21 - Right arm pain, nausea, body aches (12 hou... Read more
2/24/21 Injection Site arm soreness (8 hours) 2/25/21 - Right arm pain, nausea, body aches (12 hours) stomach pain (6 hours) Migraine-like headache (8 hours) 2/26/21 Tired 8 hours
50 2021-02-26 injection site bruising, hardening Injection site was bruise about 2 inches around and whole top arm was swollen and hard for 4 days. C... Read more
Injection site was bruise about 2 inches around and whole top arm was swollen and hard for 4 days. Could not raise arm without being in pain. Tired, headache behind the eyes, hard time breathing, chills (no fever) and dizziness. Still have headache and some dizziness and it has been a week and 2 days since the shot. Have not gone to the doctors. I have been treating myself with my inhalers and migraine medicine. Arm is better as far as soreness, but still have some bruising.
50 2021-02-28 hives, itchy skin 1st - arm pain and heaviness from shot - 1 day after shot - took Tylenol 2nd - mild itching on face ... Read more
1st - arm pain and heaviness from shot - 1 day after shot - took Tylenol 2nd - mild itching on face and head - 3 -4 days after shot - did not recognize it as a reaction - no treatment given 3rd - difficulty breathing, asthma attack, full body covered with hives - 5 days after shot - took Benadryl for 24 hours - went to urgent care the next morning and was given steroid medication to take each day for a week, directed to continued to take Benadryl until steroids stop the hives 4th - second respiratory reaction with coughing and difficulty breathing - took an extra Benadryl.
50 2021-02-28 hives Starting day two - five. Hives fatigue. Felt like bones were melting. Body aches. After one week, b... Read more
Starting day two - five. Hives fatigue. Felt like bones were melting. Body aches. After one week, began experiencing tendon pain in ankles,knees, elbows, wrists. Fatigue continues.
50 2021-03-01 bruising, rash At first I did not associate the rash to the COVID vaccine but have been hearing others reporting ra... Read more
At first I did not associate the rash to the COVID vaccine but have been hearing others reporting rash similar to mine. It has been ongoing to quite some time now and it seems to be spreading. I have a rash in my armpits and upper arms, on my trunk-back and front and on my Right forearm. I am also noticing small bruises under my breast which occurred first and bumps on the sides of my breasts.
50 2021-03-01 rash rash on both arms, moved to lower left leg (shin area)
50 2021-03-02 injection site swelling, injection site redness, injection site pain, injection site warmth "The shot itself was very unpleasant, the vaccine stung. The nurse was concerned about this since ... Read more
"The shot itself was very unpleasant, the vaccine stung. The nurse was concerned about this since it shouldn?t cause any discomfort at all. Other than immediate onset of a painful injection site no other symptoms occurred until later in the evening. I started feeling kind of yucky before I left work but nothing specific. By the early evening I was running a low grade fever and having muscle and joint pain. I didn?t sleep very well due to body aches and severe organ pain. At one point I woke up because my heart was beating so hard and fast I could feel it in my forehead. My lips and eyes were swollen and my neck was visibly swollen as well, I think due to the lymph nodes in my neck. My throat was some swollen but not enough to cause a breathing issue. The heartbeat issue didn?t last terribly long. I took a Benadryl to try and stop the reaction. I ran fever of a 102 give or take a few degrees either way for 2 ½ days. In addition, the injection site and whole shoulder area was swollen and hot with redness that wrapped around the front of my arm."
50 2021-03-02 vaccination site pain Injection site pain; Chills; nausea; fever 99.5; This is a spontaneous report from a contactable con... Read more
Injection site pain; Chills; nausea; fever 99.5; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the right arm on 30Jan2021 10:00 at a single dose for COVID-19 immunization in a clinic. Medical history included high blood pressure and COVID-19 prior to vaccination. The patient was not pregnant. Concomitant medication included hydrochlorothiazide, lisinopril hydrochlorthiazid, loratadine, and fluticasone propionate (FLONASE). The patient experienced injection site pain, chills, nausea, fever 99.5 on 30Jan2021 10:00. The patient did not receive any treatment for the events. The patient was recovering from the events. Information on lot/ batch number has been requested.
50 2021-03-02 rash Noticeable rash developed on upper part of both legs, on arms and front section of my neck. Never o... Read more
Noticeable rash developed on upper part of both legs, on arms and front section of my neck. Never on the torso.
50 2021-03-02 itchy rash Pt c/o heart palpitations and lightheadedness. Paramedic assessed pt; HR-188; B/P- 171/105; SpO2- 9... Read more
Pt c/o heart palpitations and lightheadedness. Paramedic assessed pt; HR-188; B/P- 171/105; SpO2- 99% on RA; completed 4 lead EKG- showed sinus tachycardia. C/O itching and rash noted on chest. Paramedic started 20G IV in R wrist and gave 50 mg of Benadryl. Transported to hospital.
50 2021-03-03 redness, itchy skin Patch of redness over the dorsum of the right thumb and inferior to left scapula. Slight itchiness. ... Read more
Patch of redness over the dorsum of the right thumb and inferior to left scapula. Slight itchiness. No other symptoms. No dizziness or SOB. Normal vital signs. Spontaneously recovered after 45 minutes.
50 2021-03-03 itchy skin, rash Scratchy, dizzy, rash, faint
50 2021-03-03 rash funny taste in mouth, felt buzzed, headache, confused, tunnel vision, pale, fainted, rash on torso
50 2021-03-03 hives hives on b/l arms
50 2021-03-04 injection site pruritus, shingles, itchy skin, injection site pain Headache; chills; aches; itching. I also had pain and severe itching of the left shoulder. I was lat... Read more
Headache; chills; aches; itching. I also had pain and severe itching of the left shoulder. I was later treated for shingles one week after the shot. I know the Pfizer triggered this. I had these symptoms of pain and itching within 2 1/2 hours of taking the vaccine.
50 2021-03-04 itchy skin, rash with redness It was a severe rash, presented like a sun burn. When it first started it was on mu upper chest, the... Read more
It was a severe rash, presented like a sun burn. When it first started it was on mu upper chest, then climber up my neck, there were spots coming up on my neck and ear area. There was heat around it just like a sun burn, it was hot to touch and itchy. The Dr. gave me steroid ointment to help with it. This lasted for a long time, it still feels different, there's little bumps there for about 2 weeks. It seem to stick around, now if I'm doing something it gets more red quicker but does not bother me.
50 2021-03-05 redness, itchy skin Appx 24 hours after the injection, the site of injection started itching very badly and a bright red... Read more
Appx 24 hours after the injection, the site of injection started itching very badly and a bright red solid spot appeared and a lump that was sore to touch. Redness was just smaller than a quarter at first. That was about 5:10pm 3/5 and then appx 8-9 hours later, while sleeping, I developed a severe cough and my nose was completely stopped up. Eyes were itching with drainage too. My husband got up and gave me a Benadryl and that calmed everything down so I could sleep again. This morning, my eyes were pretty red and still had some drainage. My cough is there but very faint and less frequent. My arm hasn?t stopped itching and the red spot is slightly larger at appx 1.5 inches tall and 1 inch wide. Still with a lump and soreness. I expected the lump and soreness.
50 2021-03-05 injection site swelling, injection site pain, injection site redness Blood pressure dropped quickly to 89/59 and oxygen level dropped. Felt dizzy like I was going to pas... Read more
Blood pressure dropped quickly to 89/59 and oxygen level dropped. Felt dizzy like I was going to pass out. Family said I looked pale and yellow in face. Nurses were great but I have never had a reaction to a vaccine before. I don?t think I will get 2nd dose. I will call my family doctor to inform him of what happened. Arm location of shot is red, swollen and tender still today. I have now been feeling ill like flu like symptoms but I was told that is normal.
50 2021-03-06 hives, itchy skin Approximately one week after receiving my second vaccine, I started itching on both elbows, side of ... Read more
Approximately one week after receiving my second vaccine, I started itching on both elbows, side of legs and my rear. As soon as I scratched any of the areas I immediately broke out in hives. It has continued day and night since it began. I have tried taking Benodril and Zyrtec, Benodril itch cream and Bactine Spray to relieve the itching and hives and I only get temporary relief.
50 2021-03-07 injection site swelling, injection site pain, injection site warmth, injection site redness "Pfizer-BioNTech COVID-19 Vaccine EUA" Around 5pm on March 7th, noticed my arm at site of vaccinatio... Read more
"Pfizer-BioNTech COVID-19 Vaccine EUA" Around 5pm on March 7th, noticed my arm at site of vaccination was feeling more tender, hot, swollen, and red. In the night, I couldn't lay on that side. Stayed the same throughout March 8th, until 7pm, became increasingly sore. My entire arm is aching. The redness and swelling has also increased. I also have a headache started this evening.
50 2021-03-07 shingles 12 hours after 2nd dose - severe body aches for 24 hours - self-treated with Ibuprofen 6 weeks after... Read more
12 hours after 2nd dose - severe body aches for 24 hours - self-treated with Ibuprofen 6 weeks after 2nd dose - shingles - treated with Valacyclovir and Gabapentin (7 days)
50 2021-03-07 injection site pain Headache and fatigue the day after injection, lasted at least 24 hours. Sore arm at the injection si... Read more
Headache and fatigue the day after injection, lasted at least 24 hours. Sore arm at the injection site, the day of and up to at least 4 days after. Swollen lymph nodes under left arm (injection site arm) the day after and lasted at least 4 days.
50 2021-03-07 rash mild rash on chest/neck. Evaluated by EMS-Cleared
50 2021-03-08 injection site pain Left arm pain at site of injection, throbbing down the arm, burning sensation and heaviness. Inabil... Read more
Left arm pain at site of injection, throbbing down the arm, burning sensation and heaviness. Inability to raise arm and entire arm swollen. In addition to this on the first day of the adverse event flu like symptoms which lasted two days. Arm pain continues as at day four since adverse event started
50 2021-03-09 rash Chills; Fever; Tired; Rash; This is a spontaneous report from a contactable consumer reported for he... Read more
Chills; Fever; Tired; Rash; This is a spontaneous report from a contactable consumer reported for herself. A 50-year-old patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL9629 and Expiration Date unknown) via an unspecified route of administration on 04Feb2021 03:00 PM at age of 50-year-old (vaccine location: Left arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3249 and Expiration Date unknown) via an unspecified route of administration on 13Jan20210 3:15 PM at age of 50-year-old (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history was reported as stroke from Oct2019, no previous covid and no known allergy. There is no other vaccine in four weeks. The concomitant medications reported as acetylsalicylic acid (ASPIRIN) and metoprolol succinate (Toprol 25MG). Patient experienced Chills, then fever, tired, rash from 05Feb2021 06:00 PM. The outcome of events was recovering without treatment given. Information on the batch/Lot number has been requested.
50 2021-03-09 hives, injection site redness Golf ball size welt and redness around injection site 8 days after first dose.
50 2021-03-09 itchy skin, redness, hives Hands and feet swelling, Redness, Hives, Itchy Skin
50 2021-03-09 hives Patient reported to nurse that she was starting to develop hives. Upon inspection patient was seen t... Read more
Patient reported to nurse that she was starting to develop hives. Upon inspection patient was seen to have red blotchy hives on her neck and chest. She reported that it felt hot but not itchy.
50 2021-03-09 rash, injection site rash, injection site redness, injection site pain, rash papular, injection site pruritus Pt given first Pfizer Covid Vaccine dose and within five minutes c/o pain ,burning and itching at le... Read more
Pt given first Pfizer Covid Vaccine dose and within five minutes c/o pain ,burning and itching at left arm site. Given Benadryl 50mg IM for sx reddness and raised rash at site, and chest. Pt felt immediate relief after Benadryl injection. vss 144/76,hr 80, o2 Sat 100%
50 2021-03-09 rash with redness, rash Red rash spots on multiple locations of the body (arm, leg, chest, back), not raised and do not itch
50 2021-03-09 vaccination site pain This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient (n... Read more
This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 05Feb2021 08:30 at the age of 50-years-old at single dose for COVID-19 immunization. Medical history included obesity, inflammatory lung disease. No known allergies. The patient's concomitant medications were not reported. The historical vaccine included BNT162B2 on 15Jan2021 at the age of 50-years-old for COVID-19 immunization. The patient experienced 6 out of 10 pain, tenderness and mass of some sort behind left collarbone pain radiating toward shoulder and neck, injection site minimally sore on 05Feb2021 20:00. Pain resolves with ibuprofen, no treatment received for the other events. The events outcome was not recovered. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. Information on the lot/batch number has been requested.
50 2021-03-09 vaccination site pain joint pain; weakness; chills; diarrhea; dizziness; minor difficulty breathing; headache; Injection s... Read more
joint pain; weakness; chills; diarrhea; dizziness; minor difficulty breathing; headache; Injection site pain; malaise; muscle cramping; swollen lymph nodes; projectile vomiting; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (not pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN9581) via an unspecified route of administration in right arm on 03Feb2021 15:45 at single dose for covid-19 immunisation. Medical history included diabetes, hypertension (HTN), and gastrooesophageal reflux disease (GERD). Known allergies included xylometazoline hydrochloride (SUDAFED). Concomitant medication included omeprazole (PROTONIX), metformin hydrochloride, sitagliptin (JANUMET), empagliflozin (JARDIANCE), insulin glargine (BASAGLAR), escitalopram oxalate (LEXAPRO). There was no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had no COVID tested post vaccination. The patient experienced joint pain, weakness, chills, diarrhea, dizziness, minor difficulty breathing, headache, injection site pain, malaise, muscle cramping, swollen lymph nodes, projectile vomiting, all on 04Feb2021 09:15 with outcome of recovering. No treatment received for the events.
50 2021-03-09 vaccination site pain metallic taste same as experienced when receiving chemo last year; mild pain at injection; This is a... Read more
metallic taste same as experienced when receiving chemo last year; mild pain at injection; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number: EL3247, via an unspecified route of administration on 24Feb2021 14:00 at a single dose in the right arm for COVID-19 immunization. Medical history included early breast cancer, metallic taste when receiving chemo last year in 2020. The patient had no allergies to medications, food, or other products. Concomitant medication included anastrozole and calcium carbonate, vitamin D. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced metallic taste same as experienced when receiving chemo last year and mild pain at injection on 24Feb2021 17:00. No treatment was received. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested positive for COVID-19 since the vaccination. The outcome of the events was not recovered.
50 2021-03-09 pain of skin painful body aches/shooting pains; chills; skin tender to the touch; This is a spontaneous report fr... Read more
painful body aches/shooting pains; chills; skin tender to the touch; This is a spontaneous report from a contactable other hcp (reported for herself). A 50-years-old female patient received first bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: EN5318), via an unspecified route of administration on 18Feb2021 14:00 at single dose for covid-19 immunisation. Medical history was not reported. Concomitant medication included bifidobacterium lactis (PROBIOTIC), ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE). On 19Feb2021 02:00 patient experienced painful body aches/shooting pains, chills, skin tender to the touch. Prior to vaccination, patient was not diagnosed with COVID-19, Since the vaccination, patient has not been tested for COVID-19. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the event was recovered on unspecified date in Feb2021.
50 2021-03-10 itchy skin ITCHY, NO RESPIRATORY DISTRESS/ STRIDOR NOTED. BENADRYL 50MG PO GIVEN X 1 @ 1045 PT WAITED 15 MIN PR... Read more
ITCHY, NO RESPIRATORY DISTRESS/ STRIDOR NOTED. BENADRYL 50MG PO GIVEN X 1 @ 1045 PT WAITED 15 MIN PRIOR TO DISCHARGE. NO FURTHER COMPLAINTS FROM PATIENT.
50 2021-03-10 rash Mild rash all over trunk
50 2021-03-10 itchy skin post vaccine complained of headache, dizziness and itchiness for 5 mins. Patient recovered, Normal V... Read more
post vaccine complained of headache, dizziness and itchiness for 5 mins. Patient recovered, Normal V/S. Zyrtec PO given
50 2021-03-11 pain of skin Fever, chills, body aches, joint pain, headache, extreme fatigue, brain fog, flare up of MS symptoms... Read more
Fever, chills, body aches, joint pain, headache, extreme fatigue, brain fog, flare up of MS symptoms, skin hurt to the touch.
50 2021-03-11 hives Hives all over body, shortness of breath, treated with IV (Benadryl, Prednisone and Pepsid)
50 2021-03-11 hives On 3/9/2021 the patient presented to the ED for an allergic reaction. She broke out in hives after s... Read more
On 3/9/2021 the patient presented to the ED for an allergic reaction. She broke out in hives after showering in the morning. The hives started on her back and spread to her abdomen. The patient was not admitted.
50 2021-03-11 bruising On day of shot, I was fine, more tired than usual by bed time. Next morning I was extremely weak an... Read more
On day of shot, I was fine, more tired than usual by bed time. Next morning I was extremely weak and fatigued not able to get out of bed for two hours. I went downstairs to get water, blacked out and completely fainted. I got out of bed around 10:25 or so, went downstairs very slowly, saw clock when I was able to get up around 10:47. I don't believe I was passed out for long. Woke up on kitchen floor, arm bruised. Thankfully head was not injured, apparently fell with arm supporting head (assumption since no head injury). Advised by nurse to come to dr. office, they tested blood pressure, top number was 82 (did the tilt test for orthostatic hypotension). EKG was normal and other blood tests were normal. Was diagnosed with dehydration and low BP. I habitually drink water and even if I did potentially skip a day, I should not faint.
50 2021-03-11 injection site pain Very sore upper arm at and around injection site. Chills Extremely tired night of vaccination only.... Read more
Very sore upper arm at and around injection site. Chills Extremely tired night of vaccination only. Mild/dull head ache Stuffy nose
50 2021-03-12 injection site pain Sore injection site on the upper left deltoid.
50 2021-03-13 injection site pain 1. Arm sore at the site of shot - from the time of shot and ongoing till Sunday, 3/14. (at the time ... Read more
1. Arm sore at the site of shot - from the time of shot and ongoing till Sunday, 3/14. (at the time of this report) 2. Headache - from day of shot evening and on going at the time of this report. Headache is on and off and not constant at all times. Only medication taken was Advil 400 mg on 3/13 at 8 pm. 3. Fever - only at bedtime - 3/12 night - 99 F and 3/13 night - 98.9 F. No fever reducer taken. 4. Body ache and tiredness, ongoing.
50 2021-03-13 rash, itchy rash Developed scratchy throat and then itchy rash at approximately 15 minutes post dose. Patient given ... Read more
Developed scratchy throat and then itchy rash at approximately 15 minutes post dose. Patient given 50 mg oral Benadryl and monitored for over 30 minutes. Patient has a history of epi pen usage due to history of allergies to sulfa, flaxseed and environmental triggers. She has received flu vaccine in the past with minimal reactions. Given oral benadryl 50mg x 1 and monitored for at least an additional 30 minutes. Per pt on my chart in March: tingling of the tongue was mild. The right ear and right side of my head was intense with pressure and it did feel like it wanted to explode. After the Benadryl it started to subside. It lasted about 50 minutes. The rash were not like hives. The rash was on my neck , arms and face. It lasted about 2 days and was a mild case. Not over body. No fainting, no low grade fever.
50 2021-03-14 rash with redness 22 minutes after vaccine was administered pt stated that she could not swallow and a red rash was no... Read more
22 minutes after vaccine was administered pt stated that she could not swallow and a red rash was noted to her neck and chest. Throat was red and swollen. Administered IM diphenhydramine and immediately took pt to ER.
50 2021-03-14 injection site pain Fine for 10+ hours. That evening, L arm really ached, really painful to lift above shoulder height. ... Read more
Fine for 10+ hours. That evening, L arm really ached, really painful to lift above shoulder height. Noticeably sore at injection spot. Joints started aching, tired, noticeably sore up through neck on L side. Was driving at night- distance vision was blurry (could have been dry eyes, not sure related to vaccine). Slept 14 hours. Woke with muscles still achy, not quite as much as day before. Neck still sore. Injection site only sore to touch. Still very tired, could have slept more. Woke up today, feel pretty normal. A bit tired.
50 2021-03-14 itchy skin I was told by my doctor after talking with his office on the phone to report my reaction and that he... Read more
I was told by my doctor after talking with his office on the phone to report my reaction and that he is recommending that I NOT HAVE THE SECOND DOSE of this vaccine. On Tuesday March 9th I had my first dose of the Pfizer vaccine at our drive up site with the health department. I did not have any tylenol or claritin that morning and only took Tylenol that night. Starting the NIGHT of the 10th I started taking my usual Child's dose of Claritin for seasonal allergies. I took Claritin the nights of the 10th, 11th and 12th (thank goodness apparently). The only issue I had the 9th and 10th was REALLY SORE ARM. One the morn ing of Saturday the 13th I woke up and my neck was itching. Then my decollete area. Then my face and head and shoulders and the back of my arms. I felt like I was flushing after a steroid shot with the pin prickly itching and very very very slight pink color to my skin. Eventually by the evening the itch moved to my bra line. I called my local pharmacy (since the urgent care center was closed) and was told to take benedryl or claritin and keep an eye on it. The ADULT dose of Claritin really helped to calm the majority of the itching. I itched a little yesterday and still itch in spots today but the Claritin is helping as is topical Cortaid. The nurse said the claritin I had in my system probably prevented me from turning red. I have been told by two doctors that I should NOT take the second dose. ALL OF THE CONVERSATION WITH MY DOCTOR WAS DONE OVER THE PHONE.
50 2021-03-14 itchy skin, rash, hives Immediately after receiving the injection, I experienced a headache right behind my eyes (similar to... Read more
Immediately after receiving the injection, I experienced a headache right behind my eyes (similar to sinus headache); after approximately 15 minutes, I experienced a ringing in my ears. I told the attending person, but she said it was probably due to being anxious about getting the shot. I left after being in the waiting area for 30 minutes and began driving home. My face felt very warm, so I opened the car window. I touched the side of my face and felt hives. My tongue felt thick, but I did not feel hives going down my throat. My torso started to itch and I had hives there as well. There was no raised area at the injection site. I became very itchy on my head, neck, and arms. When I arrived home, I took a dose of benadryl. Four hours later, I took a dose of zyrtec. My hives subsided and my tongue returned to normal, but I was still itchy. The next morning, I took a dose of claritin and called my doctor. In the afternoon, I took benadryl. In the evening, I took zyrtec. I continued this for 2 more days. The day after my vaccine, a node between my thumb and forefinger on my left hand was swollen and painful to the touch. My hand was swollen and my finger joints ached. I went to the doctor for an examination. The swelling and pain in my hand continued to worsen during the day and overnight. I kept ice packs on my hand and it felt better after 3 days.
50 2021-03-14 itchy rash Patient developed an itchy rash on the opposite (right) forearm within the 15-minute observation per... Read more
Patient developed an itchy rash on the opposite (right) forearm within the 15-minute observation period. Patient was given an IM shot of 25 mg of Benadryl in the hip. Problem was resolved and no other adverse effects occurred.
50 2021-03-15 skin warm After getting the shot I had instant metal/ chemical taste in my mouth, it lasted all day. I also fe... Read more
After getting the shot I had instant metal/ chemical taste in my mouth, it lasted all day. I also felt it go into my body like a warm rush throughout. I got a little light headed.
50 2021-03-15 itchy rash, injection site warmth, rash papular, skin tightness, injection site pain, injection site reaction day of: queasiness, tightness at site of injection 1 day after: heaviness/weighed down, headache, qu... Read more
day of: queasiness, tightness at site of injection 1 day after: heaviness/weighed down, headache, queasiness, sore arm 2 days after: muscle aches, loss of appetite. night time: arm hurts 3 days after: loss of appetite, arm has raised rash about 3"x4" near the site of injection -hurts like a bruise, itchy, warm/hot 4 days after: rash symptoms same as above 5 days after: rash is beginning to dissipate, still itchy at times
50 2021-03-15 redness, itchy skin pt. experiencing redness to chest and some itching on L. thigh. pt. states this reaction is normal... Read more
pt. experiencing redness to chest and some itching on L. thigh. pt. states this reaction is normal with contact with her dog? she recently had contact. pt. denies any other S/S. pt. advised to wait an additional 15 mins.
50 2021-03-15 skin warm pt. experiencing tingling to the L. leg and warmth throughout the body. pt. advised to wait an addi... Read more
pt. experiencing tingling to the L. leg and warmth throughout the body. pt. advised to wait an additional 15 mins.
50 2021-03-16 hives, rash, itchy skin A severe case of welt-like rash on legs, thigh, torso, scalp, underside of arms. I?m taking Zyrtec,... Read more
A severe case of welt-like rash on legs, thigh, torso, scalp, underside of arms. I?m taking Zyrtec, generic Benadryl, cortisone cream. The rash was a slow build. It started with scattered hives (which I had been getting prior to the shot) day 3-6 is when it worsened and they became giant rashes similar to the photos posted online related to Covid rash. None on my toes or fingers. They are predominately on my thighs, torso, arms, and scalp. Thy are hot, itchy, and stinging. Day 6 I also had a low grade fever (100.1) and swollen tonsils.
50 2021-03-16 itchy skin, rash macular, redness Pt vaccinated 2/25/01. Aprox 60-90 minutes after vaccination, pt noted feeling hot and itchy, she lo... Read more
Pt vaccinated 2/25/01. Aprox 60-90 minutes after vaccination, pt noted feeling hot and itchy, she looked in the mirror and was red/blotchy all over. She took 25mg benadryl as she was driving home and took another 25mg benadryl 20-30 min later when she arrived home. She continued to feel hot and itchy so took benadryl for the next 48 hours before those symptoms resolved. On day 4 after vaccine (2/29/01) pt began to notice redness in her right eye. The eye became more "bloodshot" as the day progressed and started feeling painful and "pressure" sensation. She went to see ophthalmologist urgently who diagnosed it as acute scleritis. She is currently on NSAIDs and topical steroid. She notes that the eye is very photosensitive and has significant "pressure" sensation. She is still experiencing these symptoms almost 3 weeks later.
50 2021-03-16 rash RIGHT AFTER VACCINATED, PATIENTS START TO PRESENT A SEVERE RASH IN HER BODY, AND HER EYES WERE VERY ... Read more
RIGHT AFTER VACCINATED, PATIENTS START TO PRESENT A SEVERE RASH IN HER BODY, AND HER EYES WERE VERY RED. PATIENTS DID NOT SHOW ANY SIGH OF SWELLING AND WAS ABLE TO BREATH. AFTER REASSES OF THE SITUATUION, PROCEED TO INJECT DIPHENHYDRAMINE 50MG/ML VIAL. PROCEED TO CALL 911, WHEN THE PARAMEDICS ARRIVED, VITAL SIGNS WERE TAKEN. AFTER 15 MINUTES OF THE ADMINISTRATION ALL RASH AND RED IN HER SKIN STARTED TO IMPROVISED. PATIENTS WAS OBSERVED FOR 30 MORE MINUTES AND THE PARAMEDICS PROCEED TO DISCHARGE HER HOME.
50 2021-03-16 hardening Severe dizziness 1 hour after immunization, cleared after 1/2 hour. Starting day after vaccination,... Read more
Severe dizziness 1 hour after immunization, cleared after 1/2 hour. Starting day after vaccination, awoke with dizziness, nausea, chills. Diarrhea later in day. Starting 3 days after vaccine, painful and swollen and hard supraclavicular, Left axilla, cervical lymph nodes. Dizziness and nausea persist. Fatigue requiring 12 hours sleep. Paresthesias (tingling, "pins and needles"), both lower extremities, from toe to knee, unremitting, worst on day 2 after vaccination.
50 2021-03-18 itchy skin About 6 hours after being vaccinated, right hand got hot and was itching between the fingers. Laste... Read more
About 6 hours after being vaccinated, right hand got hot and was itching between the fingers. Lasted about 10 minutes.
50 2021-03-18 injection site pain Day 7 post vaccine arm pain at injection site. Sometimes a dull ache and sometimes sharp pain with ... Read more
Day 7 post vaccine arm pain at injection site. Sometimes a dull ache and sometimes sharp pain with movement.
50 2021-03-18 skin swelling Large irratating knots over my body mostly on the left side.
50 2021-03-18 shingles Shingles left temple
50 2021-03-18 hives a welt the size of a ping pong ball developed below the injection site; entire arm in pain with vein... Read more
a welt the size of a ping pong ball developed below the injection site; entire arm in pain with veins swelling; entire arm in pain with veins swelling; This is a spontaneous report from a contactable nurse, the patient. A 50-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration, administered in the left arm on 12Feb2021 at 15:00 (at the age of 50 years-old) as single dose for COVID-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. The patient has no allergies to medication, food or other products. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2, via an unspecified route of administration, administered in the left arm on 22Jan2021 at 16:00 (at the age of 50 years old) for COVID-19 immunisation. Prior to the vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Feb2021 at 00:00 (reported as 12:00 AM), two days after the second dose (as reported), the patient experienced entire arm in pain with veins swelling, and on 14Feb2021 (exact time unknown), day 3 after the second dose, a welt the size of a ping pong ball developed below the injection site. The patient reported the events as non-serious. Therapeutic measures were taken as a result of entire arm in pain with veins swelling and a welt the size of a ping pong ball developed below the injection site included unspecified home pain medications and creams. The outcome of the events entire arm in pain with veins swelling and a welt the size of a ping pong ball developed below the injection site was recovering. It was also reported that since the vaccination the patient has not been tested for COVID-19. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
50 2021-03-18 injection site pruritus, injection site redness, injection site pain, rash macular, injection site swelling about 6 days after the injection I noticed a large swollen red spot around where the injection was a... Read more
about 6 days after the injection I noticed a large swollen red spot around where the injection was administered. It is about the size of the palm of my hand, is red, swollen, sore to the touch, and extremely itchy.
50 2021-03-19 itchy skin 10:50 Pt c/o "severe itching", mostly on extremities, but some "mild itching" on tongue. Denies sho... Read more
10:50 Pt c/o "severe itching", mostly on extremities, but some "mild itching" on tongue. Denies shortness of breath, difficulty breathing throughout episode, observed unlabored breathing, appropriate verbal responses
50 2021-03-19 injection site swelling, injection site redness, injection site pruritus Mild Itching at injection site . Today 3/20/2021, 8 days after the shot) the itching has gotten sli... Read more
Mild Itching at injection site . Today 3/20/2021, 8 days after the shot) the itching has gotten slightly more and there is redness and swelling at the injection site. The red patch area and swelling is about 2? diameter.
50 2021-03-19 blister Slight headache beginning evening of vaccination. Progressed to fever <100.2, body aches, extreme t... Read more
Slight headache beginning evening of vaccination. Progressed to fever <100.2, body aches, extreme trembling, chills and twitching, blistering of the skin on the forearm of the same injection arm, delirium and hallucinations, wet cough with blood in sputum. Patient called pharmacy on Saturday 3/20/21 03:45pm to advise of reaction, RPh advised patient to go to a physician ASAP for evaluation of symptoms.
50 2021-03-20 rash A rash on my inner forearm near my wrists. It looked like tiny pinprick sized blood dots at first. N... Read more
A rash on my inner forearm near my wrists. It looked like tiny pinprick sized blood dots at first. Now it looks more like a traditional rash. Also a little swollen. I felt a wave of dizziness. That has passed.
50 2021-03-20 hives Patient in 30 minute observation area developed hives on back, chest and arms. Evaluated by EMS. No... Read more
Patient in 30 minute observation area developed hives on back, chest and arms. Evaluated by EMS. No shortness of breath; lung sounds were clear. Monitored for 30+ minutes. Negative change. Refused treatment and transport.
50 2021-03-20 injection site warmth, injection site nodule Started at 1 am. from 1st vaccination. Sever headache , vomiting, chills, body aches, fever from 101... Read more
Started at 1 am. from 1st vaccination. Sever headache , vomiting, chills, body aches, fever from 101 to 102.7, nausea, few times I thought I was going to pass out, weakness., arm extremely sore As of 3/21/21 still weak, have a headache (not as intense) fever runs 99 to 101, arm still sore with a knot and is hot
50 2021-03-21 injection site pain Arm became very sore a few hours after injection. Soreness went away by second morning after.
50 2021-03-21 injection site pain Lightheadedness, chills, fever, headache, body aches, fatigue, cough, injection sight pain
50 2021-03-21 injection site pain My arm has been aching since the 1st one. I let the RN giving me the 2nd shot aware and he said that... Read more
My arm has been aching since the 1st one. I let the RN giving me the 2nd shot aware and he said that?s weird. I just happened to have the same person injecting both times. Never reported or had me speak with anyone at that time. He said I could get it in the left, but I denied due to I didn?t want the pain in both arms. When he gave me the 2nd shot I felt it so much more than the first shot that I blurted out that hurts and a felt a twinge in my arm, as if it hit something other than the muscle. My arm 2 mos later is not let up the pain. I can only raise it so high. I cannot sleep on either side w/o pain. Same days are worse than others. The pain is right at the injection site. This is the only thing I have had done to my arm so I know it has something to do with the vaccine. I alternate ice and heat along with ibuprofen and it does not touch the pain/aches. It is a constant ache in my arm. I did contact my employee health at work and she advised me to fill out report on this website and in the Hospital safety report.
50 2021-03-22 injection site pain, injection site rash, injection site bruising Lymph notes all over my body are inflamed and tiredness (started 3/20/21 - the day after I received... Read more
Lymph notes all over my body are inflamed and tiredness (started 3/20/21 - the day after I received injection), and now COVID-arm (bruise at injection site, rash, pain) this started 3/22/21.
50 2021-03-22 shingles, itchy skin On the 16th, I had the right ear and head pain. That lasted Sat, Sun and Mon. I woke up Tuesday morn... Read more
On the 16th, I had the right ear and head pain. That lasted Sat, Sun and Mon. I woke up Tuesday morning (18th), I had a small Shingles lesion along with those symptoms. . I went to the doctor's office and saw the NP, who diagnosed me with an ear infection--right Otis externa. On Wed (19th) my right eye was swollen and my scalp, right forehead and eye were covered in shingles. On the 20th, I was diagnosed with having Ocular Shingles. I was put on steroids and sent to an emergent appointment with ophthalmologist because they were concerned that I would lose my sight. He put me on Acyclovir 800mg, 5 times a day and increased my steroids to: 40mg a day for 2 days, 30mg for 3 days and 20mg for 3 days and 10mg for 4 days. Fortunately the branch that goes into my cornea was not affected. I was in bed the entire time. I still had lesions when I went back to see him, which is why he kept me off work until Feb 1st. I continued to have neuralgia (nerve pain) and then I started itching. I went back to quick care and put on Atarax. I took that every 4 hours for about a week. Then I tapered it down to about twice a day. It eventually got better, but I do itch sometimes. Looking back, I did have a little right ear pain after the 1st dose of the vaccine.
50 2021-03-22 itchy skin Patient felt itchy on vaccinated arm (L), left buttocks, and on back prior to leaving vaccination si... Read more
Patient felt itchy on vaccinated arm (L), left buttocks, and on back prior to leaving vaccination site (less than 30 minutes). Patient given Benedryl and released home.
50 2021-03-22 hives Symptoms began with tingling in back of throat on left side. Within 30 minutes I was having difficu... Read more
Symptoms began with tingling in back of throat on left side. Within 30 minutes I was having difficulty swallowing and hives began to appear on chest and arms. I was given Benadryl through IV about 10:45. I was taken by ambulance to hospital and remained there for about an hour and a half until symptoms subsided
50 2021-03-22 redness left ring finder tender on Monday 03/22/21, Woke up Tuesday, 03/23/21 finger swollen, as the day ha... Read more
left ring finder tender on Monday 03/22/21, Woke up Tuesday, 03/23/21 finger swollen, as the day has gone on it has gotten redder Called and spoke with a Teladoc doctor, said to take ibuprofen and ice, watch for 24/48 hours if gets redder or hot go and have it checked out for possible infection
50 2021-03-22 rash rash developed on the back of arm and shoulder as well as chest
50 2021-03-23 rash, bruising Got it at 330 stayed for 30 min. By 7 that evening had a horrible headache, very tired, left haw pai... Read more
Got it at 330 stayed for 30 min. By 7 that evening had a horrible headache, very tired, left haw pain, and a welt on my tongue. Blood sugar high in 300s The next day tongue was a bit better other symptoms the same and heart felt fluttery, and my left breast and center between felt like bruises and small lumps. Headache finally gone by Tuesday and sugars in high 200s but the rest is about the same. Less tired though
50 2021-03-23 itchy rash Rash Itching
50 2021-03-23 itchy skin, rash diagnosed acute right eye scleritis; Rash on face, neck, chest, arms, hands; flushed in the face; it... Read more
diagnosed acute right eye scleritis; Rash on face, neck, chest, arms, hands; flushed in the face; itchy all over the body; hot all over within 45 minutes of the shot administration; This is a spontaneous report from a contactable consumer reported for herself. A 50-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 25Feb2021 13:00 (Lot Number: EL9266, at age of 50-year-old) at single dose for covid-19 immunization. The COVID-19 vaccine was administered at facility of workplace clinic. Medical history included hashimotos thyroiditis, allergies to sulfa, penicillin, latex. The patient is not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication with in 2 weeks of vaccination included thyroid (THYROID). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Feb2021 at 13:45, the patient experienced rash on face, neck, chest, arms, hands, flushed in the face, itchy all over the body, hot all over within 45 minutes of the shot administration. Diphenhydramine hydrochloride (BENADRYL) was required for 36 hours to mitigate the reaction. Then on 01Mar2021, right eye developed increased pressure, pain, inflamed blood vessels, severe photosensitivity. At emergent eye doctor appointment, the patient was diagnosed acute right eye scleritis. Treatment for the events included diphenhydramine hydrochloride, steroid eye drop, antiinflammation meds. The events were non-serious per reporter. The events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of the events was unknown. Follow up attempts are needed. Further information has been requested.
50 2021-03-24 injection site hives, injection site redness Allergic reaction. Hives/redness on injection site (arm). Hives/redness, mottled skin on chest and a... Read more
Allergic reaction. Hives/redness on injection site (arm). Hives/redness, mottled skin on chest and abdomen. Patient has had anaphylaxis to shellfish stated it felt the same as before.
50 2021-03-24 rash Date and time adverse event started: 3-22-21 @3pm; rash to abdomen, face, behind her ears, thighs. r... Read more
Date and time adverse event started: 3-22-21 @3pm; rash to abdomen, face, behind her ears, thighs. recommended antihistamine (benadryl,zyretec,claritin), fluids; caller verbalized understanding.
50 2021-03-24 injection site pain Site: Pain at Injection Site-Mild, Systemic: Mouth sores-Mild
50 2021-03-25 hives, injection site pain, injection site reaction, injection site swelling Injection site pain, arm pain extending down to the hand, swelling and welps, difficulty breathing, ... Read more
Injection site pain, arm pain extending down to the hand, swelling and welps, difficulty breathing, dizziness, ringing of ears
50 2021-03-25 injection site redness, injection site tingling, injection site pruritus, injection site swelling, injection site pain Quite a bit of swelling at injection site accompanied by some sensitivity/tenderness/soreness and so... Read more
Quite a bit of swelling at injection site accompanied by some sensitivity/tenderness/soreness and some tickle/itching and slight redness.
50 2021-03-26 hives, rash macular Patient stated that approximately 5 minutes after receiving Pfizer COVID-19 vaccine (1st dose), she ... Read more
Patient stated that approximately 5 minutes after receiving Pfizer COVID-19 vaccine (1st dose), she began to feel nauseous and notified RN gave patient a bottled water. RN assessed patient and notified EMS on scene. During assessment, patient admitted allergies to bee stings (was previously prescribed an Epi-Pen, but has "not had one in a while"). Patient also admitted having recent allergic reaction to seafood 2 months ago that caused lightheadedness and nausea; patient was seen at Hospital for this reaction. Patient also stated an allergy to aspirin that causes "flu-like symptoms." During this assessment, patient appeared to be alert and oriented x 3 with no signs of respiratory distress. During assessment, patient developed red patches on the posterior and bilateral neck, along with red hives (approximately 1/2 inch in size). Patient complained of feeling lightheaded and nauseous. Hands were trembling. Patients vitals were within normal limits, although blood pressure was slightly elevated.
50 2021-03-27 itchy skin Pain in left arm and running down into my fingers and joints - two weeks Pain on left side of my bod... Read more
Pain in left arm and running down into my fingers and joints - two weeks Pain on left side of my body 1-2 days All of my body ached 1-2 days Headache for a day or two (not extreme) Scratchy throat off and on for a few days Nauseous/ nothing sounded good to eat 3-5 days Upset stomach and rolling stomach with borderline diarrhea about 3 days Itchy all over (no rash at all) for a solid two weeks and now just occasionally Left hand and joints swelled slightly 2 weeks+ Tightness in chest 2 days and periodically for 2 days more
50 2021-03-27 injection site pain Within minutes - shot upper arm hurt. Wrist on shot arm hurt. LOUD Ringing in my ears. Pressure in e... Read more
Within minutes - shot upper arm hurt. Wrist on shot arm hurt. LOUD Ringing in my ears. Pressure in ears. Ringing ended day of shot. Wrist hurt for a day. Arm still hurts as of now
50 2021-03-28 rash with redness On Mar 26 I was achy and frigid. On Mar 27 I have poke up to a red rash on chest, face and neck, swo... Read more
On Mar 26 I was achy and frigid. On Mar 27 I have poke up to a red rash on chest, face and neck, swollen lymph nodes in throat, sore throat, and very large swollen lymph node in left arm pit. This lasted thru Sunday Mar 28. On Mar 29 I woke up to severe, frequent watery diarrhea and stomach gurgling along with burping and general gastro discomfort.
50 2021-03-29 vaccination site pain soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 50... Read more
soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3247), via an unspecified route of administration on 24Feb2021 at 08:15 (at the age of 50-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included high blood pressure from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. Concomitant medications included nebivolol hydrochloride (BYSTOLIC), hydrochlorothiazide (MANUFACTURER UNKNOWN) and birth control all from an unknown date. The patient preciously received ACE inhibitors and potentially experienced allergic reaction. The patient did not receive other vaccines within 4 weeks prior to vaccination. On 24Feb2021 at 17:00, the patient experienced soreness at the injection site. Therapeutic measures were not given for the events. The clinical outcome of the event vaccination site pain was recovering.
50 2021-03-30 vaccination site pain, redness blood clots in arm/Blood Clots in Left Arm; swollen lymph nodes /Swollen Lymph Nodes in Left Arm; no... Read more
blood clots in arm/Blood Clots in Left Arm; swollen lymph nodes /Swollen Lymph Nodes in Left Arm; nodules were found on her lungs/Nodules in Lungs; arm swelling /Left Arm Swelling; Left Arm Redness; Left Arm Discomfort; Soreness at the Injection Site; This is a spontaneous report from a contactable consumer (Patient's Mother) calling on behalf of daughter. A 50-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiration date unknown), via an unspecified route of administration, administered in Arm Left on 05Mar2021 13:30 at age of 50 years old at single dose for covid-19 immunisation. There was no medical history. There were no concomitant medications. The patient did not have prior vaccinations within 4 weeks. No adverse events following prior vaccinations. There were no additional vaccines administered on same date of the Pfizer suspect. The patient experienced the following after first dose. The patient experienced arm swelling /left arm swelling (hospitalization) on 09Mar2021 with outcome of recovering , blood clots in arm/blood clots in left arm (hospitalization) on 11Mar2021 with outcome of not recovered , swollen lymph nodes /swollen lymph nodes in left arm (hospitalization) on 11Mar2021 with outcome of not recovered , nodules were found on her lungs/nodules in lungs (hospitalization) on 11Mar2021 with outcome of unknown , soreness at the injection site on 05Mar2021 with outcome of not recovered , left arm discomfort on 08Mar2021 with outcome of not recovered , left arm redness on 09Mar2021 with outcome of not recovered. The patient was hospitalized from 11Mar2021 to 12Mar2021. On 05Mar2021 she began to have arm pain. 48 hours later, patient's arm started really hurting her, something about her arm being sore on the day of injection and reporter said she was going to be sore and when she got back from going away for the weekend, she thought uh oh, there was a problem here, this was not normal, not right. On 10Mar2021, she experienced swells arm swelling and went to urgent care which was diagnosed with swollen lymph nodes and given Cheplex prescription at urgent care. 11Mar2021, daughter was admitted to hospital by her provider. Daughter was found to have blood clots in arm and continued swollen lymph nodes. Daughter was given IV cheplex and Eliquis while in hospital. Daughter will have to be on Eliquis for next 3 months per reporter. The patient had her first vaccine, Pfizer, and became ill with blood clots, swollen lymph nodes, and wound up in the hospital. Reporter stated that she and the patient were worried about her getting the second shot. The patient was on blood thinners and was seeing a pulmonary doctor and hematologist. She didn't know about her getting the second shot and thought this should be reported. The patient was due for the second vaccine next week on 26Mar2021 and she was still sick, should it be postponed or what? The patient went the night before the hospitalization to the Urgent Care and the doctor prescribed Keflex, an antibiotic and saw her primary care doctor the next morning and she put her in the hospital. Reporter stated they were getting nervous and wanted to report for side effects. She stated the patient was home from the hospital but still sick really bad. The patient went to Urgent Care 10Mar2021, saw her primary care 11Mar2021 and was sent to the hospital 11Mar2021. Reporter later clarified that the patient was sent to the Emergency Room and after a few hours, she was sent upstairs to be admitted for a 24 hour hospital stay. The patient received Eliquis; Keflex as treatment. Fluids at the hospital, unknown type. Reporter stated they decided the patient wasn't doing really well and went to the Urgent Care that night and were given Keflex because they felt there was an infection. When they discovered it further that there were blood clots, the patient was told to stay on the antibiotic and given fluids and put on blood thinner, Eliquis, states patient had never been on a blood thinner before. Patient was admitted on 11Mar2021 for 24 hours. Reporter stated that they kept the medicine going and then felt she was stable enough to be discharged the next night at around 18:00 to continue with Keflex antibiotic and Eliquis for 3 months. Reporter stated they were told to contact a hematologist and pulmonary doctor for the nodules in her lungs and to contact her primary doctor if not doing better in one week, but they will probably contact her tomorrow. Reporter clarified that the patient had a chest x-ray a couple of months ago and everything appeared fine, so she thinks that the nodules developed after the vaccine. The patient had a chest x-ray on 11Mar2021 and nodules were found on her lungs, scheduled to follow up with lung doctor. Reporter stated whether they were there before or not was unknown. No follow up X ray yet. Reporter would like to know if daughter should get second dose? Second dose was scheduled 26Mar2021. Adverse events required visit to emergency room: Urgent Care the night before, follow up the next morning with primary doctor, the doctor got her in right away and said she needs to go to the hospital. Yes, patient went through the ER, doctor said that she would be coming and then after there a while, she was admitted to the hospital. Adverse events required visit to physician office. Patient saw the doctor on 11Mar2021 and was sent to the hospital. Information about lot/batch has been requested.
50 2021-04-01 injection site pain Tender/ soreness at injection site. Pain and swelling underarm area
50 2021-04-14 redness, rash, itchy skin blackout or passed out, dizziness, unable to walk, bitter taste in the mouth, dry heaving, rash, sho... Read more
blackout or passed out, dizziness, unable to walk, bitter taste in the mouth, dry heaving, rash, shortness of breath, extreme blood pressure immediately upon injection for 1 hour. Continued reactions 48 hours, extreme fatigue, blood pressure, dizziness, metal and bitter taste in the mouth, migraine, stomach upset, red polka dots on hands, itchiness underarms, cough, sore throat, and fever
50 2021-04-16 injection site discolouration, injection site rash, injection site numbness, injection site bruising After receiving vaccine within two hours became very tired and tightness in throat. Went home laid d... Read more
After receiving vaccine within two hours became very tired and tightness in throat. Went home laid down. By evening nausea started. Went to bed woke up an vomited a few time through night. Nausea and vomiting continued for about 3-4 days along with lethargy. Was in bed for about 5 days. Completely out of it for about two weeks. Noticed a bruise at injection site within a few days. White ara abpout the size of a softball around that and pinkish-red rash around outside of that. Numbness developed at site of injection. Pain in joints developed within about a week and loss of mobility of L arm as well. Intermittant diahrrea and vomiting and constant nausea for a few weeks then intermittant nausea after. Continued pain
50 2021-04-20 blister, shingles Shingles. January 26th - Received first Pfizer vacccine at hospital February 8th - infusion of R... Read more
Shingles. January 26th - Received first Pfizer vacccine at hospital February 8th - infusion of Remicade 500 mg February 13th - skin started to get pins and needles and very painful February 15th - Received second Pfizer vaccine at hospital February 17th - Patches started appearing, extremely painful, went to dermatologist and was diagnosed with Shingles. February 18th - blisters started appearing on right side of face . Cheekbones, nose, under eye, cheek, upper lip
50 2021-04-21 redness, skin warm *4/4 Morning felt like I couldn't walk, knew my feet were their, but couldn't register to move for h... Read more
*4/4 Morning felt like I couldn't walk, knew my feet were their, but couldn't register to move for hr and then got up, EXTREME pain in center of my left armpit (to point of almost crying and it was worse than my kidney stone pain I had for a week) and all over pain in body-hard to even move much this day...I slept in 12 hr increments till next day. Noticed my Heart rate was very high constantly between 100-115 ( on my wrist monitor) * On 4/5 Woke up and told myself to get moving for day, arm was turning very red at this point and swelling bad along with armpit along edge and was hot and still painful. Was up for 7 hr.. I got in shower that evening and felt weird midway and my head felt like a whoosh and thought I was going to pass out (normal temp in shower) held onto shower got out was fine for about 20 min and then I started extreme shaking uncontrollably and teeth were chattering from chills. Went to get a Tylenol because I knew something was not right and within 30 min started sweating profusely with fever (I didn't even get up because I felt so crappy) *4/6 Woke up, felt a little better, arm, armpit and side of armpit red, hot and swollen still. Was up for 9 hrs, but when I went to bed and laid down, I felt like I couldn't breathe well...something told me to take a deep breath and I felt something like a pop in chest and then I felt like I was breathing better. Was not still feeling good on 4/7 but went back to work, on 4/8 felt a lot better, then woke 4/9 with Migraine and felt terrible and my heart felt weird...I called the Health Department and asked what to do and they recommended going to doctor... but a Nurse followed up with me which was very nice. Went to doctor and my Blood Pressure was 179/98 at that time. They ran blood work and prescribed me a antibiotic for my arm and armpit area. I want to add as well, not sure if this matters, but my shot was not in center of arm...it was closer to inner part of upper shoulder closer to chest.
50 2021-04-22 injection site pruritus, itchy skin, rash Site: Itching at Injection Site-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-... Read more
Site: Itching at Injection Site-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium
50 2021-04-26 bruising, skin laceration fainted; slammed my face on the bathroom floor and broke my nose (among other cuts & bruises); nause... Read more
fainted; slammed my face on the bathroom floor and broke my nose (among other cuts & bruises); nausea/mild queasiness; dizziness; heat; slammed my face on the bathroom floor and broke my nose (among other cuts & bruises); slammed my face on the bathroom floor and broke my nose (among other cuts & bruises); slight fever/mild queasiness; slammed my face on the bathroom floor; This is a spontaneous report from a contactable consumer, the patient. This 50 year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: ER8733), dose 1 , single dose via an unspecified route of administration in the left arm on 31Mar2021 at 02:30 PM (at the age of 50 years-old) for COVID-19 vaccination. Medical history included Grave's disease under control with medication. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included desogestrel, ethinylestradiol (KARIVA), methimazole, lansoprazole and atorvastatin. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 01Apr2021 at 12: 30 AM, 10 hours after vaccination administration, the patient experienced a sudden wave of severe nausea, dizziness, and heat and fainted. She slammed her face on the bathroom floor and broke her nose (among other cuts & bruises). Afterwards, her only symptoms were fainting injuries, slight fever/mild queasiness for 2 days. The events required a doctor or other healthcare professional office/clinic visit. Laboratory tests included a nose X-ray. Treatment was received for nausea, dizziness, heat and fainted, fever, slammed face, broke her nose (among other cuts & bruises). The clinical outcome of nausea, dizziness, heat and fainted, fever, slammed face, broke her nose (among other cuts & bruises) was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
50 2021-04-30 cellulitis A Blood clot was found; Cellulitis; Migraine started within 24 hours; left calf pain/Leg increased i... Read more
A Blood clot was found; Cellulitis; Migraine started within 24 hours; left calf pain/Leg increased in swelling and burning pain; severe swelling and burning sensation; severe swelling and burning sensation; Leg increased in swelling and burning pain; Phlebitis; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199/EN5318), via an unspecified route of administration administered in left arm at doctor's office/urgent care facility on 12Mar2021 15:00 as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient was not COVID tested post vaccination. The patient had no other vaccines in four weeks. Medical history included high blood pressure and sleep apnea. Concomitant medications included amoxicillin, valsartan, amlodipine, and vitamin d [vitamin d nos]. The patient previously took doxycycline and experienced allergies. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunisation. On 05Apr2021 at 03:00 PM, the patient experienced a blood clot was found, cellulitis, migraine started within 24 hours, left calf pain/leg increased in swelling and burning pain, severe swelling and burning sensation, leg increased in swelling and burning pain, and phlebitis. It was further reported that migraine started within 24 hours. 48 hour left calf pain that got increasingly worse leading to a severe swelling and burning sensation. The patient went to right time urgent care on Friday, 09Apr2021. The patient was diagnosed with cellulitis. It was also reported that pain increased swelling spread and went to emergency room (ER) on 10Apr2021 for ultrasound of leg. No clots and was advised if worsened to come back. The patient's leg increased in swelling and burning pain. The patient went to urgent care patient first on 11Apr2021 and then the doctor on Monday, 12Apr2021 where she was sent for a STAT ultrasound due to major pain and swelling. A blood clot was found. Phlebitis was diagnosis. The patient was sent to a vascular surgeon on 13Apr2021 and vein specialist on 15Apr2021. The patient was given Xarelto blood thinners and started taking them on 15Apr2021. All of this began 48 hours after taking the second vaccination (pending clarification) and has the patient worried. The events resulted to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of all events. The patient had not yet recovered from all events.
50 2021-04-30 vaccination site pain Slight headache; chills; soreness at injection site; lightheadedness; This is a spontaneous report f... Read more
Slight headache; chills; soreness at injection site; lightheadedness; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration in the left arm on 30Mar2021 at 08:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer, neuropathy, and pre-diabetes. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atorvastatin calcium (LIPITOR), herbal pollen (RELIZEN), and unspecified multivitamins. The patient previously took cefazolin sodium (KEFZOL) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced slight headache, chills, soreness at injection site, and lightheadedness on 30Mar2021 at 09:00. The patient did not receive any treatment as a result of the events. The clinical outcome of slight headache, chills, soreness at injection site, and lightheadedness was recovering. No follow-up attempts are possible. No further information is expected.
50 2021-05-03 vaccination site pain fainting; hot burning sensation down left arm from injection site to wrist; hot burning sensation do... Read more
fainting; hot burning sensation down left arm from injection site to wrist; hot burning sensation down left arm from injection site to wrist; hot burning sensation down left arm from injection site to wrist; dry throat; intense thirst; difficulty swallowing; vertigo; cloudy vision; waves of nausea; weak/numb hands; weak/numb hands; uncontrollable shaking; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 18Apr2021 at 09:45 (Batch/Lot Number: EW0164) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took pneumococcal vaccine for immunisation and experienced allergy, tylenol and experienced allergy, codeine and experienced allergy. The patient experienced fainting, hot burning sensation down left arm from injection site to wrist, dry throat, intense thirst, difficulty swallowing, vertigo, cloudy vision, waves of nausea, weak/numb hands, uncontrollable shaking; all on 18Apr2021 with outcome of recovered in Apr2021. No treatment received for the events. All events resulted in doctor or other healthcare professional office/clinic visit.
50 2021-05-07 vaccination site pain Chills; Body aches; Sore injection site; Tiredness; Heartrate high 90s; feeling Unwell; This is a sp... Read more
Chills; Body aches; Sore injection site; Tiredness; Heartrate high 90s; feeling Unwell; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263) via an unspecified route of administration at left arm on 06Feb2021 10:30 (50-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included COVID-19 (prior vaccination), hypertension, asthma, anxiety, and allergies to honey. Concomitant medications in two weeks included losartan and montelukast sodium (SINGULAIR). There was no other vaccine in four weeks. On 06Feb2021 02:00 (as reported), the patient experienced chills, body aches, sore injection site, tiredness, heartrate high 90s, and feeling unwell. Adverse events did not result in emergency room visit or physician office visit. COVID-19 was not tested post vaccination. Therapeutic measures were taken as a result of the events and included Tylenol 1000 mg. The outcome of the events was not recovered.
51 2020-12-31 injection site pain *12/21-22-increased soreness at site of injection...resolved Onset on 12/28 of Swollen lymph nodes, ... Read more
*12/21-22-increased soreness at site of injection...resolved Onset on 12/28 of Swollen lymph nodes, with pain, on Right side of body with increased sensitivity at Left Axillary/side of breast area. Onset on 12/30 Fever, Severe Body aches/joint pain, dry cough, chest pain with min SOB, Headache. *Exposure to 4 people on Sat 12/26 who have tested positive for Covid on 1/1/20 but their symptoms began 12/28 through 01/30.
51 2021-01-02 hives Hives - Benadryl
51 2021-01-03 redness, itchy skin 20 minutes after receiving the vaccination the resident started to not feel well. She said she felt ... Read more
20 minutes after receiving the vaccination the resident started to not feel well. She said she felt very far away and just kept repeating I don't feel well. She was diaphoretic and her chest was very red and she kept scratching and rubbing it at it. I asked if she wanted IM Benadryl or epipen and she at first denied. She also said she felt like she needed to focus on her breathing. At this time we decided it was best to administer Epipen x 1 dose. Immediately after she felt better. She was observed for another 30 minutes and then went home. at 7:17pm I called and spoke with her. She said her arm was sore and that her oxygen levels were about 88-89% which is low for her but she said she felt fine and is currently working right now.
51 2021-01-03 hives Patient developed hives that worsened on 12/30/2020. Self treated with topical diphenhydramine cream... Read more
Patient developed hives that worsened on 12/30/2020. Self treated with topical diphenhydramine cream at home.
51 2021-01-04 rash papular Approximately 15 small pencil point red bumps on arms and legs. Itchy. Not raised. Did not increase ... Read more
Approximately 15 small pencil point red bumps on arms and legs. Itchy. Not raised. Did not increase in size. Kept appearing within 5 days after the shot.; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EK5730 intramuscular in the left deltoid, from 22Dec2020 15:00 at a, single dose, for COVID-19 immunization. Patient received another Pfizer vaccine on the same date. Medical history included hypertension (HTN), guillain-barre syndrome from 2008. Patient's allergies included penicillin and ASA. Concomitant medication included paroxetine and amlodipine. On 23Dec2020 08:00, approximately 15 small pencil point res bumps on arms and legs. Itchy. Not raised. Did not increase in size. Kept appearing within 5 days after the shot. The outcome of events was recovered. no treatment or hospitalization was required. Follow-up attempts are completed. Information on the batch/lot number has been obtained.
51 2021-01-04 itchy skin, hives Headache, Anaphylaxis, UrticariaPruritus & NauseaVomiting
51 2021-01-04 injection site redness, injection site warmth, injection site pruritus Sat 12-19-20 red spot around injection site, Mon 12/21/20 it feels warm and itching the redness is l... Read more
Sat 12-19-20 red spot around injection site, Mon 12/21/20 it feels warm and itching the redness is larger PT states she has taken Benadryl for symptoms
51 2021-01-04 itchy skin felt like she had a stroke; fell down; Pain in leg; itchiness in her head; left leg not functioning ... Read more
felt like she had a stroke; fell down; Pain in leg; itchiness in her head; left leg not functioning normally; This is a spontaneous report from a contactable nurse (reporting for herself). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EH9899), via an unspecified route of administration in the left deltoid on 21Dec2020 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. There were no prior vaccinations within 4 weeks prior to the first administration of the suspect vaccine. On 21Dec2020, the patient experienced left leg not functioning normally, which was reported with the seriousness criteria of disability. On 21Dec2020, the patient had itchiness in her head. The patient felt like she had a stroke, fell down and pain in leg on 22Dec2020, which were all reported with the seriousness criteria of disability. The patient called the doctor office and spoke with the doctor on call and was told to use diphenhydramine hydrochloride (BENADRYL). No further details provided. The patient was sent home for 10 days and she was sent back to work. The patient underwent lab tests and procedures which included COVID: negative in Dec2020. The outcome of the events was not recovered. The reported assessed the events related to the suspect product, BNT162B2.; Sender's Comments: The reported events leg dragging, leg pain and fall and suspected stroke were possibly related to the use of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. However, stroke was not diagnosed. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
51 2021-01-04 rash lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/... Read more
lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; swelling in face; swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 28Dec2020 03:30 PM at single dose (lot number: EH9899) for COVID-19 immunization. Medical history included asthma and known allergies to medications, food, or other products. Concomitant medications include Estradiol received in two weeks. No other vaccine in four weeks. The patient was not pregnant. The patient experienced lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here that resembled sunburn, but was not painful; on 28Dec2020 04:00 PM. The patient took antihistamine (Claritin) and rest as treatment. All events were reported as non-serious. The patient had no Covid prior vaccination, no Covid tested post vaccination. Outcome of all events was recovering.
51 2021-01-04 vaccination site pain tired and laid down; soreness to the injection site; paresthesia - tingling in hands and feet; hands... Read more
tired and laid down; soreness to the injection site; paresthesia - tingling in hands and feet; hands and feet are cold/She felt cold; This is a spontaneous report from a contactable nurse (patient). A 51 years old female patient received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 28Dec2020 10:00 at single dose in the arm left for covid-19 immunisation. Medical history included change in taste, altered taste. Concomitant medications were none. Caller reported she was having side effects with the COVID vaccine she received yesterday (28Dec2020) morning at 10am. The patient experienced paresthesia, tingling in hands and feet and they are cold, said she "felt cold" and has soreness in the injection site on 28Dec2020 17:00. Caller confirmed the above details. Her hands got really cold and tingling to them and she was wondering what this is and went to her other half and asked him to take a look. It passed and lasted about 10-15 minutes and just thought it was unusual. Did a 5:00pm check-in and she was doing okay and everything was fine so she didn't mention it. At 7:00pm she got tired and laid down and started feeling the tingling in the fingers and her hands. Upon waking this morning when her feet met the ground it was intensified, the tingling, and she went to walk it out it got better, but she is still having the tingling in both fingers/hands and feet. Stated unsure of seriousness criteria for the tingling in hands and feet and coldness. Wondered if it is something she needs to worry about that is why she called. Is it something that could go away or worse like with Guillain-barre syndrome. It's not disabling, but it is concerning. Unable to provide the NDC or expiry for COVID vaccine given. Stated she can't understand the writing on the card provided for her with product details. Does see on card Pfizer, X40113 and stated the lot number looks to be either "ES1685 or EJ1685 or E51685". Unable to provide the dose/strength. Received this vaccine at her workplace. Mentioned in past she had flu vaccine with the additive of mercury and experienced changes in taste, altered taste. It was reported to her primary care provider. This was between 6-8 years ago, unable to provide name of vaccine, NDC, Lot, or expiry. Since then she only receives single dose vials instead of multidose vials. They were looking for a list of side effects and wanted to know if she should seek care for her symptoms, it's unusual. Wanted to know if the side effects she is having is something Pfizer has been seeing and will it go away and when. Previous transfer agent sent her to safety. It is difficult to navigate the website. Outcome of event fatigue was unknown, while outcome of other events was not recovered. Causal relationship between vaccine and events "paresthesia, tingling in hands and feet" "hands and feet are cold" "soreness in injection site" were related by agency and Primary Source Reporter. Information about Lot/Batch number has been requested.
51 2021-01-05 pain of skin, skin warm Little ball size in the beginning. Left inner upper arm, warm to touch, very tender. Now about the s... Read more
Little ball size in the beginning. Left inner upper arm, warm to touch, very tender. Now about the size of a quarter. Seems to be getting larger with the warm compresses, per Dr's orders.
51 2021-01-05 itchy skin States that she has experienced generalized itching since receiving first dose of COVID-19. Also s... Read more
States that she has experienced generalized itching since receiving first dose of COVID-19. Also states that she has noticed her sclerea becoming yellow and skin "jaundice" in color.
51 2021-01-06 itchy skin, rash, hives Headache, Myalgia, Fever, Rash & Urticaria Pruritus
51 2021-01-06 injection site pain, injection site redness, injection site bruising, rash papular Large, red, raised, painful injection site reaction with bruising up to 2 weeks later Narrative:
51 2021-01-06 hives Patient experience severe headache, welts, nausea, extreme fatigue, and reported feeling like walkin... Read more
Patient experience severe headache, welts, nausea, extreme fatigue, and reported feeling like walking on broken bones. All over body pain.
51 2021-01-06 hives Patient started experiencing extreme fatigue and headache on 1/6/2021. She arrived at work on 1/7/20... Read more
Patient started experiencing extreme fatigue and headache on 1/6/2021. She arrived at work on 1/7/2021 and was experiencing extreme fatigue, severe headache, welts, naussea, and feeling of walking on broken bones. Patient was advised to go home from work.
51 2021-01-06 itchy skin, rash Rash, NauseaVomiting, pruritus Narrative: Developed dry heaves, rash and itching 9 min after receiv... Read more
Rash, NauseaVomiting, pruritus Narrative: Developed dry heaves, rash and itching 9 min after receiving COVID vaccine (1st dose) during observation; Epipen given in vaccination room; transferred to R by ambulance. In ER she was given Diphenhydramine 25 mg PO and Famotidine 20 mg PO. Observed for 1-1/2 hours and discharged.
51 2021-01-06 itchy skin, hives UrticariaPruritus & NauseaVomiting Narrative: 1000-Patient stated right hand itching no hives seen; ... Read more
UrticariaPruritus & NauseaVomiting Narrative: 1000-Patient stated right hand itching no hives seen; VS-126/84;P-76;R-16;SAT-100%; MD at bedside to evaluate. Denies Respiratory difficulties; CP. 1007-Patient states nauseated, RRT at bedside, patient trying to vomit, turned to right side. Dr. from RRT ordered Epi 0.3mg/ml to be given, Epi administered to left thigh, EMS called. 1015- VS; P-69;R-16;BP-110/72, Sat-98, EMS on scene. Patient A & O x4. No difficulty breathing, loaded on EMS stretcher. 1022- VS-127/63; P-73; R-16: Sat-96 and capnography-41. Patient left T205 via EMS at 1022.
51 2021-01-06 itchy skin c/o itching palms 15 minutes after immunization that did not travel to any other areas. No other c/o... Read more
c/o itching palms 15 minutes after immunization that did not travel to any other areas. No other c/o Narrative: Vaccine given at 1410 and c/o itching on palms at 1425. Pt. stated sensation was "faint and subtle, gradually became more noticeable after 15 minutes post vaccination. Cetirizine 10mg, given po at 1440: BP 155/89, P 72, R20, O2Sat. 99%. @ 1500: BP 144/90, 75, 18, 100% o2sat; @ 1510 and prior to discharge: BP 136/85, 79, 18, 100% o2sat. Stated, "it's still itchy but it's feeling better." Denied any breathing difficulty or itching in other areas, except Rt. palm. d/c'd back to work at 1510 in stable condition. RN explained Cetirizine and effects/possible sleepiness/drowsiness.
51 2021-01-06 rash with redness, itchy skin had, headache, body aches, chills ,GI upset, heartburn, sweats the next day. then 2 days later had ... Read more
had, headache, body aches, chills ,GI upset, heartburn, sweats the next day. then 2 days later had loose stools, day 3 swollen lymph nodes in my next. day 4 rash on my back that was red, itched, burned . went away about 12 hours after they came.
51 2021-01-06 rash, rash with redness, itchy rash severe red rash/hives on bilateral arms. Very itchy. spread drom hands up to shoulders, Benadryl and... Read more
severe red rash/hives on bilateral arms. Very itchy. spread drom hands up to shoulders, Benadryl and Prednisone taper
51 2021-01-07 vaccination site pain, vaccination site swelling Headache; nausea; tiredness; site injection swelling; site injection pain; This is a spontaneous rep... Read more
Headache; nausea; tiredness; site injection swelling; site injection pain; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 28Dec2020 at 14:30 (at the age of 51-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 28Dec2020, the patient experienced headache, nausea, tiredness, injection site swelling and injection site pain. Treatment was not received for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events headache, nausea, tiredness, injection site swelling, and injection site pain were recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
51 2021-01-07 vaccination site pain Muscle pain; Shortness of breath; Tiredness; Nausea; Sweating; Mild soreness at infection site; Mild... Read more
Muscle pain; Shortness of breath; Tiredness; Nausea; Sweating; Mild soreness at infection site; Mild soreness at infection site; This is a Spontaneous report from a contactable Other HCP (patient). A 51-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number=EH9899), on 30Dec2020 12:00 PM, Intramuscularly at single dose (first dose), (vaccine location=Left arm) for COVID-19 immunization. Medical history included Covid; Hypertension; Diabetes Type 2. Concomitant medications were not reported. Patient was no Known allergies. Patient experienced Muscle pain, shortness of breath, tiredness, nausea, sweating, mild soreness at infection site on 02Jan2021 09:00 AM. Patient did not receive any treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient did not have been tested for COVID-19. The outcome of the events was not recovered. This case was assessed non-serious by reporter. And the events did not result in Death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.
51 2021-01-07 injection site pain On January 5,2021, developed chills, muscle ache, headache, joint pain ,fever and left arm pain. Tak... Read more
On January 5,2021, developed chills, muscle ache, headache, joint pain ,fever and left arm pain. Taken Acetaminophen
51 2021-01-07 injection site redness, injection site bruising Patient received second Pfizer vaccine on 1.5.21. On 1.7.21 at 2:40pm the patient experienced aches ... Read more
Patient received second Pfizer vaccine on 1.5.21. On 1.7.21 at 2:40pm the patient experienced aches and weakness that evening, took tylenol with relief. 1/8/21 patient woke up in the middle of the night with fever, blister on the inside of her lip, and her right cheek twitching. 1/8/21 patient went to PCP to be checked out. Discovered redness and bruising at the injection site. Patient has had relief with tylenol and zyrtec.
51 2021-01-07 hives Patient received vaccine at 13:30. She started feeling anxious after receiving vaccine but went back... Read more
Patient received vaccine at 13:30. She started feeling anxious after receiving vaccine but went back to work. Patient received 50 mg of diphenhydramine at 14:30, she then started experiencing hives and shortness of breath. She was administer 0.3 mg of epinephrine into the thigh and EMS was called.
51 2021-01-07 injection site redness, injection site swelling Redness and swelling at injection site. This happened at the time of injection then went away and ca... Read more
Redness and swelling at injection site. This happened at the time of injection then went away and came back = 1 week after injection & is still there.
51 2021-01-07 injection site pain Soreness in left arm at injection site similar to receiving flu vaccine. On 1/7/21 I had a headache,... Read more
Soreness in left arm at injection site similar to receiving flu vaccine. On 1/7/21 I had a headache, stiff/achy neck and shoulders and some chills. Upon waking on 1/8/21 my left armpit is sore and swollen.
51 2021-01-07 itchy skin Symptoms - ? Patient reports itchiness to bilateral hands approximately 25 mins after vaccination, d... Read more
Symptoms - ? Patient reports itchiness to bilateral hands approximately 25 mins after vaccination, denies rash. Patient reports she struggles with allergies and prophylactically medicated prior to first dose with 50 mg of Benadryl and Xytal. Patient reports no adverse reaction after 1st vaccine. Patient reports she prophylactically medicated last night as well but only took 25 mg and no Xytal, patient endorses she believes that is the difference in her symptoms between the first and second dose. Patient endorses allergies to high dose Vitamin D (50,000 units). Patient denies difficulty breath or SOB at this time. Patient reports she is able to move freely at this time. Last day of work and shift - ? currently working at home today Home remedies? - 50 mg Benadryl at 08:00 and Pepcid and Xytal at 11:20 (did not disclose dosage) Any improvement? ? Patient reports mild improvement Recommendation? Patient encouraged to take allergy medication as directed and to call vaccine support if symptoms worsen. Patient educated to call 911 or seek immediate care if any airway issues or difficulty breathing.
51 2021-01-07 injection site pain Tinnitus, generalized fatigue, muscle- specifically mid back, achiness, neck muscle/trapezius achine... Read more
Tinnitus, generalized fatigue, muscle- specifically mid back, achiness, neck muscle/trapezius achiness, soreness at injection site
51 2021-01-07 injection site pain injection site pain, lymphadenopathy Narrative: 12/18 received the vaccine. 12/19 injection site a... Read more
injection site pain, lymphadenopathy Narrative: 12/18 received the vaccine. 12/19 injection site and upper arm pain. 12/20 onset of supraclavicular lymphadenopathy. Still present 12/28. Nodes are palpable, mobile, and non-tender.
51 2021-01-08 itchy skin, redness Within five minutes after the vaccine administration the pt reported R arm tingling, feeling "differ... Read more
Within five minutes after the vaccine administration the pt reported R arm tingling, feeling "different" and spotty non-confluent erythema and pruritis over affected arm, upper chest, posterior neck. She reported feeling faint and began to have mild hyperventilation. Vital signs remained stable and WNL, lungs were clear with good air movement and there was no mucosal involvement. Pt was treated with PO bendryl. Over the course of 45 minutes her rash faded and her sense of pruritis also lessened. She was able to return to work with no further symptoms
51 2021-01-08 redness, hives lip swelling, facial hives/erythema, burning
51 2021-01-09 rash papular, injection site pruritus 4 Raised bumps around injection site, in the shape of a ring around the site. Mild itching at site. ... Read more
4 Raised bumps around injection site, in the shape of a ring around the site. Mild itching at site. No redness Headache
51 2021-01-09 injection site swelling Received vaccine on 1/5/2021 and is complaining of swollen and stiff left arm and inability to move ... Read more
Received vaccine on 1/5/2021 and is complaining of swollen and stiff left arm and inability to move the left arm. States pain is 10 on a 10-point pain scale . Has been on Advil and Tylenol with no relief
51 2021-01-10 injection site pruritus 0900 - Vaccine given 0910 - felling warm all over, fast HR, itchy arm at injection site (x5min) 0920... Read more
0900 - Vaccine given 0910 - felling warm all over, fast HR, itchy arm at injection site (x5min) 0920 - symptoms improving
51 2021-01-10 injection site pain Body aches. Headache. Extreme fatigue. Shot site pain. Fever 100.4 All continued overnight. In a.m.... Read more
Body aches. Headache. Extreme fatigue. Shot site pain. Fever 100.4 All continued overnight. In a.m. next day all continued except fever, down to 98 - 99. Pain in my arm is worse, not able to use arm much.
51 2021-01-10 sensitive skin I am a health care professional and received my first vaccine 12/17/20. I had the my first reaction... Read more
I am a health care professional and received my first vaccine 12/17/20. I had the my first reaction on 12/19/20. Horrible fatigue, body aches. My second dose was given on 1/7/21. After 6 hours, I felt myalgias, arthralgias, skin sensitivity to anything that touched me. Severe fatigue and headache. Took Tylenol with no relief. The worst day hit at 1/8/21 at 3:00 a.m. I could not move without extreme pain. Sweating and chills. No appetite. Had to be assisted to toilet. Tried to go into hospital to do vaccine clinic today, 1/11/21 and had to return home as I was extremely fatigued and excessive sweating.
51 2021-01-10 itchy skin Received dose 2hours post dose, itching throat, ears. facial swelling. Bendryl 50mg taken. Symptoms ... Read more
Received dose 2hours post dose, itching throat, ears. facial swelling. Bendryl 50mg taken. Symptoms continued for the day of shot and day after shot. Day 2 additional Bendryl total 200mg taken before relief of symptoms. My PCP is aware of reaction and will place allergy on chart.
51 2021-01-10 shingles Shingles diagnosed on 1/8/2021 in PCP office--may be unrelated to vaccine?
51 2021-01-10 shingles, rash Shingles, diagnosed on January 7 2021 by my PCP. First symptoms (pain and rash) first appeared Janua... Read more
Shingles, diagnosed on January 7 2021 by my PCP. First symptoms (pain and rash) first appeared January 5th.
51 2021-01-10 injection site pain, injection site inflammation Started having chills at 11pm, took tylenol 650mg. However, the symptoms not relieved, could not sle... Read more
Started having chills at 11pm, took tylenol 650mg. However, the symptoms not relieved, could not sleep the whole night. fever went up to 101F. Also feeling extreme fatigue, not able to get up from the bed, took another dose 1000mg tylenol, completely lost appetite, body ache. Low grade ever lasted up to 1/8/21. Even now still feeling fatigue and frequent headache. The injection site felt fine two days following injection. But started feeling inlamed and painful on 1/8/21. On 1/9/21, the pain of the site expanded towards the armpit and left upper shoulder and back.
51 2021-01-11 itchy skin, injection site pruritus 1628 itching at site of injection, Benadryl 25mg given po, 1643 little itching of ear same side as i... Read more
1628 itching at site of injection, Benadryl 25mg given po, 1643 little itching of ear same side as injection, 1648 itching inner eyes, monitoring patient another 15 minutes, 1703 no increase in itching, "not any different, not progressing", denies rash, patient left after discussing with NP.
51 2021-01-11 injection site redness, injection site swelling, injection site pain Developed pain, redness and swelling (injection site) about 8-9 hrs. after receiving the vaccine. Sy... Read more
Developed pain, redness and swelling (injection site) about 8-9 hrs. after receiving the vaccine. Symptoms increased day 2 with swelling as big as a lemon fruit. Day 3 - aside from pain & swelling at the injection site, I developed Left axillary lymphadenopathy. Day 4 - severe headache lip numbness & body ache Took Ibuprofen 400 mg each day
51 2021-01-11 vaccination site pain Fever/temperature 99.9-100.2/feverish/They were not high readings; rigors/chills; Achiness/achiness ... Read more
Fever/temperature 99.9-100.2/feverish/They were not high readings; rigors/chills; Achiness/achiness all over; Neck is also really sore; head hurt/headache was in the occipital area; mild pain at the injection site; Her whole arm is swollen and sore/Sore upper arm/arm achy; Her whole arm is swollen and sore/Sore upper arm; whole arm felt warm/warm to the touch; This is a spontaneous report from a contactable Nurse(patient). A 51-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization(reported as for work). She worked in the hospital. She just got it at work. She didn't have a prescribing doctor. Her first dose was 3 weeks before today. Her first vaccine was a Pfizer vaccine with lot:13551. She got the 2nd dose 20 days later. She got the second dose on 05Jan2021. Medical history and concomitant medications reported as none. Also reported she did have other medical conditions, but she got the go ahead to get the vaccine from her rheumatologist. Patient received her second dose of vaccine 05Jan2021 and was experiencing fever, chills, achiness during the night last night on 06Jan2021. She was asking if she was experiencing adverse events or Sars-COV-2 symptoms. At first, she had mild pain at the injection site, but then in the middle of the night, her whole upper arm became sore and swollen. Not just at the injection site. Onset date of sore upper arm was 05Jan2021. She developed rigors/chills. She had achiness all over. She checked her temperature a half an hour to 45 min ago, and it was 99.9-100.2. She usually runs 96-97. It was around 3-4 am that she felt chilled, but not feverish. She was just chilled/ had rigors. It was a couple hours later at 7 am that she felt feverish. They were not high readings. In the past 10 minutes, her head had started to hurt. Her neck was also really sore. Her headache was in the occipital area. It had only been 10 mins that this had came on, and it was about the same. It really hurt. Onset date of headache/ neck pain was 06Jan2021. Her whole arm was swollen and sore. It was warm to the touch. Her whole arm felt warm and achy. She had used an ice pack, and it did help some. She was assuming this was just an expected immune response. She just didn't want to put anyone at risk. She was always very careful. She mostly worked from home, but she was in the office yesterday with two masks and a face shield. She also used a lot of spray and hand sanitizer. The outcome of events fever, achiness, "Her whole arm is swollen and sore/Sore upper arm/arm achy" and headache, neck pain was not recovered, of chills was recovered in Jan2021, of other events was unknown. Sore upper arm was reported as worsened.
51 2021-01-11 injection site pain Headaches, body aches, pain at injection site (left arm sore) and exhaustion. lymph nodes in left ... Read more
Headaches, body aches, pain at injection site (left arm sore) and exhaustion. lymph nodes in left armpit became swollen and painful to the touch starting on 1/8/21 until 1/11/21.
51 2021-01-11 itchy skin Hot flash, lasted whole day; Itching all over whole body/Itching in hands and feet all the time; Thi... Read more
Hot flash, lasted whole day; Itching all over whole body/Itching in hands and feet all the time; This is a spontaneous report from a contactable Nurse (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization. Vaccine location was arm. None medical history. The patient's concomitant medications were not reported. Patient stated she had the COVID vaccine on Dec18th, her first one and she was fine, no issues and she would say the following Wednesday (23Dec2020), she started getting like a hot flash, it lasted whole day and then her feet started itching. And now, she have got itching all over her whole body and especially in her hands and her feet all the time. She went to her family doctor. She have not had this issue before and she don't have any known allergies. And she went to family doctor and he prescribed some antihistamines and of course they are still bothering patient. Besides itching, she was not having any other complication. Patient went to family doctor last week and he put her on a prescription of antihistamine trying to help. It is not helping, Benadryl helped her. When probed for the name of the product, patient stated she think the name of it is Lyrica. The events were persisting. She had better times but then it was other times when it is worse. When asked the causality, the patient stated she think so. She has never had a reaction like this and it has been going on everyday ever since. The only thing that worries is she was due to get her second one on the 8th which is this Friday and she have heard people rumors saying that when get second vaccine, whatever symptoms she was having are even worse. Patient don't know is it true. And of course everyone is saying like, normally they say - any reactions you get like the first 24-48 hours but her didn't happen until almost halfway till first week.
51 2021-01-11 vaccination site itchiness, vaccination site redness, vaccination site mass, vaccination site pain Painful lump on arm that has turned red and itches when she pressed on it/as a site reaction; Painfu... Read more
Painful lump on arm that has turned red and itches when she pressed on it/as a site reaction; Painful lump on arm that has turned red and itches when she pressed on it/as a site reaction; Painful lump on arm that has turned red and itches when she pressed on it/as a site reaction; It seemed that it had persisted longer and he said it sounded like it was getting infected; it was painful almost immediately/as a site reaction; This is a spontaneous report from a contactable nurse (patient) via Pfizer Sales Representative. A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date unknown), via an unspecified route of administration on 28Dec2020 injected in unknown arm at single dose for precaution as a front line healthcare worker in hospital. The patient's medical history and concomitant medications were not reported. In the last 9 months, she worked in the COVID unit. It was unknown if additional vaccines administered on same date of bnt162b2. Prior vaccinations within 4 weeks was unknown. Patient said she got the bnt162b2 through her hospital on 28Dec2020, and still had a painful lump on arm that had turned red and itches when she pressed it was reported as worsened on 28Dec2020, it was painful almost immediately, like you would normally get with any vaccination. It seemed that it had persisted longer and he (Sales Representative) said it sounded like it was getting infected. She said it was painful when she pressed on it and he told her not to press on it. Compared to when she had gotten other vaccines in the arm, this seemed out of the ordinary for how long it had been painful as a site reaction. No ER or physician's office required. The outcome of the events was not recovered. Information on lot/batch number has been requested.
51 2021-01-11 injection site rash, injection site redness Quarter size red rash at injection site
51 2021-01-11 skin infection at injection site Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; S... Read more
Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; This is a spontaneous report from a contactable Nurse (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EH9899), intramuscularly on 28Dec2020 14:30 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The facility type vaccine was hospital. Medical history included migraine from an unknown date. Concomitant medication included erenumab aooe (AIMOVIG), estradiol, diphenhydramine hydrochloride (BENADRYL), trazodone hydrochloride (TRAZODON). No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site on 28Dec2020 15:00. Patient received Antibiotics, steroids epi as treatment for the adverse events. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of event migraine was recovered in Jan2021, other events was recovered on an unknown date. The events were reported as non-serious.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Vaccination site cellulitis, shortness of breath, stridor and migraine, due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
51 2021-01-11 vaccination site pain, vaccination site redness, vaccination site swelling The swelling started on 31Dec2020 like a knot under the skin at the site of the injection; Soreness ... Read more
The swelling started on 31Dec2020 like a knot under the skin at the site of the injection; Soreness in her arm; Redness; This is a spontaneous report from a contactable consumer (patient herself). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration (left arm), on 29Dec2020 at 13:00 at a single dose, for COVID-19 immunization. Medical history included Modular Sponge Kidney stage one (being monitored; this predates her vaccination), Gastrooesophageal reflux disease (GERD), and high cholesterol. Family history included diabetes. Concomitant medications included dexlansoprazole (DEXILANT) from an unspecified date and ongoing for 10 years for GERD, ongoing estrogens conjugated, medroxyprogesterone acetate (PREMPRO) for hormone replacement therapy, pravastatin from an unspecified date and ongoing for 2 years and ezetimibe from an unspecified date and ongoing for six months both taken for high cholesterol. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a drug store.This pharmacy tech received the vaccine on 29Dec2020 at 1300 in the left arm and then had some of the soreness, redness, swelling, and a large knot that grew to the size of a 50 cent piece. It went away and then it came back. She noticed the soreness in her arm and redness at the site on 30Dec2020. The swelling started on 31Dec2020 like a knot under the skin at the site of the injection which grew to the size of a 50-cent piece. The knot went away by the 02Jan2021. Then it started to come back yesterday 05Jan2021 with a knot; and today 06Jan2021 it is also red again and the size of a quarter. Patient is planning to have the second dose on 19Jan2021. She has not treated herself in any way other than rubbing the site. The events did not require emergency or physician visit. Outcome of the events was not recovered. Information on the batch/lot number has been requested.
51 2021-01-11 itchy skin anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry... Read more
anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry wheezy cough a little dizziness; dizziness; tachycardia; Itching; chills; numb R foot; Low grade temp; h/a today; This is a spontaneous report from a contactable Nurse (patient). A 51-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el3248), via an unspecified route of administration on 06Jan2021 11:00 at the first single dose at left arm for covid-19 immunisation. Medical history included supraventricular tachycardia, adrenal insufficiency, hypothyroidism, attention deficit hyperactivity disorder, hypermobility syndrome, developmental hip. Concomitant medication included hydrocortisone, trazodone, levothyroxine sodium (LEVOTHROID), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin, morphine and experienced drug hypersensitivity. The patient experienced anaphylaxis, throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache on 06Jan2021 11:15. Seriousness criteria reported as life threatening. Taken to ER had IV benadryl, solumedrol, pepcid for anaphylaxis. Placed on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely fine prior to vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Jan2021. The outcome of events was recovering. No other vaccine in four weeks; No covid prior vaccination.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis presented as throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition of drug allergies may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
51 2021-01-11 blister, skin burning sensation, rash maculo-papular erythematous swollen thick raised sores with vesicles; 2 swollen erythematous maculopapular round ar... Read more
erythematous swollen thick raised sores with vesicles; 2 swollen erythematous maculopapular round areas on the left side of neck; feel more inflamed; burning feeling to the touch; Is getting slightly painful; Discomfort; This is a spontaneous report from a contactable physician (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), via an unspecified route of administration on the left arm on 27Dec2020 05:30 at a single dose for COVID-19 immunization. Medical history included atopic dermatitis. Patient previously took DUPIXENT, last dose was 18Dec2020 (due to a lack of knowledge about DUPIXENT) and the COVID vaccine, patient have not taken next due dose of DUPIXANT on 01Jan2021). Patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced allergies. On 31Dec2020 02:00 (reported as day 4 after the injection), patient developed 2 swollen erythematous maculopapular round areas on the left side of neck that were sore and slightly have a burning sensation (not pins/needle) to the touch also described as 2 very large erythematous swollen thick raised sores with vesicles on the left side of neck. Patient showed photos to internist a couple days later when they did not go away. As of this reported, it was now day 10 and they are not bigger but they feel more inflamed and have more of a burning feeling to the touch. The small vesicle on each sore had disappeared. Patient stated she had a history of atopic dermatitis but looked and felt nothing like it. Initially had little vesicular areas in the center but the vesicles aren't there today. Discomfort remains. No associated fever or headache. Patient had read of zoster developing with COVID-19 infection, but not associated with the actual vaccine. She was asking if this might be a weird varicella zoster reaction to the vaccine and any data about this. This did not seem to be going away and was getting slightly painful (though so far tolerable) though does not seem to be spreading at this point. Outcome of the events was not recovered. No treatment was received for the events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Information on the lot/batch number has been requested.
51 2021-01-11 rash with redness, rash, itchy rash rash on both lower legs that was red and itchy that is still there - started 2 days after 1st dose
51 2021-01-12 itchy skin, redness, skin warm Extreme erythema covering entire abdomen. Painful, burning, and itchy. Hot to the touch. Lasting 6 d... Read more
Extreme erythema covering entire abdomen. Painful, burning, and itchy. Hot to the touch. Lasting 6 days. Treated with steroid injection and Benadryl. Treatment started January 4, 2021.
51 2021-01-12 rash Flushing of face and rash all over chest. Swelling to eyes, nausea, stabbing pain and heaviness to ... Read more
Flushing of face and rash all over chest. Swelling to eyes, nausea, stabbing pain and heaviness to left neck and under arm, chest pressure, vomiting, and loose stools
51 2021-01-12 injection site swelling, injection site pain No reaction immediately after receiving vaccine. Next day, 1/10/2021, noted left axillary pain, min... Read more
No reaction immediately after receiving vaccine. Next day, 1/10/2021, noted left axillary pain, minimal pain at left deltoid injection site. Used Tylenol for ineffective relief of discomfort. Next day, 1/11/21, noted swelling and pain along left collarbone area on chest/neck area. Called to speak with Dr. Told that I had left supraclavicular lymph node swelling causing discomfort, and still had swelling of left axillary lymph node causing discomfort. Also noted minimal left groin lymph node enlargement with no pain. Told to monitor symptoms and continue to use Tylenol or Advil as needed. Recommended that I call back if symptoms worsen, change or have additional symptoms.
51 2021-01-12 blister Pt received COVID vaccine on 12/27/2020 at 1421 and tolerated well. By 1700 that same day, pt felt f... Read more
Pt received COVID vaccine on 12/27/2020 at 1421 and tolerated well. By 1700 that same day, pt felt flushed in her hands and face. She felt a little short of breath. She started to get fluid-filled blisters on bilateral palms. This is a milder form of the reaction pt has to flu vaccines (she was advised by PCP not to receive flu vaccines because of the blistering). Pt took diphenhyramine 25 mg PO x 1 and the fluid-filled blisters resolved within a few hours. 12/28 around 0330, pt awoke and felt like her right carotid was "pulsating." Pt drank water, did not go back to sleep. "Pulsating" resoved within an hour. No other symptoms develped. In the morning, pt called employee health RN who instructed her to contact PCP and report the reaction. Pt called PCP who advised pt not to get second dose of vaccine due to her reaction to COVID and the flu vaccines.
51 2021-01-12 rash Rash on neck and torso.
51 2021-01-12 injection site mass, hardening, injection site pruritus, injection site redness Received her 2nd Covid Vaccine from Pfizer on 1/7/2021. She stated that she developed side effects ... Read more
Received her 2nd Covid Vaccine from Pfizer on 1/7/2021. She stated that she developed side effects about 2am reporting elevated temp of 101, dizziness, muscle aches all over, nausea, and just didn't feel well. She states she developed a knot on her arm at injection site with redness and itching. She reports this knot was hard initially but next day was better. She reports these side effects lasted all weekend.
51 2021-01-12 injection site pain Severe pain at site starting by 1800 01/11/2021. 01/12/2021 Severe pain at site kept me awake most t... Read more
Severe pain at site starting by 1800 01/11/2021. 01/12/2021 Severe pain at site kept me awake most the night, headache, nausea, joint pain starting at 0615 01/12/2021 which continued to get worse through out the day. Left work early 01/12/2021. Woke 01/13/2021 with slight headache still.
51 2021-01-12 injection site pruritus Site: Itching at Injection Site-Mild, Systemic: pt had tingling on left side of face from lips to ea... Read more
Site: Itching at Injection Site-Mild, Systemic: pt had tingling on left side of face from lips to ear and arm felt funny
51 2021-01-13 injection site pain Initial injection area hurt for 2 days. Began feeling overall sluggish, upset stomach, nausea and f... Read more
Initial injection area hurt for 2 days. Began feeling overall sluggish, upset stomach, nausea and flu like symptoms. Next day the symptoms progressively got worse to include chills, body aches and joint pain and headaches, sluggish and no energy. Had to leave work early due to feeling tired, no energy and went home slept rest of day throughout night, unable to eat. Symptoms stayed the same throughout a Friday Jan 8th still with chills, aches, joint pain and headaches, nausea started to subside finally ate some soup and drank liquids , again was sluggish no energy still and went to bed early. Saturday January 9ththe headaches subsided and I started to feel better... Saturday January 9ththe headaches subsided and I started to feel better, but still did not feel like myself, all over less aches and pains but still not feeling well, still tired and Sunday the same but was able to have an appetite. Monday went into work still not 100% but was able to function. Started feeling like myself by wednesday 1/13.
51 2021-01-13 hives Itchy tingling sensation in mouth and throat, hives on torso and spreading, itchy eyes and inside ea... Read more
Itchy tingling sensation in mouth and throat, hives on torso and spreading, itchy eyes and inside ears, swollen lymph nodes in neck and groin area
51 2021-01-13 rash, hives Severe headache middle of night first night accompanied by nausea Moderate headache next 48 hrs Fat... Read more
Severe headache middle of night first night accompanied by nausea Moderate headache next 48 hrs Fatigue Aches first 24 hrs more unusual reaction => starting on day 2, hives/rash over most of the body for <24hrs
51 2021-01-13 injection site pain Soreness at the injection site, Headache. Treatment: Tylenol, Outcome: No improvement.
51 2021-01-13 injection site redness, injection site pain Swelling on left neck chest collarbone. Swollen lymph nodes. Redness pain. Only on left side. Left a... Read more
Swelling on left neck chest collarbone. Swollen lymph nodes. Redness pain. Only on left side. Left arm was injection site. Malaise. Have appt today 1/14/2021 at 230 at doctor's office.
51 2021-01-13 rash Systemic: Rash (other than injection site)-Mild
51 2021-01-13 bruising received my shot at 8:15 am, within approximately 45min I felt a very slight heaviness to my breath... Read more
received my shot at 8:15 am, within approximately 45min I felt a very slight heaviness to my breathing something similar to allergy season belreathing, and a slight headache on my rr temple. This was nothing that stopped me or slowed me down that day. At approx 10:30pm I awoke from a deep sleep with SHARP chest pains, at 11pm chills, 1am fever and discomfort, 2am muscle aches. I slept on my left side to keep blood circulating to my heart which seemed to ease some of my discomfort. My first night was rough. I awoke Thurs (12/24) with a swollen left foot and leg. some rt leg pain, joint pain in my left knee. I pushed myself to get up and move and go about my day. Friday, I still had a little left foot foot swelling and pain, knee pain, but kept pushing. The handout says if symptoms persist for longer than 24-48 to seek medical care, I have not. Friday, (12/25/20)was Christmas and much of the day was non eventful. At approx 530pm. I felt a bulging not in the center of my chest which was tender to the touch. This concerned me. I gently messaged the area, rested a bit but continued to move up and down the stairs. That discomfort and the bulge decreased within a few hours. Saturday, (12/26) 4:am and I have notice much of the swelling in my foot and legs has decreased, however, I now have bruising. The sore arm is gone, and I am hopefully, all is well. I forgot to mention, I have had intermittent persistent cough with slight sob, something similar to the start of allergy season, but it is brief. I have been coughing at night. I have a history of whooping cough. And gastric bypass.
51 2021-01-14 injection site hardening, injection site warmth, injection site swelling, injection site pain, injection site redness 2nd dose: chills, fever 100., body aches, flu like symptoms. 1/13/21 injection site redness, swollen... Read more
2nd dose: chills, fever 100., body aches, flu like symptoms. 1/13/21 injection site redness, swollen as a rock, hot to touch and sore. 1/15/21 injection site redness, swollen as a rock, hot to touch and sore; skin temp taken 100.0 at injection site, localized in area, not feeling well, weakness, neck stiffness, headaches Midrin taken for intense headache. Pt has been resting all week, off work returned today no fever. 1st dose: no ae to report
51 2021-01-14 sensitive skin Fever, sensation of heart pounding in my chest, dizziness and weakness, fatigue, severe joint pain, ... Read more
Fever, sensation of heart pounding in my chest, dizziness and weakness, fatigue, severe joint pain, body aches, skin sensitivity, headache, chest tightness and burning on inspiration, runny nose, unproductive cough, just felt horrible with all of this for two days fever ran between 99.7 and 100.6. Symptoms began to resolve and no fever by day three. Every day after continued to improve but joint pain, weakness with a general malaise through Thursday. It is now the following Friday and I am still experiencing fatigue and just a general feeling of not being quite 100%.
51 2021-01-14 rash, bruising, skin discolouration On the 1/11/2021 I noted a discoloration to the outer left axilla area- resembling bruising, and a r... Read more
On the 1/11/2021 I noted a discoloration to the outer left axilla area- resembling bruising, and a round, flat rash like area. I have swelling to my left axilla, with 3 points of pain with palpation within it. I also have tenderness in my left breast closest to my axilla.
51 2021-01-14 injection site swelling, injection site pain Pain, swelling to injection site, pain, aches all over, fever and headache started approx 10 hours a... Read more
Pain, swelling to injection site, pain, aches all over, fever and headache started approx 10 hours after injection, lasting approx 29 hours. Approx 48 hours after injection swollen, tender area approx size of golf ball under left arm ( injection arm) and conintues to be there on 3rd day
51 2021-01-14 vaccination site pain R arm pain--at site of injection; significant nausea; headache; body aches; chills; fatigue; This is... Read more
R arm pain--at site of injection; significant nausea; headache; body aches; chills; fatigue; This is a spontaneous report from a contactable Physician (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL6142), via an unspecified route of administration on 07Jan2021 14:45 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. Medical history included hypothyroidism, hx of Hodgkins from 1994, breast cancer from 2005. Concomitant drug included levothyroxine sodium (SYNTHROID). The known allergies included Bactrim, bacitracin, non-ionic contrast. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Right arm pain - at site of injection, significant nausea, headache, body aches and chills. fatigue on 07Jan2021 20:00 with outcome of recovering. Patient didn't receive treatment for the adverse events. The events were reported as non-serious.
51 2021-01-14 rash Rash, swollen tongue and 2 seizures. Admitted to hospital with diagnosis of seizure and allergic re... Read more
Rash, swollen tongue and 2 seizures. Admitted to hospital with diagnosis of seizure and allergic reaction.,
51 2021-01-14 injection site swelling, injection site pain, injection site redness Reactions: Injection site pain Injection site swelling Injection site redness Sever fatigue Swelling... Read more
Reactions: Injection site pain Injection site swelling Injection site redness Sever fatigue Swelling face/eyes Muscle pain - legs Muscle weakness - legs New onset hypertension Dizziness
51 2021-01-14 vaccination site itchiness, itchy skin Slight allergic reaction; itchiness immediately after the injection in the injection area; itchiness... Read more
Slight allergic reaction; itchiness immediately after the injection in the injection area; itchiness spread to parts of patients body like the back of her throat and tongue; itchiness spread to parts of the patients body like the back of their throat and tongue; itching to the area of the leg, the face, the head; This is a spontaneous report from a contactable consumer (patient). The 51-year-old patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) intramuscular (upper left arm), on 21Dec2020, at a single dose, for COVID-19 immunization/ prophylaxis. Relevant medical history included root canal. The patient has no concomitant medications. The patient previously took thimerosal (preservative) and experienced allergy. Patient knows the vaccine is preservative free. The patient received the first dose on 21Dec2020. She had a slight allergic reaction where she experienced itchiness immediately after the injection in the injection area (itching in the arm) and the itchiness spread to parts of her body like the back of her throat, tongue, area of the leg, the face, the head. She took three Benadryl as treatment for these events. The patient recovered completely that same evening (on 21Dec2020) before she went to bed around 10 or 11 that night after her third Benadryl. She was due to go back to get her second dose between 11Jan2021 and 13Jan2021, next week. She is concerned about getting the second dose since she had somewhat of a reaction with the first dose. She had to have a root canal and she was taking an antibiotic which she clarifies as a Z-pack, azithromycin. States her last antibiotic pill is due to be taken on Monday, 11Jan2021. She was asking if she can get the second dose. She is also concerned about how she may react to the 2nd dose of the vaccine while taking Azithromycin. They were informed at work that the 2nd dose of the vaccine should be administered between days 21 and 23 after the first one. Information about lot/batch number has been requested.
51 2021-01-14 injection site pain Staff member states continued soreness in injected arm 10 days post vaccination
51 2021-01-14 itchy skin body itching, eye itching and irritation, body warm, chest tightness, bradycardia
51 2021-01-14 itchy skin body itching, eye itching and irritation, body warmth, chest tightness, bradycardia
51 2021-01-14 vaccination site pain soreness at the injection site; I slept off and on from 8:00pm to 12:00am - I did not really feel li... Read more
soreness at the injection site; I slept off and on from 8:00pm to 12:00am - I did not really feel like moving from the couch, but got up to go to bed; my entire left arm felt "odd" - not painful, just different than my right arm; very tired; joints/muscles on my left side (neck, leg, arm) started to ache; joints/muscles on my left side (neck, leg, arm) started to ache; This is a spontaneous report from a non-contactable consumer (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration (left arm), on 08Jan2021 at 12:00, at a single dose for COVID-19 immunization. The patient's medical history included stomach flu (about 2 years ago), pneumonia (14 years ago), and oral surgery (recently). Concomitant medications included lisdexamfetamine mesilate (VYVANSE), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), calcium, ergocalciferol (VIT D) and red yeast rice. The patient previously received influenza vaccine. The patient has no known allergies. Patient's body mass index (BMI) was 32.5. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the pharmacy or drug store. About 30 min after vaccination on 08Jan2020, the patient's entire left arm felt "odd" not painful, just different than my right arm. About 6 hours after the shot, the patient started getting very tired, and my joints/muscles on my left side (neck, leg, arm) started to ache. She slept off and on from 20:00 to 12:00 and she did not really feel like moving from the couch, but got up to go to bed. She checked for fever around 19:30 and 12:00 but had none. She took one of my left over 600 mg ibuprofen (from a recent oral surgery) as treatment, then went to bed and woke up feeling much better. Today, she only has soreness at the injection site (as she normally did with a flu vaccine). She decided to be proactive and took another 600 ibuprofen around 15:00 and felt consistent all day. Patient stated that how she felt the evening of the vaccine was not painful; just "different" than she experienced before. Outcome of the events was recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
51 2021-01-17 itchy rash, skin warm, rash Hot pink itchy rash bilateral flank areas and across lower abdomen Felt itchy for the next 48 hours... Read more
Hot pink itchy rash bilateral flank areas and across lower abdomen Felt itchy for the next 48 hours Today rash has cleared up on abdomen Still has rash lighter pink on bilateral flank areas and still itchy
51 2021-01-17 injection site pain Nausea, palpitations, Headache, Chills, severe achiness and fatigue, fever, pain at the injection s... Read more
Nausea, palpitations, Headache, Chills, severe achiness and fatigue, fever, pain at the injection site and whole injection site arm soreness.
51 2021-01-17 vaccination site pain Stiffness on the right arm where she got the vaccine shot that is painful; Stiffness on the right ar... Read more
Stiffness on the right arm where she got the vaccine shot that is painful; Stiffness on the right arm where she got the vaccine shot that is painful; Cold chills; Body aches; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: SJ1865), via an unspecified route of administration on 06Jan2021 10:00 at SINGLE DOSE at right arm for COVID-19 immunization. Medical history included ongoing Diabetic- Started 4-5 years ago. Concomitant medication included ongoing metformin for diabetic. The patient clarified the side effects she experienced were cold chills, body aches, and stiffness on the right arm where she got the vaccine shot and there was pain. The cold chills started late afternoon on 06Jan2021 around 1:00 PM or 1:30PM. She confirmed these have gone away and she has recovered completely. The body aches started around this same time as well. The stiffness on the right arm where she got the vaccine shot is painful. She noticed the stiffness and pain about 30 minutes after she got the vaccine, it was like 10:30 AM when she noticed this. She is no longer hurting and the stiffness has gone away. It went away on Saturday late in the evening like 7:00PM or 8:00 PM. The outcome of the events was recovered on 09Jan2021.
51 2021-01-18 itchy skin 10 min after recieving vaccine: - increased HR - itchy over entire body - Benadryl given - ER for fu... Read more
10 min after recieving vaccine: - increased HR - itchy over entire body - Benadryl given - ER for further eveluas
51 2021-01-18 vaccination site pain, injection site pain At the time of the vaccine administration the vaccine was burning going in from the injection site u... Read more
At the time of the vaccine administration the vaccine was burning going in from the injection site up to my shoulder. I think the shot was given to high. The pain in the arm was bad for the first 3 days. The pain in the shoulder, almost right on the bone, is still present.
51 2021-01-18 vaccination site pain Bleeding at left arm injection site; Flu like symptoms; feeling unwell; fatigue; mild headache; inje... Read more
Bleeding at left arm injection site; Flu like symptoms; feeling unwell; fatigue; mild headache; injection site pain; injection site pain, increased soreness in 24 hrs; This is a spontaneous report from a contactable nurse. A 51-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1685), intramuscular into the left arm on 17Dec2020 at 02:45 PM at single dose for COVID-19 immunization. Medical history included Childhood asthma, NIDDM and known allergies to Latex. Concomitant drugs included Metformin, Glyburide, Lisinopril, Jardiance, Januvia, Atorvastatin, Proventil, Advair, Tylenol, MVI, D3, Diosmin, Niacin, Flonase, Vit C. On 17Dec2020 after first dose administered, at 03:00 PM, the patient experienced injection site pain, increased soreness in 24 hrs, bleeding at left arm injection site; flu like symptoms at the 12th hour of vaccination despite of tylenol and ibuprofen alternate medication. Generalized feeling unwell, fatigue, mild headache. At the time of reporting, the patient was recovered.
51 2021-01-18 injection site pain, hair loss Fever lasting 2 days, injection site soreness, nausea, joint pain for 2 days, hair loss for 2 weeks,... Read more
Fever lasting 2 days, injection site soreness, nausea, joint pain for 2 days, hair loss for 2 weeks, extreme fatigue for 2 weeks
51 2021-01-18 hives, hardening, redness, skin warm PPD like reaction, 4cmX6cm red, hot, indurated wheal. As of today (1/19/21), smaller indurated wheal... Read more
PPD like reaction, 4cmX6cm red, hot, indurated wheal. As of today (1/19/21), smaller indurated wheal, but redness is markedly fading.
51 2021-01-18 injection site pain Pain at injection site, diarrhea, loss of appetite, thirst, joint pains, fatigue, chills
51 2021-01-18 itchy skin Patient received Covid vaccine ?around 3:45?. Patient?s initial complaint was feeling ?alittle bit i... Read more
Patient received Covid vaccine ?around 3:45?. Patient?s initial complaint was feeling ?alittle bit itchy? and her ?nose was closing up?. Vitals taken at 3:48- 129/75 BP, 98 HR, 98% O2. Continuing complaint of ?itching?. 1 mL of Benadryl (Lot #080010, Exp 08/22) given at 3:52. Vitals taken again at 3:54- 150/84 BP, 92 HR, 97% O2. Patient sipped water and speaking with responding nurses at 3:55. At 4:00, reported ?throat itching? and had hoarseness, coughing, and congestion. 4:01, 0.3 mg Epi given via autoinjector (Lot #0GM147, Exp 11/21). 4:06 patient reported her tongue was less ?itchy? and decreased congestion. 4:14 vitals were 123/72 BP, 106 HR, 98% O2 & patient reported no improvement of symptoms. 4:15, Dr. was called at which time recommended to call EMS. 4:16, RN called EMS. 4:18 patient reports ?someone is pushing on my throat?. 4:20 a 0.3 mg Epi given via autoinjector (Lot #0GM147, Exp 11/21). 4:22 vitals were 126/81 BP, 107 HR, 96% O2. 4:26 EMS arrived at clinic and left via stretcher. EMS provided with medications given to patient.
51 2021-01-18 hives, injection site hives Urticaria staring at injection site and spreading across chest, neck and torso.
51 2021-01-19 itchy skin Patient described all over itching approximately 5 minutes after receiving vaccine. Vital signs with... Read more
Patient described all over itching approximately 5 minutes after receiving vaccine. Vital signs within normal limits. 25 MG IM Benadryl administered
51 2021-01-19 hives Patient presents back to the COVID clinic approximately one hour post vaccine with chief complaints ... Read more
Patient presents back to the COVID clinic approximately one hour post vaccine with chief complaints of total body urticaria and light headed
51 2021-01-20 rash vesicular 12 days after 2nd vaccine-started with fever/chills, cervical lymphadenopathy and redness/vesicular ... Read more
12 days after 2nd vaccine-started with fever/chills, cervical lymphadenopathy and redness/vesicular type eruption on nose. Fever/chills persisted through night, followed by 16hr N/V and worsening of eruption- vesicular/pustular on nose, then with subsequent right facial swelling.
51 2021-01-20 injection site pain Body aches, chills, fever, headache, sweats, dizzy, arm soreness, tender at injection site
51 2021-01-20 vaccination site pain Fatigue; arm pain at shot site; muscle aches; nausea; fever; basic flu symptoms; This is a spontaneo... Read more
Fatigue; arm pain at shot site; muscle aches; nausea; fever; basic flu symptoms; This is a spontaneous report from a non-contactable other HCP (Patient). A 51-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at left arm on 08Jan2021 09:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included asthma, covid-19 prior vaccination. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 18Dec2020 09:30 at single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Jan2021 at time of 06:30 PM, the patient experienced fatigue, arm pain at shot site, muscle aches, nausea, fever, basic flu symptoms. No treatment received for the events. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered in Jan2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
51 2021-01-20 rash, shingles Herpes zoster on right eye and bridge of nose. Also has rash on back of head on left side radiating... Read more
Herpes zoster on right eye and bridge of nose. Also has rash on back of head on left side radiating up
51 2021-01-20 itchy skin Itchiness all over. No visible rash, just feeling itchy all over with no redness. It feels like I'... Read more
Itchiness all over. No visible rash, just feeling itchy all over with no redness. It feels like I'm itching from the inside.
51 2021-01-20 itchy skin Itching
51 2021-01-20 itchy skin Since 1 week after the vaccine she has been experiencing intermittent chills without fever, pruritis... Read more
Since 1 week after the vaccine she has been experiencing intermittent chills without fever, pruritis from the waist up starting 1/17/21 and changes in her taste with no loss of taste or smell.
51 2021-01-20 itchy skin Starting 1 week after the vaccine she began experiencing intermittent chills with no fever. On 1/17/... Read more
Starting 1 week after the vaccine she began experiencing intermittent chills with no fever. On 1/17/21 she started to have itching from the waist up and she is taking Zyrtec. She has also notice some taste changes but no loss of taste or smell.
51 2021-01-20 injection site pain Symptoms were first noted 12/24/2020. She had the Pfizer Covid vaccine at about 6pm. At about 10 pm ... Read more
Symptoms were first noted 12/24/2020. She had the Pfizer Covid vaccine at about 6pm. At about 10 pm she had mild chest tightness. It persisted for >24. hours. She also had injection site soreness. She was tired for a day. If she talked a lot or got angry, she found it a little difficult to breathe. (Her mother was in the hospital and she had been talking a lot.) She did not have any other symptoms. She reports she was not stressed when she had the vaccine: her mother?s stressful problem started in January. The patient?s symptom severity is rated as: ?mild,? ?not very severe.? If she did not talk, she did not feel anything. The SECOND DOSE was given at my office. The Covid vaccine was administered and the patient was observed for two hours. This was from Pfizer-Biontech Lot EL3246, expiring 4/2021. She had some chest tightness and was given an albuterol nebulizer treatment. Her symptoms resolved and she was discharged to home. I phoned her the next day. She had mild dyspnea the day after the vaccination that resolved that night. She did not have a fever, but did have local soreness, fatigue, body ache, and a headache, for which she took Tylenol. She did see her primary care physician and they discussed the patient?s anxiety due to her mother?s poor health. An EKG will be done.
51 2021-01-20 rash macular, rash with redness body aches vomiting diarrhea temp 101 chills flat, red, splotchy rash
51 2021-01-20 vaccination site pain injection site pain; feeling feverish; This is a spontaneous report from a contactable nurse reporte... Read more
injection site pain; feeling feverish; This is a spontaneous report from a contactable nurse reported for herself. This 51-year-old female patient (No pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), via an unspecified route of administration in right arm on 07Jan2021 at single dose for COVID-19 immunization. Medical history included childhood asthma, Type 2 diabetes mellitus (NIDDM), Latex allergies. Concomitant medication included Metformin, Glyburide, Lisinopril, empagliflozin (JARDIANCE), sitagliptin (JANUVIA), Atorvastatin, salbutamol (PROVENTIL), fluticasone propionate, salmeterol xinafoate (ADVAIR), paracetamol (TYLENOL), colecalciferol (D3), Diosmin, Niacin, fluticasone propionate (FLONASE), ascorbic acid (VIT C), MVI. Patient received first dose of BNT162B2 intramuscular in left arm on 17Dec2020 02:45 PM and experienced injection site pain, increased soreness in 24 hrs, Bleeding at left arm injection site, Flu like symptoms at the 12th hour of vaccination, feeling unwell, fatigue, mild headache. After the second dose on 07Jan2021, the patient experienced injection site pain and feeling feverish the first hour. The outcome of events was unknown. No COVID prior vaccination, no COVID tested post vaccination. No follow-up attempts are possible. No further information is expected.
51 2021-01-20 skin peeling myalgias beginning 9 hours after injection and lasting additional 20 hours more interesting is palm... Read more
myalgias beginning 9 hours after injection and lasting additional 20 hours more interesting is palm and lip peeling beginning 2 days after vaccine and lasting additional 5 days (peeled persistently for all 5 days, think scarlet fever type peeling). Not bullous, not pemphigoid, confined to epidermis. pictures available
51 2021-01-21 injection site warmth, injection site swelling, injection site reaction Chills, nausea, I felt feverish but did not take my temperature, I had sweats, headache, warm and at... Read more
Chills, nausea, I felt feverish but did not take my temperature, I had sweats, headache, warm and at the injection site it swollen and red happened in the middle of the night. For the next 2 days I had extreme fatigue and after that I was fine (by Sunday). I did not have any energy but no chills or nothing. I took Tylenol and it helped me. I was able to return to work on Monday and as the day passed I started feeling like myself. I also developed a lump on my neck on 01/18/2021 on the left side (on my collarbone) and my PCP prescribed Doxycycline 2 tablets a day. I also developed a lump on my right side when I took the first dose and took a ZPack and that lump is still here on my neck.
51 2021-01-21 injection site pain I felt fine after the vaccine. Did just have a little soreness at the injection site. Then a co-work... Read more
I felt fine after the vaccine. Did just have a little soreness at the injection site. Then a co-worker told me my voice was strange, was hoarse. I was feeling fine. The next day I lost my sense of smell. Talked to my PCP and he told me to get tested for COVID, to my surprise I was positive. That was on the 28 or 29 of December. I also developed a lump on my neck on the right side and my PCP prescribed a Z Pack. I finished it but it never went away. I developed another lump on my left side when I took the second dose and I am taking Doxycicline for it.
51 2021-01-21 injection site pain Injection site pain, body aches, fatigue, throat pain. Resolved.
51 2021-01-21 injection site pain Injection site pain, headache. Resolved.
51 2021-01-21 itchy skin, rash Pfizer-BioNTech COVID-19 Vaccine EUA 25 minutes after my 2nd dose I feel warm , my lips slightly it... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA 25 minutes after my 2nd dose I feel warm , my lips slightly itch, pinpoint itch at my scalp and different parts of my body, fine rash in my bilateral forearm near my wrist, immediately I took Zyrtec, my rash started to fade but every now and then I fell fine itch in different parts of my body more than 2 hours now.
51 2021-01-21 injection site swelling Swollen on injection site (about 2inches circumference) blood pressure and hear rate elevated (153/1... Read more
Swollen on injection site (about 2inches circumference) blood pressure and hear rate elevated (153/103 pulse99) -patient refused to call 911 and asking staff to drive to hospital at 9:45am. hospital and nurse in charge at the facility, has contacted each other. At 11:46am nurse has inforemed me that hospital provided IVBenadryl/Fluid IV/Epipen, her heart still raised up, and has twitching, patient has left hospital and back to facility at 12:20pm
51 2021-01-22 redness 20 Jan 2021 face and arms reddening and burning about half hour after injection. 21 Jan 2021 fatigu... Read more
20 Jan 2021 face and arms reddening and burning about half hour after injection. 21 Jan 2021 fatigue, body aches, dizziness throughout day, went to bed very early no appetite, nauseous 22 Jan 2021 fatigue, body aches, dizziness. Temp 99.3 higher than normal. No appetite 23 Jan 2021 condition improved. No symptoms.
51 2021-01-22 rash, rash with redness EXTREME COLDNESS started around 8am the day after the shot. Also all over body aches. 1/23/2021 wo... Read more
EXTREME COLDNESS started around 8am the day after the shot. Also all over body aches. 1/23/2021 woke up with patchy red torso rash
51 2021-01-22 injection site pain Injection site to left arm was extremely sore to touch. Could not raise arm for 3/4 days. After 4th ... Read more
Injection site to left arm was extremely sore to touch. Could not raise arm for 3/4 days. After 4th day arm felt better.
51 2021-01-22 hives Received vaccine at 8:45am. Face felt hot and developed hives at 11:15am. Took Benadryl 25mg at 1pm.... Read more
Received vaccine at 8:45am. Face felt hot and developed hives at 11:15am. Took Benadryl 25mg at 1pm. Continued to work. Two Pepcid and ice at 2:30pm. Had little improvement. Took Claritin at 4:30pm then Benadryl 50mg. Symptoms resolved that am - no further issues.
51 2021-01-23 injection site pain By 10pm on 1/23/21, I was experiencing chills, fatigue, and swollen lymph node in my right armpit a... Read more
By 10pm on 1/23/21, I was experiencing chills, fatigue, and swollen lymph node in my right armpit as well as soreness at the injection site (which started hours earlier). On 1/24/20, chills and extreme fatigue continued along with dull headache, lack of appetite, and general feeling of unwellness. Temperature at 3:30pm was 101.2F.
51 2021-01-24 bruising I started with sore throat,feeling like it was swelling and no difficulty breathing around 5pm. At 7... Read more
I started with sore throat,feeling like it was swelling and no difficulty breathing around 5pm. At 7 pm started exp chills, fever 101.9, the highest it got over next 2 days 100.5. The pain in my legs cause me to not be able to walk and severe headache. Due to the pain in my legs exp bruises in both legs of calf muscles. I felt as if I had Covid therefore I went to the doctor 4 days.
51 2021-01-24 skin burning sensation, itchy skin Within 5 minutes, throat closing and generalized itchiness, tongue swelling, joint ache, skin on fir... Read more
Within 5 minutes, throat closing and generalized itchiness, tongue swelling, joint ache, skin on fire, short of breath. 2 doses of PO Benadryl at clinic, transferred to ED where she received epinephrine and 4 days of prednisone and allergy consult. Nausea began evening of 1/21/21 with headache. Fever 100.6 began 1/22/21. Headache and nausea still remain, not fully recovered.
51 2021-01-24 injection site pain pain at site, joint pain, headache, fever and nausea
51 2021-01-25 rash Excess mucus production, choking on sputum, body rash,- Similar reaction when nut products consumed ... Read more
Excess mucus production, choking on sputum, body rash,- Similar reaction when nut products consumed in the past. 1 alavert sublingual tablet taken, 2 puffs of albuterol inhaler and benadryl tablet taken
51 2021-01-26 injection site redness, injection site warmth, redness, skin warm, injection site hives About 5-10 min after injection, I started to feel a little bit shaky and I felt my heart rate had i... Read more
About 5-10 min after injection, I started to feel a little bit shaky and I felt my heart rate had increased a lot. I just did not feel myself, out of sorts. Paramedics checked my heart rate, pulse ox and BP. O2 was normal - I did not have any respiratory symptoms. My heart rate was quite elevated and blood pressure as well. They had me come to the ambulance to monitor me for a bit longer. Around the injection site I had a large ring of hives, it was red and quite warm. I was red and warm also on my neck and somewhat on the top of my back. They hooked me up to EKG, took my blood pressure, pulse ox and heart rate again, BP and heart rate were still high, O2 sats were normal, but I was feeling better. We waited 15 minutes approximately and they checked my vitals again and my blood pressure has down, as well as my heart rate. So they felt it was OK to discharge me with instructions to take an antihistamine when I got home, and to call emergency services if I needed further help. My symptoms all subsided completely and I was fine at home.
51 2021-01-26 rash Forty five minutes after administration the patient felt scratchy throat, persistent cough, vomit, d... Read more
Forty five minutes after administration the patient felt scratchy throat, persistent cough, vomit, difficulty breathing, swollen face, rash on the neck , torso and arms, itchiness of the eyes, chills . Took some benadryl, cream and pills. Next day malaise, swollen hands, body aches.
51 2021-01-26 rash Nausea, fever, bodyaches, headache, fatigue, rash
51 2021-01-27 skin warm Felt throat tightness, warm, and had sweaty forehead. Given two bottles of water and improved enough... Read more
Felt throat tightness, warm, and had sweaty forehead. Given two bottles of water and improved enough to leave for home.
51 2021-01-27 vaccination site pain Fever/Temperature running 99-100 during the day and running 101-102 for 6 nights now; Sore arm the f... Read more
Fever/Temperature running 99-100 during the day and running 101-102 for 6 nights now; Sore arm the first day; This is a spontaneous report received from a contactable nurse (who is also the patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date: unknown), via an unspecified route of administration in the left arm, on 08Jan2021 11:00, at single dose, for covid-19 immunization, in the hospital. Medical history included asthma, Raynaud's phenomenon, eczema, environmental allergies, and COVID-19 (prior to vaccination). The patient is not pregnant. Concomitant medication included ergocalciferol (VIT D), calcium, ascorbic acid (VIT C), thiamine and zinc. The patient did not receive other vaccines in four weeks. The patient experienced sore arm the first day, on 09Jan2021. Fever started about 30 hours after injection, on 09Jan2021 at 17:00. Her temperature was running 99-100 during the day and running 101-102 for 6 nights now. The patient did not receive treatment for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events was not recovered.
51 2021-01-27 rash rash on chest and upper back; sore throat; muscle twitching around left eye; Fatigue; headache; musc... Read more
rash on chest and upper back; sore throat; muscle twitching around left eye; Fatigue; headache; muscle aches; swelling on left side of body including facial, arm pit, and arm down toward elbow, upper back under shoulder blade; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284, expiration date unspecified), intramuscular on 12Jan2021, at 13:00 at single dose (left arm) for COVID-19 immunization. Medical history included Covid-19 (prior vaccination). The patient was not pregnant and had no known allergies. Concomitant medication included acetylsalicylic acid (ASPIRIN). On 12Jan2021, at 15:00, the patient experienced fatigue, headache, muscle aches, swelling on left side of body including facial, arm pit, and arm down toward elbow, and upper back under shoulder blade, rash on chest and upper back, sore throat, and muscle twitching around left eye. The patient had no treatment for the events. The patient had no other vaccine in 4 weeks; and patient was not Covid tested post vaccination. Outcome of the events was not recovered.
51 2021-01-28 injection site reaction, injection site mass, rash papular, rash with redness 2 inch lump at injection site developed within 24 hours and which lasted 2days; two separate areas... Read more
2 inch lump at injection site developed within 24 hours and which lasted 2days; two separate areas of raised red rash on the skin, one over the injection site about 1 1/2 inches in diameter and a second smaller one above it about 1/2 inch in diameter which were first noticed in the morning 1 1/2 days after the injection. I sought medical care at my primary doctor and was seen by a nurse practictioner on the day I saw the redness/rash ( 2/26). She advised me to use a cold compress and come back in if the area increased in size, became more painful, or I developed a fever. The rash diminished on Friday 1/29/21 as did the lump.
51 2021-01-28 vaccination site pain Her arm killed her and was painful for two days, she could barely move her arm; Her arm killed her a... Read more
Her arm killed her and was painful for two days, she could barely move her arm; Her arm killed her and was painful for two days, she could barely move her arm; She also experienced numbness in her face, jaw, cheeks, mouth that lasted for about 3 hours; She also experienced numbness in her face, jaw, cheeks, mouth that lasted for about 3 hours; This is a spontaneous report from a contactable nurse. A 51-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EK5730), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. Medical history included ongoing asthma for approximately 25 years ago. There were no concomitant medications. After she took the first dose, on an unknown date, her arm killed her and was painful for two days, she could barely move her arm. She also had numbness in her mouth, face, jaws, and cheeks that lasted about 3 hours. The outcome of the events was unknown.
51 2021-01-28 rash macular Patient reported tongue numbness and throat itching sensation within three minutes of vaccine admi... Read more
Patient reported tongue numbness and throat itching sensation within three minutes of vaccine administration. BP 131/87, HR 80, O2 97%. Patient then developed macular rash on bilateral arms and described sensation of generalized warmth about 15 minutes after vaccine administration. presented to vaccine clinic for consult, patient was then transferred to ER via stretcher.
51 2021-01-28 hives, rash, itchy rash Started day after injection and worsened 2 days after. Large raised rash/large hive that started a... Read more
Started day after injection and worsened 2 days after. Large raised rash/large hive that started at the top of my arm and itched (ice helped) Rash proceeded to get larger and move down my arm. Day 4 on started to lessen. Advil taken for pain.
51 2021-01-30 injection site pain Injection site pain mild
51 2021-01-30 injection site swelling, injection site pain Moderate pain and swelling at site
51 2021-01-30 rash, shingles The day after I got my vaccine, I started to have pain in my right arm (opposite arm of vaccine). I... Read more
The day after I got my vaccine, I started to have pain in my right arm (opposite arm of vaccine). It kept getting more intense every day, and I developed a rash on my right arm, right shoulder, and right side of my chest. It started to scab over in parts. I saw my nurse practitioner on 1/19/21 who said it was most likely shingles, and prescribed anti viral and nerve pain meds.
51 2021-01-31 injection site swelling, bruising, injection site nodule 1st shot on 1/5/2021 felt really tired and fatigued. Woke up at 5:30am on 1/6/2021 with chills and ... Read more
1st shot on 1/5/2021 felt really tired and fatigued. Woke up at 5:30am on 1/6/2021 with chills and a headache. Some light swelling and soreness at the injection site on the left arm. 2nd shot on 1/26/21 @ 4:15pm. Right arm swollen, muscle very sore and tight feeling. Some bruising. Half dollar sized knot at the inject site.
51 2021-01-31 injection site tingling, injection site numbness 51yo F rec'd Pfizer Covid-19 vaccine 2nd dose on 1/19/21. Two days later, patient reported numbness/... Read more
51yo F rec'd Pfizer Covid-19 vaccine 2nd dose on 1/19/21. Two days later, patient reported numbness/tingling at injection site, left thumb and left facial cheek area without muscle weakness, facial drooping, drooling, slur speech, headaches, nausea, fever, or rash.
51 2021-01-31 vaccination site swelling malaise/ feeling of severe unwell; migraine; neck pain; heart racing; blurry vision; muscle spasms; ... Read more
malaise/ feeling of severe unwell; migraine; neck pain; heart racing; blurry vision; muscle spasms; muscle pain; nausea; dizziness; swollen entire left arm injection arm; joint pain; kidney pain; unable to think clearly; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on 13Jan2021 12:00 PM at a single dose on left arm for COVID-19 immunization. The patient medical history was not reported. No known allergies. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 23Dec2020, 05:00 PM at a single dose on left arm for COVID-19 immunization and experienced cold frostbite like hands and feet, dizziness when warmed up too quickly, racing heart rate, trouble finding words, with extreme fatigue, nausea, achiness at joints, and swollen lymph nodes. The patient experienced malaise, feeling of severe unwell, migraine and neck pain, heart racing, blurry vision, muscle spasms, muscle pain, nausea, dizziness swollen entire left arm injection arm, joint pain, kidney pain, unable to think clearly on 14Jan2021. AE resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of muscle pain and nausea. The outcome of the events was recovering. The patient was not pregnant. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not tested for COVID post vaccination.
51 2021-02-01 hives, itchy skin, injection site warmth This was the 2nd and final vaccine i got on Friday afternoon. My injection site was extremely hot ... Read more
This was the 2nd and final vaccine i got on Friday afternoon. My injection site was extremely hot on Saturday morning, a welt on my arm and itchy. I then came down with a fever of 101.3 and with that came a headache and my body was aching. I was feeling extremely tired. I had contacted our work number n spoke with some medical providers; they had me alternating take Tylenol and Ibuprofen every couple hours!! My fever hit its highest at 103.00 on Monday night with a severe headache, body aches and I was also nauseated.
51 2021-02-02 injection site reaction, injection site warmth I got my dose 2 and all I had was a sore arm in 6 hrs. At the 28 hr mark, I had tachycardia that st... Read more
I got my dose 2 and all I had was a sore arm in 6 hrs. At the 28 hr mark, I had tachycardia that stayed continuious. It was at 133 when I went to the doctor's office. My arm at the site was hot without brusing and redness. I am currently wearing a Holter Monitor for 2 weeks.
51 2021-02-02 rash headache (day 2 - now), body aches (day 2 - now) , fever on and off (day 2 - now), runny nose, rash ... Read more
headache (day 2 - now), body aches (day 2 - now) , fever on and off (day 2 - now), runny nose, rash from head to toe (day 2) and now is dormant
51 2021-02-03 skin warm, injection site pain, itchy skin Hot feeling on arm. Itchy all over my body. Mainly on arms and trunk, ears face nose. neck head... Read more
Hot feeling on arm. Itchy all over my body. Mainly on arms and trunk, ears face nose. neck head . Heavy feeling in chest. Pain around ribs stomach area an hour after shot. Pain in area of shot. Headache and ache in shoulder of arm with shot. Back ache.
51 2021-02-03 itchy skin, hives Severe itching and hives, shortness of breath causing chest pain
51 2021-02-03 vaccination site mass, vaccination site redness, vaccination site itchiness, vaccination site swelling Swelling, redness, irritation, itching, a visible bump approximately the size of a quarter on the ar... Read more
Swelling, redness, irritation, itching, a visible bump approximately the size of a quarter on the arm and irritation site is the size of a 1/2 dollar; Swelling, redness, irritation, itching, a visible bump approximately the size of a quarter on the arm and irritation site is the size of a 1/2 dollar; Swelling, redness, irritation, itching, a visible bump approximately the size of a quarter on the arm and irritation site is the size of a 1/2 dollar; Swelling, redness, irritation, itching, a visible bump approximately the size of a quarter on the arm and irritation site is the size of a 1/2 dollar; Swelling, redness, irritation, itching, a visible bump approximately the size of a quarter on the arm and irritation site is the size of a 1/2 dollar; This is a spontaneous report from a contactable other healthcare professional, the patient. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3249), via an unspecified route of administration in the left arm on 07Jan2021 at 15:45 (at the age of 51-years-old) as a single dose, for COVID-19 vaccination. There was no medical history. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were unknown. There were no allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jan2021 at 10:00 PM, the patient experienced swelling, redness, irritation, itching, a visible bump approximately the size of a quarter on the arm and irritation site is the size of a 1/2 dollar. The events were reported as non-serious and continued 2 weeks after the first injection. The patient did not receive any treatment for the events. The clinical outcome of swelling, redness, irritation, itching, a visible bump approximately the size of a quarter on the arm and irritation site is the size of a 1/2 dollar were recovered with lasting effects. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
51 2021-02-03 itchy skin The first Pfizer shot I was very fatigued and had sore, stiff muscles on my left side of body. The ... Read more
The first Pfizer shot I was very fatigued and had sore, stiff muscles on my left side of body. The second dose: I did not experience fatigue or the soreness... however, I started itching about 6-7 after the injection. The itching was in random places, but the itching was more like a pinch - it was sharper, but not long lasting.
51 2021-02-03 bruising This employee sent me an email on 12/23/20. "Subject: Re: Attention Covid Vaccine Volunteers Hell... Read more
This employee sent me an email on 12/23/20. "Subject: Re: Attention Covid Vaccine Volunteers Hello, I had received my vaccine earlier today and just awoken to chest pains. I do not think it wise to be there for my shift in the next 8 hrs. I will stay and observe for additional symptoms. I was on vacay and had out-of-office notice set for my email. I discovered this email yesterday while catching up on emails. I immediately called her. She described the details of the events; stated she has not sought medical care; all symptoms resolved spontaneously but still has some intermittent, mild SOB> She sent me this email describing the reaction: Here explanation of the reaction: Thank you for the follow up. Below is a list of symptoms I experienced after I received my initial dose of the Pfizer vaccine. I am scheduled to receive my 2nd dose next week on the 13th of January. following up: I received my shot at 8:15 am, within approximately 45 min I felt a very slight heaviness to my breathing something similar to allergy season breathing, and a slight headache on my rt temple. This was nothing that stopped me or slowed me down that day. At ~ 10:30pm I awoke from a deep sleep with SHARP chest pains, at 11pm chills, 1am fever and discomfort, 2am muscle aches. I slept on my left side to keep blood circulating to my heart which seemed to ease some of my discomfort. My first night was rough. I awoke Thurs (12/24) with a swollen left foot and leg. some rt leg pain, joint pain in my left knee. I pushed myself to get up and move and go about my day. Friday, I still had a little left foot swelling and pain, knee pain, but kept pushing. The handout says if symptoms persist for longer than 24-48 to seek medical care, I have not. Friday, (12/25/20)was Christmas and much of the day was non eventful. At ~ 530pm. I felt a bulging not in the center of my chest which was tender to the touch. This concerned me. I gently messaged the area, rested a bit but continued to move up and down the stairs. That discomfort and the bulge decreased within a few hours. Saturday, (12/26) 4:am and I noticed much of the swelling in my foot and legs has decreased, however, I now have bruising. The sore arm is gone, and I am hopeful that all is well. I forgot to mention, I have had intermittent persistent cough with slight sob, something similar to the start of allergy season, but it is brief. I have been coughing at night." I advised she contact her PCP to determine if follow up is indicated given persistent, intermittent cough and SOB.
51 2021-02-04 injection site pain 02/02/2021 at 11:30am breathing uneasy; I took Benadryl at home and slept for 10 hours. Pain to inj... Read more
02/02/2021 at 11:30am breathing uneasy; I took Benadryl at home and slept for 10 hours. Pain to injection site upon waking; I took Tylenol 8 hrs and drank 20 oz water. 02/03/2021 at 130am running nose and nausea started. At 9am I took some alka seltzer cold tabs. At 5pm I realized pain to right arm was worsening after full inspection I recognize swollen axillary lymph nodes; entire arm pit is swollen. I applied moist heat compress throughout the night and took more Tylenol. I hydrated with water and just layed around resting my body. 02/04/20 swelling continues with some decreased visible; pain to right arm pit continues and nausea continues.
51 2021-02-04 hives, itchy skin 10:16 Pt came up to me and said she worked downstairs. She had her vaccine earlier and was feeling v... Read more
10:16 Pt came up to me and said she worked downstairs. She had her vaccine earlier and was feeling very itchy, like hives all over. She stated she was shaky and felt anxious. I walked her over to the AMR team. 10:17 epinephrine given by AMR in Right Arm 10:20 VS:140/81, 137, 100% 1025 EKG leads applied 1025 IV L arm with flush 1028 Benadryl 50 mg IV given by AMR 1029 BS 156 Patient had a blank expression and when asked to respond she stated it felt like she couldn't take a breath. We asked if she wanted some water and she said yes. We gave her water but she didn't drink any. AMR transferred her to stretcher and transported to ED at 1035. 1034 VS HR128, 100% She stated that she had a hx of anaphylaxis of unknown cause Pfizer vaccine dose #1 given 1/6/21 in right arm- only side effects were fever and chills
51 2021-02-04 injection site pain, injection site swelling FEVER, SWEATS/CHILLS, FATIGUE, FLUTTERING, PALPITATIONS, HEADACHES, WEAKNESS, SHORTNESS OF BREATH, C... Read more
FEVER, SWEATS/CHILLS, FATIGUE, FLUTTERING, PALPITATIONS, HEADACHES, WEAKNESS, SHORTNESS OF BREATH, COUGH, LOWER ABDOMINAL PAIN, MUSCLE PAIN, CHEST PAIN. PAIN AND SWELLING AT INJECTION SITE.
51 2021-02-04 redness Her neck was red and then patient stated it hurt and that she can't breathe. Given 50mg Benadryl IM... Read more
Her neck was red and then patient stated it hurt and that she can't breathe. Given 50mg Benadryl IM and 1mg of Epi IM and transported to emergency department
51 2021-02-04 injection site pain Numbness in face, dizziness, tiredness, pain in muscle at injection site, joint pain
51 2021-02-05 itchy skin Itchy skin
51 2021-02-06 itchy rash Rash that is itchy and headache. I still have the rash with it being itchy at times.
51 2021-02-07 vaccination site pain Muscle soreness at injection site for ~24 hrs after injection; This is a spontaneous report from a n... Read more
Muscle soreness at injection site for ~24 hrs after injection; This is a spontaneous report from a non-contactable consumer reported for self. This 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL3248) at single dose in right arm on 12Jan2021for COVID-19 immunization. Medical history was not reported. Concomitant medications included amlodipine besilate (NORVASC), lisinopril, potassium/calcium supplements. There was no other vaccine in four weeks. There was no covid prior vaccination; no covid tested post vaccination. Patient experienced muscle soreness at injection site for 24 hrs after injection (in Jan2021). The outcome of event was recovered (in Jan2021). No follow-up attempts are possible. No further information is expected.
51 2021-02-07 rash, injection site pruritus Rt. arm rash, itching at the injection site. Pain and swelling under armpit and rt. chest area on r... Read more
Rt. arm rash, itching at the injection site. Pain and swelling under armpit and rt. chest area on rt. side (injection side), no treatment given at this time, Pain continues will see MD. Pain noted under armpit when lying on that side. Visible swelling of armpit and rt. chest area present.
51 2021-02-07 redness, injection site pain Sore arm at the site of injection. Extreme pain and swelling in big right toe. Toe also felt hot to ... Read more
Sore arm at the site of injection. Extreme pain and swelling in big right toe. Toe also felt hot to the touch. I iced both locations and ultimately took 2 200mg Advil tablets. Arm is still tender the second day. The toe felt fine all day then at 5:30pm it started to feel like it was swelling again. I immediately took 2 200mg of Advil.
51 2021-02-07 rash, itchy skin felt warm; lower lip was slightly itchy; pinpoint itch mostly in her scalp left ear; cluster fine ra... Read more
felt warm; lower lip was slightly itchy; pinpoint itch mostly in her scalp left ear; cluster fine rash in her bilateral forearm near the wrist; on and off pinpoint itch in different parts of her body; medical history of Chronic Hep B, borderline DM, HTN, high cholesterol; medical history of Chronic Hep B, borderline DM, HTN, high cholesterol; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982), via intramuscular route of administration on 22Jan2021 at 08:15 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included Chronic Hep B, borderline DM, HTN, high cholesterol. Concomitant medications included losartan, amlodipine, atorvastatin, metformin, fish oil, and docusate sodium (COLACE). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730) on 04Jan2021 at 08:30 am (age: 51 years), intramuscular, in the left arm for COVID-19 immunization; flu vaccine in 2010 and experienced allergies; and Penicillin G and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 22Jan2021 at 08:35, the patient felt warm. At the same time, her lower lip was slightly itchy. She also had pinpoint itch mostly in her scalp left ear and cluster fine rash in her bilateral forearm near the wrist, and four hours on and off pinpoint itch in different parts of her body. The patient was given Zyrtec as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
51 2021-02-08 injection site pain Developed ache in arm of injection-site - but NOT at the site itself - rather all around it from elb... Read more
Developed ache in arm of injection-site - but NOT at the site itself - rather all around it from elbow to neck to scapula. Started about 12hours after injection (woke me at 4:00am). Then over the next several hours developed fever up to 101.5, ibuprofen reduced only to 100.4. This cycle continued through the following day, when temp peaked at 102.2 around 48hr post-injection. Added Tylenol to the ibuprofen, temp then decreased to 100.4. Woke the third day with un-medicated temp between 99-100 all day, but L axillary lymph nodes now swollen. Spent all 3 days on couch, resting and pushing fluids. No GI symptoms at all. Day 4 - Temp normal, but slightly dizzy. Pain and some edema from elbow to scapula to neck continued throughout and still continues now. Axillary lymph nodes still swollen and sore. Some nasal congestion, still a bit dizzy. Never had any pain (just tender to touch) at the actual injection site. Also, I never had any symptoms at all with the first injection. I see nowhere else to put this - I received the injection at my workplace.
51 2021-02-08 itchy skin, hives Patient received the Pfizer Covid vaccine number 2 and about 15 minutes after the dose began itching... Read more
Patient received the Pfizer Covid vaccine number 2 and about 15 minutes after the dose began itching and showing some raised red hives on arms and scalp and a little on the back. we administered Benedryl 50mg IM and within about 10 minutes itching decreased and no additional symptoms have arrisen
51 2021-02-09 redness General fatigue Red, sore arm
51 2021-02-10 redness, blister, rash 2 hrs after 2nd injection, felt like i was burning from inside out; skin red; flushed; rash; scratch... Read more
2 hrs after 2nd injection, felt like i was burning from inside out; skin red; flushed; rash; scratch throat; body aches; dizziness; headache; lymp nodes tender; eye swelling; blurred vision; blisters on the trunk of my body as well as lips and gums; blisters on the trunk of my body as well as lips and gums; blisters on the trunk of my body as well as lips and gums; tooth pain; jaw pain; i also had leg and bilateral foot pain x 4 days; all my mucos membranes were red, irritated and blistered; all my mucos membranes were red, irritated and blistered; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 19Jan2021 10:45 at a single dose on left arm for COVID-19 immunization. Medical history included allergies: sulfa. Concomitant medication included bupropion (BUPROPION). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient experienced 2 hrs after 2nd injection, 'felt like I was burning from inside out', Skin red, flushed, rash, scratch throat, temp, body aches, dizziness, headache, lymph nodes tender, eye swelling, blurred vision, 'blisters on the trunk of my body as well as lips and gums', tooth pain, jaw pain. All of these symptoms lasted 3 days (as reported), blisters and gum issues lasted 4 days (as reported). Patient also had leg and bilateral foot pain x 4 days. All mucous membranes were red, irritated and blistered. The adverse events were experienced on 19Jan2021 12:30. Therapeutic measures were taken as a result of the events which included Benadryl, steroid injection. The outcome of the events was recovering (as reported). Adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
51 2021-02-14 shingles Developed Shingles (never had before) a month after getting vaccine. Not sure if related but thought... Read more
Developed Shingles (never had before) a month after getting vaccine. Not sure if related but thought I should report
51 2021-02-14 itchy skin, hives Patient is a 51 year old female c/o possible reaction to covid vaccine. C/o tingling of lips, left a... Read more
Patient is a 51 year old female c/o possible reaction to covid vaccine. C/o tingling of lips, left arm, hands and feet. Hives and itching. Received 1st dose of covid vaccine at 1635 today. Developed sxs 2-3 minutes after. Was given bendryl 25 mg po at 1643. Was brought by nurse. Hx of chronic urticaria, takes claritin daily with control. Hx of allergic reaction to bactrim. Has epi pen with her. Nurse brought note from Doctor, to order tryptase lab
51 2021-02-14 skin spots Patient received dose #1 of COVID-19 vaccine on 1/16/21. Within 3 days, she developed petechiae up t... Read more
Patient received dose #1 of COVID-19 vaccine on 1/16/21. Within 3 days, she developed petechiae up to ankles, later rising up to her knees. Pt admitted to hospital on 2/6/21 for symptomatic anemia 2/2 vaginal bleeding. Patient received 4 units FFP, 4 units PRBC, 1 unit cryoprecipitate, and vitamin K 5 mg IV. Also started on medroxyprogesterone 20 mg PO TID. Alectinib d/ced due to worsening liver function. Evalauted by OB/GYN and Hematology. Diagnosed with DIC. Patient with worsening bilateral lower extremity edema and purpura with pain and weakness. Palliative care consulted. Patient passed away on 2/11.
51 2021-02-15 injection site swelling At arm pain at 11:00 pm. The following day, my left arm swelled up from wrist to shoulder - three ti... Read more
At arm pain at 11:00 pm. The following day, my left arm swelled up from wrist to shoulder - three times it's size. I couldn't move my arm for 24 hours. Arm pain was gone after 24 hours. Two days after - I was freezing cold, on the couch. Following day, I called my doctor. He told me to rest. I had a high fever and I had body aches. I was really cold. I felt like I had the flu for about a week - missed a couple days of work.
51 2021-02-16 injection site pain General soreness at the injection site for 48 hours. 4 days later left arm (injection) swelling of ... Read more
General soreness at the injection site for 48 hours. 4 days later left arm (injection) swelling of armpit lymph node. And later entire arm. Very painful, tender, sore and with restricted movement. Home medical visit Sat and Monday with Doctor. Ice/heat, liquids, Ibuprofen compression sleeve and elevation
51 2021-02-17 vaccination site pain Cold hands and feet; Chills; Back of the head aches; Stinging in injection arm; This is a spontaneou... Read more
Cold hands and feet; Chills; Back of the head aches; Stinging in injection arm; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 9265, expiry date: unknown), via an unspecified route of administration in the left arm, on 28Jan2021, at single dose, for covid-19 immunization, at an urgent care center. Medical history included known allergies to seafood. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included metformin, and hydrochlorothiazide, telmisartan. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. The patient experienced cold hands and feet, chills, back of the head aches and stinging in injection arm on 28Jan2021. No treatment was given for the events. The patient was recovering from the events. The events were assessed as non-serious.
51 2021-02-17 vaccination site swelling, vaccination site pain Severe pain and swelling at injection site; Severe pain and swelling at injection site; This is a sp... Read more
Severe pain and swelling at injection site; Severe pain and swelling at injection site; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810), via an unspecified route of administration (right arm) on 05Feb2021 12:00 (at the age of 51years) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EL3247) on 15Jan2021 (10:00AM) (at the age of 51years) at right arm for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Feb2021, the patient experienced severe pain and swelling at injection site. There was no treatment received for the adverse events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious. No follow-up attempts are possible. No further information is expected.
51 2021-02-18 injection site pain Dizzy after 30 minutes. By noon felt disoriented and had a headache. Fatigued about 1300. Left work ... Read more
Dizzy after 30 minutes. By noon felt disoriented and had a headache. Fatigued about 1300. Left work to go home, to bed at 1800. On next day had a fever 101.9, chills and sweats, headache, sore throat, confusion, nausea, and intense pain at injection site, neck and back pain, extreme fatigue. All prior symptoms continued until the evening of January 31. Slept almost continuously until February 1. On this day still had chills, confusion, fatigue and a headache. Did go to work on February 1. Most symptoms were improved by February 4. Mildly confused until February 9.
51 2021-02-19 hives, rash, itchy skin Itching began about 12 hours after the second injection. Followed by moderate patchy hives. Treate... Read more
Itching began about 12 hours after the second injection. Followed by moderate patchy hives. Treated with OTC Benedryl, Pepcid, and Zyrtec. Had a decrease in itching and mild improvement in the rash. At about 26 hours post-vaccination itching and severe hives developed a sought treatment in the emergency department for severe hives, severe itching, throat swelling, and hoarseness in voice. Was treated with solu-medrol, Pepcid, and Benedryl. Sent home with steroids and Benedryl. Then on 2/20/2021 began to develop throat swelling and voice hoarseness again. Sought the emergency room again for the same treatment list above.
51 2021-02-21 rash, redness, injection site redness Immediate erythema from injection site down to wrist. Rash on wrist. Resolved in 1-2 hours.
51 2021-02-21 pain of skin On day 5 after receiving the vaccine I developed swollen lymphnodes under my left armpit and above m... Read more
On day 5 after receiving the vaccine I developed swollen lymphnodes under my left armpit and above my left clavical bone. My neck felt and under my chin felt sore and tender. It is day 9 and I still have the swollen nodes, soreness and tender feeling in neck, shoulder and chin.
51 2021-02-21 rash Pt developed rash on chest, tingling in abdominal area, and anxiousness. Pt given zyretec 10mg PO wi... Read more
Pt developed rash on chest, tingling in abdominal area, and anxiousness. Pt given zyretec 10mg PO with water, monitored closely for 1 hr. Instructed per Dr. not to have the second dose administered and to discuss with her physician. Symptoms subsided and pt sent home.
51 2021-02-22 injection site pain A little over 24 hours after my second dose I started to feel muscle aches, a fever of 102.4, headac... Read more
A little over 24 hours after my second dose I started to feel muscle aches, a fever of 102.4, headache, chills, fatigue, diarrhea, sweating, injection site pain, stomach pain and upset. I have been taking Tylenol and Ibuprofen to help with the aches and pains and NyQuil at night to help with fever and aches. It is helpful. I have been eating a BRAT diet and drinking a lot of vitamin water with 0 sugars.
51 2021-02-22 itchy skin, hives Left arm 1st dose given at 12:39 pm. 15 mins post vaccination, patient began having a warms sensatio... Read more
Left arm 1st dose given at 12:39 pm. 15 mins post vaccination, patient began having a warms sensation on her left shoulder blade followed by itching in her extremities. She was brought to observation and reported urticaria all over, flushing of the face, and hives in her upper and lower extremities. Vitals taken and were stable. Benadryl 50mg was administered 15 mins post vaccination and immediately patient reported decreasing symptoms of warmth sensation, itching, and hives. Patient reports she has recently developed hives with cortisone injections. Patient examined 20 mins post vaccination: S1,S2, CTA, hives noted on bilateral UE and LE. Hives resolved 25 mins post vaccination. Patient monitored for over 45mins and reported her symptoms were mild. She declined transportation to the ER. She left in stable condition with her husband.
51 2021-02-23 shingles, hives, skin burning sensation, rash, blister Developed shingles. One day after vaccine: fatigue, intermittent headache on one side of head, achy ... Read more
Developed shingles. One day after vaccine: fatigue, intermittent headache on one side of head, achy body, tingling sensitive scalp, stiff neck. Two days after vaccine: rash and swollen lymph nodes behind and in front of ear, in a line down neck, and at collarbone. Rash on one side of body only, in a band from the back of neck, across ear, down side of jaw and neck to collarbone. Slight pain and sensitivity in entire arm where I received the vaccine, which is the same side of body as rash. Three days after vaccine: rash continues, some blisters erupt. Four days after vaccine: rash is worse, tingling and burning, painful welts;visited clinic and diagnosed with shingles and prescribed topical medications.
51 2021-02-23 injection site swelling, itchy skin Swelling on injection site, itchiness
51 2021-02-24 injection site hardening, injection site swelling, hives 1/4 vaccination Within 24 hours, right away the area of injection site was swollen, hard, grew to th... Read more
1/4 vaccination Within 24 hours, right away the area of injection site was swollen, hard, grew to the size of my hand. The following day, I started getting hives, SOB, and my sinus swelled up, face and extremities. I took Benadryl and went to Urgent Care. Urgent Care put me on medication; vertigo, allergic reaction and sinus infection. Start taking Famotidine, Hydroxyzine-pamoate, prednisone. Followed up with PCM; benadryl Sinuses are still swollen, facial parts still swollen. Going to follow up with PCM I take a nebulizer. That medicine, the albuterol, inhaler Prevail.
51 2021-02-24 rash She did not have any reactions to the first dose; however, this dose made her feel lightheaded, dizz... Read more
She did not have any reactions to the first dose; however, this dose made her feel lightheaded, dizzy, and nauseas. She felt "off" to the point of tears. EMS took a look at her and her blood pressure was elevated. When she developed a rash the decided to transport her to the hospital for further evaluation. She was given Benadryl 12.5mg PO before she left the clinic. They started an IV for the patient but did not hook any medications or fluids up at the time.
51 2021-02-25 itchy skin 1011 Immediately after receiving vaccination patient had c/o itching to chest and head. Patient rep... Read more
1011 Immediately after receiving vaccination patient had c/o itching to chest and head. Patient reports that after the 1st dose of the vaccine she have itching after making it home. Patient also stated that she has had reaction of itching with influenza vaccine. Patient has Allergy to penicillin and is not taking any medications currently. 1016 Patient given Benadryl 25mg Oral liquid. 1020 patient taken to First aid area where patient was assessed by nurse, paramedics and provider on duty. Patient was A & O x3 and all VSS. Patient refused ER transport and signed release and VSS remained stable. Patient advised of the following action plan: repeat dose of Benadryl in 4-6 hours after initial dose. Patient advised to seek immediate medical attention by calling 911 for worsening or persistent symptoms: SOB, swelling to tongue/throat. Pt verbalized understanding of information provided and was discharged home after patient had returned to baseline.
51 2021-02-25 itchy skin At the vaccine administration location, patient experienced the following symptoms: tightness in che... Read more
At the vaccine administration location, patient experienced the following symptoms: tightness in chest, tightness in throat, nausea, ithcy tingley lips, burning lips, bumps/gives on inside of lips. Patient given diphenhydramine 25 mg oral solution PO x1. Vitals taken: WNL. Patient denied EMS transport to ER and transported self to ER. Per ED Provider Notes: Patient reports vaccine was given about 1.5 hours prior to arrival. Pt reported sensation of swelling of her arms, left eye itchiness, and itchiness on the inside of her lips. She denied any difficult, no abnormal sensation in her throat, throat swelling or swelling elsewhere in her mouth. Pruritus documented, no rash. Nausea. At the time of the ER provider examining patient. it is reported that patient was not having anaphylaxis but does have a flat appearing raised lesions on side aspect of upper lower lip. Pt treated with IV diphenhydramine, PO Prednisone and IV famotidine along with NS. Patient observed for 2.5 hours and then discharged. No swelling, itching or swelling and time of discharge and reports resolution of symptoms.
51 2021-02-25 vaccination site pain Body aches; Joint pains; Chills; Right arm injection muscular pain radiating to elbow; Slight nausea... Read more
Body aches; Joint pains; Chills; Right arm injection muscular pain radiating to elbow; Slight nausea; Slight headache; Right arm injection muscular pain radiating to elbow; This is a spontaneous report from a contactable Nurse. This 51-year-old female Nurse (patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3246), intramuscular at right arm on 25Jan2021 15:30 at single dose for COVID-19 immunization. Facility type vaccine: Hospital. Medical history included HTN, cholesterol, known allergies: sulfa. Historical vaccine included the first dose of BNT162B2 (lot number=EJ1686) on 04Jan2021 13:00 via intramuscular at left arm for COVID-19 immunization. Concomitant medication included amlodipine, rosuvastatin calcium (CRESTOR), clonazepam. On 26Jan2021 12:00, patient had body aches, joint pains, chills, right arm injection muscular pain radiating to elbow, slight nausea, slight headache with outcome of unknown. No treatment was received. The patient underwent lab tests included COVID-19 virus test (nasal swab): negative on 10Jan2021. Patient was not pregnant. No other vaccine in four weeks. No covid prior vaccination.
51 2021-02-26 redness 20 minutes status post vaccination while sitting in the observation area the patient indicated to th... Read more
20 minutes status post vaccination while sitting in the observation area the patient indicated to the RN nurse observer that she "felt her face was flushed". Pt was seen and evaluated by NP, a redness was observed on patients bilateral cheeks and forehead. Pt was negative for chest pain, SOB, Facial Swelling, or N/V. There was no rash noted vital signs were taken, Patient was treated with 50mg of oral diphenhydramine, EMS was activated, pt was able to ambulate out of the vaccination center under the care of EMS and was transfered to the Hospital for further evaluation.
51 2021-02-26 injection site redness, injection site hardening, injection site pruritus Red spot, hard and itchy at injection site
51 2021-02-27 redness, injection site redness, injection site pruritus, itchy skin Extreme itching and redness in upper left quadrant (scalp, face, shoulder, arm, into upper thigh) ap... Read more
Extreme itching and redness in upper left quadrant (scalp, face, shoulder, arm, into upper thigh) approximately 12- 15 minutes after injection, dizziness, tingling mouth; ambulance called, taken to hospital, benadryl administered en route and steroids given at hospital
51 2021-02-28 injection site pain Side effects included chills for nearly 15 hours, extremely sore back, especially lower back, inject... Read more
Side effects included chills for nearly 15 hours, extremely sore back, especially lower back, injection site soreness of muscle area and back of legs were very sore. It was uncomfortable to walk. Could not get warm until I went to bed and wore fleece and used a down comforter and a fleece blanket. Laid on a heating pad to help ease the back pain. When I got up the following morning, all side effects were gone and nothing hurt. Also, I had Covid at the end of November, beginning of December 2020. I will not be getting the second vaccination - do not trust what is "not known". The side effects were worse than my experience with Covid.
51 2021-02-28 itchy skin Within 15 minutes of shot, itching and muscle pain. Within 45 minutes of shot muscle cramping in ex... Read more
Within 15 minutes of shot, itching and muscle pain. Within 45 minutes of shot muscle cramping in extremities. Had taken 2 benadryl to ward off allergic reaction. That evening these symptoms continued and fatigue as well as low mood occurred. Next morning, right flank over the kidney pain-all day. Muscle pain- all day. Fatigued. Sunday, severe vertigo that lasted for several hours. Remitted for 5 hours and then returned. Dr. and Neurologist contacted.
51 2021-03-01 itchy skin 1230 pm Received 2nd dose of Pfizer chief compliant generalized pruritus and headache after vaccine,... Read more
1230 pm Received 2nd dose of Pfizer chief compliant generalized pruritus and headache after vaccine, administered Benadryl 25mg @ 1235pm continued to experience itching in back of throat . 1245pm another Benadryl 25mg capsule given. started to feel better itching less intense. 1255 pm Exited home in stable condition.
51 2021-03-01 cellulitis, injection site swelling My arm swollen from my shoulder to my elbow. My doctor stated its cellulitis.
51 2021-03-01 hives Swollen lips, mild anaphylaxis, hives all started 60 minutes after vaccination. We traveled from our... Read more
Swollen lips, mild anaphylaxis, hives all started 60 minutes after vaccination. We traveled from our home (approx 2 hr drive) & were on road. My husband is a physician & when we noticed symptoms administered Benadryl, Claritin, & famatodine.
51 2021-03-01 injection site rash treatment - benadryl, hydration, rest, monitoring vitals at home
51 2021-03-02 rash, itchy skin, shingles 1st vaccination 12/23/2020 2nd vaccination 1/19/2020 *in between vaccinations, diagnosed with Shin... Read more
1st vaccination 12/23/2020 2nd vaccination 1/19/2020 *in between vaccinations, diagnosed with Shingles 1/7/2020 *I have had consistent pain. The Shingles presented itself I had rash on right side, abdomen and back. The dr. gave antiviral, stated I have Shingles, and she also gave me narcotic pain med for pain. I had the pain and rash for 3 weeks. 1/19 I was recovered, had 2nd vaccination, a week later presented rash on both arms, itching. I take Ibuprofen daily, the pain on my back is same location. 10-15 days of constant pain, LEVEL 7-8/10. I also had another rash in between my breasts, arms, and nipples. Using over the counter hydrocortisone cream.
51 2021-03-02 injection site swelling, redness, injection site redness, injection site pain, injection site pruritus, injection site warmth, itchy skin After the first dose for the Pfizer, I experienced a metal like taste in mouth, shortly after. Howev... Read more
After the first dose for the Pfizer, I experienced a metal like taste in mouth, shortly after. However, that went away within an hour. I had the typical low side effects of localized injection soreness, swelling, redness, warmth feeling and it was red around the injection site. The following two days after vaccination (2/22/21) I experienced the expected low side effects. On the third day after vaccination, I was feeling well again. However, yesterday 3/2/21, I noticed the area where I received the Covid vaccine was red again, with itching, warmth feeling, redness, and a bit of burning sensation. This is only apparent on the injection site. I contacted the CDC today, 3/3/21 and they directed me to you to report this and also to contact my healthcare provider, which I have. The CDC was not able to tell me if it was considered normal to have the localized injection site side effects resurface again a week after receiving the 1st dose vaccine. Therefore, I was advised by the CDC to report it. It is also unclear to me if the reason for the localized injection site side-effects being more prominent because of where the injection was administered. There is a question about it having been administered closer to subcutaneously by the nurse than intramuscular, but I do not know.
51 2021-03-02 injection site swelling In the early evening after my second Covid vaccine I began to have moderate body aches, fatigue, inj... Read more
In the early evening after my second Covid vaccine I began to have moderate body aches, fatigue, injection site swelling and headaches. Some of my headaches developed into migraines. The body aches lasted about 14 hours but the headaches persisted for almost two weeks before resolving.
51 2021-03-02 itchy skin, redness Mild itchiness of the face and neck and ears severely red. Took half of a Benadryl and it resolved ... Read more
Mild itchiness of the face and neck and ears severely red. Took half of a Benadryl and it resolved after a short time. I still have periodic itchiness of face and neck. I take claritin everyday.
51 2021-03-02 vaccination site pain low grade fever 101 highest; hot/cold flashes; hot/cold flashes; exhausted; overall body achy; sore ... Read more
low grade fever 101 highest; hot/cold flashes; hot/cold flashes; exhausted; overall body achy; sore arm at/around injection site; This is a spontaneous report from a contactable consumer. A 51-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EN 5318), via an unspecified route of administration at Left arm on 16Feb2021 08:45 at single dose for covid-19 immunisation. The patient medical history was not reported. Allergies to medications, food, or other products: none. Prior to vaccination, was the patient was not diagnosed with COVID-19. Concomitant medication included naproxen sodium (ALEVE) and multi vitamins. The patient previously received first dose of bnt162b2 on 26Jan2021 for covid-19 immunisation. The patient experienced low grade fever 101 highest, hot/cold flashes, exhausted, overall body achy, sore arm at/around injection site on 16Feb2021 12:30. No treatment received for the events. Outcome of events was recovering.
51 2021-03-02 vaccination site pain patient had pain in the arm that she received the vaccine; patient had pain in the arm that she rece... Read more
patient had pain in the arm that she received the vaccine; patient had pain in the arm that she received the vaccine. It was also a little swollen; the lymph nodes under that same arm was really swollen and there was some pain and discomfort along with it; the lymph nodes under that same arm was really swollen and there was some pain and discomfort along with it; This is a spontaneous report from a contactable other health professional (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL9262, via an unspecified route of administration in the left arm, on an unspecified date at SINGLE DOSE for covid-19 immunization. Medical history included covid-19 diagnosed prior vaccination. Concomitant medication included spironolactone, linaclotide (LINZESS), paracetamol (TYLENOL) and caffeine, paracetamol (EXCEDRIN). On 30Jan2021, 20:45, the patient had pain in the arm that she received the vaccine. It was also a little swollen. As well as the lymph nodes under that same arm was really swollen and there was some pain and discomfort along with it. Outcome of events was not recovered. Patient did not receive treatment due to the events. Follow-up attempts are completed. The following information on the batch number has been obtained.
51 2021-03-02 itchy skin patient reported itching all over body after dose today when she got her booster. It resolved after ... Read more
patient reported itching all over body after dose today when she got her booster. It resolved after a day.
51 2021-03-03 rash with redness, injection site discolouration, injection site reaction, injection site swelling 20 hours after dose extreme fatigue, chills, achiness, runny nose and earache. 48 hours after dose ... Read more
20 hours after dose extreme fatigue, chills, achiness, runny nose and earache. 48 hours after dose red rash at injection site, extreme fatigue and symptoms previously stated. 72 hours after dose extreme fatigue, swelling and discoloration at injection site with unusual feeling in right arm, mouth, tongue and lip burning. 96 hours after injection until present, extreme fatigue, burning mouth, tongue and lip sensation, unusual feeling in right arm.
51 2021-03-03 injection site pain Migraine, vomiting, intense injection arm pain ( unable to lift arm), joint pain, diarrhea
51 2021-03-03 rash macular, redness half hour - itchy mouth, dizzy, lightheaded, headache (30 mins) - BP surge 151/104 (2 hours after),... Read more
half hour - itchy mouth, dizzy, lightheaded, headache (30 mins) - BP surge 151/104 (2 hours after), chest tightness, heart racing (3 hours after) - some of this went away after a while - mostly subsided (still having some chest pains and racing heart off and on) - red blotchy face, hands, bit of nausea - 1 day following
51 2021-03-04 injection site pain, injection site redness, injection site warmth Headaches, underarm glands swollen, body aches, soreness, redness of arm, fever near area
51 2021-03-04 vaccination site pain Muscle soreness at injection site. Chills starting 18 hours after injection & lasting for several ho... Read more
Muscle soreness at injection site. Chills starting 18 hours after injection & lasting for several hours.; Muscle soreness at injection site. Chills starting 18 hours after injection & lasting for several hours.; This is a spontaneous report from a non-contactable consumer (patient). A 51-year-old female patient received the second dose of bnt162b2 (BNT162B2 also reported as COVID 19 vaccine brand Pfizer, lot EL3248), via an unspecified route of administration in the right arm 02Feb2021 08:30 at SINGLE DOSE for Covid-19 immunisation. Medical history included high blood pressure. She had her first dose of bnt162b2 (lot EL3248) in the right arm and she had muscle soreness at injection site. Concomitant medications included lisinopril, amlodipine and potassium. The patient experienced muscle soreness at injection site and chills starting 18 hours after injection & lasting for several hours on 02Feb2021, no treatment reported. The outcome of events recovered. No follow up attempts are possible. No further information is expected.
51 2021-03-05 injection site pain 11:17am Tightness around chest, as if bra band was suddenly two sizes too small, but no problem brea... Read more
11:17am Tightness around chest, as if bra band was suddenly two sizes too small, but no problem breathing. Lasted five minutes. 11:20am Slight tightness in throat. Lasted five minutes. 5:00pm Injection site pain, intermittent for two weeks.
51 2021-03-05 injection site pain Significant moderate joint pain in left knee, minor pain in left arm at injection site.
51 2021-03-06 injection site warmth, injection site pain At about 2:54 after shot at 2:50 I got a headache around my temples didnt last long maybe 5 mins. Ju... Read more
At about 2:54 after shot at 2:50 I got a headache around my temples didnt last long maybe 5 mins. Just felt weird like a heaviness all over my body. About 3:10 I started getting a metal taste in my mouth and throat it was gone by 3:30, but kept coming back through the rest of the day and next morning. By evening 8:45 PM my arm where shot was given started to hurt and bothered me through the night could not lay on it. Next morning my arm was hurting really bad at injection site and was warm to touch. I had some errands to do so I did use the arm sometimes the pain was not as bad other times just my coat touching my arm hurt. Around 4pm I took a tylenol and slept a little not better. Sunday morning March 7 it was still sore not as bad, but after using while doing some chores it is now burning and hurting again at 2pm. I feel nauseous and really dont have a appetite.
51 2021-03-06 injection site pain Sore arm at injection site for 48 hours. Severe headache, mostly in the evenings, for 72 hours. Sore... Read more
Sore arm at injection site for 48 hours. Severe headache, mostly in the evenings, for 72 hours. Soreness throughout left side of body accompanied headaches.
51 2021-03-07 injection site redness, injection site pain 02/20/2021-COVID vaccine injected high into the upper shoulder causing redness/soreness immediately ... Read more
02/20/2021-COVID vaccine injected high into the upper shoulder causing redness/soreness immediately at the site, ct felt neck swell 'like a balloon', monitored x 30 min, RNs at clinic determined not an anaphylactic reaction. PHN at site recommended after 24hrs to take antinflammatory and warm pack on site. Neck sensation continued x couple of days, referred to PCP for evaluation.
51 2021-03-07 shingles, rash Already did previously
51 2021-03-07 injection site pain I felt fine after the vaccine. That night, I had a sore injection site, but no other symptoms. I wok... Read more
I felt fine after the vaccine. That night, I had a sore injection site, but no other symptoms. I woke up at 1:15 a.m., felt okay, walked to the bathroom, and suddenly felt extremely nauseous and thought I might vomit. After walking a few steps, I fainted unexpectedly and got a concussion from the fall. Note: I had hit my head earlier that day on something while standing up, but that had not caused any symptoms.
51 2021-03-07 rash rash over entire body, heart palpitations, increased blood pressure
51 2021-03-09 hives I had bad hives allergy reacción and swollen face ,
51 2021-03-09 itchy skin Itching began on 3/6, followed by pustules extending from left shoulder to elbow. Pustules started s... Read more
Itching began on 3/6, followed by pustules extending from left shoulder to elbow. Pustules started small and are now much larger. Right sided facial numbness.
51 2021-03-10 skin warm, rash At 1615 Patient reported symptoms after coivd19 vaccine Pfizer 2nd dose. With left arm rash, warm to... Read more
At 1615 Patient reported symptoms after coivd19 vaccine Pfizer 2nd dose. With left arm rash, warm to touch and numbness. Same symptoms were reported by patient after receiving the first dose coivd19 vaccine Pfizer. Adverse reactions were reported to Dr. and RN. for further medical intervention As per Dr. orders, Benadryl 25 mg IM.
51 2021-03-10 redness At time if waking up around 7:30 to 8 am on 3/9, started sneezing, running nose, foggy brain, red fa... Read more
At time if waking up around 7:30 to 8 am on 3/9, started sneezing, running nose, foggy brain, red face, some minor headache but no fever. It lasted that day (3/9) but brain doggies lasted till 3/10 early afternoon
51 2021-03-10 itchy skin chest tightness, throat tightness, itching, headache, and nausea, which are consistent with her usua... Read more
chest tightness, throat tightness, itching, headache, and nausea, which are consistent with her usual anaphylaxis symptoms with first COVID-19 mRNA vaccine IM. Called RRT. Taken to ED. Took diphenhydramine 50 mg PO. Patient had an EpiPen, but wanted to wait to see if diphenhydramine worked. Symptoms improved over 20 minutes. Observed patient until fully resolved. Instructed patient to return to ED if symptoms worsened or returned.
51 2021-03-11 itchy skin Allergy - itch in ears ., face back throat felt a bit tight on one side swollen a bit and nose insi... Read more
Allergy - itch in ears ., face back throat felt a bit tight on one side swollen a bit and nose inside felt swollen took a Benadryl there blood pressure was high
51 2021-03-11 injection site pain Receive 0.3 ml of Pfizer vaccine. Discovered later that vial had been diluted with 1.6 ml instead of... Read more
Receive 0.3 ml of Pfizer vaccine. Discovered later that vial had been diluted with 1.6 ml instead of the recommended 1.8 ml normal saline. Patient experienced Dizziness, BP 173/83, HX HTN, took BP meds. Symptoms resolved and released home. Patient contacted by phone 03/11/2021 and still reported Dizziness; BP 173/83 currently just has injection site soreness but feels fine.
51 2021-03-12 skin warm PT FELT WARM ,HER BLOOD PRESSURE WAS LOW .GAVE PT ICE PACK AND ELEVATED FLEET. PT ALSO FELT LIGHTHEA... Read more
PT FELT WARM ,HER BLOOD PRESSURE WAS LOW .GAVE PT ICE PACK AND ELEVATED FLEET. PT ALSO FELT LIGHTHEADEDED
51 2021-03-12 redness, skin warm Patient received vaccine and1 minute after patient had a warm flushing sensation that she described ... Read more
Patient received vaccine and1 minute after patient had a warm flushing sensation that she described as being similar to getting contrast. She stated that the back of her throat was warm and the tip of her tongue as well, she was remvoed from the cell and brought to the observation area, her blood pressure was 173/87, heart rate 109, pulse ox 98 in the L arm. She was observed and follow up at 0906 was 174/96, pulse 99 and pulse ox 100. She was observed for another minutes and at 0920 in the R arm her blood pressure was 152/ 85 and heart rate 101. She stated that the warm feeling was resolving and that her tongue still felt a little warm. She did have reddened arms as well in her bilateral arms, no other skin changes noted.
51 2021-03-13 injection site pain WITHIN 3 HOURS OF SHOT: LETHARGY, HEAVINESS IN MUSCLES, FUNNY TASTE IN MOUTH, NEXT MORNING (18 HOU... Read more
WITHIN 3 HOURS OF SHOT: LETHARGY, HEAVINESS IN MUSCLES, FUNNY TASTE IN MOUTH, NEXT MORNING (18 HOURS AFTERE SHOT) PAIN/SORENESS AT INJECTION SITE AND IN UPPER ARM, DIGESTIVE DISCOMFORT
51 2021-03-14 rash, skin burning sensation Extreme Headache, Rash on lower portion of both arms, felt like my skin was on fire from the inside ... Read more
Extreme Headache, Rash on lower portion of both arms, felt like my skin was on fire from the inside out on my face, neck and arms, extreme fatigue, chills. Lasted for a week. Longer Effects, extreme fatigue and brain fogginess ( it's now March 15th, I am still having these effects)
51 2021-03-14 itchy skin Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat T... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium
51 2021-03-15 injection site pain At the time of my vaccine, the nurse asked me if I experienced any pain at the site and happened to ... Read more
At the time of my vaccine, the nurse asked me if I experienced any pain at the site and happened to mention that the needle being used did not retract from my arm. I did not experience any pain in that moment. Later in the evening, I begun to experience muscle pain at the site of the vaccination but believed it was due to the shot. It has now been about a week and a half and pain is now in my shoulder and has traveled down my arm.
51 2021-03-15 injection site pruritus Dry mouth and difficulty swallowing felt like my throat swelled up . palpitations and sob ..within 5... Read more
Dry mouth and difficulty swallowing felt like my throat swelled up . palpitations and sob ..within 5 -10 minutes resolved . Weakness within 20 minutes and dizziness later that night into next day . Itchy injection site at night .
51 2021-03-15 itchy skin TINGLING ON THE TIP OF MY TONGUE!!! ITCHY SCALP AND SKIN LEGS AND ARMS STARTED ABOUT HOUR AND HAL... Read more
TINGLING ON THE TIP OF MY TONGUE!!! ITCHY SCALP AND SKIN LEGS AND ARMS STARTED ABOUT HOUR AND HALF AFTER SHOT DRANK WATER IT LASTED 15 TO 20 MINUTES. SOME DAYS STILL ITCHY AND TIRES ALSO EXTREME FATIGUE
51 2021-03-16 itchy skin, injection site pain, rash 4-6 hours post vaccine, mild fever, pain at injection site left arm, itchiness and bumps all over. ... Read more
4-6 hours post vaccine, mild fever, pain at injection site left arm, itchiness and bumps all over. Ibuprofen and Benadryl 50mg taken. Symptoms resolved. 5 days later, tinnitus in right ear occurs and has been ongoing since then.
51 2021-03-16 hives, itchy skin After injection, immediately felt warm squeezy feeling and pain going up to my neck and going to my ... Read more
After injection, immediately felt warm squeezy feeling and pain going up to my neck and going to my head and giving me a headache. It eased up. About an hour later, I was getting itchy - arms; legs. Big welts on arms and legs and one my back. I took Benadryl hoping it would go away - took it for three days. It wasn't going away. I would scratch and every time I would scratch then hives would spread throughout the whole area that I scratched. Called my Dr's office - he told me to take Benadryl. By Saturday, I went to clinic. Was given steroid pills and prescription for Claritin or Zyrtec. No testing. The meds helped with the smaller hives but my welts still remained and by rubbing the welts I would still get hives around it and they get re-inflamed and they swell up - even it it's my clothes that rub against it. Still have dry patches but they are a little raised but as much as before. I was told to put some cortisone cream on them to help them go away. I was advised not to get second shot.
51 2021-03-16 rash I had a reaction about 10 hours after the vaccination. At midnight I awoke with a full body bright r... Read more
I had a reaction about 10 hours after the vaccination. At midnight I awoke with a full body bright red burning painful rash that lasted for about 25 minutes. I also had the same experience on 3/13 and 3/15 during the day when I was on the train. I have never experienced anything like this before the vaccination.
51 2021-03-16 hives I received the first dose of the Pfizer vaccine on February 25, 2021 at approximately 9:30 AM. Abou... Read more
I received the first dose of the Pfizer vaccine on February 25, 2021 at approximately 9:30 AM. About 2 hours later I began to sneeze quite frequently. About 3 1/2 hours after the shot hives began to break out on both my hands. Later, during the early evening hours I began to sneeze more rapidly and repeatedly. I also began blowing my nose repeatedly due to the massive amount of mucous my body was producing. I became very sick with a cold and stayed in the bed Friday (2-26-2021) through Monday (3-1-21). I also began breaking out in hives on the back of my neck in patches and individual hives over various parts of my body. I went to a Medical clinic on Tuesday (3-2-21) and was given Zyrtec. Feeling much worse the next day (3-3-21) I went to the Medical clinic and received a COVID test (both the rapid and PCR tests were negative. I was prescribed cough medicine and given a steroid shot. My symptoms persisted after this visit and did not get better. Particularly, my cough became extremely bad. I coughed so much my throat became sore from the coughing and became nauseated. Also, a patch of hives had surfaced under my chin. I returned to the Medical clinic on March 12th. I was given a COVID rapid test and a Flu test. Both were negative. The chest x-ray was also clear. I was prescribed the following medications during the March 12th visit: Albuterol Sulfate Inhaler, Azithromycin pack, Virtussin cough medicine, and sudafed. My symptoms subsided somewhat, but the cough remained relentless. I want to a Primary Care Physician on March 16th and was prescribed a Methylprednisolone (6-day steroid) pack. I also made an appointment to see an Allergist. I was diagnosed with Asthma and was prescribed Symbicort, fluticasone, and levocetirizine. The Allergist advised that I continue with the steroid pack as well. Please note, I have never been diagnosed with or suffered from allergies or asthma prior to taking the vaccine shot.
51 2021-03-16 injection site pain Mild headache, very sore arm, exhaustion - headache was day of injection, soreness of arm began day ... Read more
Mild headache, very sore arm, exhaustion - headache was day of injection, soreness of arm began day of and lasted one full day, exhaustion was day after injection
51 2021-03-16 rash Rash on the L hand at 0826 Monitored nausea at 0845
51 2021-03-16 hair loss Report severe hair loss. Treatment: PCP visit Outcome: All test were normal except vitamin D was l... Read more
Report severe hair loss. Treatment: PCP visit Outcome: All test were normal except vitamin D was low and placed on vitamin D supplements. Scheduled to see a dermatologist.
51 2021-03-16 injection site pain Tenderness at injection site Light throbbing headache Strong throbbing headache Fatigue
51 2021-03-17 rash I received a mild rash and swelling. No big deal, and I have photos. I was happy to receive the vacc... Read more
I received a mild rash and swelling. No big deal, and I have photos. I was happy to receive the vaccine and look forward to the second injection.
51 2021-03-17 itchy skin Patient complained of palpitations & itching to her face & scalp at 1:33pm post pfizer second dose v... Read more
Patient complained of palpitations & itching to her face & scalp at 1:33pm post pfizer second dose vaccine. BP=168/85, P-93, SPO2-99%, RR-24 at 1:33pm. No complaints of shortness of breath. No hives or swelling noted. Patient self medicated with Benadryl 50mg PO at 1:35pm. Assisted patient to the nurse's station. BP=149/79, PULSE-83, RR-22, SPO2-99% at 1:57pm. Patient observed for an hour and left with no distress noted. She stated "I feel better" at 2:15pm. Doctor informed & cleared patient.
51 2021-03-17 hives Patient received her vaccine and had no symptoms in 30 min. post vaccination on 1/29/21. By that aft... Read more
Patient received her vaccine and had no symptoms in 30 min. post vaccination on 1/29/21. By that afternoon, she had generalized hives, malaise, and started wheezing. She developed additional symptoms of lip swelling, edema, lightheaded, dyspnea. She had medical contacts with telemedicine, 2 office visits here with her PCP and a couple phone follow ups with her PCP. She was treated with benadryl, a 10 day prednisone course and a ventolin inhaler. Her symptoms resolved after a week.
51 2021-03-17 skin warm, redness Swelling of arm began evening of injection and continues to get worse-hot, red, sore, and very swoll... Read more
Swelling of arm began evening of injection and continues to get worse-hot, red, sore, and very swollen. Headache began about 9 pm on 3/16 and is still present on 3/18. 3/17 body aches, chills, sweats, worse headache.
51 2021-03-18 itchy skin Anaphylaxis. Five minutes after vaccination felt itching. Mouth, tongue, throat began swelling 10 mi... Read more
Anaphylaxis. Five minutes after vaccination felt itching. Mouth, tongue, throat began swelling 10 minutes after vaccination. Received Benadryl, then treated with treated with epinephrine or EpiPen. Transported by EMS to hospital where she received IV famotidine and methylprednisolone sodium succinate.
51 2021-03-18 injection site pain At time of injection had sharp pain in arm, underarm, back of shoulder spreading up neck. Nurse apo... Read more
At time of injection had sharp pain in arm, underarm, back of shoulder spreading up neck. Nurse apologized and told me she thinks she hit a nerve. Later that day had sharp neck and head pain. Iced all areas for two days and took naprosyn. On day 3, the arm, underarm and back of shoulder pain has resolved. But the neck and head pain persist. Was wondering if this is a result of the shot hitting a nerve or is it a side effect of the medicine in the shot.
51 2021-03-18 vaccination site redness, vaccination site pain, hives, rash macular, itchy skin, redness, vaccination site warmth Headache; her whole left arm and left hand are sore; allergic reaction; left arm started feeling flu... Read more
Headache; her whole left arm and left hand are sore; allergic reaction; left arm started feeling flushed; her left arm started getting hot, and the hot sensation traveled down her left arm to her left hand, and up to her left shoulder and neck/her left arm was much warmer than her right arm; upper part of her left arm started turning pink, and then red; burning feeling in her left hand fingers; her left hand got numb and tingly; her left hand got numb and tingly; her fingers in her left hand became itchy/it was a deep down itch in her left hand fingers; the muscles in her left arm between the inside of her left elbow down to the inside of her left wrist were "twingey"; blood glucose was at 295 when she checked before bedtime of 17Feb2021, and at 185 before breakfast in the morning of 18Feb2021; she looked like she had hives; rash going down her left arm/clarified the blotchy red marks go in a line from the inside of her top left elbow down to her left wrist; there is a flush color around the vaccine injection site, but not on the vaccine injection site; Injection site pain/injection site is sore; left shoulder is warm to the touch around her COVID-19 Vaccine injection site; she looked completely wiped out, and pale; looked completely wiped out/Tiredness; Short of breath; her pulse was 101; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200, expiry date: 21Feb2021), via an unspecified route of administration in the left arm, on 17Feb2021 15:40, as single dose, for COVID-19 immunisation. Medical history included type 2 diabetes mellitus from 2012 to (diagnosed with Type 2 Diabetes Mellitus almost 9 years ago), neuropathy in her feet/nerves and reported that she only turns pink if she gets overheated. There were no concomitant medications. The patient did not receive any prior vaccinations within 4 weeks. Historical vaccines included influenza vaccine (reported as flu vaccine) which she gets every year and pneumococcal vaccine (reported as pneumonia vaccine) which she gets every 5 years. The patient reported that she received her first Pfizer COVID-19 vaccine on 17Feb2021 and had an allergic reaction. She said she was at a podiatry appointment, and her podiatrist told her the pharmacy had an extra COVID-19 Vaccine available. She said the pharmacy staff came to her podiatrist's office to administer her COVID-19 Vaccine. She said about 5 minutes after she received the COVID-19 Vaccine injection, on 17Feb2021 15:45, her left arm started feeling flushed, her left arm started getting hot, and the hot sensation traveled down her left arm to her left hand, and up to her left shoulder and neck. She said 20 minutes later, she walked from her podiatrist's office to a nurse's station to be monitored further. She said while she was at the nurse's station, a doctor came by twice to evaluate. She clarified the upper part of her left arm started turning pink, and then red. She said her podiatrist asked her if that was a normal reaction for her. She said she told her podiatrist she only turns pink if she gets overheated. She said her left hand got numb and tingly. She said the muscles in her left arm between the inside of her left elbow down to the inside of her left wrist were "twingey". She said her podiatrist and his nurse felt both her arms, and said her left arm was much warmer than her right arm. While she was at the nurse's station being monitored, she felt short of breath. She said she wasn't sure if she was short of breath because of her nerves. She said her oxygen level was checked and it was at 99%. She said her pulse was 101, her blood pressure was 118/76, and her blood glucose finger stick test was 128. She said she was told by the staff monitoring her, she should expect her blood glucose number to skyrocket because there is a steroid in the COVID-19 Vaccine shot. She said the staff also mentioned she can expect blood glucose spikes as the COVID-19 Vaccine's steroid goes through her system. Her fingers in her left hand became itchy while she was at the nurse's station being monitored. It was a deep down itch in her left hand fingers. She said she asked for an ice pack to put on her left hand because she uses ice packs for neuropathy in her feet, and she felt an ice pack would help with the itch and burning feeling in her left hand fingers. The doctor came to look at her again and wanted to give her IV Benadryl. Then the doctor decided against the IV Benadryl because she would be too sleepy to drive home but the doctor did eventually give her an intramuscular injection of Benadryl 25mg (clarified as Diphenhydramine 25mg in a syringe) in her upper right arm. Within 5 minutes the itching in her left hand fingers calmed down, and the redness in her left arm calmed down to a pink color. She said 20 minutes later her left arm was still pink and warm. She said she was told by the doctor if her reaction moved out of the localized area of her left arm, to go to the Emergency Room, and to use an icepack, again, on her left hand. When she arrived home, her husband said she looked like she had hives and a rash going down her left arm. Her left arm was not itchy though. She clarified the blotchy red marks go in a line from the inside of her top left elbow down to her left wrist. She reported that while she was at her podiatrist's office her left arm was a solid pink. She then mentioned that when she goes out in the sun and gets overheated, she turns pink. She said from her left shoulder to left elbow was warm to the touch. She said by the COVID-19 Vaccine injection site there is a flush color around the vaccine injection site, but not on the vaccine injection site. She said the COVID-19 Vaccine injection site is sore and her left shoulder is warm to the touch around her COVID-19 Vaccine injection site. She reported there were no blotchy, red marks on her left arm on 18Feb2021. She said her left arm is a pretty normal on 18Feb2021. The nurse who monitored her after the COVID-19 Vaccine shot said she needed to report her allergic reaction. She was told she needs to let the COVID-19 Vaccine staff know of her reaction before she gets her second COVID-19 Vaccine injection, so she can be monitored closely. She took no other treatment after she returned home from receiving her COVID-19 Vaccine. She reported she had a headache on 18Feb2021, clarifying her whole head hurts, and the headache has been persisting all day. She said she experienced tiredness, as well. She said the tiredness started on 17Feb2021 and can be partially attributed to the Diphenhydramine 25mg injection she was given. Her husband told her she looked completely wiped out, and pale when she got home after getting her COVID-19 Vaccine on 17Feb2021. She said she remembers being tired when she got home because her eyes were squinty. She reported feeling more tired on 18Feb2021 and her whole left arm and left hand are sore. She clarified her blood glucose was at 295 when she checked before bedtime of 17Feb2021, and at 185 before breakfast in the morning of 18Feb2021. The patient recovered from the events "her fingers in her left hand became itchy/it was a deep down itch in her left hand fingers" on 17Feb2021; from "upper part of her left arm started turning pink, and then red" and "rash going down her left arm/clarified the blotchy red marks go in a line from the inside of her top left elbow down to her left wrist" on 18Feb2021; from "her left hand got numb and tingly", "the muscles in her left arm between the inside of her left elbow down to the inside of her left wrist were twingey", short of breath, "burning feeling in her left hand fingers" and "she looked completely wiped out, and pale" in Feb2021; was recovering from "left arm started feeling flushed"; has not recovered from "her left arm started getting hot, and the hot sensation traveled down her left arm to her left hand, and up to her left shoulder and neck/her left arm was much warmer than her right arm", "blood glucose was at 295 when she checked before bedtime of 17Feb2021, and at 185 before breakfast in the morning of 18Feb2021", "there is a flush color around the vaccine injection site, but not on the vaccine injection site", "Injection site pain/injection site is sore", "left shoulder is warm to the touch around her COVID-19 Vaccine injection site", "looked completely wiped out/Tiredness", "Headache" and "her whole left arm and left hand are sore". The outcome of the events allergic reaction, "her pulse was 101", "she looked like she had hives" was unknown.
51 2021-03-18 rash with redness, rash Numbness of the lips hands and feet. Swelling of the hands purple red rash a long arms. Highly eleva... Read more
Numbness of the lips hands and feet. Swelling of the hands purple red rash a long arms. Highly elevated blood pressure. Tunnel vision. Shaking. 30 minutes after receiving second vaccine for Covid.
51 2021-03-19 injection site redness, injection site inflammation, injection site pain, injection site pruritus Headache since day 1; pain at injection site since day 1; bitter, "disgusting" taste in mouth since ... Read more
Headache since day 1; pain at injection site since day 1; bitter, "disgusting" taste in mouth since day 1; brain fog since day 3; PMS like symptoms (cramps, achy feet) only on day 3; itchiness around injection site since day 1; redness and inflammation around injection site (moderate redness, size of adult woman's thumb from day 1 to day 3; increased about 25% in size on day 4 and had returned to previous size with a less red color). Has taken Tylenol when pain was present, removed headache pain on days 1-3 but not on day 4. Used cold compress on day 3 to reduce swelling but did not affect redness/swelling. Has not slept on injection site arm.
51 2021-03-19 redness, bruising, injection site bruising, injection site redness, injection site pain, injection site pruritus, itchy skin Thursday night arm became sore, red, swollen and itchy. Took Benadryl. Next morning, not better. Arm... Read more
Thursday night arm became sore, red, swollen and itchy. Took Benadryl. Next morning, not better. Arm was hot, swollen, red, itchy and bruising occurred. All was on left arm at injection site.
51 2021-03-20 skin laceration The day after the vaccine, pt experienced typical side effects of fatigue and fever that was control... Read more
The day after the vaccine, pt experienced typical side effects of fatigue and fever that was controlled by Tylenol. The fatigue was extreme and has continued to present day. Also, she has inability to focus and concentrate. She is nauseated daily intermittently. The main complication was in post vaccination day 5, she felt worse than before. Vertigo, nausea, extreme fatigue and inability to perform ADLs and spent most of the day in bed. Approximately 1 am the next morning she woke me, cold, clammy and pale collapsing on the side of the bed with a feeling of impending doom after having diarrhea saying ?something is really wrong.? She went back to the toilet, but had a syncopal episode from standing where she fell straight and flat on her back with no attempt to break her fall. She hit her head on the marble floor and shoe molding. She was unresponsive for 10-20 seconds with no palpable pulse or visible respiratory effort before becoming arousable. She was groggy, but oriented to person and place. She was amnestic for the event. She had an approximately 6 inch full thickness laceration to her posterior scalp that required staples. I took her BP- 85/56, pulse 50, respirations were normal. Ambulance called. Mild hypotension that responded to fluid bolus. CT of head was negative and other than non-specific leukocytosis, labs were normal (CBC, CMP, TFTs, Mg and PO4).
51 2021-03-20 redness, skin discolouration arm discoloration, mottling, redness after vaccine injected. No itching, urticaria, SOB, angioedema,... Read more
arm discoloration, mottling, redness after vaccine injected. No itching, urticaria, SOB, angioedema, nausea/vomiting. NO pain or discomfort. No additional complaints. Had similar reaction, but more severe to Sulfa drugs in the past. Given po Benadryl, observed for additional 30 minutes prior to discharge
51 2021-03-21 itchy skin, rash Dizziness, extreme fatigue, body aches, nausea, diarrhea, rash/itchiness (ALL over)
51 2021-03-21 itchy skin Patient received Pfizer vaccine @ 1045AM. She begin to c/o itching and flushed feeling all over @ ap... Read more
Patient received Pfizer vaccine @ 1045AM. She begin to c/o itching and flushed feeling all over @ approx 11:00am. She was escorted to triage area where she begin to c/o increased itching and tongue swelling. Epi pen and Benadryl was administered. Patient then begin to c/o difficulty swallowing and breathing. She remained alert and oriented to self, time, place and situation. She was taken to Regional per EMT's.
51 2021-03-21 rash with redness, rash Severe Rash on both arms. Centering in the creases in both elbows. Look like a severe sunburn
51 2021-03-21 injection site swelling Severe swelling and injection site area.
51 2021-03-21 injection site pruritus, injection site swelling, injection site pain Sight of injection hurt and was sore right away. After a few hours the sight of the shot became very... Read more
Sight of injection hurt and was sore right away. After a few hours the sight of the shot became very itchy and a little swollen, no redness. I felt achy and tired for rest of day. On 3/21/21 I awoke and felt very, very tired and unwell. Became incredibly nauseous, dizzy at times and had a very strong headache which lasted all day, chills, face was slightly swollen, muscle and joint aches. Injection site still hurt.
51 2021-03-22 itchy skin, hives Difficulty breathing, severe tingling in hands and feet, spike in heart rate and blood pressure, clo... Read more
Difficulty breathing, severe tingling in hands and feet, spike in heart rate and blood pressure, closing throat, itching and hives, heart palpitations and taste of vaccine after injection and nausea.
51 2021-03-22 rash, itchy skin I had the injection on Saturday afternoon and woke up Sunday morning with a rash on my abdomen and a... Read more
I had the injection on Saturday afternoon and woke up Sunday morning with a rash on my abdomen and a few spots on my right arm. I was clearing my throat over and over. By Monday the rash Was also on my back and now on Tuesday the rash is even larger and even more pronounced all over torso and back. There is a slight itchiness to it but not terribly itchy. I have been taking Benadryl But it has not made it go away.
51 2021-03-22 rash, itchy skin Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (speci... Read more
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Chills-Medium, Systemic: Tachycardia-Medium
51 2021-03-22 injection site hives Within 10 minutes I had a headache, racing heart and my tongue felt weird-tingly and numb. Within a ... Read more
Within 10 minutes I had a headache, racing heart and my tongue felt weird-tingly and numb. Within a half hour my lips tongue and throat were swollen. After an hour neck glands were sore and there were a few hives around injection site. Then I took Benadryl and the reaction didn't get any worse but continues into the next day. I have been taking Benadryl every 4 hours.
51 2021-03-22 injection site pain Within 45 mins started sweating, feeling a bit weak, got home still feeling weakness and tiredness, ... Read more
Within 45 mins started sweating, feeling a bit weak, got home still feeling weakness and tiredness, headache and muscle aches to injection site and leg, still have muscle aches today. Yesterday AM awoke and stomach still bothering me - when asked she has upper abdominal pain - the equivalent to a bad stomach ache ie something didn't agree with it, worst the first day and yesterday pretty bothersome. Two weeks before vaccine started breaking out in hives, small red bumps that were red and irritated and appeared on upper back, below cleavage and on on face, thought reaction to something she ate or something she may have touched even tho she wears gloves when she leaves her home, she took Benadryl for 3 days and improved. Yesterday started itching again, sister looked at back and bumps are two fold to back and buttock, traces today on face. When asked, not bites, looks like reaction to something. Caller states she doubts related as started two weeks ago, plans to see physician today, typically would get some form of steroid, how would that affect her as it lowers the immune system. Advised ok to receive the steroid if needed for other medical condition. Patient states she moved to this last year, where she typically experiences seasonal allergies and takes meds for same this time of year. Caller also states she had some left over steroid cream that she has used.
51 2021-03-23 hives, itchy skin, rash with redness 2 days after Pfizer?s 1st Covid-19 dose, neck and chest area became progressively itchy most of the ... Read more
2 days after Pfizer?s 1st Covid-19 dose, neck and chest area became progressively itchy most of the day with hives / red bumps covering lower neck and chest area when I checked it at night. Day 2: the same area remains itchy and burning at night but considerably less than the night before.
51 2021-03-23 redness Left arm swollen with big red hot knot. It was medium size early today now it?s spreaded wider and h... Read more
Left arm swollen with big red hot knot. It was medium size early today now it?s spreaded wider and hurts
51 2021-03-23 itchy skin Patient reports facial itching 5 minutes after vaccination. Benadryl given at 10:39am. Patient rep... Read more
Patient reports facial itching 5 minutes after vaccination. Benadryl given at 10:39am. Patient reports having to "concentrate to swallow". Epi Pen administered at 11:06am.
51 2021-03-24 hives, pain of skin, itchy skin 4 days post vaccination, recipient developed hives on entire body except head area that are painful ... Read more
4 days post vaccination, recipient developed hives on entire body except head area that are painful and severely itchy. The rash lasts for 4 hours or so than subsides for a few hours only to re-surface again. No other symptoms reported. Recipient was seen in the ER, Dermatologist, ENT, and Allergist and put on a steroid tapering dose + antihistamines on 3/24.
51 2021-03-24 injection site rash Difficulty breathing - asthma attack was induced 45 minutes later after injection and had to use res... Read more
Difficulty breathing - asthma attack was induced 45 minutes later after injection and had to use rescue inhaler 2X; Tingling sensation of tongue w/i 10 min of injection; Lips felt puffy w/i 10 min of injection; Increased heartbeat - RN measured it at 95 BPM after injection w/i 10 min of injection - normally it is at 66 BPM resting; Bad rash on left arm around injection site after returned home 1 hour later - took orally one Benadryl tablet 25mg Dizziness w/i 15 min of injection - had to lay down at hospital; Felt sick to stomach w/i 15 min of injection - had to lay down at hospital
51 2021-03-24 redness, skin mass Patient stated she had a 2 to 3 inch round mass on arm opposite the injection site. It is red and in... Read more
Patient stated she had a 2 to 3 inch round mass on arm opposite the injection site. It is red and inflamed.
51 2021-03-24 itchy skin, hair loss exacerbation of psoriatic eczema outbreak to include bilateral upper and lower extremities, all of b... Read more
exacerbation of psoriatic eczema outbreak to include bilateral upper and lower extremities, all of back, abdomen and chest, buttocks, eyebrows, scalp and hair line. Increased itching that is unrelieved by any cream/lotion to include triamcinolone. Hair loss to include large clumps after washing and increased shedding when dry and/or brushing.
51 2021-03-25 injection site pain Arm sore at injection site, with fatigue starting later in day on 3/23. Severe headache started even... Read more
Arm sore at injection site, with fatigue starting later in day on 3/23. Severe headache started evening of 3/23, with slight fever and continued fatigue and continuing through 3/24. Extreme nausea and slight fever throughout the day on 3/25.
51 2021-03-26 hives, redness, itchy skin Turned red/ had hives/ itching, throat itched
51 2021-03-27 injection site redness, injection site swelling Fever chills diarrhea body aches red bump where shot was given.
51 2021-03-27 skin warm Patient following vaccine developed right hand tremor following getting vaccine in her left arm. Pa... Read more
Patient following vaccine developed right hand tremor following getting vaccine in her left arm. Patient was removed from cell and brought to the medical observation area. Her BP was 128/82, P 62 RR 16 @ 3:25 she was alert and oriented times 3 ,at 3:38 her blood pressure was 141/94 and at 3:45 was 148/91 HR 68 at , O2 sat 100%. Her tremors began in her right hand and then went to her trunk and legs. She began to hyperventilate, patient was warm to the touch and an ice pack was provided to her She was not able to have a mask in place and she was hyperventilating, we asked her to focus and take deep breaths she was responsive to that and stated that helped to calm her down. Her husband was brought to her side, her vital signs continued to be obtained. at 3:50 her bP was 156/99, HR 104, pulse ox 99, at 3:55 BP was 150/102 HR 106. EMS was called as patient continued with tremors and her blood pressure continued to be elevated . EMS arrived , her final blood pressure was 156/99, HR 90 and pulse ox was 99%. EMS transported patient out of the center via stretcher. Patients husband planned to follow her to the hospital
51 2021-03-27 injection site pain Site: Pain at Injection Site-Mild, Systemic: Seizure-Medium, Additional Details: Patient sitting on ... Read more
Site: Pain at Injection Site-Mild, Systemic: Seizure-Medium, Additional Details: Patient sitting on chair post vaccine (waiting area) she reported (after seizure and fall) that she was feeling dizzy. She doesn't remember after that and was awake on the floor. Customer reported witnessing a seizure for 4-7 seconds BEFORE the fall. She has an abrasion on her left temple post fall. EMS called and patient refused to go to the ED. She said she would go with her friend.
51 2021-03-28 skin warm, injection site swelling Chills, fever x2 days. From shot #1. Chills, Fever x2 days, 2nd day swelling size of a quarter devel... Read more
Chills, fever x2 days. From shot #1. Chills, Fever x2 days, 2nd day swelling size of a quarter developed. 3rd day R arm swelling, hot to touch, sheering pain size half of a grapefruit. Tingling in right hand. Sought medical help.
51 2021-03-28 hives I have had hives all over my body for the past two weeks .. they don't seem to be going away and I a... Read more
I have had hives all over my body for the past two weeks .. they don't seem to be going away and I am concerned about getting the 2nd dose. I am miserable
51 2021-03-28 cellulitis, injection site redness, injection site swelling, injection site warmth, rash, hives Redness at injection site. Swollen and hot. Redness spread down and underneath the right arm. Had... Read more
Redness at injection site. Swollen and hot. Redness spread down and underneath the right arm. Had rash and hives on body, mostly on the face. Shortness of breath. Doctor said I got Cellulitus.
51 2021-03-30 hives Very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with... Read more
Very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it)/Swell occurred 5 days post injection and remained for several days; Very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it) with corresponding ear ache and rough throat; Very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it) with corresponding ear ache and rough throat; Small hives on bottoms of feet and on hands; This is a spontaneous report from a contactable consumer (patient herself). A 51-year-old female patient received the first dose of bnt162b2 (formulation: solution for injection), via an unspecified route of administration in right arm on 30Jan2021 at 08:00 as single dose for COVID-19 immunization. The patient's medical history included psoriasis, psoriatic arthritis and lupus, and was allergic to Benzodiazepines. Concomitant medication included guselkumab (TREMFYA). The patient was not pregnant at the time of vaccination. Prior to the COVID vaccine, the patient did not receive any other vaccines within 4 weeks and was not diagnosed with COVID-19. On 03Feb2021, the patient experienced very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it) with corresponding earache and rough throat. Swell occurred 5 days post injection and remained for several days. The patient also experienced small hives on bottoms of feet and on hands (the patient had psoriatic arthritis and lupus, so it was not unexpected). The patient was nervous, so underwent a COVID test on the sixth day (negative). The patient underwent lab tests and procedures on 05Feb2021 which include Qualitative PCR: negative and nasal swab: negative. 11 days out and the patient still have some lymph node swelling, but its nearly gone. The patient did not received treatment for the adverse event. The outcome of the events was recovering. Information on the lot/batch number has been requested.
51 2021-03-31 vaccination site swelling DVT (deep vein thrombosis) in right medial subclavian; superficial thrombosis in right proximal basi... Read more
DVT (deep vein thrombosis) in right medial subclavian; superficial thrombosis in right proximal basilic vein; right arm swelling in the setting of receiving her Pfizer covid vaccine in the right arm 1 week prior; This is a spontaneous report received from a contactable healthcare professional. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in arm right in Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included hyperlipidemia, acute pancreatitis, May-Thurner syndrome, and allergies: penicillin, IV contrast. Concomitant medications included drospirenone, ethinylestradiol betadex clathrate (YAZ), fenofibrate, and levothyroxine. Patient is not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient was seen at the ED for right arm swelling in the setting of receiving her Pfizer COVID vaccine in the right arm 1 week prior. She was found to have a DVT (deep vein thrombosis) in right medial subclavian and superficial thrombosis in right proximal basilic vein. The events started on 17Mar2021 09:00. AE resulted in emergency room/department or urgent care. Patient was recovering from the events. Treatment for AEs include anticoagulation. Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of subject vaccine cannot be excluded for the DVT and other reported events, based on temporal relationship. However the reported events may likely represent intercurrent medical conditions in this patient. There is very limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
51 2021-04-02 itchy skin, injection site redness headache; arm started aching; The lymph nodes in her arm are still swollen; Swelling in the armpits ... Read more
headache; arm started aching; The lymph nodes in her arm are still swollen; Swelling in the armpits (for about 7 days) that got very itchy for 3-4 days but has since disappeared/severe itching and swelling in her arm pits/lymph nodes in her arm are still swollen/It is both armpits; Swelling in the armpits (for about 7 days) that got very itchy for 3-4 days but has since disappeared/severe itching and swelling in her arm pits/lymph nodes in her arm are still swollen/It is both armpits; itching on both of her feet; red circle where she got the injection. It was the size of a dime and only there on 28Jan2021; arm that she got the vaccine in got very large; Swelling in the upper breast area/swelling in her upper chest; Swelling and pain in the neck/Neck pain; Swelling and pain in the neck/Neck pain; This is a spontaneous report from a contactable consumer. A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 27Jan2021 15:00 as single dose for covid-19 immunization.Medical history included menopause or has been through menopause, Flu shot, hormonal issues, she started with a bizarre virus, whole lymph node response; It was lymph nodes in her neck, arm pits, and groin. Every two days she would have lymph nodes reacting, she had a little infection and inflammatory markers come back positive. Concomitant medication included probiotics, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) and vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]). The patient previously took flu for influenza immunisation and experienced peripheral swelling, tetanus vaccine for immunisation, amoxicillin, and experienced drug hypersensitivity, flagyl [metronidazole] and experienced drug hypersensitivity. The patient reported adverse events associated with her first Pfizer COVID vaccine shot. She experienced swelling in the upper breast area, swelling and pain in the neck, swelling in the armpits (for about 7 days) that got very itchy for 3-4 days but has since disappeared. She thought on whether to get the second shot of the vaccine considering these side effects since her doctor did not know why this was happening according to her. She thought she would report some side effects after one shot of the Pfizer COVID19 Vaccine. It was strange. She did not read the symptoms until seven days out. Then she saw some have reported a lot less. After the shot, that night she had swelling in her upper chest. She thought it was lymph nodes in the breast and chest area on the side she got the shot. The next day her arm that she got the vaccine in got very large. Then, she does not know if it was related, two days later she had itching on both of her feet. It was the tops of her feet and only for a couple of days. She is not counting that. Day five after the shot has been the main problem. Her armpits started itching like crazy. It was severe itching and swelling in her armpits. The itching lasted for three to four days. The lymph nodes in her arm are still swollen. It was five days after the shot. It was both armpits. The night of the shot she had a lot of neck pain and she thought it was probably the lymph nodes in the back of her neck. That has lasted and was slowly diminishing. The patient was not planning on getting it. There was an agency that for assisted living for people that need help. They were giving it and had extra doses. This guy in charge at the assisted living house offered it to caller and caller's husband because her and her husband run a behavior health counseling. He offered it to them as healthcare professionals. He was given a batch for the residential agency but had extras. She was going through menopause or has been through menopause. She has hot flashes and has hormonal issues. The first week of December she started with a bizarre virus. She got tested for COVID and it was negative. It was not a rapid test it was a sendoff. Through that illness she had a whole lymph node response which was super unusual. The doctor said it was really strange. It was lymph nodes in her neck, arm pits, and groin. Every two days she would have lymph nodes reacting. She had recovered from that and was back to normal. Four days before she got the shot all of that had resolved. Prior to getting the vaccine she had been tested for Lymphoma and it was negative, and she had a little infection, and her white blood count was normal. She had inflammatory markers come back positive prior to getting the vaccine. She went to the doctor on 27Jan2021 and asked if she should get the shot. The doctor said to do it because if she got COVID it would be worse. She was going to have a follow up with doctor for the ongoing stuff and he might do more test. Never in the course of any of that did she have itching armpits or swelling that lasted all this time. She never had chest swelling. The shot in the arm and it moved across her chest. It was reported that, back in the 90's, in 1993 or 1994, flu shots caused her arm to swell really large and stayed swollen for three months. That was the last three flu shots she got in the 90's. Then the doctor said not to get them. No one said why. She doesn't have allergy to eggs or anything that she knows to cause that. She has gotten all other vaccines and tetanus within the last 10 years. Her arm would kind of react but not like that. It went away in a reasonable amount of time. She didn't get a fever. The patient does not have NDC, lot and expiry for flu shots, other vaccines or tetanus to provide. When her kids were younger, they all had to be vaccinated for rabies. She did not have any reaction at all with those vaccines. She has allergies to antibiotics. She does not have lot numbers, NDC, or expiry for the antibiotics she was allergic to. She was allergic to Amoxicillin, Flagyl, Doxycycline, and Sulfa drugs. She has allergies to adhesive and contrast dye. No food allergies. She has allergies to dog and other environmental allergies. She does not take any medications for any of that. She has never had any anaphylactic shock of any kind. It has always been hives. The patient experienced swelling in the upper breast area/swelling in her upper chest, swelling and pain in the neck/neck pain, swelling and pain in the neck/neck pain, swelling in the armpits (for about 7 days) that got very itchy for 3-4 days but has since disappeared/severe itching and swelling in her arm pits/lymph nodes in her arm are still swollen/it is both armpits, arm that she got the vaccine in got very large, itching on both of her feet, red circle where she got the injection. It was the size of a dime and only there on 28jan2021, headache, arm started aching and the lymph nodes in her arm are still swollen. Outcome of the events Swelling in the upper breast area/swelling in her upper chest and arm that she got the vaccine in got very large was recovering, outcome of the events Swelling and pain in the neck/Neck pain, Swelling in the armpits (for about 7 days) that got very itchy for 3-4 days but has since disappeared/severe itching and swelling in her arm pits/lymph nodes in her arm are still swollen/It is both armpits, itching on both of her feet and red circle where she got the injection. It was the size of a dime and only there on 28Jan2021 was recovered and outcome unknown for other events. Information on the lot/batch number has been requested.
51 2021-04-04 injection site pain My should and arm became horribly painful and I could not move my arm at all by the end of the night... Read more
My should and arm became horribly painful and I could not move my arm at all by the end of the night. Nothing helped. I tool Aleve, Tylenol, used ice packs and heating pads. It took four days for me to be able to move my left arm again, and be able to move my arm above my head, but the pain persisted. Today, two weeks and two days later, I still have pain and problems in my range of motion when putting my left arm above my head. Somehow, my left shoulder or shoulder joint was injured by my receiving the vaccination
51 2021-04-09 hives, itchy skin all over itching and hives; all over itching and hives; This is a spontaneous report from a contacta... Read more
all over itching and hives; all over itching and hives; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 10Mar2021 18:30 (Batch/Lot Number: Unknown) as SINGLE DOSE for covid-19 immunisation. Medical history included Hashimoto's disease from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took biaxin and experienced allergy. On 12Mar2021 14:15, the patient experienced all over itching and hives. The events were considered as serious requiring doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures on 18Mar2021 which included sars-cov-2 antibody test: negative. Therapeutic measures were taken as a result of all over itching and hives includes: EpiPen injection. Outcome of events was recovering. Information on the lot/batch number has been requested. Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities. Additional information received on 02Apr2021 to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
51 2021-04-12 rash macular, itchy skin Day 1 (within 30 minutes of vaccine): Tingling and prickling on left fingers and left toes; general ... Read more
Day 1 (within 30 minutes of vaccine): Tingling and prickling on left fingers and left toes; general malaise; fatigue; difficulty concentrating; Day 2: General malaise, fatigue; difficulty concentrating; headache; lower back pain Day 3: Fatigue; runny nose, sneezing, cough, aches all over the body; headache; a red, itchy blotch on the right index finger; lower and upper back pain Day 4: Same as above, but vision problems right before bedtime; Day 5: Severe headache, lightheadedness, difficulty talking, numb left side of thCT e face, left hand, left arm, left food. Went to ER and still in the hospital in observation (Day 6)
51 2021-04-12 itchy skin I was brought to the hospital by the ambulance because my throat swelled up.; eyes are tired; My bod... Read more
I was brought to the hospital by the ambulance because my throat swelled up.; eyes are tired; My body is itchy and feel like crap; My body is itchy and feel like crap; she's allergic to the Covid 19 vaccine; I was wheezing within 10 minutes after receiving the first dose of the vaccine.; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: ER8732 and expiry date: 31Jul2021) via an unspecified route of administration in left arm on 29Mar2021 at single dose for covid-19 immunisation. Medical history included Multiple sclerosis (from 1996 to ongoing), 2006-2007, it was because of an MS drug (Interferon (receiving 3 times a week)), it gave her mild cardiomyopathy. She just stopped taking another treatment for multiple sclerosis called Mavenclad. Mavenclad is a chemotherapy drug. She received her first dose in Oct2020, she took Mavenclad for 5 days. Then in Nov2020 she started taking the Mavenclad again for 5 days. She doesn't restart the Mavenclad again until Oct2021. She reports the Mavenclad takes the B and T cells out of her bone marrow. When she has the next dose of Mavenclad, the B and T cells will be depleted again and when the B and T cells come back they are "tricked" so they won't attack her body. Her hair fell out in clumps with the Mavenclad and her throat swelled too. She would really like a haircut to fix her hair. She premedicated prior to receiving the Mavenclad. She reports she was premedicated for 3 days prior and the day she received the Mavenclad, with Benadryl. Within 15 to 20 minutes of taking the Mavenclad she had a reaction. Concomitant medications included vitamin b12 (about a year) for vitamin b12 deficiency and vitamin d (10-15 years) with calcium for Vitamin D deficiency. On 29Mar2021 within 10 minutes after receiving first dose her throat swelled up. The next thing she knows is people are all around her, she's on a gurney and she's going to the hospital in an ambulance. She would say she's allergic to the Covid 19 vaccine. In the emergency department she had to have an IV with all kinds of medications. Yesterday in the emergency department the doctor wanted to give her an epi pen. She told the doctor she didn't want to have the epi pen. In her IV in the emergency department she received Solu-Medrol, Benadryl (as needed), and Famotidine (20mg twice a day 10 days). She was prescribed Prednisone 20mg tablets, take 3 tablets orally every day for 5 days. She also reports she is allergic to egg whites, not deathly allergic. She can eat a hardboiled egg but she has to take Benadryl because her throat will start to close up. She can eat scrambled eggs just fine because the eggs are cooked different. The emergency room was watching her because if she didn't improve, they were going to give her the epinephrine. She started to improve, and she was thankful. She was afraid something else could have happened to her and her husband was in the parking lot and wouldn't have known. She's not sure how many hours she spent in the emergency room. She was not admitted to the hospital; she was discharged from the emergency room. Now she's taking medication for the next 5-10 days. She's not shocked, with her history and her reactions to medications. She didn't really think an allergic reaction was going to happen because the Covid 19 vaccine is not a live vaccine or anything like that. She's not going to look online for allergic reaction information because her eyes are tired. She's been up since 1:30 AM because of all the steroids she's on. On 30Mar2021, her whole body is itchy. She's taking Benadryl and the Benadryl has helped. The itchy feeling is moving on to different parts of her body. She had the swine flu when it came out and it was hellacious. She feels like Covid is much worse and she she believes in science. She knows Covid 19 isn't made up. She's all for the Covid 19 vaccine. Give her the Covid 19 vaccine so she can move on. She reports everyone in her family got the vaccine, and they were all fine besides aches and pains. When probing for specific information regarding the caller's family members, she reports her daughter, who is in nursing school had the Covid 19 vaccine. After her daughter's first Covid 19 vaccine, she had a sore arm that night and she was really tired. The next day her daughter felt a little lightheaded and she felt like she had flu symptoms. She had some body aches. Then under her daughter's armpit where her lymph nodes are were swollen. By the third day her daughter felt better. She was totally fine. She thinks her daughter may have reported her experience online. The outcome of event eyes are tired and I was wheezing within 10 minutes after receiving the first dose of the vaccine was unknown, the outcome of event My body is itchy and feel like crap, My body is itchy and feel like crap and she's allergic to the Covid 19 vaccine was not recovered where the patient recovering from the event I was brought to the hospital by the ambulance because my throat swelled up.
51 2021-04-15 injection site pain Pfizer dose #1 EJ1686 1/1/2021 12:30 pm Onset of symptoms 2 pm 1/1/2021, around 1.5 hrs post vaccin... Read more
Pfizer dose #1 EJ1686 1/1/2021 12:30 pm Onset of symptoms 2 pm 1/1/2021, around 1.5 hrs post vaccine: severe headache, stiff neck ache, dizziness, nausea, chills, extreme fatigue, feverish but below 100.4, severe muscle aches, loss of taste and smell. Loose bowels at times, slept all the rest of the day and night, drank lots of fluids and electrolytes (low sugar). Felt more weak and dizzy the next day, and when walking felt veering right more, more issues with extended activity. e next dose on 1/22 onwards, and has never gone away fully. R arm pain and raised, tender area at vaccine site contiued to hurt for weeks, even into the next dose on 1/22 onwards, and has never gone away fully. 1/3.2021 woke up 5:30 am sudden onset shortness of breath, deep lung pain in the center of the chest. I felt like my R lung blocked, and started to cough up large amounts of clear mucus, and vomiting mucus due to airway feeling blocked. I did a 4 albuterol puffs to try to open my airway, but I was not wheezing, and did not have any respiratory symptoms or illness at the time before this started. I had been having continued less lung capacity for many months prior due to having been very sick in March 2020 onwards, including loss of sense of smell and taste, shortness of breath, deep lung pain, fever, No wheezing, not sick. Pfizer dose #2 EL9261 1/22/2021 3:50 pm after work. Onset of symptoms by 5:30 pm with headache, dizziness, nausea, extreme fatigue, increased R arm pain at the vaccine site, but it was still hurting at the site from the 1/1/21 shot too, before this dose. Drank fluids and went to bed. Loss of smell and taste returned 1/23/21. Had continued bad headache from 1/22 onwards, with nausea and feeling more dizzy at times, and on 1/26/21 I was at work with increased headache, dizziness and nausea, and went home early from my shift (I am an RN) due to symptoms. Went to bed early, due to continued nausea and headache and dizziness at times. 1/27 continued bad headache, then in the afternoon around 3 pm, GI felt bloated, bad nausea, and then felt shortness of breath around 4 pm and faster heart rate in the upper 80?s lasting for minutes, despite laying down in bed, so I too used my oximeter (I Have photos) and the sats were staying at 88% continuously, and had shortness of breath and return of deep internal mid lung pain, and this lasted for over 10 min. I used a canister of Boost oxygen for 5-6 puffs to try to recover, and the sats raised to 90%. No wheezing. Not sick. I had a bad headache and nausea, and was not feeling good and went to bed. On 1/28/21 I woke up at 5:30 with severe vertigo and dizziness, nausea and a bad headache and could not walk due to the vertigo, and vomited when I was trying to have my head up. I had to crawl to the bathroom on my hands and knees. I called out sick for work due to this and contacted my DR. I was started meclizine 25 mg 3 times a day for vertigo, and was taking Zofran to help. 1/31/21 noted my Re upper eyelid was doing a lot of spastic twitching at times, that would stop and start, but did not think about it much. The vertigo was unrelenting and then I started to have Right arm and hand weakness noted on 2/3/21 and was still very dizzy, nauseated and had a constant headache since I got dose #2 of the COVID vaccine on 1/22. I was using a walking stick for the dizziness to be stable, and also felt weaker on the R side, and drifting to the right when walking .On 2/4/21 I had my first MRI (no contrast, unfortunately) and noticed I could not fully shut my Right eye in the MRI, and by 2/5/21 my face was drooping. I still had the constant headache, nausea and dizziness, and increased R hand, arm and R leg weakness and R hip weakness. I could not lift my R leg up to walk well, cannot grip well with the R hand, and uncoordinated, and cannot walk straight, and am unstable when trying to walk heel to toe, or even stand still with my eyes shut, and have had some double vision with the R eye. I was started on Prednisone and on Klonopin for the vertigo on 2/9 after seeing my neurologist. I took Prednisone for 5 days, from 2/9-2/13 and did not have improvement with the R facial droop or R side weakness and the headaches have persisted, along with some dizziness and nausea. on2/14-15 I had increased shortness of breath and R lung felt like it was not inflating much, and got an xray, and went onto Zithromax for 5 days, which did help my lungs to improve, and I was able to breathe better, and got my Right lung capacity back. I stopped the Klonopin after a week (2/9-2/16), to manage through the symptoms without it, and have been doing physical therapy and. Vestibular therapy. I had another MRI, with contrast on 2/25, after an in-person neurology appointment, and was having some improvement with the vertigo, so I started back to a desk job, not my RN job on 3/4/21, but I was still having the constant headache, nausea, and some dizziness, R face droop, R hand weakness, R leg weakness and walk with a walking stick, and have increased issues with exertion, but have been walking and doing therapies to get stronger.3 I started to have increased R facial droop. EMG done on 3/23 of my R arm. Worse headache, nausea, dizziness at the desk, and fatigue, but R side weakness issues increased, so I started back onto Prednisone on 3/28/21 with 50mg day for 3 days, then 40mg for 3 days, 30mg for 3 days then 230mg for 2 days, but had increasingly bad headache,nausea and increasing R facial droop, and much worse R hand weakness, R arm weakness and pain, and R hip pain and weakness, worse walking, cannot lift my R leg or foot as high as the L, again, and am struggling to walk, and get worse with exertion with R side walking and weakness. I also had shooting pains in my R jaw start on 4/6-7, along with R jaw and face pain and increased numbness, more face droop shooting pains in my R hip, and arm and body pain and a worse headache making it hard to even sleep, and some increased issues with my R eye that I need to have checked. The prednisone last dose was on 4/7, and stopped due to the symptoms I was having, after a video visit with the neurologist. Increased R leg weakness, R weak hip vs left, R foot drag/drop, with increased issues to maintain walking with progressive walking, still using walking stick to try to walk, but now for stability and to keep from drifting, R facial droop increasing and now some R eye blurring 4/9 onwards, that is new.
51 2021-04-20 rash, redness All my muscles and whole body is hurting; All my muscles and whole body is hurting; Chills; Joint pa... Read more
All my muscles and whole body is hurting; All my muscles and whole body is hurting; Chills; Joint pain; I had some wired nausea, I can even hardly eat; I had some wired nausea, I can even hardly eat; My heart rate is kind of low but it's been 125 for last 2 days; I have a rash; I feel dizzy and weak; cannot stand up and walk; I feel dizzy and weak; cannot stand up and walk; I feel dizzy and weak; cannot stand up and walk; My lymph nodes are very swollen; I have ray nods also that's circulation disorder; I feel like I have been freezing cold ever since I got the second shot; I got half fever; I have ray nods also that's circulation disorder; I feel like I have been freezing cold ever since I got the second shot; I got half fever; I have been passed out; I had mine my fever gone up to 104.9 and down to 103; my arm is swollen, hard and hurts terribly; my arm is swollen, hard and hurts terribly; whole arm get deep red; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, in the left arm on 01Apr2021 (Batch/Lot Number: EN6199) (at the age of 51 years old) at a single dose for covid-19 immunisation. Medical history included lupus and high blood pressure both from an unknown date. Concomitant medications included sertraline hydrochloride (ZOLOFT), clonazepam (KLONOPIN) and topiramate (TOPAMAX) all taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of BNT162B2 on 12Mar2021 (lot number: EN6198) (at the age of 51 years old) and reported that she was really not feeling well. On 01Apr2021, the patient got the second dose of covid vaccination and reported that she had a pretty serious side effect since the first one. The patient then reported her fever gone up to 104.9 and down to 103 and reported that she was worried about herself, not only the fever; her arm is swollen, hard and hurts terribly; patient reported that all her muscles and whole body is hurting and the chills, the joint pain of course the fever and further reported that had some wired nausea, she can even hardly eat. The patient then stated that within a few hours after her shot, she started having mild problems: swelling of her arm, her whole arm get deep red and throughout pain in her arm. The patient had a video call with her primary care doctor, the doctor said it's just normal, don't worry about it, the doctor didn't let the patient give all her symptoms (as reported). The patient further stated she have that pain and something is not right in her body and that she have been taking Tylenol. The patient also reported that her heart rate is kind of low but it's been 125 for last 2 days (as reported), patient reported that she has a rash, feel dizzy and weak, cannot stand up and walk, the patient have attended to go for her family house for the Easter and she was there for 15 minutes. Keep in mind Covid normally they all were vaccinated and it's been a very special time, but within 15 minutes the patient have been passed out and had been taking home and further reported that her lymph nodes are very swollen and her head is killing her. The patient have an electric blanket in her arm because she have chills so bad, her joints are hurting and she have ray nods (as reported) also that's circulation disorder and she feel like she have been freezing cold ever since she got the second shot. The outcome of the events was unknown.
51 2021-04-30 rash Rash on face, neck, chest, and (lighter on abdomen); This is a spontaneous report from a contactable... Read more
Rash on face, neck, chest, and (lighter on abdomen); This is a spontaneous report from a contactable consumer (patient). A non-pregnant 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in the left arm on 20Mar2021 at 09:30 (Batch/Lot Number: EN6206) at 51-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient did not have COVID prior to the vaccination. The patient's medical history and concomitant medications were not reported. On 26Mar2021 at 21:00, the patient experienced: rash on face, neck, chest, and (lighter on abdomen) (non-serious). Therapeutic measures were not taken as a result of the rash. The clinical outcome of the event was recovering. The patient was not tested for COVID post vaccination. No follow-up attempts are needed. No further information is expected.
51 2021-04-30 hives, itchy skin hives; itching all over her body; This is a spontaneous report from a contactable consumer. A 51-y... Read more
hives; itching all over her body; This is a spontaneous report from a contactable consumer. A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Left Arm on 17Mar2021 16:00 (Batch/Lot Number: EP7534) as SINGLE DOSE (at the age of 51 years) for covid-19 immunisation. Medical history included mycotic allergy from an unknown date, seasonal allergy from an unknown date ( Grass/ Weeds allergies), allergy to animal from an unknown (various animals), asthma from an unknown date, sinusitis from 2021 to an unknown date, fruit allergy from an unknown date (she has had reactions to strawberries, apples, basically every fruit except bananas). Concomitant medications included loratadine (LORATADINE) taken for outside allergies; triamcinolone acetonide (NASACORT) taken for sinus infection and budesonide, formoterol fumarate (SYMBICORT) taken for asthma. Patient states that she started immunotherapy around Oct2020 and gives herself unspecified "allergy shots" every other day. Dr. did not know how they would interact with Covid vaccine and sent her a letter advising her to stop allergy shots 48 hours before and 48 hours after receiving Pfizer COVID-19 vaccine, which she did. She started taking her allergy shots in 16Feb2021 and had no problems, no hives, no reactions, no itching until she got the Pfizer COVID-19 vaccine. The patient experienced hives on 18Mar2021 with outcome of recovering and itching all over her body on 18Mar2021 with outcome of not recovered. She had hives on her feet, neck, and legs. Therapeutic measures were taken as a result of hives and itching all over her body. She has taken Calamine lotion, oatmeal baths, and Benadryl (not brand name) to treat her symptoms. She has seen a doctor who prescribed steroids to take. She was prescribed Prednisone 20mg tablets twice a day on 13Apr2021. She states her doctor advised her to take a break on the allergy shots since on prednisone. She does have an Epi pen but didn't feel any kind of respiratory distress, she did not feel she needed to use it. No additional vaccines administered on same date of the Pfizer product. No other vaccines were given within 4 weeks of the Pfizer product. She states on 07Apr2021 she was supposed to get her second Pfizer COVID-19 vaccine, but she was advised not to take the second dose by her MD. She never had a reaction to any vaccination, and she has had unspecified pneumonia and flu vaccinations. No follow-up attempts are possible; No further information is expected.
51 2021-05-03 injection site pain I had immediate, sharp, and severe pain at injection site that has not resolved 12 hours later. I s... Read more
I had immediate, sharp, and severe pain at injection site that has not resolved 12 hours later. I suspect injury to my anterior branch of axillary nerve.
52 2021-01-01 injection site pain 12/29/2020 (date of injection) soreness at injection site, Headache & increased Heart Rate. 12/30/2... Read more
12/29/2020 (date of injection) soreness at injection site, Headache & increased Heart Rate. 12/30/2020 Headache, Chills, Body Aches, Fatigue. 12/31/2020 Headache, increased Chills, increased Body Aches, increased Fatigue, feeling Feverish (not able to do ADL's). 1/1/2021 Headache, increased Chills, increased Body Aches, increased Fatigue, feeling Feverish (not able to do ADL's). 1/2/2021 All symptoms are getting better, still slightly there.
52 2021-01-02 itchy skin Pfizer-BioNTech COVID-19 Vaccine EUA Slight chest pain and slight difficulty taking deep breath for ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Slight chest pain and slight difficulty taking deep breath for a few seconds it - did not go past 15 minute observation. Felt nauseated for a brief time - did not go past the 15 minutes. About 25 minutes after the tip of my tongue, section of my bottom lip and sides of my tongue were tingly. The tip of my tongue continues to be like that day #2 after and there is a small blood blister underneath the tip of my tongue. Parts of my body feel a little itchy an hour after vaccine and continues very infrequently at this time and it disappears in seconds.
52 2021-01-03 rash papular, rash Arm soreness Arm swelling Headache Right side neck pain Bumps on both cheeks (face)
52 2021-01-03 injection site hives, redness, hives Hives on left arm close the injection site. Hives and skin redness on upper chest between breasts
52 2021-01-03 injection site pain Nausea, headache, muscle ache, exhaustion, chills, low grade fever, and pain at the injection site.
52 2021-01-03 rash, rash maculo-papular, itchy skin Pfizer-BioNTech COVID-19 Vaccine EUA - Patient with history of anaphylaxis requiring intubation to b... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA - Patient with history of anaphylaxis requiring intubation to benzonatate. Patient answered "no" to questionnaire about allergic reactions prior to vaccination. 11 minutes after vaccination, patient reported tingling of lips and swelling of face. Developed hoarseness. SWAT was called and patient given benadryl and taken to ED (1055). Patient received steroids and H1/H2 blockers in addition to epinephrine. Patient brought to ICU for monitoring. Patient continued on therapy and was discharged 1/2 at 1113. Patient returned to ED on 1/3 at 1558 with macular papular rash on leg, chest and back with itching on eyelids and face. No respiratory involvement. Patient given benadryl and predinisone and discharged from ED at 2016.
52 2021-01-03 injection site redness, injection site rash injection site was red and had a rash achy chills extreme joint pain on left side, hip, knee and ank... Read more
injection site was red and had a rash achy chills extreme joint pain on left side, hip, knee and ankle cough
52 2021-01-04 rash Lower right leg skin rash. Localized size of Quarter
52 2021-01-04 blister Patient described leg heaviness the following day (12/18/20), then onset on 12/19/20 of blisters to ... Read more
Patient described leg heaviness the following day (12/18/20), then onset on 12/19/20 of blisters to neck, chest and abdomen, chest pain, and elevated blood pressure. Patient states she is already on cardiac medications so she took an additional dose for her blood pressure and monitored herself closely.
52 2021-01-04 injection site pain within 20 of the injection I strted to salivate and feeling nauseated. returned to clinic and was m... Read more
within 20 of the injection I strted to salivate and feeling nauseated. returned to clinic and was monitor there. my blood pressure was noted to be low at 115/41. HR 74. reepat BP was 121/48 which is much lower than my usal BP. i was observed for about 1 hrs. the sx's did not go away but the BP improved a little to 130/64 standing. I went home develop injection site pain, fatigue, headache and the pesistent salivation did not go away. after 1 wk it decreased in frequency but still present today. I can not do my normal activity as this worsen the symptom. and my blood pressure has not normalized. still run in 110's/60's. the headaches and fatigue are becoming a burden.
52 2021-01-05 injection site pain, injection site warmth, injection site swelling Fever, body aches, severe headaches, the vaccine site is hot and swollen and painful
52 2021-01-05 injection site pain Fever, pain below the injection site, fatigue/weakness, facial swelling; her PCP sent her to the ER ... Read more
Fever, pain below the injection site, fatigue/weakness, facial swelling; her PCP sent her to the ER for IV fluids and oral Tylenol.
52 2021-01-05 injection site swelling, injection site pain Pain and swelling on injection site, Cold chills, headache and fatigued
52 2021-01-05 rash Rash on right torso (belt line) side of the back of and front of thighs and buttocks
52 2021-01-06 itchy skin, rash, redness Approximately 10 minutes after receiving vaccine patient complaint of itchy eyes and hands. Upon re... Read more
Approximately 10 minutes after receiving vaccine patient complaint of itchy eyes and hands. Upon review, patient eyes red and swollen, palms of hands red and sweaty, chest rashy, ears red. Injection site WNL.
52 2021-01-06 injection site pain Patient with low grade fever (tmax 99.6), body aches, and pain at injection site. Taking motrin wit... Read more
Patient with low grade fever (tmax 99.6), body aches, and pain at injection site. Taking motrin with some relief.
52 2021-01-06 injection site rash Reported difficulty breathing, rash at injection site, throat closing. Used Epi pen ( history of all... Read more
Reported difficulty breathing, rash at injection site, throat closing. Used Epi pen ( history of allergies). Transferred to ED
52 2021-01-07 itchy skin, injection site redness, injection site hives 12/28/2020 - Eye Swelling 01/05/2021 - Injection site: Redness, Sore arm. Hive in injection site., i... Read more
12/28/2020 - Eye Swelling 01/05/2021 - Injection site: Redness, Sore arm. Hive in injection site., itching (Brazo caliente)
52 2021-01-07 injection site pain Injection site pain Muscle pain Headache Fatigue
52 2021-01-07 rash macular, rash Mid back pain, Right hip numbness, macular rash on administered arm
52 2021-01-07 injection site pain, injection site swelling, injection site redness Pain, redness and swelling in right arm after Covid vaccine administered in incorrect injection site... Read more
Pain, redness and swelling in right arm after Covid vaccine administered in incorrect injection site.
52 2021-01-07 pain of skin Severe pain in arm with bump from shot. Clamy, cold chills, Then started getting hot with fever. Ski... Read more
Severe pain in arm with bump from shot. Clamy, cold chills, Then started getting hot with fever. Skin is sore from the fever. Headache, temp 100.3. Weak and loopy, slept all day. Hurts under the arm. SOB.
52 2021-01-08 injection site pain - Strong injection site pain extending to neck and shoulder area
52 2021-01-08 redness ErythemaMultiform Pt complains of flushing; chest/neck/face/ears reddened; VS: P-126; R-16; BP-158/9... Read more
ErythemaMultiform Pt complains of flushing; chest/neck/face/ears reddened; VS: P-126; R-16; BP-158/98;SAT-100%; Dr at bedside to evaluate pt. 1300- No repiratory distress;VS- 143/83; 104; 100%; 16; MD advised pt to take 25-50mg of benadryl every 6 hrs for 24 hr Narrative: Patient with flushed skin; VSS; denies difficulty breathing; advised by Dr to take 25-50mg benadryl every 6hrs and follow up if any change in or worsening of symptoms. Ambulated from clinic with husband. No assistance needed.
52 2021-01-08 itchy skin Observed patient aggressively scratching arm. Occurred ~ 5 mins, lasted 30 mins. vitals/ lung sounds... Read more
Observed patient aggressively scratching arm. Occurred ~ 5 mins, lasted 30 mins. vitals/ lung sounds clear. administered 25mg Benadryl + 40mg Pepci AC patient left under own accord. 61 y/o female who presents with (L) arm itching shortly after her vaccine, no other symptoms. No significant Physical findings Probable localized allergic rxn.
52 2021-01-08 itchy skin, hives UrticariaPruritus Narrative: Employee self treating with benadryl. It started on 1/5/21
52 2021-01-09 rash Turned red in upper torso, swelling to tongue and heightened blood pressure.
52 2021-01-10 rash with redness 52 y.o. female presented to provider visit on 1.11 in response to a reaction to the 2nd COVID vaccin... Read more
52 y.o. female presented to provider visit on 1.11 in response to a reaction to the 2nd COVID vaccine received on 1.6. Patient has not worked since 1/6. Her symptoms started 1/7. She showed the provider a photo from her phone from 1/9 where her face was diffusely swollen and erythematous. She has not had dyspnea. She reports low grade fever off and on since vaccination. No n/v. She had stomach cramps for a whole, but those have fully resolved. At the visit on 1.11, her main symptoms are puffy eyes, and somewhat swollen and flushed face. Patient also reports dizziness, and still feels unsteady. Patient received a dexamethasone and depo-medrol injection in clinic on 1.11. Patient given return instructions. Provider will follow up in a few days to check on the patient.
52 2021-01-10 itchy skin Received 2nd dose Pfizer Lot EL0142 in right arm. About 15 minutes after receiving dose, she started... Read more
Received 2nd dose Pfizer Lot EL0142 in right arm. About 15 minutes after receiving dose, she started to develop itch in right forearm and nose
52 2021-01-10 rash macular, rash with redness red, blotchy rash. Given 50 mg Benadryl po
52 2021-01-10 blister within 12 hours of receiving the vaccine, both eyelids swelled and her right eye developed puss-fill... Read more
within 12 hours of receiving the vaccine, both eyelids swelled and her right eye developed puss-filled lesions. Has an appointment with the family physician at 4:40 pm today January 11, 2021
52 2021-01-11 vaccination site pain, vaccination site swelling, vaccination site redness Had pain at the injection site; tiredness; headache; muscle pain; chills; joint pain; fever; injecti... Read more
Had pain at the injection site; tiredness; headache; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; difficulty breathing; she has a bad cough; This is a spontaneous report from a non-contactable consumer. A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration from 05Jan2021 to 05Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. In Jan2021, the patient reported all of the symptoms on the sheet including injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, feeling unwell. The reporter also stated that the patient had difficulty breathing, she stated that every few words she has to catch her breath and she has a bad cough. The outcome of the event was unknown. No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.
52 2021-01-11 vaccination site pain Headache; muscle soreness; general all over the body soreness; her arm was very sore/ This was at th... Read more
Headache; muscle soreness; general all over the body soreness; her arm was very sore/ This was at the injection site; a low grade fever/ a fever of 101.0; chills; This is a spontaneous report from a contactable registered nurse (patient). A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142, Expiry Date: Mar2021), via an unspecified route of administration in the left biceps of her arm on 05Jan2021 07:15 at single dose for COVID-19 immunization. Medical history included positive on 19Dec2020 for the COVID virus. She had no allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported a side effect she experienced after having the shot. Afterward her arm was very sore. The patient got it at 7:15 am and it didn't feel the sore until about midway through the day (05Jan2021). This was at the injection site. When she got home she had chills and a low grade fever (05Jan2021) so she took Tylenol. The morning (06Jan2021) she woke up with headache and a fever of 101.0. She still had the muscle soreness, it was more at the administration site but there was some general all over the body soreness too. The patient explained she was positive on 19Dec2020 for the COVID virus and felt like these were the same symptoms she had with the virus. When asked about a seriousness criteria, she stated she reported that her fever improved with the Tylenol and she was feeling better now. The outcome of soreness at injection site was not recovered, of fever, headache was recovering, of the other events was unknown. No emergency room or physician office was involved. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.
52 2021-01-11 hives Hives, patient monitored
52 2021-01-11 injection site redness, injection site pain, injection site swelling Injection site swelling, burning, redness, pain post injection to current day still pain, swelling a... Read more
Injection site swelling, burning, redness, pain post injection to current day still pain, swelling and burning
52 2021-01-11 rash Lips and tongue became numb, throat felt itchy, severe nausea, headache, chest tightness, rash - fir... Read more
Lips and tongue became numb, throat felt itchy, severe nausea, headache, chest tightness, rash - first neck and face then rash progressed to a diffuse rash over entire body. I was on my way home and drove to Er and was seen. I was given Zolfran, Pepcid Solumedrol, Benadryl and Epinephrin.
52 2021-01-11 injection site pruritus, injection site redness, injection site rash, rash, injection site pain Mildly sore arm at injection site. Headache and chills. Redness and rash with terrible itching on ... Read more
Mildly sore arm at injection site. Headache and chills. Redness and rash with terrible itching on upper arm near injection site and across chest, collar bone, neck and chin. Took Benedryl , Allegra, and Tylenol for 24 hours. Symptoms mostly resolved by 4:00pm on 1/8/21.
52 2021-01-11 redness Patient started to become flushed within 5 minutes of receiving injection. At 9:20 she the stated sh... Read more
Patient started to become flushed within 5 minutes of receiving injection. At 9:20 she the stated she was hot and her hands were sweaty. after 15 minutes post injection patient was red going down her neck. She was then evaluated by the EMTs. She stated she felt a little better by 9:45 but we continued to observe. By 10:05 patient was still flushed and was getting cold hand . Gave Benadryl 25 mg po at 10:17 AM. By 1035 Patient was very cold but her face was still flushed and felt hot to her. Her hands were clammy and cold. EMT transported to hospital at 10:45. This was her second dose of Pfizer.
52 2021-01-11 itchy skin, injection site swelling, injection site warmth injection site hot and swollen, itching on left arm belly and face, tingling on upper lip, numbness ... Read more
injection site hot and swollen, itching on left arm belly and face, tingling on upper lip, numbness on tong, headache, pain on back of neck, body pain down the back, diarrhea, stomach cramps, very tired, nausea, stomach bloating
52 2021-01-11 injection site pain, injection site swelling, injection site mass swelling and tenderness with palpable lump and lymph nodes at rt clavicular region and right axilla,... Read more
swelling and tenderness with palpable lump and lymph nodes at rt clavicular region and right axilla, starting approximately starting 45 hours post injection and continuing at time of this report
52 2021-01-11 injection site pain woke up at 4 am the day after vaccination with pain in injection site arm 8/10. Had general muscle/... Read more
woke up at 4 am the day after vaccination with pain in injection site arm 8/10. Had general muscle/joint pain that made it difficult to get out of bed. Nausea and low grade fever. Unable to go into work. Felt I was not able to get out of bed to even take medication. Fianlly took 600mg of ibuprofen at 1:30 p.m. Was able to sleep and at 4pm was able to get out of bed. Still felt very fatigued. Slept well then next night and felt 90% better the next morning. Feeling much better today. No s&s.
52 2021-01-12 redness After about 20 minutes, the patient stated she felt short of breath, chest tightness, and her face b... Read more
After about 20 minutes, the patient stated she felt short of breath, chest tightness, and her face became red. The nurses took her vitals which showed hypertension and tachycardia. She was lowered to the ground and given some juice while a code was called. When the code team arrived, the patient was alert and oriented within the vaccination clinic, she was then transferred to the ER by nursing staff and hospital security.
52 2021-01-12 injection site pain I had a mild headache the evening of the shot, I had a headache the next two days that was relieved ... Read more
I had a mild headache the evening of the shot, I had a headache the next two days that was relieved by Advil. I had a very sore arm at the injection site Friday and Saturday after the shot was given. The arm pain was gone Sunday morning. I was very tired on Saturday especially and slept through the morning and early afternoon on and off until about 3:00 pm. On Friday during the day, I noticed my right ear starting to feel unusual and uncomfortable. On Saturday, the ear issue continued, I felt like I had some hearing loss and a constant buzzing and ear fullness feeling. On Sunday, the ear issued continued with the hearing loss, buzzing and fullness and has through today and hasn't stopped. I tried some nasal decongestant on Sunday afternoon, but it didn't have any effect. I made an appointment with the ENT doctor on Monday morning for Tuesday. I had a hearing test on Tuesday and saw the ENT doctor on Wednesday. He prescribed prednisone and ordered an MRI. I will be starting the prednisone later today (Wednesday) when the pharmacy has the prescription ready.
52 2021-01-12 pain of skin Insomnia, headache, fever, aches, skin pain
52 2021-01-12 rash papular, rash with redness, rash, hives Patient developed red rash (hives) with raised wheals covering almost all of anterior chest and abdo... Read more
Patient developed red rash (hives) with raised wheals covering almost all of anterior chest and abdomen within 1 hour after receiving the vaccine. There has been no rash on back, legs, or arms. No reaction at the injection site. No other symptoms. Patient will take benadryl 25 mg orally three times daily (starting tonight) and use hydrocortisone 1% cream topically three times daily (starting tonight). Outcomes are yet to be determined. Will continue to monitor.
52 2021-01-13 rash About 10 to 12 minutes after the injection, I started feeling like my throat was constricted. I fel... Read more
About 10 to 12 minutes after the injection, I started feeling like my throat was constricted. I felt pain in my temple and I also felt like my ears were clogged. My tonugue was tingling and I had pain across my chest. I had trouble swallowing and taking a deep breath. The medical providers assessed me and since my heart was not racing and I did not have a rash all over my body, deemed I was okay. When I went home, I noticed a rash on my chest from my collarbone to my sternum and alongside my ears on my neck. My sister is an ER Doctor and I did a video conference with her. She had me take Benadryl. I have never had any reaction to any vaccine nor have I ever had to take Benadryl.
52 2021-01-13 skin burning sensation Nausea, headache, body aches and pains, fever of 100.7 orally and chills, chest pain, feeling of bu... Read more
Nausea, headache, body aches and pains, fever of 100.7 orally and chills, chest pain, feeling of burning at surgical scar site, malaise starting around 18 hours post injection and lasting about 14 hours. Minimal to zero relief with Ibuprophen, or Acetaminophen. No medical treatment required. Headache continues to persist but chronic headaches are part of normal history.
52 2021-01-13 rash maculo-papular, itchy skin generalize papular rash; very itchy, 4 days post vaccine, lasted 48hrs; treated with Benadryl
52 2021-01-14 injection site tingling 23 minutes after the patient receive the shot she complained of tingling at the site and down her ar... Read more
23 minutes after the patient receive the shot she complained of tingling at the site and down her arm. Provided patient with 2 25mg Benadryl to self administer. Upon checking at 1pm and 7:00pm patient was feeling better.
52 2021-01-14 rash, skin spots A petechial rash developed on my bilateral palms of hands, left greater than right, on 01/10/2021. ... Read more
A petechial rash developed on my bilateral palms of hands, left greater than right, on 01/10/2021. There was no rash noted on my feet or body habitus. When the lesions became darker and more punctate , decision was made to seek medical attention. There was no history of trauma, fever, or skin injury. I saw my Internist, on 01/14/2021 for evaluation and treatment.
52 2021-01-14 redness, skin warm, rash, skin burning sensation, itchy skin, blister Exactly 12 days after the vaccine I reported a fine rash with small blisters covering the backs of b... Read more
Exactly 12 days after the vaccine I reported a fine rash with small blisters covering the backs of both of my hands with itching and warm redness in them both (I have pictures) Within an hour it began feverish red itching and slight burning on both of The undersides of my forearms. I was advised by the pharmacists on duty in the covid clinic site to use topical Benadryl cream and or take Benadryl by mouth if it worsened. I was told to seek emergency dept help if any signs of breathing issues presented. The next morning the itching was gone the redness subsided and the rash was markedly better but still raised in the tops of my hands. By 1030am on 1/12/21, I could not detect taste or smell at all. I was advised then to report to employee healthline for further instruction. I was told to leave work and proceed to our employee Covid swab testing drive thru facility for Covid testing and remain home for results the following morning on 1/13/21. At approximately 10am 1/13/21 I was confirmed positive for COVID-19 via the swab results. I was told to quarantine and given a return to work date of 1/24/21 as long as my symptoms were resolved. I am currently in home quarantine still suffering no taste or smell, muscle cramps in legs, thighs and back. Fatigue, Loss of appetite, sinus pressure and headache not relieved with medications.
52 2021-01-14 injection site hardening Localiized pain started on 1/13/21 Left arm induration of 5-10cm started on 1/14/21 at noon time Le... Read more
Localiized pain started on 1/13/21 Left arm induration of 5-10cm started on 1/14/21 at noon time Left arm induration of 15-20cm noted 1/15/21 at 8am
52 2021-01-14 injection site pain Severe burning in injection site immediately. Severe headache starting 3-5 hours since vaccination.... Read more
Severe burning in injection site immediately. Severe headache starting 3-5 hours since vaccination. Still experiencing as of 1/15/2021. On 1/14/2021 experienced throbbing under ear to jaw bone.
52 2021-01-14 injection site redness, injection site warmth, injection site pruritus, injection site pain injection site is red 9cm down my arm, warm to the touch, itchy, and sore
52 2021-01-15 skin warm 11:40 am - receives the 1 dose of the Pfizer Covid vaccine 0.3mg IM 11:50 am - reports the symptoms ... Read more
11:40 am - receives the 1 dose of the Pfizer Covid vaccine 0.3mg IM 11:50 am - reports the symptoms of tingling, warmness, pressure, burning on her upper left chest. Nausea and dizziness 11:58 am - takes diphenhydramine 50mg, (2 capsules of 25mg) by mouth 12:02 pm - receives 1 dose of EpiPen autoinjector 0.3mg IM. 911 call 12:05 pm - reports feelings of tightening in her throat and receives 2nd dose of EpiPen autoinjector 0.3mg IM 12:10 pm - reports that tightening in her throat is relieving 12:15 pm - EMS arrives and is transporting her to the ER
52 2021-01-16 injection site pain 101.8 temp, malaise, fatigue. Tyl and Motrin only gets temp down to 100.5. Soreness at injection sit... Read more
101.8 temp, malaise, fatigue. Tyl and Motrin only gets temp down to 100.5. Soreness at injection site.
52 2021-01-16 injection site redness Headache Chills Pain / redness in injection site Fatigue several hours after injection Headache las... Read more
Headache Chills Pain / redness in injection site Fatigue several hours after injection Headache lasted 3 days , chills intermittent for several days fatigue still have
52 2021-01-16 redness Redness over face/arms
52 2021-01-16 injection site pain headache, muscle ache, fever, chills, fever, lymphadenopathy, injection site pain, tiredness
52 2021-01-16 redness received vaccine at 1330. Observed until 1350. After leaving building, noticed redness/flushing on f... Read more
received vaccine at 1330. Observed until 1350. After leaving building, noticed redness/flushing on face and chest. Came back to building for additional observation at 1400. Given Benadryl and observed.
52 2021-01-17 injection site redness, injection site swelling 18 hours after second Pfizer vaccine for Covid-19 I awoke with fever, chills and body aches. Symptom... Read more
18 hours after second Pfizer vaccine for Covid-19 I awoke with fever, chills and body aches. Symptoms resolved after about 36 hours. The first 12 hours being the most severe. Temperature went as high as 102 F. Localized swelling and redness at injection site gradually increased over the following days. One week out and all symptoms (besides arm) have resolved.
52 2021-01-17 injection site pain Fatigue; pain at injection site Headache on Right side of head Severe Nausea Muscle and joint Pa... Read more
Fatigue; pain at injection site Headache on Right side of head Severe Nausea Muscle and joint Pain Temp 100.3 Chills Lasted 24 hr Slept and try to stay hydrated
52 2021-01-17 rash, rash with redness, skin warm Headache, chills, fever (101.6), muscle and joint pain and fatigue that started approximately 30 hou... Read more
Headache, chills, fever (101.6), muscle and joint pain and fatigue that started approximately 30 hours after vaccination. Treated with acetaminophen and ibuprofen. On 1/14/2021, forty-eight (48) hours after the vaccine administration, rash appeared on trunk and neck. Rash was red, warm not itchy and was treated with diphenhydramine oral and topical hydrocortisone. Rash persisted for 24-36 hours.
52 2021-01-17 hives, itchy skin Received vaccine at 11:30 on 1/15, at 5:30pm developed itchiness from head to toe, took 25mg of Ben... Read more
Received vaccine at 11:30 on 1/15, at 5:30pm developed itchiness from head to toe, took 25mg of Benadryl 1/15 at 9:30pm developed hives on back, stomach, hips and upper thighs,, hands were swollen took 25mg of Benadryl 1/16 at 3am took another 25mg Benadryl hives and itching. 1/16 630am took 25mg Benadryl and Claritin hives and itching improving. 1/16 at 9am all but 2 hives resolved to oatmeal bath and applied hydrocortisone. 1/16 at 630pm felt throat was swelling, voice change, tingling lips and thick tongue took 50 mg of Benadryl went to ER around 730pm. Was given Pepcid and 50mg prednisone in the Emergency Room. 1/16 11pm.Discharged home with prescriptions for prednisone, Benadryl and epi-pen and Pepcid. Continues now with lingering sore throat
52 2021-01-18 injection site redness, injection site pain, injection site swelling, injection site warmth Bump on left arm at injection site, redness, warmth, and soreness. Improves with icing.
52 2021-01-19 itchy skin About 6 hrs after vaccine, I started itching down around my ankles and it kept getting worse and it ... Read more
About 6 hrs after vaccine, I started itching down around my ankles and it kept getting worse and it spread and into the next day. I tried to deal with it with Benadryl for 5 days Urgent Care and was given: 4 - Zyrtec and -2- Xantac : took that once a day for two days. Symptoms started resolving after that. Still had itching for 3-4 days after that but it was mild and then it went away. Went to my Rheumatogist and he said to take Prednisone but I didn't.
52 2021-01-19 rash RASH, SWELLING LEGS AND SEVERE PAIN INABILITY TO GO UP STAIRS, BREAKOUT IN MOUTH ,FAST HEARTBEAT, FE... Read more
RASH, SWELLING LEGS AND SEVERE PAIN INABILITY TO GO UP STAIRS, BREAKOUT IN MOUTH ,FAST HEARTBEAT, FEVER
52 2021-01-20 rash, redness 10 min. after vaccine injection: headache, scratchy throat and throat tightening lasting for about 1... Read more
10 min. after vaccine injection: headache, scratchy throat and throat tightening lasting for about 10min and subsided. 50 min. after vaccine injection: flushed, redness in face, ears, and neck progressing to rash on chest, neck. Lasted for about 10min and subsided. Never progressing into full anaphylaxis reaction. No treatment taken.
52 2021-01-20 vaccination site rash, vaccination site pain Mild feeling of throat constricting; dizziness; palpitations; Left arm sore; Circular rash next to i... Read more
Mild feeling of throat constricting; dizziness; palpitations; Left arm sore; Circular rash next to injection site; This is a spontaneous report from a contactable other hcp (patient). A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ELO140), via an unspecified route of administration in left arm on 06Jan2021 14:30 at single dose for COVID-19 immunization. Medical history included high blood pressure and brachial radial puritis. Concomitant medication included metoprolol succinate (TOPROL) and estrogens conjugated (PREMARIN). No COVID prior vaccination. No other vaccine in four weeks. The patient experienced mild feeling of throat constricting, dizziness, and palpitations, left arm sore, Circular rash next to injection site on 06Jan2021 14:45 (for about 20 minutes), left arm sore for about 4 days. No treatment received. No COVID tested post vaccination. The outcome of events was recovered in Jan2021.
52 2021-01-20 itchy skin Pt woke up on day 2 following second vaccine dose and had itchy face, scalp, and swollen lower eyeli... Read more
Pt woke up on day 2 following second vaccine dose and had itchy face, scalp, and swollen lower eyelids.
52 2021-01-20 redness, vaccination site swelling Severe swelling of left upper arm, left anterior chest wall; Severe swelling of left upper arm, left... Read more
Severe swelling of left upper arm, left anterior chest wall; Severe swelling of left upper arm, left anterior chest wall; Underarm and neck with pain; Underarm and neck with pain; Heat; Redness; This is a spontaneous report from a contactable healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1686; Expiration date was not reported) on 08Jan2021 (15:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. The patient had no relevant medical history. The patient's concomitant medications were not reported. On 10Jan2021 (15:00), the patient had severe swelling on the left upper arm and left anterior chest wall; underarm and neck were with pain; was in heat; and had redness. The adverse events resulted in the patient having a visit on the doctor or other healthcare professional office/clinic. The patient had received treatment for the reported adverse events. The outcome of the events, 'severe swelling on the left upper arm and left anterior chest wall', 'underarm and neck were with pain', 'heat' and 'redness', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination.
52 2021-01-20 rash, redness, itchy skin Started having itchiness on both hands and around ankles 1/17/2021 notice itchiness started to go t... Read more
Started having itchiness on both hands and around ankles 1/17/2021 notice itchiness started to go to my arms and legs than I notice little bumps on my inner arms itchy and red; than my legs stared getting bumps didn't notice redness yet until Wednesday but both legs where real itchy, and my back itch a little bit, but my hands, arms and legs are the worse.1/21/2021 Today I went to get some Hydrocortisone Cream with vitamins & Aloe and I did take Benadryl also. I contacted my Primary Physician still waiting on her response of what I need to do.
52 2021-01-20 redness, injection site warmth, injection site swelling, injection site redness red, swollen warmth at site. Redness into armpit and rt breast. Tylenol and cold compress. No furt... Read more
red, swollen warmth at site. Redness into armpit and rt breast. Tylenol and cold compress. No further treatment yet. Awaiting response from occ med
52 2021-01-21 rash 2 HOUR AFTER VACCINE EMPLOYEE DEVOLOPED RASH ON LEGS AND ARMS PERSISTED UNTIL ATLEAST 1/14/20201, M... Read more
2 HOUR AFTER VACCINE EMPLOYEE DEVOLOPED RASH ON LEGS AND ARMS PERSISTED UNTIL ATLEAST 1/14/20201, MAY STILL BE ON GOING.
52 2021-01-21 rash 52 yo female vaccinated 1-8-21 with Pfizer. No reaction. Then had massage yesterday and then today d... Read more
52 yo female vaccinated 1-8-21 with Pfizer. No reaction. Then had massage yesterday and then today developed chills and fever. 101.5 now. Also has rash on breast and stomach. Flushed. Headache, nausea and myalgias.
52 2021-01-21 injection site redness, injection site swelling, injection site warmth Early morning of January 21st right arm very sore from injection then at 2:00 p.m. January 21st almo... Read more
Early morning of January 21st right arm very sore from injection then at 2:00 p.m. January 21st almost exactly 24 hours after the shot, I started feeling very tired, severe body aches and chills. The next morning on January 22nd about 3:00 a.m. those symptoms where much better BUT down below the injection site is swelled up, red in the size of about a softball and very hot. It is now 5:40 p.m. January 22nd and no improvement with that.
52 2021-01-21 rash, itchy skin GENERALIZED RASH WITH PRURITUS. SHORTNESS OF BREATH. EDEMA IN EXTREMITIES, FACE, NECK . FEVER. PATI... Read more
GENERALIZED RASH WITH PRURITUS. SHORTNESS OF BREATH. EDEMA IN EXTREMITIES, FACE, NECK . FEVER. PATIENT TOOK BENADRYL. SYMPTOMS RESOLVED NEXT MORNING
52 2021-01-21 rash Once I received the shot and went to my car I noticed I had a rash on my face so I immediately took ... Read more
Once I received the shot and went to my car I noticed I had a rash on my face so I immediately took benadryl. When I woke up the next morning I was extremely dizzy and fell in the shower. It was more than just being dizzy it was like I couldn't see and it was hard to pick myself up. I may have fainted because I didn't recall falling just noticed I was on the shower floor. I thought I had gotten up but then again I was still on the floor. I made it back to bed and slept for a few hours. After that I seemed fine.
52 2021-01-21 injection site warmth, injection site redness, injection site swelling Sore arm started on evening of January 20th (date of injection), 2:00 p.m. January 21st severe body ... Read more
Sore arm started on evening of January 20th (date of injection), 2:00 p.m. January 21st severe body aches, chills and extremely tired. Around 3 a.m. of January 22nd those symptoms where getting better but just below the injection site there is a large red area that is hot and swollen and that is still continuing as of 7:08 p.m. January 22nd
52 2021-01-21 rash, rash vesicular Under my left breast/ upper stomach area, I developed a rash about the size of a quarter. The rash i... Read more
Under my left breast/ upper stomach area, I developed a rash about the size of a quarter. The rash is painful with small like blisters, which after sleeping on my stomach appeared to have removed any fluid. As of today, 1/22/21, is looks like the rash attempting to heal but very sore.
52 2021-01-21 injection site swelling, injection site hardening after the first vaccine shot my muscles started aching with general fatigue. this lasted about a day... Read more
after the first vaccine shot my muscles started aching with general fatigue. this lasted about a day and felt like it came and went very quickly. the injection site was still hard and edematous after about 2 weeks. After the second vaccine I became slightly achy the same day I got the shot but pre-emptively took ibuprofen, which worked well. it wasn't until the day after my shot (towards the end of my work day) that I became incredibly fatigued and muscles ached. Later in the evening I developed a sore throat and slight cough, I did not take my temperature but felt I had a slight temperature increase. the 2nd and 3rd day post shot I was incredibly fatigued with a slight sore throat. by 4th day post shot I was feeling back to my normal self.
52 2021-01-21 itchy skin, injection site hives, hives hives 2 hours post injection at injection site and above arm, shoulder, neck and chest and head. ... Read more
hives 2 hours post injection at injection site and above arm, shoulder, neck and chest and head. Itching. later feeling fatigue, body aches and headache.
52 2021-01-22 injection site pain fever 102f, chills, headache, body aches, joint pain leg hip, injection site pain
52 2021-01-23 skin swelling, pain of skin 1/21/21 5:00 AM chills and body aches, no fever 12:00 PM chills, fatigued 4:00 PM fever 101.3 1/22... Read more
1/21/21 5:00 AM chills and body aches, no fever 12:00 PM chills, fatigued 4:00 PM fever 101.3 1/22/21 AM chills, body aches, fatigued, fever 101.1 1/21/21 PM no fever 1/23/21 body aches, swelling noted and tenderness to right armpit
52 2021-01-24 injection site swelling Pneumonia; Left Arm Swelling / her arm and shoulder became swollen; Left Arm Swelling / her arm and ... Read more
Pneumonia; Left Arm Swelling / her arm and shoulder became swollen; Left Arm Swelling / her arm and shoulder became swollen; she also has something else going on in her shoulder; achy all over in her neck, arm, and shoulder; achy all over in her neck, arm, and shoulder; Felt sick to her stomach; her arm was sore that evening; This is a spontaneous report from a Pfizer Sponsored Program made from a contactable consumer (patient). This 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EK5730) at single dose on left arm on 23-Dec-2020 for COVID-19 immunization. Medical history included sleep apnea; high blood pressure; COPD (chronic obstructive pulmonary disease). Concomitant Medication was nothing new, her normal medication, she took vitamins, and high blood pressure medication. She had had no positive test for Covid prior to the vaccine, she had had no antibody test, she had had no issues with vaccine in the past. The patient experienced left arm swelling in Jan2021 and pneumonia on 08Jan2021. The patient worked in a hospital and received her first dose on 23Dec2020 and she was supposed to get the second dose today but she was not at work today. She was wanting to know if she should go ahead and take the second dose because her arm was still swollen. The product was the Covid vaccine. She stated that her arm was still swollen, when she got shot she was fine, her arm was sore that evening (Dec2020) and then nothing, then a weekend after new years her arm and shoulder became swollen (Jan2021) and she had been to the ER and the doctor thought the swelling was because of the shot, but she also had something else going on in her shoulder (Jan2021). So in the meantime she went to the ER and they took X rays, and they told her that she was starting to develop pneumonia. She was going back to work tomorrow, being that she was on the antibiotics now, still had swelling in the arm, and had pneumonia, should she still get the 2nd shot. She noticed the swelling Saturday after New Years. She was also achy all over in her neck, arm, and shoulder (Jan2021). She felt sick to her stomach, this was all the first Week of Jan2021. She went to the ER, she was not admitted and came home the same day. She went to the ER on 08Jan2021. 08Jan2021 was also when the pneumonia was diagnosed. The name of antibiotic she was prescribed was doxycycline. She started it on Saturday 09Jan2021, she was prescribed 100 mg 2 pills a day for 10 days. When they did the X ray, they said that the pneumonia had showed up, or she was just starting to get pneumonia. Patient stated that she didn't believe because they made a comment about the way she was laying however she had been taking the medication and feeling better. She was schedule for the second dose today. She did reschedule for Friday, and wanted to know if she should still get it. In the ER, they said it could have been a blood clot and so they did a scan to find blood clots but it was negative. The outcome of event pneumonia was resolving; events left arm swelling and shoulder became swollen was not resolved. The outcome of rest evens was unknown..
52 2021-01-24 injection site nodule, injection site pain QUARTER SIZE KNOT AT INJECTION SITE WITH SEVERE PAIN. UNABLE TO RAISE ARM DUE TO PAIN X 48 HOURS. K... Read more
QUARTER SIZE KNOT AT INJECTION SITE WITH SEVERE PAIN. UNABLE TO RAISE ARM DUE TO PAIN X 48 HOURS. KNOT AT INJECTION SITE LASTED FOR 7 DAYS. PAIN HAS DECREASED TO CURRENTLY ABOUT A 2.
52 2021-01-24 pain of skin Went to receive my second shot on 1/23/2021 by mistake instead of scheduled appt 1/30/2021. Provide... Read more
Went to receive my second shot on 1/23/2021 by mistake instead of scheduled appt 1/30/2021. Provider informed me I was there on the wrong day but told me she would fit me in so I would not have to come back. After receiving the 2nd dose and waiting the 15 minutes, I realized that the time between shots were 14 days instead of 21. The HCP was contacted and was to reach out to vaccine provider. 1/23/2021 = date of receiving shot = no symptoms 1/24/2021 = 3:10 am woke with 102.1 fever, sore arm, body aches, and my skin hurt. Woke again at 8:00am with fever of 101.3 and the same symptoms. Alternated Tylenol and Ibuprofen every 2 yours. Fever went away around 10:00am but went still had body and skin aches and tired. 1/25/2021 = woke with no fever, but arm still hurt and so does the gland in my armpit. Still have body & skin aches. I am tired and I feel slightly off. My eyes are very tired.
52 2021-01-24 skin spots headache with in 30 mins, 3 days later GI upset diarrhea, SOB LAsting 3days. now 17 day later petec... Read more
headache with in 30 mins, 3 days later GI upset diarrhea, SOB LAsting 3days. now 17 day later petechiae on abdomen abd burning pain (lymph nodes) in right underarm.
52 2021-01-25 itchy skin, hives Itching and Hives
52 2021-01-25 vaccination site redness, vaccination site warmth, vaccination site swelling Mild swelling (2" x 1" area) near injection site on left deltoid area; noticeable redness and warm t... Read more
Mild swelling (2" x 1" area) near injection site on left deltoid area; noticeable redness and warm to touch; noticeable redness and warm to touch; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284) via an unspecified route of administration at left arm (deltoid), on 06Jan2021 14:15 at single dose for COVID-19 immunization. Medical history included sulfa allergy. Patient was not pregnant at the time of vaccination. Patient did not have COVID prior vaccination. Concomitant medication included tocopherol (VITAMIN E). Patient did not receive other vaccine in four weeks. Patient experienced mild swelling (2" x 1" area) near injection site on left deltoid area, noticeable redness and warm to touch, appeared 8 days after injection on 14Jan2021 05:00. No treatment received. No COVID tested post vaccination. Outcome of the events was not recovered.
52 2021-01-25 injection site swelling, injection site warmth, injection site redness On same day of injection, recipient developed a headache, swollen lymph nodes under arm, red and war... Read more
On same day of injection, recipient developed a headache, swollen lymph nodes under arm, red and warm swollen injection site area
52 2021-01-25 rash Systemic: Rash (other than injection site)-Mild; symptoms lasted 2 days
52 2021-01-26 redness Swollen arm, redness, hot Headache Chills Body aches Runny nose Sneezing
52 2021-01-27 injection site swelling, injection site redness, injection site pruritus FOLLOWING MORNING AFTER INJECTION, INJECTION SITE WAS RED, ITCHY, SWOLLEN. SWELLING PERSISTED THORUG... Read more
FOLLOWING MORNING AFTER INJECTION, INJECTION SITE WAS RED, ITCHY, SWOLLEN. SWELLING PERSISTED THORUGH 1/25/21
52 2021-01-27 injection site redness, injection site pruritus, injection site swelling INJECTION SITE SWOLLEN, RED, ITCHY; SWELLING PERSISTED AS OF 1/25/21
52 2021-01-27 vaccination site pain Injection site tenderness; fatigue; headache; fever; chills; muscle pain; axillary swollen lymph nod... Read more
Injection site tenderness; fatigue; headache; fever; chills; muscle pain; axillary swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular at left arm on 13Jan2021 at 16:00 at single dose for COVID-19 immunization. The patient medical history included hypertension and penicillin allergy, both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took BIAXIN and experienced allergy on an unspecified date, the patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular at left arm on 23Dec2020 at 15:45 at single dose for COVID-19 immunization. On 14Jan2021 at 03:00, the patient experienced injection site tenderness, fatigue, headache, fever, chills, muscle pain, axillary swollen lymph nodes. The patient outcome of the events was recovered.
52 2021-01-27 vaccination site pain Moderate general body pain; Mild Headache; chills; Mild abdominal pain; received the first dose of b... Read more
Moderate general body pain; Mild Headache; chills; Mild abdominal pain; received the first dose of bnt162b2 on left arm/ left arm pain; This is a spontaneous report from a contactable consumer reporting for herself. A 52-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number: EL3249, expiry date: not reported), via an unspecified route of administration, on 13Jan2021 07:00 PM at a single dose on left arm for COVID-19 immunization. The patient was not pregnant. The vaccine was administered at a hospital. The patient did not receive other vaccines in four weeks. The patient did not have covid prior to vaccination. Medical history included Diabetic type 2 and HBP (high blood pressure). She had no known allergies. Concomitant medications (other medications in two weeks) included losartan 100mg qd (once a day) and escitalopram 10mg qd (once a day). On 13Jan2021 10:00 PM, the patient experienced moderate general body pain, mild headache, chills, mild abdominal pain, left arm pain. The patient had undergone laboratory tests and procedures which included: covid test type = Blood test, covid test name = Serology, covid test date = 16Jul2020, covid test result=Negative; covid test date = 05Aug2020, covid test type = Nasal Swab, covid test name = Nasopharyngeal, covid test result = Negative. The patient did not receive any treatment for the reported adverse events. Outcome of the events was not recovered.
52 2021-01-27 vaccination site pain chills; dizzy; body aches; fever 99.5; fatigue; joint aches; jaw hurts more on Rt side (lower behind... Read more
chills; dizzy; body aches; fever 99.5; fatigue; joint aches; jaw hurts more on Rt side (lower behind12 yr molars); Slept a lot so far; injection arm very sore; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL1283), intramuscular on 13Jan2021 09:30 AM at single dose on the right arm for COVID-19 immunization. Patient is not pregnant. The patient medical history was not reported. Concomitant medications included tocopherol (VITAMIN E [TOCOPHEROL]), colecalciferol (D3), estradiol (ESTROGEN), progesterone, "bioidenticle" and multivitamin, reported as "Other medications in two weeks: Multi vitamin, vitamin E, D3, bioidenticle estrogen/progesterone"). The patient previously took iodine, metronidazole (FLAGYL), doxycycline and telithromycin (KETEK) and experienced allergies to all. No other vaccine in four weeks. Facility type vaccine was hospital. The patient received the first dose on 23Dec2020 04:45 PM (lot number: EL0140), intramuscular on the right arm and patient felt slightly light headed. Within 5 minutes right (Rt) hand got red & hot, numb, heat in Rt arm and Rt side of jaw felt numb as if blew up balloons. Blood pressure went up to something over 90. Patient took benadryl. Next few days was reported as "v fatigued & on p.m. of 24th it hurt to open my mouth (gland by Rt ear felt swollen). I got a line of inflammation in my Rt inside cheek & a tissue mound that has not gone away". On 14Jan2021 (reported as today), the patient experienced chills, dizzy, body aches, fever 99.5, fatigue, joint aches, injection arm very sore (started yesterday on 13Jan2021), jaw hurts more on right (Rt) side (lower behind12 yr molars). Patient took Tylenol and slept a lot so far. No treatment was received (If treatment AE: No) - pending clarification. Outcome of the events was recovering. Patient has no COVID prior vaccination. Patient was not tested for COVID post vaccination.
52 2021-01-27 redness slightly light headed; rt hand got red & hot; rt hand got red & hot; numb, heat in rt arm/right sid... Read more
slightly light headed; rt hand got red & hot; rt hand got red & hot; numb, heat in rt arm/right side of jaw felt numb; Blood pressure went up to something over 90; fatigued; it hurt to open my mouth (gland by rt ear felt swollen); got a line of inflammation in my rt inside cheek; This is a spontaneous report from a contactable other HCP (patient). A 52-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number= EL0140), intramuscular at right arm on 23Dec2020 16:45 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication in two weeks included Multi vitamin, tocopherol (VITAMIN E), vitamin d3, bioidenticle estrogen/progesterone. The patient previously took Iodine, metronidazole (FLAGYL), Doxycycline, clarithromycin (KETEK); and known allergies to them. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient felt slightly light headed. Within 5 minutes right hand got red & hot, numb, heat in right arm & right side of jaw felt numb as if blew up balloons. Blood pressure went up to something over 90. The patient took a benadryl. Next few days v fatigued & on p.m. of 24th it hurt to open her mouth (gland by right ear felt swollen). The patient got a line of inflammation in her right inside cheek & a tissue mound that had not gone away. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.
52 2021-01-28 injection site hives, injection site swelling Headache first, Injection site swelling, then hives in the middle of the night at injection site, wo... Read more
Headache first, Injection site swelling, then hives in the middle of the night at injection site, woke up with muscle aches everywhere, diarrhea started mid day, fever 100.4
52 2021-01-28 itchy skin Mild Soreness and fatigue first day; chills and light headache the next 2 days. Symptoms resolved on... Read more
Mild Soreness and fatigue first day; chills and light headache the next 2 days. Symptoms resolved on January 21. Generalized body itching started on January 26 and then woke up on January 27 with facial swelling. Instructed to follow-up with PCP or urgent care.
52 2021-01-28 hives Patient developed hives on face 2 days after first dose Pfizer lot# EK 5730 on 12/16/2020. Could hav... Read more
Patient developed hives on face 2 days after first dose Pfizer lot# EK 5730 on 12/16/2020. Could have been contributing from new N95? However, per patient, she consulted and was approved for the second dose by Dr. and Dr. She received second dose Pfizer lot# EK 9231 on 1/6/2021.
52 2021-01-28 itchy skin, redness Patient experienced redness/itching on neck/upper back during 15 minute monitoring period and was ke... Read more
Patient experienced redness/itching on neck/upper back during 15 minute monitoring period and was kept for an extra 15 minutes, in which this improved. Patient received first dose Pfizer lot# EK 5730 in 12/17/2020.
52 2021-01-28 skin spots Petechia; felt fatigued; This is a spontaneous report from a contactable physician. A 52-years-old f... Read more
Petechia; felt fatigued; This is a spontaneous report from a contactable physician. A 52-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular on deltoid left from 05Jan2021 to 05Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included ongoing blood cholesterol increased/high cholesterol and allergy to sulfa drugs. Concomitant medication included ongoing rosuvastatin calcium (CRESTOR) for blood cholesterol increased. The reporter stated that about 5 days later she noticed petechiae on her hands (10Jan2021). The patient also felt fatigue on Jan2021. She went to see her primary care doctor. She had lab work, blood count, clotting factors, and CMP done and states her labs were ok and the other test had unknown results on an unspecified date. The patient's weight ranges from 140-145 lbs. The petechiae has slowly faded. Outcome of the event petechia was recovering while outcome of the event fatigue was unknown.
52 2021-01-28 redness Pt. states that she developed bilateral facial redness around mouth around 09:50 am after receiving ... Read more
Pt. states that she developed bilateral facial redness around mouth around 09:50 am after receiving the first pfizer vaccine to left arm at 09:40 am.
52 2021-01-28 skin irritation, rash, itchy skin Started to feel an irritation behand my right ear, then along my jaw line. Thought it was irritatio... Read more
Started to feel an irritation behand my right ear, then along my jaw line. Thought it was irritation from mask wearing. Then I had a burning sensation in my hair. Similar to a sunburn then getting chills. Wednesday night I noticed three pimple like bumps in my hair--right posteriorly. A bit itchy at times. Thursday right under my jaw line seems to have swelling. This morning it feels the same. Burning like irritation in my hair.
52 2021-01-28 hives Tightness in throat, hypertensive, tachycardia, hives on face and upper chest, vomitting
52 2021-01-29 injection site pain Sever headache off and on for 3 days so far chills sweat, sever fatigue x 2 days Injection site pa... Read more
Sever headache off and on for 3 days so far chills sweat, sever fatigue x 2 days Injection site pain to the point of not moving arm
52 2021-01-29 itchy skin Within 10 minutes, sensation of very cold skin through out my body, lasted 4 hours. Transient elevat... Read more
Within 10 minutes, sensation of very cold skin through out my body, lasted 4 hours. Transient elevated systolic BP, better within 30 mins. Also mild body itching, still having. Woke up this morning, ~24 hours post- injection with sever joint and muscle aches, chills etc. had to cancel work.
52 2021-01-31 injection site pain 5 minutes post vaccine: nausea and dizziness, hypoglycemia ( EMTs at immunization site offered ER, w... Read more
5 minutes post vaccine: nausea and dizziness, hypoglycemia ( EMTs at immunization site offered ER, went home) 30 minutes post: severe chills ( resolved after 3 hours) 30 minutes post: headache (resolved by 3rd day) 30 minutes post: severe hypersomnolence ( slept the remainder of that day and through that night) 30 minutes post: body pain ( felt like it was in my bones rather than muscular)resolved after 3rd day 3 hours post: injection site pain (lasted about 5 days)
52 2021-01-31 hives Anaphylaxis, tongue swelling, difficulty breathing, & hives, Ambulance transported pt to the nearest... Read more
Anaphylaxis, tongue swelling, difficulty breathing, & hives, Ambulance transported pt to the nearest ER, required Epinephrine injections 1mg IM X3, IV Methylprednisolone 50mg and IV Benadryl 50mg, pt had to be transferred to higher level of care due to ongoing symptoms and was kept until 1/24/21. Pt said staff at the ER told her they knew they should report the reaction to someone but didn't know how to report it.
52 2021-01-31 injection site swelling, injection site pruritus, injection site redness Day after vaccine, severe arm pain to the extent left arm was minimally functional. Moderate arm pai... Read more
Day after vaccine, severe arm pain to the extent left arm was minimally functional. Moderate arm pain 2 additional days. Minor arm pain for few more days. Fatigue, general tiredness, sore throat for a week, although still experiencing sore throat. Unsure if that's environmental. Back pain (kidney area) beginning few days after injection, lasting several days. Non-muscular pain, more internal such as kidney pain. Worst symptoms: Itching, redness, swelling, inflammation below the injection site, approx 3"Hx7"W band across my left arm,beginning about 2" below the point of injection. Today is day 12 and I'm still experiencing this. Moderate itching 24 hrs, mild swelling, red, hot, inflamed. Symptoms are less severe at this point.
52 2021-01-31 injection site mass, injection site pain, injection site warmth Pt states first s/s at 1500 she started to feel body aches, HA, dizzy, nausea, loss of appetite chil... Read more
Pt states first s/s at 1500 she started to feel body aches, HA, dizzy, nausea, loss of appetite chills and fever of 100.7 with episodes of sweating profusely. 1/19/21 Pt states fever continues, body aches, (L) axillary lymph node swelling, HA, Nausea and a episode of Tachycardia that she recorded temp. ranged 101-102.2. 1/21/20 Pt stated to have cont. fever 102.2, HA, BA, sweating and lymph nodes swelling from (L) axillary to back painful. Pt States on 1/21/21 cont. sweating loss of appetite, nausea, weakness, fatigue injection site pain, no redness, warm, and palpable lump. Pt stated 1/23/21 body aches and fever. Pt resting drinking fluids as tolerated and taking advil 400 mg PRN 4mg Zofran
52 2021-01-31 injection site redness, injection site pain pain and redness at injection site, low grade fever, chills, body aches, arm pit pain, dizziness
52 2021-02-01 bruising Bruises on hands; This is a spontaneous report from a contactable nurse (patient). This 52-year-old ... Read more
Bruises on hands; This is a spontaneous report from a contactable nurse (patient). This 52-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982 and expiry date unknown), via an unspecified route of administration on 16Jan2021 10:00 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient had no known allergies. The patient received the first dose of bnt162b2 (brand: Pfizer, lot number: EL0140) on 26Dec2020 10:00 in the left arm. The patient is not pregnant. The patient received no other vaccine in four weeks and had no other medications in two weeks. The patient had bruises on hands on 17Jan2021 with outcome of unknown. No treatment was received. The patient had no COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination.
52 2021-02-01 hives, rash Chills, Fever, Myalgia, Rash, Hives, Lymphedema, and Swelling
52 2021-02-01 rash Systemic: Rash (other than injection site)-Mild; symptoms lasted 1 day
52 2021-02-01 vaccination site warmth, vaccination site pain general feeling unwell; chills; tiredness; she was trying to do a walk but could not; pain at inject... Read more
general feeling unwell; chills; tiredness; she was trying to do a walk but could not; pain at injection site; pain at injection site; That side was hot; headache got worse after getting the COVID 19 vaccine; joint pain; muscle pain continued to get worse; preventing her from sleeping/ she could not sleep; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration at the left arm on 18Jan2021 13:33 at a single dose for COVID-19 immunization. Medical history included back pain (a lot of time due to physical work). She had COVID in Aug2020 and she had muscle pain and was sick. The patient also had headache started initially the day before got the vaccine on 17Jan2021. The patient also has ongoing grass allergy. Concomitant medication included acetylsalicylic acid (ASPIRIN), ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS) and unspecified pain medicine for back pain. She had the flu shot and Tetanus shot 2 months ago (2020) both for immunization. The patient started to notice the muscle pain on 18Jan2021 while diving back from the place she received the vaccination. She normally has muscle pain, but she thought this was something normally occurring. However, the muscle pain continued to get worse. She went to sleep, and the muscle pain continued to occur when she was trying to sleep. The muscle pain was occurring in the middle of the night and she was in so much pain it was preventing her from sleeping. She took a muscle relaxant for the pain and felt better. She noticed the pain at injection site initially around 6PM on 18Jan2021 but noticed it more when she was going to bed like 11PM. She tried to sleep on that side and it hurt. That side was hot, so she placed some ice on it. The headache started initially the day before got the vaccine 17Jan2021, but it got worse after getting the COVID 19 vaccine. It was worse on 18Jan2021, on 19Jan2021 it was better. She noticed the joint pain on 18Jan2021 but does not know really what time. She thinks it was around time noticed muscle pain. She woke up at 3AM something from the pain because she could not sleep. The chills started 4AM or 5AM on 19Jan2021. She noticed she felt tired, so tired when she woke up on 19Jan2021. She mentioned she was trying to do a walk but could not on 19Jan2021. She also mentioned she works at 1PM and would have to call out 2 hours before. She commented she needed her glasses to read the lot written on the patient card. Also was feeling unwell on an unspecified date. The events did not require Emergency Room nor Physician Office visit. The outcome of the events was recovering.
52 2021-02-02 itchy skin, rash 4 days post vaccine developed front and back torso rash with burning and itching
52 2021-02-02 injection site swelling, injection site warmth, injection site redness, injection site inflammation At the moment of the vaccination it didn't have any incidents, but during the night she touched her ... Read more
At the moment of the vaccination it didn't have any incidents, but during the night she touched her left arm and feeled a bump (inflammation, edema on the injection site) at the next day she continue to have the edema and redness area. After these days I continued noticing her arm hot to touch and the edema.
52 2021-02-02 injection site swelling, injection site pain Fever of 100.0 for 2 days, injection site swelling & pain
52 2021-02-02 injection site pain I exp fever greater than 100.9, fatigue, screaming headache,chills,weakness lasting about 4 day. Als... Read more
I exp fever greater than 100.9, fatigue, screaming headache,chills,weakness lasting about 4 day. Also around the injection site was extreme pain. I missed 2 days of work.
52 2021-02-03 injection site rash Normal vaccine related symptoms 24-48 he following vaccine, seemed resolved by day 5. On day 6 start... Read more
Normal vaccine related symptoms 24-48 he following vaccine, seemed resolved by day 5. On day 6 starting feeling a burning sensation, a sore developed at the injection site. Today is 17 days post injection, the sore is scabbed and resolving, burning has subsided, but shoulder is tight and somewhat painful when doing something like yoga.
52 2021-02-03 redness, itchy skin The patient developed dizziness, diffuse skin redness, mild facial itching dysphagia with a feeling ... Read more
The patient developed dizziness, diffuse skin redness, mild facial itching dysphagia with a feeling of swelling in the throat. She is not having shortness of breath, nausea, vomiting, diarrhea. Patient was given 10 mg of dexamethasone IV at 18:04, Benadryl 25 mg IV at 18:04 and epinephrine 0.3 mg IM at 18:12. Patient was observed for approximately 3 hours and discharged from the ED to home in stable condition.
52 2021-02-03 redness Within 10 mins I had swelling, tingling and some numbness in my face and neck. I was checked by EMS ... Read more
Within 10 mins I had swelling, tingling and some numbness in my face and neck. I was checked by EMS at the site. Waited another 20 mins and the symptoms did not get worse or rapidly improve. I had a prescheduled doctor appointment and went directly to the doctor's office after the vaccine. Dr. confirmed that I had swelling and redness in my face and prescribed Methylpredsisolone 4mg 21 pack of steriods to take. That medication removed the symptoms. On 02/01/21, 24 hrs after the last dose of the pack, the face swelling and tingling returned. As recommended I took Benedryl 2 tablets / 3 doses. I returned to Doctor's office on Tues 02/02 where she prescribed Presnisone 20mg for 5 days after seeing the swelling in my face and she said my lymph nodes were swollen as well.
52 2021-02-03 injection site pain, injection site redness, itchy skin allergic reaction, went to ED; 1/25 The symptoms first occurred about 7 minutes after the second vac... Read more
allergic reaction, went to ED; 1/25 The symptoms first occurred about 7 minutes after the second vaccination. I felt a "thickening" in my throat and it became difficult to swallow. A Rapid RN was called and my airway was assessed- no stridor, no decrease in sats. They evaluatedI started feeling better towards the end of last week. Additional information for Item 18: allergic reaction, went to ED; 1/25 The symptoms first occurred about 7 minutes after the second vaccination. I felt a "thickening" in my throat and it became difficult to swallow. A Rapid RN was called and my airway was assessed- no stridor, no decrease in sats. me for another 15 minutes and they recommended that I be evaluated in the ED. The right arm was noticed to be red. The injection site was painful. I was evaluated by the MD and given medications per their protocol (epi, Benadryl, famotidine, steroid). I was discharged home around 1830 (with a ride) after my throat seemed to be getting better. I was discharged with an Rx for steroids, blockers and and epi pen. Later that night at about 2200, I woke up with my face/scalp itching. I continued feeling achy, intense headache, hot/cold, foggy mind. I called in sick for my shift on 1/19. I returned to work on 1/20 with minor symptoms.I was evaluated by my MD on 1/21 and had minor expiratory wheezes (I have asthma). I seemed to be feeling better until Saturday and then stomach cramping/muscle cramping (noticeable on the right hand/injection side), bad headaches, fatigue have resumed. ; 2/2 I started feeling better towards the end of last week. Still feeling off but able to do my normal routines.
52 2021-02-03 vaccination site pain fever 102F; headache; chills; body aches, joint pain, injections site pain; joint pain; injections s... Read more
fever 102F; headache; chills; body aches, joint pain, injections site pain; joint pain; injections site pain; patient received the second dose of BNT162B2, which was 23 days after the first dose; This is a spontaneous report from a contactable pharmacist, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration in the left arm on 22Jan2021 at 07:45 (at the age of 52-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received the first dose of BNT162B2 (Lot Number: EL1284) on 30Dec2020 at 16:00 (at the age of 52-years-old) in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination (except the first dose). On 22Jan2021 at 07:45, the patient received the second dose of BNT162B2, which was 23 days after the first dose. On 22Jan2021 at 18:00, the patient experienced fever of 102 degrees Fahrenheit, headache, chills, body aches, joint pain, and injections site pain. Therapeutic measures were taken for the fever, headache, chills, body aches, joint pain, and injections site pain and included treatment with acetaminophen (TYLENOL) orally at 650 mg. The clinical outcomes of the fever, headache, chills, body aches, joint pain, and injections site pain were recovered in Jan2021.
52 2021-02-04 injection site warmth, injection site redness, injection site swelling 24 hours post injection chills, low grade temp 100.5, generalized achiness lasting 8-10 hours.; 24 h... Read more
24 hours post injection chills, low grade temp 100.5, generalized achiness lasting 8-10 hours.; 24 hours post injection chills, low grade temp 100.5, generalized achiness lasting 8-10 hours.; 24 hours post injection chills, low grade temp 100.5, generalized achiness lasting 8-10 hours; Injection site red, swollen and warm to touch extending 4"x2"; Injection site red, swollen and warm to touch extending 4"x2; Injection site red, swollen and warm to touch extending 4"x2; This is a spontaneous report from a contactable nurse reporting for herself. A 52-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number EL0142, via intramuscular route in left arm on 19Jan2021 at 11:45 at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Vaccination history included first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number EJ1685, via intramuscular route in left arm on 29Dec2020 at 12:00 PM, administered in Hospital. Medical history included allergy to sulfa drugs from an unknown date. The patient was not diagnosed with COVID-19 prior vaccination and was not tested positive for COVID-19 post vaccination. Unspecified concomitant medications were administered. On 20Jan2021 at 03:00 the patient experienced injection site red, swollen and warm to touch extending 4"x2". Twenty-four hours after vaccination the patient experienced chills, low grade temperature at 100.5 and generalized achiness lasting 8-10 hours. No treatment was administered for the reported events. The event "Generalized achiness" resolved on 19Jan2021, whereas the other reported events were resolving at the time of the report.
52 2021-02-04 rash with redness, itchy rash, rash papular Raised itched red rash to both forearms
52 2021-02-04 rash Rash to neck, face and hands noted on 2/5/2021
52 2021-02-06 injection site pain 1.1/14/2021- first dose Pfizer COV19 vaccine injection - day#1- left arm (injection arm) feel so... Read more
1.1/14/2021- first dose Pfizer COV19 vaccine injection - day#1- left arm (injection arm) feel soreness and ache - day#2- feel entire back/neck aching, entire left side down to my toes feel pain. Headache and nausea, feverish - day#3- feel entire back/neck aching, entire left side down to my toes feel pain. Headache and nausea, feverish, plus irregular heart beat - day#4- feel entire back/neck aching, entire left side down to my toes feel pain. Headache and nausea, feverish intensified - day #5- body ache subsided, Headache and nausea continued to feel intensified. Fever now turn into chills - day#6- unbearable headache and worse nausea feeling, chills, need to leave work in the afternoon. Throwed up and shaking. Took many headache medications and antinausea medications but nothing work. 2. 2/5/2021 @1630- received 2nd dose Pfizer COVID 19 vaccine - day#1, 1 hour into receiving vaccine, feeling dizzy and "hangover" type reaction. 2 hours into receiving vaccine, developed irregular heart beats. Left arm injection pain and sore arm. - day# 2: entire body ache, joint pain, headache and nausea - day#3: severe headache and feeling nauseous. Took many headache and antinausea medications. - will continue to follow adverse reactions.
52 2021-02-07 redness, injection site rash, injection site pruritus, injection site redness At about 12 pm day of immunization patient began having the following symptoms: redness to neck and ... Read more
At about 12 pm day of immunization patient began having the following symptoms: redness to neck and front chest, injection site ( right arm) redness , itching, rash below and above injection, reports blood pressure 169/96 ( checked at site ) , dizziness with standing, denied shortness of breath or chest pain at that time. En route home began having mid sternal chest pain , radiated to left side of chest, checked blood pressure at home 175/100. Patient states took additional Benadryl 25mg PO . After Benadryl chest pain subsided. At this time reports headache, dizziness, vertigo, chills , and fever. Vital signs stable, patient aaox3, report to Occupational Health provider. No obvious distress noted.
52 2021-02-07 vaccination site pain Mildly sore 2 inches around the vaccination site; This is a spontaneous report from a contactable co... Read more
Mildly sore 2 inches around the vaccination site; This is a spontaneous report from a contactable consumer reported for herself. A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL 3247) on 22Jan2021 11:30 AM at single dose (vaccine location=right arm) for Covid-19 immunization. Medical history was none. Concomitant medications included vitamins (unspecified) and birth control. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Mildly sore 2 inches around the vaccination site on 22Jan2021, no treatment received for the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The outcome of event was recovering.
52 2021-02-07 injection site mass, injection site warmth, injection site redness lump on injection site, hot, redness size of hand, fever 100.0 for 2 days on and off, swelling of ar... Read more
lump on injection site, hot, redness size of hand, fever 100.0 for 2 days on and off, swelling of arm, fatigue, hangover feeling
52 2021-02-08 redness, skin warm Approximately 12 hours post vaccination EE reported red mark 2x1" warm to touch. Severe pain radiat... Read more
Approximately 12 hours post vaccination EE reported red mark 2x1" warm to touch. Severe pain radiated up neck and to head causing headache. Went to office clinic for assessment 1/6/2021 ee states diagnosis was local reaction.
52 2021-02-08 redness, itchy skin Development of left arm redness, itching
52 2021-02-08 hives Patient received 1st dose 3 weeks prior without reaction. She received second dose today at approxim... Read more
Patient received 1st dose 3 weeks prior without reaction. She received second dose today at approximately 11:30am. She felt fine after the second vaccination, until about 1:30-1:45pm. Patient c/o a "heat rush", headache, and hives on BUE. Patient vitals were WNL except HR was slightly tachycardia at 107bpm. Respirations were baseline at 18. Patient denies sob/anaphylaxis. Benadryl administered orally, and monitored. No reaction was had with the first vaccine.
52 2021-02-09 injection site pain After 1 vaccine Fatigue and headache approx 8 hours after shot - resolved without medication. Did no... Read more
After 1 vaccine Fatigue and headache approx 8 hours after shot - resolved without medication. Did not miss work After 2 shot, Fever and chills approx 14 hrs after the shot. Resolved after 24 hours - took fever reducing medication- combination Advil and Tylenol Headaches, pain at the injection site, arm pit pain missed one day of work
52 2021-02-09 injection site pain Extremely sore arm post vaccination which left me unable to work for one day. Side effects abated an... Read more
Extremely sore arm post vaccination which left me unable to work for one day. Side effects abated and then reoccurred 9 days after injection. Been 2 days of pain with certain arm rotations. Unable to lift arm above my head without pain. Ibuprofen helps but pain inhibits driving, sleeping, getting dressed, exercising, etc.
52 2021-02-09 injection site pain Moderate pain in arm of the injection, some all over body aches, fatigue approximately 1 day after t... Read more
Moderate pain in arm of the injection, some all over body aches, fatigue approximately 1 day after the second injection. After the first injection only pain in the arm which received the injection. Took 2 Tylenol with onset of the pain and repeated when necessary with the first injection. For second injection took 2 Tylenol pills and arm pain and body aches subsided. After both injections, side effects only lasted a day.
52 2021-02-10 injection site pain pain at injection site and tired
52 2021-02-14 rash, hives starting around 8 pm 2/12, patient experienced sharp pain around the liver and gallbladder. by the t... Read more
starting around 8 pm 2/12, patient experienced sharp pain around the liver and gallbladder. by the time she went to bed, she was experiencing extreme bloating and gas, and developed diarrhea soon after. on saturday 2/13, the patient's arm began to swell and a rash developed on several parts of the body (trunk, arms, legs). swelling and hives went away after patient took benadryl, diarhhea and bloating have lessened, by are still present as of monday 2/15
52 2021-02-15 hives Hives on face and neck developed 3-4 hours (roughly, possibly earlier) after 2nd dose of vaccine I c... Read more
Hives on face and neck developed 3-4 hours (roughly, possibly earlier) after 2nd dose of vaccine I called the nurse hotline for my insurance and also spoke with a nurse from the Health Dept. who both recommended Benadryl and monitoring of symptoms
52 2021-02-16 rash Patient experiences numbness and tingling on left side of face 3-4 hours after vaccination. She ment... Read more
Patient experiences numbness and tingling on left side of face 3-4 hours after vaccination. She mentioned it felt like going to the dentist and having numbing medicine. She states it lasted for 3 days without medical intervention. Shed stated that on Monday the 8th she went in for estrogen and testosterone "pellets", Symptoms of numbness and tingling returned on Saturday the 13th with numbness, tingling on left side of her face and roof of her mouth. On Sunday the 14th she started getting a rash on the left side of her face and jaw line. She called today to report these symptoms and will be speaking with her PMD tomorrow.
52 2021-02-16 injection site pain Tired Vaccine site tender Lymph node in arm pit slightly swollen and tender
52 2021-02-16 itchy skin not feeling well , seizure like activity. I ER itch feeling. treated with Benadryl.
52 2021-02-18 injection site pain, injection site swelling, injection site redness, hives, injection site warmth, itchy skin Immediately felt heart tightness/warmth; completely resolved the following morning Delayed- itching ... Read more
Immediately felt heart tightness/warmth; completely resolved the following morning Delayed- itching (full body); Began after 15-20min lasted the remainder of the day and nearly completely resolved the following morning. Delayed Hives (to neck/face above neck); resolved the following morning Delayed injection site soreness; Began 4-5hrs after the injection worsened, extremely tender to touch Following morning the injection site is slightly raised, red to pink, warm to touch, swollen 2-2.5cm in circumference around the injection site, some itching remains. General fatigue 4-5hrs following the injection. Resolved the following morning
52 2021-02-21 injection site swelling 02/20 Approx. 4:30pm: very sharp but steady pain in liver that subsided in about 5 minutes. 02/20 Ap... Read more
02/20 Approx. 4:30pm: very sharp but steady pain in liver that subsided in about 5 minutes. 02/20 Approx. 5:30pm: cramp type pain in spleen area that subsided in approx. 15 minutes. 02/20 Approx. 6:00pm: arm pain & swelling at injection site that slowly increased over time. 02/21: Arm pain increased - very painful, swelling, limited ability to move arm without pain. 02/22: At the time of this submission, the arm pain & swelling is not as bad - it's minor now.
52 2021-02-21 skin spots 16 hours after injection, had chills, temp 99.8, body aches that lasted about 16 hours. Then had 2 s... Read more
16 hours after injection, had chills, temp 99.8, body aches that lasted about 16 hours. Then had 2 small nosebleeds that lasted less than 1 minute-one about 48 hours after injection and one about 72 hours after injection. About 79 hours after injection, noticed petechiae on bilateral lower legs only . . Notified my PCP the next day. No nosebleed on day 4 after injection and petechiae stable - maybe spread a little but still below the knees. ( Had previous COVID-19 infection that symptoms started around 11/29/2020)
52 2021-02-21 injection site swelling, injection site pruritus Itching, swelling at injection site, pain, heart palpitations, lymph node swelling
52 2021-02-21 rash Patient arrived for 2nd dose of Pfizer vaccine. Administered with no difficulty. Approximately 20 mi... Read more
Patient arrived for 2nd dose of Pfizer vaccine. Administered with no difficulty. Approximately 20 mins after receiving vaccine, patient began to report shortness of breath and chest tightness and rash to chest, that continued to worsen. She was brought into the urgent care (on-site) and was evaluated by MD and urgent care team. Intravenous access was established, placed on cardiac monitoring and supplemental oxygen was administered. Benadryl, Pepcid, Epinephrine (2 doses), Solumedrol, normal saline intravenous transfusion was administered. SOB and chest tightness resolved, rash improved. Monitored in urgent care for additional 5 hours, discharged home with prednisone and epi-pen.
52 2021-02-21 skin warm Within 15 minutes, left arm got got really cold - like ice. Lasted about 2 hours. The arm to the to... Read more
Within 15 minutes, left arm got got really cold - like ice. Lasted about 2 hours. The arm to the touch was warm but it felt like it was in ice bucket. They kept me for 2 hours. Started to resolve in those two hours but didn't go away completely. By evening it was mostly returned to normal. Next day, I woke up with flu-like symptoms - felt like I had the flu. Every hair on my head hurt; wanted to sleep; no appetite. Three in afternoon - I felt much better. As quickly as it came on, it went away quickly.
52 2021-02-21 itchy skin, rash ed in ER: given predisone and breathing treatment and was was released at 1:36 pm. Was given an Rx t... Read more
ed in ER: given predisone and breathing treatment and was was released at 1:36 pm. Was given an Rx to take 50 MG of Prevacid to take 1x a day for 5 days. Saturday: 2/20/2021 -- Took 50 mg of prevacid at 9 am and 10 mg of pepcid 4:50 pm. Eyes swelled, lump in throat Went to ER Was admitted for observation at hospital. Received predisone and benedryl through IV 1:30 bottom lip started to swell was given 25 mg of benadryl by mouth Around 7:30 am scalp started to itch - Was given 20 mg of predisone orally Around 9 am rash on face was given 50 mg of benadryl Around 2:30 pm Doctor came into room because my throat felt tight. She looked at it and said "its not too bad." She had the nurse give me benadryl via interveniously Was discharged around 3:30 pm on Sunday, February 21, 2021 Monday: 2/22/2021 Around 1:15 pm felt lump in throat, felt like my neck was swollen, took 25 mg of benadryl. Called Doctor. Took another 25 mg of Benadryl. Still didn't feel right. Went over to Dr office, my asthma and allergy doctor. At Dr office, I was given two injections of medication. (He told me what it was, but I cant recall the names.) He sent me home with the following instructions: zyretc 10 mg am and pm bendryl 25 mg every 4 hours as needed pepcid 20 mg am and pm predisone 20 mg 3x1 day tomorrow take 20 mg of predisone I am to call his office after 1 pm tomorrow 2/23/2021 to give status report on how I am doing
52 2021-02-22 itchy skin Burning itchness all over body
52 2021-02-22 rash I had light headedness,breaking out severe sweats, nausea and vomited (1). I was transported to ER w... Read more
I had light headedness,breaking out severe sweats, nausea and vomited (1). I was transported to ER with a 103.5 fever lasted for 10 days, Covid test, Epipen,swollen lymph nodes(right arm) painful,increased fatigue.During the 10 day period I had went to the ER again 5th day got tested for Covid and rechecked symptoms.
52 2021-02-22 hives, itchy skin Patient is a 52 year old female who presents with concerns of headaches, nausea, fatigue, hives/itch... Read more
Patient is a 52 year old female who presents with concerns of headaches, nausea, fatigue, hives/itching, and SOB since receiving her Covid-19 vaccine 3 weeks ago. Got the Pfizer vaccine at the Center on 1/17/21 around 12:30PM. She had no side effects during the 15 minutes she was kept for observation after receiving the vaccine. She did develop a headache and fatigue approximately 1.5 hours after she got the vaccine and then later that day developed nausea. SOB developed the following day. She developed hives on her chest approximately 2-3 days after the vaccine. States she cannot recall the exact date that the hives started. Hives have appeared like pink raised plaques. Largest plaque was 1 inch in diameter she estimates. The hives have continued to come and go from different areas of her body including her shoulders, buttock, upper legs. SOB is present at rest and with exertion. She has had no chest pain/pressure/tightness/wheezing , palpitations, or feeling of her throat closing. States her exertion capacity is reduced.
52 2021-02-22 redness, rash Rash to the top of bilateral thighs, waist and breast bilaterallys, Palms of bilateral hands bright ... Read more
Rash to the top of bilateral thighs, waist and breast bilaterallys, Palms of bilateral hands bright red and tongue felt a little thich
52 2021-02-22 itchy rash Recipient reports itching left arm and rash on left arm noted the day after receiving the vaccine.... Read more
Recipient reports itching left arm and rash on left arm noted the day after receiving the vaccine. She added that the itching is gone and no new bumps have appeared.
52 2021-02-23 injection site tingling Tingling in left shoulder blade and left arm
52 2021-02-24 redness, itchy skin, vaccination site redness Eyes have gotten worse; red streaks going up arms and splotches/ splotchy red whelps and streaks up ... Read more
Eyes have gotten worse; red streaks going up arms and splotches/ splotchy red whelps and streaks up her arm; real red spot on wrist; her arms started stinging and itching; Hand and feet were itching off; burning; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1283) intramuscular on the left arm on 13Jan2021 13:15 at a single dose for COVID-19 immunization. Medical history included acid reflux, antidepressant, normally wears contacts and puts reading glasses on over it. Family medical history of cancer. Concomitant medication included omeprazole (PROTONIX [OMEPRAZOLE]) for acid reflux and bupropion hydrochloride (WELLBUTRIN) as antidepressant. The patient went and got her first shot 2 weeks ago. She is a dental assistant. She woke up between 2am-3am on 13Jan2021 and her hands and feet were itching off. They were burning and itching and she did not have any rash. So Thursday, she had to work until 1. Her hands itched and she went home, took Benadryl and put Cortisone cream on hands and feet. She does not have a dose, lot or expiration for either. It would take 2 doses of Benadryl. They just continued to itch until Saturday and she went to a doc in the box and the doctor felt it was a reaction from the vaccine. You could not see anything except red where she scratched it. She gave her some medicine and she just went to pharmacy and the pharmacist said that is just like Benadryl. She started taking it and it immediately helped, but she only gave it to her for 5 days and when she finished, the itching started again. On 27Jan2021, her hands were itching off and she has red streaks going up arms and splotches. She does not have the name. It was like hydro something. She threw bottle away. She does not have a dose, lot or expiration. It improved and stopped when she was taking the medicine and on 26Jan2021, she had a real red spot on wrist, her hands have itched and itched. When her arms started stinging and itching, she pulled her sleeve up and it looks like streaks on her arms and elbows. She has these splotchy red whelps and streaks up her arm. She also noticed she had itching on her torso the day before. She needed to get glasses to see vaccine card. This was required before she took the vaccine, but she did feel like her eyes are worse all of a sudden. She normally wears contacts and puts reading glasses on over it. It has only been in the last few weeks that she has noticed this. Now, her arms were starting to itch again after a dose of Benadryl. She was worried about 2nd shot. She does not want it to get worse and continue. She would like to speak with someone to find out if it would be recommended for her to get second dose or not. No ER or physician's office required: Doctor visit on 16Jan2021 and they prescribed a medication to help with itching and burning for 5 days and it worked and when she stopped taking it, it started back. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the vaccine was administered was at a Clinic for the hospital. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of Pfizer suspect. Outcome of the events itching and eyes have gotten worse was not recovered, events burning and pain in arm was unknown and recovering for the other events.
52 2021-02-24 itchy skin Hard to breath, itching .. hot feeling from left arm area spread to neck face head. Itchying all ... Read more
Hard to breath, itching .. hot feeling from left arm area spread to neck face head. Itchying all over, pins and needles feeling in my hands, numbness in lips ear cheek , headache neck pain. Tiredness.
52 2021-02-24 injection site mass I have a 3 inch in diameter mass of swollen lymph nodes under my left arm (had both shots in left ar... Read more
I have a 3 inch in diameter mass of swollen lymph nodes under my left arm (had both shots in left arm). I read online that this is a sign of my body fighting the vaccine and it is a good sign. I went to my doctor just to have it checked out and because both of my eyes look like I have pink eye. My doctor isn't sure if my eyes have anything to do with the vaccine but said probably not. She said that I needed to report my mass as it is not one of the most common side effects. I also went to the health department, where I had both shots, and had them look at the mass. They said the same thing about my body fighting the vaccine. My doctor and the health department said that while they have seen the swollen lymph nodes from the shot, they haven't seen such a large mass like mine. Both of them said I needed to report this.
52 2021-02-25 sensitive skin Chills Sensitive skin Severe headache
52 2021-02-25 injection site pain Progress Notes (Nurse Practitioner) Pt called for follow up s/p covid-19 vaccine done on 02/24/2... Read more
Progress Notes (Nurse Practitioner) Pt called for follow up s/p covid-19 vaccine done on 02/24/21. She reports doing well and better today. She still has a sore arm where the injection site is. No redness or swelling nor fever. She also states that her cotton mouth sensation is gone. She is overall well. Pt is appreciative for the phone call. Denies any other concerns. Progress Notes (Nurse Practitioner) Attempt to reach patient for follow up. No answer. Progress Notes (Nurse Practitioner) Cosign Needed Expand AllCollapse All Date: 2/24/2021 Subjective Pt is a 52 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 30 minute waiting period after the injection, the patient began to experience chills/shaking "as if my internals are trying to come out.". She also reports of R arm pain "as if someone socked me in the arm" at injection site. She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency room area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, collapse, hypotension, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. PMH: depression/PTSD, recovered alcoholic and pill user x 8 years come this April. Currently on Zoloft, Abilify, Wellbutrin. ALLERGY REVIEW OF SYSTEMS: Patient complains of chills, muscle aches (R arm pain where injection site was) and headaches (she developed a headache later while she was in the bay about 15 minutes into her visit. Rates pain at 8/10) Patient denies fever, malaise/fatigue, facial swelling, ear pain, itching in ears, sore throat, frequent throat clearing, eyes watering, eyes itching, puffy eyes, eye redness, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, itching of skin and abdominal pain She reported about 15 minutes into her visit with me of "Sudden onset of dry mouth.": Previous Reactions: when she was younger, she had an adverse reaction, unable to recall what, to the chicken pox vaccine. She's only been able to get one shot. She's tolerated other vaccines w/o issues. Objective Vitals Vitals: 02/24/21 0907 02/24/21 0926 02/24/21 0943 02/24/21 1000 BP: 135/84 128/71 120/73 101/71 BP Location: Left arm Left arm Patient Position: Sitting Sitting Pulse: 93 82 68 SpO2: 97% 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is obese. She is not diaphoretic. Comments: intially appeared fatigued, not as alert. After drinking water, eating a granola bar. She started to come around HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal: Cervical back: Neck supple. Skin: General: Skin is warm and dry. Comments: R arm inspected. Warm, no erythema, swelling nor rash. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood is anxious. Affect is flat. Comments: initially flat/anxious. Pt was able to have normal mood by end of visit. Assessment/Plan Treatment included: water, snacks and ibuprofen for headache Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health), Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Doing well after observation. She has a ride. She was able to ambulate out to the front with co-worker. She is aware of precautions to watch for. Advised to place warm compress or ice to R arm. F/up with pcp as needed. Electronically Signed 2/24/2021 12:50 PM
52 2021-02-25 injection site swelling Swelling. Obvious in hands, rings tight, could not remove. +3 pound weight increase overnight decrea... Read more
Swelling. Obvious in hands, rings tight, could not remove. +3 pound weight increase overnight decreased in 48 hours, persists in shot arm, axillary and arm
52 2021-02-26 itchy skin Felt like throat was closing up, itchiness, self administered Benadryl. Refused transport by EMS.
52 2021-02-27 itchy skin, redness, rash Rash: neck, face, arms, leg. Treated with Benadryl, 24, waited 30 minutes, rash still present, incre... Read more
Rash: neck, face, arms, leg. Treated with Benadryl, 24, waited 30 minutes, rash still present, increased redness. checked airways-open. Tongue itching reported. Contacted 911. 911 assessed. Patient refused to go to the hospital. Patient when home and took additional doses of Benadryl 50... redness, rash nearly disappeared. 5 hours later, rash reappeared, some itching. Patient took 50 Benadryl. Rash and itching improved. Symptoms had not appeared within 12 hours of last dose of Benadryl.
52 2021-02-27 injection site tingling The night after the shot I became ill with mild flulike symptoms: headache, fever of 101, aches, chi... Read more
The night after the shot I became ill with mild flulike symptoms: headache, fever of 101, aches, chills. This seemed fully within what I had expected and been told might happen, but as these symptoms eased up over the next 48 hours, I experienced, and continue to experience, a weird neurological paresthesia-type symptom where it feels as though my skin is covered in some kind of cold minty lotion. (Not the same as chills, though it sounds like it, I realize.) Mostly on my upper back, but also at the injection site, and sometimes other places too. Not painful, just distracting and kind of worrying. Not anything I have ever experienced before, and not related to any sort of external variable. I consulted with both a doctor and my brother and his wife (both doctors) by telephone. Everyone has advised a wait and see approach, but my brother (an epidemiologist) recommended that I report this as an adverse event.
52 2021-03-01 injection site bruising ?Pfizer-BioNTech COVID-19 Vaccine EUA? fatigue, chills, fever (101 degrees), joint pain (all joints... Read more
?Pfizer-BioNTech COVID-19 Vaccine EUA? fatigue, chills, fever (101 degrees), joint pain (all joints including fingers, headache, 2 inch bruise at injection site, lymph node/underarm swelling, insomnia
52 2021-03-01 injection site bruising, injection site pruritus, rash, injection site warmth, itchy skin, injection site redness, skin warm, injection site swelling Left Arm - bruising, swelling, redness, itching, hot to the touch. Right arm - rash that includes i... Read more
Left Arm - bruising, swelling, redness, itching, hot to the touch. Right arm - rash that includes itching, red bumps, and warm to touch. I am very tired. My eyes are cloudy.
52 2021-03-01 rash, rash with redness, itchy skin Within 15 minutes the right side of my face became itchy. My tongue also felt a weird sensation. B... Read more
Within 15 minutes the right side of my face became itchy. My tongue also felt a weird sensation. By 12:30 am that night my chest became itchy and I had red bumps on my chest, then around 2 pm the next day my stomach began to get itchy and red with a red bump.
52 2021-03-02 rash, itchy skin Reaction started on 2.27 mid-morning- she began having a sensation in the back of her neck. Rash beg... Read more
Reaction started on 2.27 mid-morning- she began having a sensation in the back of her neck. Rash began on the nap of neck- swollen bumps. traveled around the front of the neck and then cheeks and eyes. Continued near tear ducks and all-around eye. Both eyes began to swell on 2.28 and she went to the ED for treatment. They gave her a steroid shot and benadryl IM. Discharged home, with no medications, but instructed to take benadryl as needed. She is taking benadryl every 6-8 hours for itching. She is not fully recovered due to itching and continued rash. Follow up appointment with PCP the end of this week begin of next.
52 2021-03-02 rash chest pain; her lips were swollen/it is on and off; Palpitations off and on; she had a rash on her a... Read more
chest pain; her lips were swollen/it is on and off; Palpitations off and on; she had a rash on her arms; she had an abnormal feeling in her throat/abnormal feeling in her throat comes and goes, off and on; maybe she is nervous and anxious; maybe she is nervous and anxious; This is a spontaneous report received from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left deltoid, on 19Dec2020, at single dose, for prevention/COVID-19 immunization, at the hospital. Medical history included allergies and allergies to propylene glycol 3350, polysorbate 20, polysulfate 20. It was reported that the patient had a "quick test" and confirmed she has allergies to propylene glycol and polysulfate 20. Her allergist gave her a list of things to stay away from and said to avoid those ingredients. She stated that COVID-19 vaccine has propylene glycol 3350. She clarified and said her allergist told her to stay away from propylene glycol products. Her allergist told her not to use the COVAX. On 19Dec2021, the patient got her first vaccine shot. Within 3 minutes of getting the vaccine, she had rash on her arms. 3 hours later, she had an abnormal feeling in her throat. She was told to go the emergency room and she was given a quick medicine (unspecified). The patient was unable to clarify what medication she received at the emergency room. On 20Dec2021 (the next day), her lips were swollen, on and off. The patient stated she uses dark shampoo and conditioners and maybe it has PEG in it or maybe she is touching something at the hospital. On 20Dec2020, the patient experienced palpitations. She asked the doctors and nurses about her palpitations and they said maybe she was nervous and anxious since she had a COVID patient in the unit. The patient reported that she thinks palpitation started when she went to pick up over the counter medications on 20Dec2020. On 02Jan2021, the patient experienced chest pain. The outcome of rash and palpitations were recovering; oropharyngeal discomfort, lip swelling, and chest pain were not recovered; and nervousness and anxiety were unknown. Information on the Lot/batch number has been requested.
52 2021-03-02 injection site pruritus, rash, itchy skin itching to bilateral axilla and neck, itching to injection site (left deltoid), light headed, itchin... Read more
itching to bilateral axilla and neck, itching to injection site (left deltoid), light headed, itching to head, back, and bilateral legs. Reports flushed to face. Bumps to forehead.
52 2021-03-03 bruising Day 1, 26 Feb 2021; headache began at noon; severe fatigue at 6:00 pm; 103 degree fever at midnight ... Read more
Day 1, 26 Feb 2021; headache began at noon; severe fatigue at 6:00 pm; 103 degree fever at midnight Day 2, 27 Feb 2021: 103 fever for 3 hours, reduced and maintained at 100 with alternating extra strength Tylenol with 800 mg Motrin every 4 hours; continued severe fatigue; continue headache, nausea started at 5:00 pm Day 3, 28 Feb 2021: Nausea, diarrhea, muscle pain, vomiting, headache, 100 degree fever for 24 hours, 6:00 pm passed out for less than 1 minute when standing to go to bathroom to vomit (aware, controlled fall); 2nd episode of passing out sometime after midnight, tried to stand, completely blacked out, woke up disoriented, called 911, transported to ER; bruised upper left arm, left side jaw/neck hitting furniture in fall, hit head on floor
52 2021-03-03 hives Facial hives, lip tingling/swelling
52 2021-03-03 redness, rash, itchy skin Pfizer Vaccine--Generalized rash over entire body 5 days post 2nd vaccination. Treatment was Benadr... Read more
Pfizer Vaccine--Generalized rash over entire body 5 days post 2nd vaccination. Treatment was Benadryl and topical cream. Rash continues to improve 4 days later, but remains itchy and red.
52 2021-03-04 skin warm At Approximately 1140, patient finished getting her 1st dose vaccine Pfizer (Lot# 6201 Exp. 06/2021... Read more
At Approximately 1140, patient finished getting her 1st dose vaccine Pfizer (Lot# 6201 Exp. 06/2021) and went to EMT observation area. At approximately 1210, patient informed EMT that she was not feeling well. Patient was given the zero gravity chair to sit in. Per EMT, patient c/o fast heart beat. EMT took vitals and assessed patient: BP systolic of 128, HR 88, pupils equally reactive, LOC X4, skin warm, RR of 8. Per EMT, patient was anxious and complaining of discomfort from occipital area of her head and nape. Per EMT, patient was instructed to do deep breathing exercises and patient was given some ice to initiate vagal response. Approximately 15-20 mins later, patient complained that she was not feeling well. At 1235 EMT came over to lead RNs stating that she was having difficulty getting an accurate BP reading due to the lack of having the proper size of BP cuff onsite. RN used personal BP cuff to take patient's vitals. Per RN, At 1238, patient's BP was 170/100, HR 88, RR 12, regular breathing. Per RN, Patient c/o swollen tongue, throat itchiness, and feeling cold, patient's skin showed visible cold urticaria. After assessment, RN instructed RN to call 911. EMT gave report to 911 operator. After the medics were on their way to site, Patient insisted needing to go to the bathroom to urinate, RN and EMT assisted patient to the bathroom. Patient was ambulatory. At 1244 Fire paramedics and AMR arrived. Patient relayed to medics that her tongue is swollen, that she is feeling itchiness in her throat, and that she has a raspy voice. Medics gave patient Benedryl IM in L arm at 1248. Patient refused to be transported to a hospital per Medics recommendation. Patient signed documents declining further medical care. Patient was instructed to call 911 for any difficulty breathing and any throat swelling. Medics and AMR left at 1258. At 1300 niece came from parking lot to assist patient to go to her car to go home.
52 2021-03-04 injection site reaction, rash with redness, itchy rash, injection site mass Red itchy rash appeared below injection site. Large Knot in arm where the itchy rash is. No more ... Read more
Red itchy rash appeared below injection site. Large Knot in arm where the itchy rash is. No more rash or itchy but can still feel knot/lump
52 2021-03-04 vaccination site warmth, vaccination site swelling, vaccination site redness, vaccination site pain palpitations; Soreness for 2.5 days; it is red and bruised/Redness; Swelling in the injection area; ... Read more
palpitations; Soreness for 2.5 days; it is red and bruised/Redness; Swelling in the injection area; bruise at the injection site/bruising is about the size of a half dollar or a little bigger/bruising was purple; Warm to touch/feels hot to touch; She felt pain immediately from the injection; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 12Feb2021 at a single dose on right arm for COVID-19 vaccination. Medical history included history of reactions to vaccination (including swelling), cardiovascular disease and she had 3 stents placed in the last 3 years, ongoing coronary artery disease, small vessel disease, heart attack (when she was 50 years old. She has been having symptoms in the last could of years), blood pressure, angina, and high cholesterol. Concomitant medication included ticagrelor (BRILINTA) as blood thinner, ranolazine (RANOLAZINE EXTENDED RELEASE) for angina, rosuvastatin for high cholesterol, losartan for blood pressure, metoprolol to help her heart not work as hard, ezetimibe as cholesterol booster, and acetylsalicylic acid (ASPIRIN) as blood thinner. The patient experienced palpitations on an unspecified date which resulted in a recent hospitalization. The patient was reported to have taken the first dose of COVID-19 vaccine on 12Feb2021 and had soreness for 2.5 days since an unspecified date, then it resolved. She reported that she felt pain immediately from the injection on 12Feb2021 and some pain after the injection and she typically have reactions where she swells. On 20Feb2021, she developed a bruise at the injection site, and it was also warm to touch. The bruising was the size of a half dollar and it was hot to touch. She stated that the bruising was purple, and she never experienced that before. She wanted to know if this could be due to the vaccine. on 12Feb2021. On 21Feb2021, she had swelling in the injection area, it is red and bruised, and the bruising was about the size of a half dollar or a little bigger. The redness looked like it was a little less, but the bruising has been more prominent. She wanted to know if she should get the second dose on 05Mar2021, as scheduled, and if she does, will the reaction be worse? The patient underwent lab tests and procedures which included exploratory tests: which revealed small vessel disease on an unknown date. The outcome of the event "Soreness for 2.5 days" was recovered; "She felt pain immediately from the injection", "it is red and bruised/Redness" was recovering; and "bruise at the injection site/bruising is about the size of a half dollar or a little bigger/bruising was purple", "Warm to touch/feels hot to touch" and "Swelling in the injection area" was not recovered, and for palpitations was unknown.
52 2021-03-05 injection site pain Headaches that would come and go Fast heart beat Dizziness Heartburn that came and went twice Sore ... Read more
Headaches that would come and go Fast heart beat Dizziness Heartburn that came and went twice Sore calf Sore quad Sore arm (injection site) Sore neck left side. Fatigue
52 2021-03-07 redness, rash 03/04/21 No symptoms until 9:15 a.m. (approximately 30 mins after vaccination), began feeling faint,... Read more
03/04/21 No symptoms until 9:15 a.m. (approximately 30 mins after vaccination), began feeling faint, weak, rapid pulse, heart skipping, numbness and tingling in fingers and toes, ringing and heat in ears, rash/redness on chest, neck and ears, intermittently "seeing stars", extremely dry mouth, hoarseness in voice and dry cough when speaking. Made my way to my sister's dental office nearby, where approximately 1 hour later, she gave me 50 mg of Benadryl and 99% Oxygen 2L/min via nasal cannula. BP 131/82, pulse 81, blood sugar 126 ml/dl. When not resolved after approximately 1.5 hours, I proceeded to the hospital Emergency Room. They did an EKG (normal), gave me famotidine and a steroid and observed me for a couple of hours. Most symptoms had subsided and was released at approximately 2:30 or 3:00 p.m.
52 2021-03-07 injection site redness, injection site mass 3 inch dark red circle with hard lump (same size as circle) at injection site. 72+ hours from inject... Read more
3 inch dark red circle with hard lump (same size as circle) at injection site. 72+ hours from injection and still present and not changing
52 2021-03-07 itchy skin, hives Hives both armas Itching sesation throughout the body
52 2021-03-07 redness My right breast on the right side closest to the vaccine injection became extremely tender. I starte... Read more
My right breast on the right side closest to the vaccine injection became extremely tender. I started running a fever and the breast became sensitive to touch, swollen and red. I had to go to an urgent care and it appears to be some sort of mastitis, but I am 52 and not nursing nor have I had any trauma to the breast. We don?t know that this was caused by the vaccine, but the symptoms came on approximately 48 hours after and it?s very unusual to get mastitis when not nursing. I?ve been on 3 different antibiotics and am still not well.
52 2021-03-07 itchy skin, rash Side effects are rash on legs and Arms & itching on back On the 3rd day swelling a little bit on foo... Read more
Side effects are rash on legs and Arms & itching on back On the 3rd day swelling a little bit on foot
52 2021-03-08 itchy skin Symptoms: generalized puritus Outcomes: monitored for 45 min and given PO Benadryl and resolved
52 2021-03-08 vaccination site pain muscle soreness at the injection site; This is a spontaneous report from a contactable pharmacist (p... Read more
muscle soreness at the injection site; This is a spontaneous report from a contactable pharmacist (patient). A 52-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) at the age of 52-years-old, via an unspecified route of administration on left arm on 04Feb2021 at 09:30 AM at single dose for COVID-19 immunization. The patient's medical history was not reported. She was not pregnant at the time of vaccination. Concomitant medications included levothyroxine and multivitamin. The facility where the most recent COVID-19 vaccine was administered was at the workplace clinic (also reported as other). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced muscle soreness at the injection site on 05Feb2021. The patient did not receive any treatment in response to the event. The outcome of the event was recovering. The event was assessed as non-serious.
52 2021-03-08 injection site redness, injection site mass red bump at injection site, developed 8 days later.
52 2021-03-09 redness, rash 10 hours after vaccination experience severe shaking, fever of 102.6 Took 2 (500 mg) Tylenol. Fever ... Read more
10 hours after vaccination experience severe shaking, fever of 102.6 Took 2 (500 mg) Tylenol. Fever kept climbing to 104.5 Took 25 mg of Benadryl for red color of face and small rash on abdomen. Placed call to Dr. Advised every 8 hours Tylenol (1000mg) and cycle with Ibprofen- 2 (200mg). Fever remained at 104 till morning, then 103.1. Fever down for 2 hours and spikes to 104. Took cold bath, reduced fever to 102. Chills, violent shaking a headache behind eyes, very dehydrated. Drank Gatorade and with fatigue slept off and on for 48 hours. Fever finally down by 03/10/2021 to 98.9 with mild headache. Did not have any body or muscle aches during this event.
52 2021-03-09 injection site redness, injection site swelling, injection site pain Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain, swelling and redness x 3 days Tiredness x ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain, swelling and redness x 3 days Tiredness x 2 days Headache x 2 days Muscle pain x 2 days Chills x 2 days Joint Pain x 2 days Fever up to 104.0 degrees x 2 days Nausea x 2 days Feeling Unwell x 2 days Swollen Lymph node left collarbone x 4 days
52 2021-03-09 redness R hand pain, redness, swelling, weakness, tingling
52 2021-03-09 vaccination site redness, vaccination site warmth, vaccination site pain glands were swollen and when swallows; glands were swollen and when swallows, sharp pain on one side... Read more
glands were swollen and when swallows; glands were swollen and when swallows, sharp pain on one side; vaccines were given in the left arm because she was left-handed; Back pain; spasms; fever; she felt like the inside of her eyes were on fire; She had a moist cough; spine pain; nausea; vomiting; She had numbness and tingling around the outside of mouth; She had numbness and tingling around the outside of mouth; She had pain in the arm at the injection site; knees would buckle; injection site was about a silver dollar size and was red and warm to touch; injection site was about a silver dollar size and was red and warm to touch; injection site was about a silver dollar size and was red and warm to touch; This is a spontaneous report from a contactable nurse (patient). This 52-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302) at single dose on 27Jan2021 via an unknown route in left arm for Covid-19 immunization. She was diagnosed diabetes six years ago (as of 23Feb2021), and her last A1C was 6.1 in Dec2020, had chronic edema since her last child was born 26 years ago. Concomitant drugs included furosemide (LASIX) 400 mg twice daily, potassium 10 meg three times daily, omeprazole (PRILOSEC) 40 mg once daily, and metformin hydrochloride (METFORMIN ER) 1000 mg twice daily, all ongoing. She did not feel like the medication she takes are relevant because she had been taking them for a very long time. Historical Vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140) intramuscular injection in left arm on 04Jan2021 for Covid-19 immunization and experienced back pain, diagnosed with COVID in between the first and second vaccine, headache, arm pain at the injection area, severe back spasms in the thoracic and lumbar (AER 2021200627). Patient experienced back pain 2-3 days after the first dose, headache, arm pain at the injection area, back pain and severe back spasms in the thoracic and lumbar. It was sharp, stabbing, crushing pain then she would have spasms. She went to urgent care and was given Voltaren and Flexeril. She was taking 1 gram of Tylenol every 8 hours. That lasted two to three days. That started on the 06Jan2021. She thought she was doing great and then on the sixth was when it started. By the morning of the ninth it was over. The reporter assessed headache, arm pain at the injection area, back pain, severe back spasms in the thoracic and lumbar were related to suspect vaccine. After the 2nd dose of the vaccine, patient experienced back pain in Jan2021, sharp, stabbing, crushing pain and spasms in Jan2021, fever for a couple of days in Jan2021, knees would buckle in Jan2021, glands were swollen and when swallows, sharp pain on one side on 09Feb2021, felt like the inside of her eyes were on fire in Jan2021, moist cough in Jan2021, spine pain in Jan2021, nausea and vomiting in Jan2021, numbness and tingling around the outside of mouth in Jan2021, pain in the arm at the injection site in Jan2021, injection site was about a silver dollar size and was red and warm to touch in Jan2021. The event clinical course was as follows: The second dose was given on 27Jan2021. She was getting over COVID and had to wait until the 27Jan2021 to get second dose. COVID symptoms started on 11Jan2021. She had PCR test on 12Jan2021 with results of her PCR test on 13Jan2021. She was diagnosed with COVID in between the first and second vaccine due to an exposure not the vaccine. At hour 25 after receiving the second dose symptoms started. Severe back pain in the entire spine. It was sharp, stabbing, crushing pain and spasms. When the back would spasm her knees would buckle. She had a fever for a couple of days. 102 fever and she felt like the inside of her eyes were on fire. She has never had that before. She had a moist cough and still has a moist cough. The spine pain was better, but it is not gone away yet. Normally she does not have back pain. At first the pain was an 8 out 10 now (as of 23Feb2021) it was 5 out of 10. Also had nausea and vomiting. She had numbness and tingling around the outside of mouth. That lasted for two days. She had pain in the arm at the injection site. The injection site was about a silver dollar size and was red and warm to touch. She had pain at the injection site and pain in the arm. Both vaccines were given in the left arm because she was left-handed. She thought she would be using that arm more. She did go to Urgent Care after the second dose as well. They gave her a shot of Toradol and another prescription for Voltaren twice a day and Flexeril at bedtime because she can't stay awake when she takes it. She has missed work because of this. The back pain and cough was almost a month now (as of 23Feb2021). She reported no matter what she did she did not get it to go away. She did a zoom call with her doctor because of COVID symptoms and because she took vaccine. She took 1000mg of Tylenol prior to receiving both doses and thought maybe it wouldn't hurt and would keep her from getting a fever. She has been taking 1000mg Tylenol three times a day and now she was taking it two times a day. She used Tylenol and generic, SunMark Acetaminophen (Lot number: OLE2349B, expiry: Sep2022). Regarding seriousness of headache, made a different in the vision. It was throbbing. for back pain: it was seven out of 10. It was disabling. She had to miss work and could barely walk across the floor. for arm pain at the injection area: gripping was not easy and moving her arm was painful. She is left handed. Heat worked better than ice. Ice made things worse. for cough: it had not been disabling. it was irritating because it had been almost 30 days. She knows it was different than the COVID cough because it was moist and when she had COVID it was a dry cough. Regarding seriousness of nausea and vomiting: it was debilitating and she couldn't go anywhere because she was throwing up with every move she made. The pain made it worse. The reporter assessed moist cough, nausea and vomiting, arm pain at the injection area were related to suspect vaccine. No investigation assessment performed. Outcome of fever, inside of her eyes were on fire, pain in the arm at the injection site was resolved. Outcome of back pain, moist cough was not resolved. Outcome of spine pain was resolving. Outcome of the other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the back pain and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including spine CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
52 2021-03-09 itchy skin no appetite for 2 weeks; extreme itching in hands, feet, scalp; Severe fatigue; This is a spontaneou... Read more
no appetite for 2 weeks; extreme itching in hands, feet, scalp; Severe fatigue; This is a spontaneous report from a contactable other hcp (reporting for herself) A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose left arm on 18Jan2021 for covid-19 immunisation. First dose was administered intramuscular on left arm on 28Dec2020 17:15. Medical history was none. The patient's concomitant medications were not reported. The patient experienced severe fatigue on 25Jan2021, no appetite for 2 weeks on an unspecified date, extreme itching in hands, feet, scalp on an unspecified date. It was reported to be unbearable, and she was treated with Medrol dose pack, now Atarax, and prednisone (higher dose) and still have uncontrollable itching with only relief at night. The events outcome was not recovered. Information on the lot/batch number has been requested.
52 2021-03-09 vaccination site pain she was diagnosed with COVID in between the first and second vaccine; she had headache; arm pain at ... Read more
she was diagnosed with COVID in between the first and second vaccine; she had headache; arm pain at the injection area; severe back spasms in the thoracic and lumbar; made a different in the vision, it was throbbing; back pain; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: EL0140), intramuscular on 04Jan2021 at single dose at left arm for covid-19 immunization. Medical history included diabetes (diagnosed six years ago. Her last A1C was 6.1 in Dec2020), chronic edema since her last child was born 26 years ago. Concomitant medications included ongoing furosemide (LASIX), ongoing potassium, ongoing omeprazole (PRILOSEC), ongoing metformin, and paracetamol (TYLENOL). Caller received the Pfizer-BioNTech COVID-19 Vaccine first dose on 04Jan2021 and second dose on 27Jan2021. Caller reported to have experienced back pain 2-3 days after the first dose, and a sharp stabbing back pain with moist cough for almost a month now after the second dose. Caller was diagnosed with COVID-19 in between. With the first vaccine she had headache, arm pain at the injection area, back pain and severe back spasms in the thoracic and lumbar. It was sharp, stabbing, crushing pain then she would have spasms. She went to urgent care and was given diclofenac (VOLTAREN) and cefixime (FLEXERIL). She was taking 1 gram of paracetamol every 8 hours. That lasted two to three days. That started on the 06Jan2021. She thought she was doing great and then on the sixth was when it started. By the morning of the ninth it was over. Seriousness criteria for back pain, it was seven out of 10. It was disabling. She had to miss work and could barely walk across the floor; for event arm pain at the injection area, gripping was not easy and moving her arm was painful. She was left handed. Heat worked better than ice. Ice made things worse; for event headache, made a different in the vision, it was throbbing. She did a zoom call with her doctor because of COVID symptoms and because she took vaccine. She took 1000mg of paracetamol prior to receiving both doses and thought maybe it wouldn't hurt and would keep her from getting a fever. She had been taking 1000mg paracetamol three times a day and now she was taking it two times a day. She was taking cefixime at bedtime because she can't stay awake when she took it. She can't take it and work. She had missed work because of this. She was taking diclofenac twice a day. Patient didn't have the first bottle of paracetamol she used because she had gone through it. Current bottle of Tylenol was the generic, SunMark Acetaminophen. She had to get her glasses to read the lot number. It was made by (Pharmacy name), Lot number: OLE2349B, expiry: Sep2022. She didn't feel like the medication she took were relevant because she had been taking them for a very long time. COVID symptoms started on 11Jan2021. She had PCR test on 12Jan2021. She got the results of her PCR test on 13Jan2021. Outcome of event back pain was not recovered, outcome of events headache, arm pain at the injection area and severe back spasms in the thoracic and lumbar was recovered in 2021, and outcome of other events was unknown. Relatedness of drug to reaction(s)/event(s): Events headache, arm pain at the injection area, back pain and severe back spasms in the thoracic and lumbar: source of assessment: primary source reporter; Method of assessment: global introspection; Drug result: Related.; Sender's Comments: Event back pain represents an intercurrent medical condition and unrelated to bnt162b2 . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
52 2021-03-11 rash, hives Chills, Muscle Pain, Joint Pain, Exhaustion, Nausea, Rash, Hives Nausea, Rash, Hives lasted for... Read more
Chills, Muscle Pain, Joint Pain, Exhaustion, Nausea, Rash, Hives Nausea, Rash, Hives lasted for 24 hours Chills, Muscle Pain, Joint Pain, Exhaustion lasted for 7 days
52 2021-03-11 itchy skin Itchy palms radiating up my arms then I became itchy all over went to the ER they prescribed hydroxy... Read more
Itchy palms radiating up my arms then I became itchy all over went to the ER they prescribed hydroxyzine
52 2021-03-11 injection site pruritus, hardening, injection site mass On day 8 after first dose injection I have a half-dollar sized lump at the injection site that it ha... Read more
On day 8 after first dose injection I have a half-dollar sized lump at the injection site that it hard and itchy.
52 2021-03-11 rash Patient experienced rash and facial/mouth swelling approximately 5 minutes after receiving vaccine. ... Read more
Patient experienced rash and facial/mouth swelling approximately 5 minutes after receiving vaccine. Patient received Epinephrine 0.3 ml of 1 mg/ml solution IM, plus benadryl 50 mg p.o. Patient was transported to ED.
52 2021-03-11 itchy skin itchy, dizzy, difficulty breathing, allergic reaction. Evaluated by EMS-Transported to Emergency ro... Read more
itchy, dizzy, difficulty breathing, allergic reaction. Evaluated by EMS-Transported to Emergency room/department or urgent care.
52 2021-03-11 itchy skin, skin discolouration pt states that she started itching between the left shoulder and left breast. As she scratched her ... Read more
pt states that she started itching between the left shoulder and left breast. As she scratched her breast she felt a small bump and noticed a brown spot. She contacted her OB/GYN via portal to let her know that about these symptoms. The Doctor advised her to see a Dermatologist. She contacted her once again since she felt like something was wrong and was told again to see a Dermatologist. Pt saw Dermatologist on 3/4/2021 and was told it did not look skin cancer and ordered some cream. Pt let Dr. know that she had taken the vax recently and that she also has breast implants. The Doctor did a small exam but did not feel a lump, but this doctor is not an OB/GYN. Pt went to an already scheduled mammogram on 3/11/2021 but they would not complete the annual exam since she was having pain issues so she was rescheduled for a diagnostic exam on 3/17/2021. Pt believes she has felt swollen lymph nodes under her left arm and has had intermittent pain for about 3 weeks now. The pain seems to move around from breast to her back.
52 2021-03-12 skin warm, redness 15 min. after shot, my neck became warm and flushed, slightly red. By 30-40 minutes after shot, my f... Read more
15 min. after shot, my neck became warm and flushed, slightly red. By 30-40 minutes after shot, my face was also flushed and the inside of my mouth (mostly roof of my mouth) and lips were itchy/tingly. Then, I took 2 Zyrtec 10 mg. as instructed by my allergist if I had a reaction. Within an hour, the flushing and itchiness were gone. 2 days later - had strange pain, swelling, and warmth in upper left shin below knee. Worried about possible blood clot, I took 2 baby aspirin. Pain and swelling went away. Not sure if related to vaccine but unaware of anything else that could have been different.
52 2021-03-12 injection site hardening, itchy rash, injection site warmth, skin discolouration, rash, injection site swelling, rash with redness, injection site reaction One week after vaccine woke with large round, very itchy rash at injection site. Area was swollen an... Read more
One week after vaccine woke with large round, very itchy rash at injection site. Area was swollen and warm with a very small hard area directly at injection site. It was very itchy for about 8 hrs and then it was only sporadic at best. The rash was very red at beginning but has faded continually since. The area is a very distinct oval or circular shape, approx. 4 inches in diameter. It is almost hard to call it a rash as the itchiness, swelling and "prickly" type skin were very short lived, 2-4 days, but the discoloration is still very distinct although faded considerably since the first appearance. I did have moderate headache and arm soreness with the first vaccine, short lived. With the second dose I had headache and then extreme axillary and neck soreness on second day. The rash did not appear until one week after the 2nd dose. It has been approx one month and the 4 inch "rash" is still apparent but faded .
52 2021-03-12 rash with redness, skin warm, rash, rash papular, hardening Reaction started on the left side of the body, it was a red rash on the lower part of the abdomen. T... Read more
Reaction started on the left side of the body, it was a red rash on the lower part of the abdomen. The forth day It then spread to the stomach, neck and arms. Now it is all over the body as a red raised bumps that itch and are hot to the touch. The doctor started me out on a cream triamcinolone acetonide and a hydroxyzine hcl 25 mg 1 tablet 3 time a day. and told me not to take the potassium due to a possible reaction between 2 of the medications. this is the 7 day and the skin of my stomach is hard to the touch itchy and sore as well as my neck. my arms have raised red bumps as well as my legs and back.
52 2021-03-12 itchy rash, rash Sore arm day after - no other affect. 9 days later I started to get rash on face. but day 10 , I... Read more
Sore arm day after - no other affect. 9 days later I started to get rash on face. but day 10 , I had a full allergic reaction. burning, itching face. I went to my dermatologist and he believes it was a delayed reaction to the vaccine. Nothing new was introduced to my world. I started a regime of Prednisone . Day 11 the redness was gone but residual effects were apparent Day 12 my skin was flaky but otherwise normal
52 2021-03-13 skin tightness Very bad pain in left arm, swelling from shoulder to elbow, swelling in left leg from just below kne... Read more
Very bad pain in left arm, swelling from shoulder to elbow, swelling in left leg from just below knee to toes feels like my skin is going to split. Right side is fine.
52 2021-03-14 injection site pain Day of vaccine thru day 3 - tired, headache, both arms sore at same location as injection in left ar... Read more
Day of vaccine thru day 3 - tired, headache, both arms sore at same location as injection in left arm. Day 4 - present - both arms sore/achy at approximately same location as injection site.
52 2021-03-15 injection site pain, injection site reaction Chills, 99.9 fever, body aches, sore and stiff arm at injection site.
52 2021-03-15 itchy skin Immediately following vaccine: itching and headache, then extreme fatigue and stabbing abdominal pa... Read more
Immediately following vaccine: itching and headache, then extreme fatigue and stabbing abdominal pain, followed by diarrhea. The next morning, I felt fine and went to work, but by 2pm, I felt like I had been hit by a truck - headache, aches, chills, felt feverish (but no fever), diarrhea. On 3/13, felt a bit better, but still fatigued and had diarrhea. Had chills off and on throughout the day. 3/14 felt a bit better, but had fatigue and body aches plus diarrhea. 3/15, severe body aches, chills, headache, diarrhea. 3/16 severe body aches and pains, chills, severe headache, feel feverish (but no fever).
52 2021-03-16 rash with redness, itchy skin, rash Patient received vaccine at 12:30. Symptoms began at 14:00. She noticed a faint pink rash on both ... Read more
Patient received vaccine at 12:30. Symptoms began at 14:00. She noticed a faint pink rash on both arms and feels itchy all over. Her tongue feels numb, but not swollen. Her voice is hoarse. Her heart was racing initially, but that resolved quickly. She also felt short of breath for a few minutes, but that also resolved prior to her seeking medical care. She has numerous medication allergies and states this feels similar to a reaction she has when she is allergic to a medication.
52 2021-03-16 dry skin Pt in COVID-19 Observation Area and complained of Dizzyness and headache. B/P @ 211/100 p-135 Sat 99... Read more
Pt in COVID-19 Observation Area and complained of Dizzyness and headache. B/P @ 211/100 p-135 Sat 99%. Manual B/P @ 200/110. Warm and dry to touch. Pt alert and oriented. Code Assist called. Pt evaulated by code asist team and taken to Clinc for furter evaluation.
52 2021-03-16 redness cheeks red, caller states this is her cousin who just texted her to say her symptoms resolved
52 2021-03-17 injection site warmth, injection site pain, injection site tingling, injection site swelling 20 minutes after vaccination Pt c/o burning/tingling at injection site (lt arm) that radiates across... Read more
20 minutes after vaccination Pt c/o burning/tingling at injection site (lt arm) that radiates across the chest to rt arm. Pt denies any DIB, chest pain, SOB, tongue or lip tingling/swelling. Swelling and hot to the touch noted at injection site. Pt given 50mg of Benadryl IM to rt arm.
52 2021-03-17 injection site pain I received the Pfizer vaccine on Saturday March 6th. My arm was sore just at the injection site for ... Read more
I received the Pfizer vaccine on Saturday March 6th. My arm was sore just at the injection site for 2 days and that went away. Tuesday, the 15th, 9 days after receiving the injection, I woke up and my whole arm hurt from my shoulder to my wrist. I thought I?d just slept on it wrong but that usually gets better as the day goes on and is gone the next day. This got worse as the day went on and I have both muscle pain that feels neurological, like a pinched nerve, and joint aches. It?s now Thursday the 18th and my arm still hurts although not as bad as it did Tuesday and yesterday. I don?t know if it?s unrelated but I see many reports of arm paid days later, so I thought it best to report.
52 2021-03-17 vaccination site pain Nausea; tiredness; headache; injection site tenderness; feeling unwell; chills; fever waves; This is... Read more
Nausea; tiredness; headache; injection site tenderness; feeling unwell; chills; fever waves; This is a spontaneous report from a contactable consumer reported for self. This 52-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 16Feb2021 11:00 AM in left arm for COVID-19 immunization. Medical history included HBP (Blood pressure high); thyroid issues; obesity; known_allergies: seasonal allergies; covid-19. Concomitant medications the patient received within 2 weeks of vaccination included levothyroxine, losartan, HCTZ, vitamin D NOS, paracetamol (TYLENOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced nausea, tiredness, headache, injection site tenderness, feeling unwell, chills/fever waves on 16Feb202112:00 PM. There was no treatment received for the adverse event. This was a non-serious report. The events did not result in death, not life threatening, not caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. The outcome of events was unknown. Information on the lot/batch number has been requested.
52 2021-03-17 injection site pain On 3/6 I started experiencing neasua, tiredness, headaches and pain at injection site over the weeke... Read more
On 3/6 I started experiencing neasua, tiredness, headaches and pain at injection site over the weekend. On 3/8/21 I had a headache and neasua which continued off an on durinig the week. On 3/15/21 to 3/17/21 I have been experiencing off and on, uncontrollable chills, followed by sweats and then headaches. I went to Urgent Care on 3/17/21 and was tested for Covid with Nasal swab and results came back negative and was told there was nothing they could do for the side affect from vaccine and just to wait for them to pass.
52 2021-03-17 injection site pain Patient reports receiving COVID-19 vaccination on 03/05/2021. Reports that the following morning, 03... Read more
Patient reports receiving COVID-19 vaccination on 03/05/2021. Reports that the following morning, 03/06/21, she had "severe arm pain rated 7/10 and she couldn't lift her arm as high as normal". Reports using ibuprofen and ice as needed over the weekend "made it a bit better, but was still there". Reports it did not interfere with her ADLs. Reports she "cannot lift her arm high without pain in her shoulder and top of the arm". Denies redness, swelling, bruising, or rash at injection site, but describes injection site as "high up" on her arm. At time of interview on 3/10/21, patient states her pain is 2/10 and has not used ibuprofen for the day. Reports she did not seek medical care.
52 2021-03-17 injection site pain Soreness at injection site and surrounding tissue. Moderate to severe headache. No treatment. Bot... Read more
Soreness at injection site and surrounding tissue. Moderate to severe headache. No treatment. Both resolved in 36hrs after injection.
52 2021-03-17 redness, hives started with tingling, numbness, and redness around the mouth and face. quickly progressed to hives ... Read more
started with tingling, numbness, and redness around the mouth and face. quickly progressed to hives and difficulty breathing. EMS administered benadryl, solumedrol, and epinephrine and transferred to ER. She responded to treatment quickly and was discharge from the ER same day.
52 2021-03-17 vaccination site pain vertigo/felt like she was going to fall out of bed; Headache; just a little fuzzy; localized injecti... Read more
vertigo/felt like she was going to fall out of bed; Headache; just a little fuzzy; localized injection pain; tired; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar event for three patients. This is the first of three reports. A 52-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN5318, expiry date: unknown), via an unspecified route of administration on 30Jan2021 15:30 (at the age of 52 years old) at a single dose in the upper right arm for covid-19 immunisation. Medical history included Hashimoto's from 2010 and ongoing (estimates she has had this since 2010, about 11 years ago). Ongoing concomitant medications included levothyroxine (has been taking for six to seven years or more), estradiol (has been taking for 15 to 16 months), and progesterone (Has been taking for 15 to 16 months). The patient previously took flu vaccine on unspecified date (reported as in Sep or Oct) for immunization. The patient had no prior vaccination in four weeks. The patient reported after administration of Pfizer vaccine, on 30Jan2021, she came home and was fine, she stated she was tired but had just traveled and flew home from the east coast so it was no surprise. On 30Jan2021, about one to two hours after the patient got the vaccination, she experienced localized injection pain. This went away by Monday morning, 01Feb2021 and she did not have the pain anymore. On 31Jan2021 0330, she had woken up to go to the bathroom she noticed the headache, but she did not have the vertigo yet, but had the headache, she debated taking something but she was tired so she just went back to sleep. When she woke up later on Sunday she took one ibuprofen (MOTRIN) unknown milligrams, in the morning and one later in the morning around 11:30 or 12. She continued by saying her headache was basically gone, just a little fuzzy (31Jan2021) but nothing she felt like she needed to do anything about. On 31Jan2021 0700, Sunday, she had extreme vertigo which she had never had before and the symptom is still continuing. She rolled over in bed, not sitting up. She felt it in bed. She stated the vertigo is a little better, but partly because she knew how to manage it, she did not move her head. The patient had a virtual visit with her doctor on 01Feb2021 and was going to prescribe meclizine and the patient asked if it was comparable to dimenhydrinate (DRAMAMINE) which the doctor clarified it was. She took DRAMAMINE yesterday (01Feb2021) morning around 9:30am and during the day she felt much better. She has a prescription of meclizine waiting, but she has not picked it up or taken it yet. She also took two paracetamol (TYLENOL). When she was falling asleep she said felt like she was going to fall out of bed, she was lying down in bed half asleep and had the sensation she was going to roll right off the bed. That is when she took the two regular TYLENOL. Therapeutic measure was taken as a result of the events vertigo, headache and localized injection pain. Outcome of the event vertigo was recovering. Outcome of the event headache was recovered on 31Jan2021. Outcome of the event localized injection pain was recovered on 01Feb2021. Outcome of all the other events was unknown.;
52 2021-03-18 vaccination site pain Feel an armpit swollen lymph lump; Body warmer than usual; Injection site pain; This is a spontaneou... Read more
Feel an armpit swollen lymph lump; Body warmer than usual; Injection site pain; This is a spontaneous report from a non-contactable consumer reporting for herself. This is the second of two reports. A 52-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot En6201, via an unspecified route of administration in left arm on 23Feb2021 13:40 (at the age of 52 years) at single dose for covid-19 immunisation. The patient previously received the first dose of bnt162b2, Lot En9264, via an unspecified route of administration in left arm on 02Feb2021 13:30 (at the age of 52 years) at single dose for covid-19 immunisation and experienced injection site pain for 1 day. Medical history included high blood pressure. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Allergies to medications, food, or other products were none. Concomitant medication included losartan, vitamin d3, ubidecarenone (Q10). The patient experienced injection site pain on 23Feb2021, body warmer than usual on 24Feb2021, feel an armpit swollen lymph lump on 25Feb2021. Laboratory data included body temperature 37.3C on 24Feb2021, and normal on 25Feb2021. No treatment was received for the events. The events were non serious with outcome unknown. No follow-up attempts are possible. No further information is expected.
52 2021-03-18 redness Fever of 102, Shooting pain in extremities, migraine, red flushed and swollen face, enlarged tongue... Read more
Fever of 102, Shooting pain in extremities, migraine, red flushed and swollen face, enlarged tongue, increased heart rate, wheezing, joint pain, severe nausea, diaherra, possible seizure, confusion.
52 2021-03-18 hives, itchy skin I broke out in hives (not itching) the day after my shot. They went away the next morning. Now I am ... Read more
I broke out in hives (not itching) the day after my shot. They went away the next morning. Now I am breaking out in hives daily and they have started just on my arms and hands and have begun to include my feet , legs and stomach and have begun to itch as well. They go away overnight with benadryl.
52 2021-03-18 vaccination site pain Injection site pain for 1 day; This is a spontaneous report from a non-contactable consumer reportin... Read more
Injection site pain for 1 day; This is a spontaneous report from a non-contactable consumer reporting for herself. This is the first of two reports. A 52-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot En9264, via an unspecified route of administration in left arm on 02Feb2021 13:30 (at the age of 52 years) at single dose for covid-19 immunisation. Medical history included high blood pressure. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Allergies to medications, food, or other products were none. Concomitant medication included losartan, vitamin d3, ubidecarenone (Q10). The patient experienced injection site pain for 1 day (non-serious) on Feb2021. No treatment was received for the event. The outcome of the event was resolved. No follow-up attempts are possible. No further information is expected
52 2021-03-18 vaccination site pain, vaccination site swelling feeling off; light body ache discomfort; light body ache discomfort; left arm swollen-pain; left arm... Read more
feeling off; light body ache discomfort; light body ache discomfort; left arm swollen-pain; left arm swollen-pain; headache; fatigue; This is a spontaneous report from a contactable other HCP (patient). A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9261), via an unknown route of administration on 03Feb2021, 13:15, Left arm at single dose for covid-19 immunisation at Hospital. The patient was not pregnant. Medical history included Diabetic type 2, HBP (high blood pressure), Depression. Not aware of known allergies. Concomitant medications received in two weeks included losartan 50mg, escitalopram 10mg. The patient didn't received any other vaccine in four weeks. Historical vaccine included first dose (at the age 52 years) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249) on Left arm on 13Jan2021 19:00 at single dose for covid-19 immunisation. The patient experienced fatigue, headache, feeling off, left arm swollen-pain, light body ache, discomfort on 03Feb2021 at 19:00. No covid prior vaccination. Covid wasn't tested post vaccination. No treatment was received for events. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
52 2021-03-21 itchy rash, rash, rash with redness, rash papular I woke up the morning after the first shot and noticed my entire torso, back and inner arms had a re... Read more
I woke up the morning after the first shot and noticed my entire torso, back and inner arms had a red rash. It proceeded to get worse by becoming more red, raised and itchy as well as spread down my legs to my knees within 2 days. It did cover most of my body from my neck to my knees. I treated with OTC antihistamines - Claritin in the morning which didn't really have any effect it seemed but I took Benadryl before going to sleep at night beginning on Sunday through Thursday which did give me relief from the itching and by Tuesday the rash was fading and continued to lessen throughout the rest of the week. The rash began to fade in the order it appeared with my legs last. I did not experience other symptoms besides the severe external rash and itching.
52 2021-03-21 itchy skin, skin warm, redness warm and itchy toes, look like chillblains, swollen, tender, red, and looking like burst blood vesse... Read more
warm and itchy toes, look like chillblains, swollen, tender, red, and looking like burst blood vessels on 2 toes on one foot, and one toe on the other foot, started on 16 or 17th, March, still visible on March 22 - used some home made remedies and some triamcinolone, acetonide cream 0.1 % for the inflammation
52 2021-03-22 skin warm, itchy skin, rash I had second shot on Frdiay, March 19. I experienced headache and low fever around 100F next day. I ... Read more
I had second shot on Frdiay, March 19. I experienced headache and low fever around 100F next day. I took 2 advil and symtons were gone. I felt Okay on Sunday March 21 and took a walk around 30 mins afternoon wearing short sleeve t shirt. I woke up with itchy and rash on both my arms on Monday March 22 morning. Rash appeared on both arms with a clear line where short sleeves are. Looks like a sunburn but with itchy and warm skin. Temperature was below 70F when I took a walk. Rash was getting light but still itchy often. I did not call doctor office or took any medicine for this. I took some photos for this and please let me know if you need these photos.
52 2021-03-22 redness Patient received vaccine at 12:30 pm. Patient started developing redness on face, arm, torso, and ba... Read more
Patient received vaccine at 12:30 pm. Patient started developing redness on face, arm, torso, and back at 12:41 pm and given Benadryl 25 mg x 1 Dose. Patient started developing tingling lips at 12:50 pm and received EpiPen 0.3 mg x 1 dose and EMS was called. Blood pressure at 122/89 at 12:55 pm; 142/87 at 12:58 pm. Patient was taken to hospital for evaluation.
52 2021-03-22 rash Patient states she had a rash on chest, palms on hands and stomach. She had swelling in the hands. S... Read more
Patient states she had a rash on chest, palms on hands and stomach. She had swelling in the hands. She said it started the day after receiving the vaccine.
52 2021-03-22 injection site pain Soreness at injection site, mild fatigue, headache, soreness in eyes
52 2021-03-22 injection site pain, injection site numbness the tech gave me a shot the pain was so intense and gave bad pain down my arm and have numbness in ... Read more
the tech gave me a shot the pain was so intense and gave bad pain down my arm and have numbness in my fingers. EMS at the site advised me to watch for potential hematoma and to go home and take tynelol and call primary physcian, Few hours passed pain persisted went to see a doctor she examined my arm and stated it is very possible that the she hit a nerve in my arm. She advised me to report this and to go back to the facility to report to supervisor. I went back to facility they advised to report on line and eventually it will feel better.
52 2021-03-23 skin warm, injection site rash, injection site swelling, injection site mass, injection site hardening Arm at injection site and lymph node swelled to approximately 2 inches round the following morning w... Read more
Arm at injection site and lymph node swelled to approximately 2 inches round the following morning when I woke up. The arm is hot to the touch. Both places were extremely painful (especially the lymph node). The lymph node finally went down after 3 days. However, the lump at injection site is still large and now it's hard and it has the area has expanded to a "Covid Arm" rash, which covers my the majority of my upper arm. I was symptomatic with chills, aches for the first two days and the lump/lymph node issue is still happening and it's been 5 days.
52 2021-03-23 itchy skin, redness Had vaccination shot #2 in right deltoid. Went to the observation area for the 15 minute period. Aft... Read more
Had vaccination shot #2 in right deltoid. Went to the observation area for the 15 minute period. After approximately 7 minutes, I felt my throat "swelling." I got up and went to the RN who administered shot. They called the RN over. Vital signs were stable, airway intact, able to speak full sentences. No shortness of breath. It took more effort to swallow. Right arm sore. They monitored me for another 15 minutes. No worsening symptoms. Swelling not improving. Recommended going to the ER (I'm an RN and this was administered at my hospital). Was escorted to ER. Hooked up to monitor. Slight redness noticed on both arms. No hives. IV started. Given IV Benadryl, famotidine, solu-medrol. No improvement. Hooked up to a monitor and given epi sub-Q. Monitored for approximately 60 minutes with improvement of throat swelling. Discharged to home with prescription for prednisone, famotidine and Benadryl x 5 days. At home, approximately 8 hours after shot, work up feeling itchy, took Benadryl PO with relief of symptoms approximately 45 minutes later. Followed up with MD on 1/21. No change in medications. Asymptomatic during the course of medications. Finished course of medications on the morning of 1/23. Later that evening started feeling tired, had chills, swollen glands. Went to bed early. On 1/24 symptoms continued including lack of appetite, increased fatigue, brain fog. Symptoms continued until 1/25 and gradually improved over the week.
52 2021-03-23 hives Patient developed urticaria days 5-7 post vaccination. Day 7-10 developed angioedema tongue- not in... Read more
Patient developed urticaria days 5-7 post vaccination. Day 7-10 developed angioedema tongue- not involving lips.
52 2021-03-24 rash Flushing face, heavy tongue, light rash left arm, stomach irritation (nausea).Patient developed a re... Read more
Flushing face, heavy tongue, light rash left arm, stomach irritation (nausea).Patient developed a reaction to COVID-19 vaccine 5 min. after injection administration flushing face, heavy tongue and light rash and nausea were the symptoms showed up by patient. V/S BP 198/886, P-63, Sat. 99%. Patient transferred to Hospital to get medical care and be under observation.
52 2021-03-24 hives I felt my throat closing up, making it more and more difficult to swallow or breathe; my throat felt... Read more
I felt my throat closing up, making it more and more difficult to swallow or breathe; my throat felt like a mild cold; more difficult to swallow; difficult to swallow or breathe; hives on my neck; swollen face and neck; swollen face and neck; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 12:00 (Batch/Lot Number: EN 620H) as single dose for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient previously took polio vaccine for immunization and experienced allergy, nickel and experienced allergy, chloroxylenol and experienced allergy, cetirizine hydrochloride (ZYRTEC) and experienced allergy, clarithromycin (CLARITIN) and experienced swelling face. The patient stated that, "After the vaccine was administered (18Mar2021 12:00) my throat felt like a mild cold making it a little more difficult to swallow. As I was sent to the high risk area I was monitored by a nurse. Upon leaving I got into my car that was warm inside. As I was driving I felt my throat closing up, making it more and more difficult to swallow or breathe. I went to a (store) and spoke to the pharmacist there. She advised me to take Benadryl immediately. She noticed hives on my neck and a swollen face and neck. As Benadryl took effect the hives receaded and the swelling of my face and neck went down. I went back to the vaccination site and seemed medical attention from the (Department name) Department team. They checked my vital signs and released me after a waiting period without any further medication being administered. I was given an appointment for 08Apr2021. I am concerned about an adverse reaction at the second appointment. Is it better to wait a little longer for the second dose to be given?" Patient is not pregnant. Therapeutic measures were taken as a result of the events included Benadryl. Outcome of the events was resolving.
52 2021-03-24 redness, itchy skin Patient is experiencing redness, swelling and severe itching. The itching started 3/24/21 and was m... Read more
Patient is experiencing redness, swelling and severe itching. The itching started 3/24/21 and was mild, but patient stated it has progressively gotten worse.
52 2021-03-24 hives, itchy skin Sore arm the night of the vaccination, Hives developed 2 days after vaccinated. Hives spread all ove... Read more
Sore arm the night of the vaccination, Hives developed 2 days after vaccinated. Hives spread all over body. Very itchy. Hives stays more than 1 week after the vaccine.
52 2021-03-24 itchy rash itchy-redness on arms, throat clear, allergic to ASA only= anaphylaxis history, positive NSAIDs, neg... Read more
itchy-redness on arms, throat clear, allergic to ASA only= anaphylaxis history, positive NSAIDs, negative dysphagia, negative airway or oropharynx component, admin 50 mg benadryl PO 12:45, admin famotidine 20 mg PO 1300, BP 130/80; HR 98; O2 sat 98% R.A., pharmacist monitored over time, pharmacist gave PO meds for home zyrtec and famotidine
52 2021-03-25 itchy skin, rash Immediately after receiving the vaccine I felt A rush in my body and my heart started beating faster... Read more
Immediately after receiving the vaccine I felt A rush in my body and my heart started beating faster and my lips began to tingle. The nurse gave me 25 mg of Benadryl and I also am experiencing itching all over my body.
52 2021-03-25 injection site mass, injection site pruritus Itching and hard lump at injection site
52 2021-03-25 injection site pain Left armpit sore and swollen. Left back side of neck sore and hurt to turn head. This lasted about... Read more
Left armpit sore and swollen. Left back side of neck sore and hurt to turn head. This lasted about 3-4 days. I can't take any Tylenol or IBUprofen, so I just used a heating pad on them a lot. Left elbow hurt to bend as well.
52 2021-03-25 itchy skin My mother had a really bad itchy sensation all over her arms and body in the middle of the night. Sh... Read more
My mother had a really bad itchy sensation all over her arms and body in the middle of the night. She woke up from her sleep and used lotion to try to calm her body down. She didn't tell me until the next day, but she couldn't sleep that night. Her left arm that received the vaccine was also very sore for her all day and it still is the next day. She doesn't feel the itchy sensation anymore though.
52 2021-03-25 rash papular, rash with redness, rash Raised red rash on chest and anaphylactic symptoms
52 2021-03-25 injection site pain Severe muscle pain at injection site at 630pm. By 10pm my body started to ache from neck, shoulders,... Read more
Severe muscle pain at injection site at 630pm. By 10pm my body started to ache from neck, shoulders, body down to legs. Severe chills with shivering for almost 2 hours. Low grade fever 99. Could not walk or stand. Took tylenol at 11pm with little effect, then again at 330am due to chills, muscle aches n spasms in legs, slight headache, very tired and miserable feeling. Slept and woke up at 8am sweating under blankets and feeling less sore muscles. Hydrated with water, and by 9am just feeling tired. Soreness of injection site gone as well as body aches. Just fatigue feeling. Will still go to work on 3-26-2021 after thinking there was no way I can move my body. Not feeling 100% at 943am but much better than earlier flu type feeling.
52 2021-03-25 hives, itchy skin Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: HIVES -Mild, Additional... Read more
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: HIVES -Mild, Additional Details: SOME HIVES ON RIGHT LITTLE FINGER AND WRIST, LEFT WRIST AND HAND, ALSO BACK
52 2021-03-26 rash, itchy rash First two days after the vaccine extremely dry mouth. Then progressively increasing rash on right pa... Read more
First two days after the vaccine extremely dry mouth. Then progressively increasing rash on right palm - Itchy and dry to the point of not able to sleep. On some days itchy tongue too. Going to see a doctor on March 30th.
52 2021-03-26 injection site reaction, injection site pain Muscle pain in injected arm. Severe difficulty in moving injected arm, and tiredness lasted 2 days.... Read more
Muscle pain in injected arm. Severe difficulty in moving injected arm, and tiredness lasted 2 days. Was unable to work or do other tasks for 2 days. Slight pain in injection site, lasted a week.
52 2021-03-26 itchy skin Vaccine given , symptoms started 1150 am, Itching, rash, lips "like bee stings", chest pressure, thr... Read more
Vaccine given , symptoms started 1150 am, Itching, rash, lips "like bee stings", chest pressure, throat scratchy. 10 minutes after vaccine administered. Benadryl 50mg and Epineprhine pen 0.3ml. Symptoms continued until EMS picked her up at 1231pm
52 2021-03-27 redness Approximately 10 minutes following vaccine, experienced L shoulder swelling (surrounding vaccine si... Read more
Approximately 10 minutes following vaccine, experienced L shoulder swelling (surrounding vaccine site) and swelling and pustular rash and swelling with redness of L hand
52 2021-03-28 injection site pain, blister Site: Pain at Injection Site-Mild, Systemic: Patient reports painful blisters breaking out on face-M... Read more
Site: Pain at Injection Site-Mild, Systemic: Patient reports painful blisters breaking out on face-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild
52 2021-03-28 redness medium size red circle on arm-- with lump. Lump grape size/circle bigger than a plum. Tender to to... Read more
medium size red circle on arm-- with lump. Lump grape size/circle bigger than a plum. Tender to touch. No itchiness
52 2021-03-30 vaccination site rash, vaccination site swelling Fever over 100; Injection site rash and swelling; Injection site rash and swelling; Severe headache;... Read more
Fever over 100; Injection site rash and swelling; Injection site rash and swelling; Severe headache; Lower body jont pain; This is a spontaneous report from a contactable Other Health Professional, the patient. A 52-year-old non-pregnant female patient, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EL 3248), via an unspecified route of administration in the left arm on 26Jan2021 at 02:00 PM (at the age of 52-years-old) as a single dose for covid-19 immunisation. Medical history included gadolinium contrast (allergies to medications, food, or other products). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date for COVID-19 immunization. On 27Jan2021 at 05:30 AM the patient exepreienced fever over 100, severe headache, lower body joint pain, injection site rash and swelling. The event were assessed as non-serious by the reporter. No treatment was received for the events. Outcome of the events were recovering.
52 2021-03-31 rash pinprick blood rash all over/ diagnosed as immune thrombocytopenia; rash on chest and neck; fever; c... Read more
pinprick blood rash all over/ diagnosed as immune thrombocytopenia; rash on chest and neck; fever; chills; headache; body ache; joint pain; fatigue; nausea; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female (not pregnant) received the first dose (dose number 1) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6202) via an unspecified route of administration in the left arm on 15Mar2021 08:15 AM at a single dose or COVID-19 immunization. Medical history included Hashimoto's disease, pulmonary hypertension, obstructive sleep apnea, dermatomyositis. Concomitant medication(s) included escitalopram; tramadol; levothyroxine; all from Mar2021 (received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had allergy to morphine. The patient was seen in the Emergency Room at a hospital on 20Mar2021 for pinprick blood rash all over the body on 16Mar2021; a doctor diagnosed it as immune thrombocytopenia from the Covid vaccine received 5 days earlier. On 16Mar2021, she had also been experiencing rash on chest and neck, fever, chills, headache, body ache, joint pain, fatigue, nausea for the past 5 days. The adverse event(s) result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the events included prednisone. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.
52 2021-04-02 vaccination site swelling She had an allergic reaction; swelling underneath her arm in the lymph node; Injection site swelling... Read more
She had an allergic reaction; swelling underneath her arm in the lymph node; Injection site swelling; This is a spontaneous report from a contactable consumer (Patient). A 52-years-old female patient received the second dose Pfizer BioNtech COVID 19 vaccine (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number EN6201), Injected in left arm unsure if given in muscle, on 09Feb2021 15:17 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. First dose of Pfizer COVID 19 vaccine given on 19Jan2021, Lot EL3247, injected on left arm and unable to confirm if intramuscular. Patient reported that after COVID 19 vaccine second shot she had an allergic reaction and got it done late afternoon on Tuesday. The lymph node under he left arm pit is completely swollen and has been since yesterday early Wednesday (10Feb2021) morning around 04:30. The injection site also swelled up immediately (09Feb2021 15:17). She had all the other stuff too, but she is only concerned about these two. The outcome of the event swelling underneath her arm in the lymph node was not recovered, event Injection site swelling was recovering. and the outcome of the event hypersensitivity was recovered. No further details provided.
52 2021-04-09 redness got extremely weak, very weak in the shower and didn't know if she will be able to keep standing up;... Read more
got extremely weak, very weak in the shower and didn't know if she will be able to keep standing up; chest pain in my right side; my left leg started aching; my toes tingle like they have fallen asleep on that left side; heart was beating faster than what it should have been, they said she was tachycardic and her heart was racing; heart was beating faster than what it should have been, they said she was tachycardic and her heart was racing; Redness; back was all red, really red; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 01Apr2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer reporting for herself. This 52 years old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EP7533) on 31Mar2021 at 09:30, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient received the vaccine on 31Mar2021 at 9:30 and was fine all day until 7 o'clock at night. She went to take her shower and got extremely weak, very weak in the shower and didn't know if she will be able to keep standing up, so she got out of the shower, went upstairs; the weakness persisted and then she started feeling chest pain in her right side, her left leg started aching and her toes tingled like they had fallen asleep on that left side so she got scared and went to the emergency room where they kept her overnight. Her heart was beating faster than what it should have been, they said she was tachycardic and her heart was racing and that was why they kept her at the hospital. She also had redness, her back was all red, really red. They did lots of lab work and blood work, a stress test, an ultrasound on her left leg for blood clot and a CAT scan on her heart, all with unknown results. When probed about hospitalization, she stated to stay overnight. She was hospitalized on 31May2021 at about 19:30 and did not get out until 13:30 on 01Apr2021. Events outcome was unknown.
52 2021-04-15 rash Days 1-2; Extreme fatigue and chills. Day 3: Felt well. Starting on Day 4: Extreme Exhaustion, musc... Read more
Days 1-2; Extreme fatigue and chills. Day 3: Felt well. Starting on Day 4: Extreme Exhaustion, muscle weakness, extreme post-exertional malaise, headache, rash on left cheek, cognitive problems (word-finding difficulty). Symptoms severe for a month, and slow improvement. I'm 2 months out and am at less than 50% of previous activity level. Muscle weakness (especially legs), moderate fatigue, and worsening fatigue after even mild exertion persists. I have had ME/CFS for 25 years, but it was mild/moderate have been at a great functioning level for over 10 years, able to exercise, easily perform ADLS. No problems with muscle weakness, etc.
52 2021-04-17 bruising Blood was coming out both nostrils and down throat and could not be stopped without intervention; we... Read more
Blood was coming out both nostrils and down throat and could not be stopped without intervention; went to emergency room with gushing bloody nose that would stop. Blood was coming out both nostrils and down throat and could not be stopped without intervention; Bruising also noticed on arm and leg; This is a spontaneous report from a contactable HCP (patient). A 52-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 25Mar2021 12:00 (Lot Number: EP7534) as SINGLE DOSE for covid-19 immunisation. Medical history included Allergic to penicillin (body rash). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medication(s) included fexofenadine hydrochloride (ALLEGRA) for Allergy pills and multi-vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took bnt162b2 dose 1 in arm left on 04Mar2021 (lot number: EN6198) for covid-19 immunization. The patient experienced blood was coming out both nostrils and down throat and could not be stopped without intervention, went to emergency room with gushing bloody nose that would stop, bruising also noticed on arm and leg on 30Mar2021 16:00. Reported as: On Tuesday 30Mar2021 went to emergency room with gushing bloody nose that would stop. Blood was coming out both nostrils and down throat and could not be stopped without intervention. Bruising also noticed on arm and leg. Bleeding resumed after returning home from ER, used Afrin to stop (Afrin up both nostrils). Now stabilize. The adverse event result in Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are needed. No further information is expected; Sender's Comments: The events "blood was coming out both nostrils and down throat" most likely represent intercurrent medical conditions that are assessed as unrelated to BNT162B2. The case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
52 2021-04-18 bruising 52-year-old woman with no significant past medical history who presented with bruising on her upper ... Read more
52-year-old woman with no significant past medical history who presented with bruising on her upper and lower extremities - non traumatic. Was found to have platelet count of 3000. Was admitted and transfused 1 unit of platelets. She was reporting chest pain but Chest CT angio negative for pulm embolism. Leg US neg for DVT. Post transfusion counts increased to 55K but slowly drifted down to 24K. She was given pulse dexamethasone. Count 30 K on discharge.
52 2021-04-19 bruising I received Pfizer dose 1 on 3/17/21 I received Pfizer dose 2 on 4/7/21 The following weekend (4/10 o... Read more
I received Pfizer dose 1 on 3/17/21 I received Pfizer dose 2 on 4/7/21 The following weekend (4/10 or 4/11) bruises began appearing on my legs. A very large round shaped swollen bruise appeared on my forearm. I work in an elementary school and our school nurse noticed the bruise on my arm and asked how it happened. I told her it just appeared and that I had them on my legs too. She looked at them and told me I needed to get in touch with my doctor ASAP. He sent me for blood work Thursday morningat 7:00 am on 4/15/21. At 4:30 pm that same day I received a call from my PCP office telling me to get to the ER because my platelet level was dangerously low and I was a risk for brain bleed. Got to the ER and my platelets were at 3,000. I received a platelet transfusion and platelets went to 55,000. Next day they were down to 46,000. Next day down to 24,000. Steroids started and Sunday my count was at 30, 000 and they let me go. Got blood work done today to see where I stand.
52 2021-04-22 itchy skin, hives pruritus urticaria began 4 days after 2nd Covid vaccine
52 2021-04-23 vaccination site pain All of the joints in both arms ached/the joints in my left arm are sore; my left hip aches; As the e... Read more
All of the joints in both arms ached/the joints in my left arm are sore; my left hip aches; As the evening progressed the throbbing pain spread across my pectorals, up to my chin, and all the way to my other arm; As the evening progressed the throbbing pain spread across my pectorals, up to my chin, and all the way to my other arm; As the evening progressed the throbbing pain spread across my pectorals, up to my chin, and all the way to my other arm; vaccine site started being sore; This is a spontaneous report from a contactable consumer/ Non-HCP (patient). This 52-year-old non-pregnant female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported) via unknown route of administration, in the left arm, on 12Feb2021at 09:30 AM (age at the time of vaccination 52 years), at single dose for COVID-19 immunisation in the hospital. Patient's medical history included hypothyroidism, irritable bowel syndrome, primary hypertension, seasonal affective depression and flu. Patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported) via unknown route of administration, in left arm on 22Jan2021 at 09:30 AM (age at the time of vaccination 52 years), at single dose for COVID-19 immunisation in the hospital. The patient had no allergies with medications, food or other products. Concomitant medications in two weeks included levothyroxine sodium(thyroxine), sertraline, hyoscyamine and lisinopril. On 12Feb2021, the patient was a little sore that day, but not the next, vaccine site started being sore. On 14Feb2021 patient spent an hour shoveling snow in the morning, but wasn't sore afterwards. On 14Feb2021 (8 plus hours after shoveling snow), the vaccine site started being sore, but the pain was on again/off again. As the evening progressed the throbbing pain spread across my pectorals, up to my chin, and all the way to my other arm. All of the joints in both arms ached, 600 mg ibuprofen didn't seem to help. On 15Feb2021(Morning), the injection site is a little sore, the joints in her left arm are sore, and, weirdly, her left hip aches. The throbbing pain last night wasn't like any over-used muscle soreness I've ever experienced and the joint aching was also unlike anything I've experienced outside of when I've had the flu. Patient did not receive other vaccines within 4 weeks or prior vaccination. No COVID-19 prior the vaccination and no COVID-19 test was done post vaccination. Patient's treatment medication included ibuprofen. Outcome of the events were recovering. Information on the lot/batch number has been requested.
52 2021-04-27 hives This is a spontaneous report from a contactable consumer (patient). A 52-year-old female non-pregnan... Read more
This is a spontaneous report from a contactable consumer (patient). A 52-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm right on 19Mar2021 09:45 (batch/lot number EN6204 and expiry date not reported) at 52 years of age as single dose for covid-19 immunization in a hospital facility. Medical history included rheumatoid arthritis, ovarian cancer and had 6 chemo treatments, Sjogren's disease, obesity. The patient had no Covid prior vaccination. Concomitant medications included meloxicam (MOBIC); venlafaxine hydrochloride (EFFEXOR); hydroxychloroquine phosphate (PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]); pantoprazole; biotin; fish oil (OMEGA 3 [FISH OIL]); all taken for an unspecified indication, start and stop date were not reported. The patient previously took Remicade, Mucinex DM and fast acting cortisol shot; all experienced allergies. The patient had no other vaccine in four weeks. The patient informed that on 19Mar2021 16:30, her rheumatoid arthritis started acting up; it started in her right shoulder and spread to almost all her joints, every joint hurt except her back, neck, and jaw; then her bones started hurting, the patient informed that she had 6 chemo treatments and it felt just like a chemo treatment, hurting deep inside the bone marrow; she also had swelling in some of the muscles that were affected with rheumatoid arthritis; she felt lethargic and tired; she also had a welt at the injection site, it was 2 inches wide and wrapped halfway around her arm. The patient took all weekend for it to go down. The patient informed that it lasted till Sunday night (unspecified date). The patient was not Covid tested post vaccination. The patient received no treatment for the events. The outcome of the events was recovered.
52 2021-04-27 injection site pain tingling on fingers, pain experienced at injection site, dizziness
52 2021-04-30 rash macular big bump on arm; rash/red blotch on arm; nose bleed, blood clots coming out of nose; nose bleed, blo... Read more
big bump on arm; rash/red blotch on arm; nose bleed, blood clots coming out of nose; nose bleed, blood clots coming out of nose; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm on 05Apr2021 (Batch/Lot Number: EW0151) as single dose, for covid-19 immunization. Medical history included ongoing sjogren's syndrome and ongoing lupus. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. 07Apr2021, she started having a nose bleed. She explains she wasn't doing anything in particular, just talking on the phone, and blood just started pouring out of her nose. Blood clots started coming out as well. She ended up calling 911 and they sent an ambulance. The EMS helped her stop the bleeding. She didn't go to the ER or anything. However, she is getting implants done for her upper teeth so she wanted to double check and make sure nothing was pressing against her nasal cavity because the nose bleeds were so off/random. The doctor said there was no pushing. The doctor completed a panoramic exam/x-ray and confirmed there was nothing pushing. The doctor did suggest she go to the ENT. She made an appointment with an ENT doctor for the following day, 08Apr2021, and the ENT put a camera down. She confirms she explained to them she just had the vaccine and she was googling information. She was told to not google anything and to let them check it out. The caller states she explained to the ENT the reason she was there was because she was concerned, she is not a nose bleeder and nose bleeds never happened to her. Once blood clots started coming out that way, she was terrified. They didn't see anything alarming, but they wanted to make sure and do further research, so basically they planned to do a CT/CAT scan. She was scheduled for a CT/CAT scan on Monday, 12Apr2021, but she was allergic to the contrast and was sent home because they were not prepared for pre-medication. She is waiting for the doctor to schedule another appointment so she can go back. She felt she needed to report these nose bleeds because she has been seeing Johnson & Johnson had severe blood clots, but she took Pfizer's vaccine, and was also getting blood clots. Her nose bleeds just happened right after both vaccines. On an unspecified date, she had a little bump that went away. She had this big bump on her arm and a big rash developed. At first, the bump was the size of a quarter and then grew double in size. The bump finally went down, but the rash she can still see. The rash hasn't grown, it's just there- there is just a red blotch on her arm. She has not had another nose bleed since the one that occurred on 07Apr2021. She just noticed when she had her first dose on 15Mar2021, the nose bleed happened within that week also. The outcome of events was unknown.
52 2021-05-11 cellulitis had an allergic reaction to it; cellulitis of left upper extremity; Panniculitis; Persisting pain; P... Read more
had an allergic reaction to it; cellulitis of left upper extremity; Panniculitis; Persisting pain; Pain in arm; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 52-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, on 09Apr2021 (Lot# EW0162), at single dose, for COVID-19 immunisation. Medical history included rheumatoid arthritis, blood pressure. Concomitant medication included unknown blood pressure medicine. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) on 19Mar2021 at 09:15 (Lot# ER2613) for COVID-19 immunisation with no adverse effect. The patient had an allergic reaction to the 2nd dose of the vaccine. She stated that it burned her skin, her skin came off, skin was burning and i red. She was burning on left arm/extremities burning sensation of. It opened up and made a wound. It spread from her inner arm gone on the top of her breast, it was warm to the touch, it was burning in the inside of her. She had redness that turned into bruising. She could see a red circle and a red circle going down her arm getting bigger and redder. There were bruise marks like a map on her arm. The symptoms were spreading more on her body, and it was redder and warmer to touch. The bottom of her arm where the muscle would be at like the bicep or whatever part this is, was burning to move her arm and just burning. Her arm was on fire. Looking at her chest where her armpit is going to the top of her shoulder there was a red big spot. There were 5 big spots that came overnight going down her right breast. It was red, like a burgundy bruise. It was a burning hot sensation and was hurting inside, not outside. It was burning on the inside, and that was what was making burns come on outside of the skin. While she was in the hospital they diagnosed cellulitis of the left upper extremity. A neurologist thought she had panniculitis on left arm. The doctors thought it was an infection. The events required emergency room visit and physician office visit such as personal care physician, a wound doctor, dermatologist, neurologist, allergist, epidemiologist and an infectious disease doctor. Therapeutic measures were taken as a result of the events and included treatment with Levaquin 750 mg oral, Vancomycin, steroids, sildersulsadiazine cream, Clobetasol Propionate cream, Silvadene, Polysporin (lot# 1480Z, Exp date 20Apr2022) or Bacitracin, ice, Curad things for her dressing. During hospitalization the patient underwent lab tests and procedures which included blood work, X-ray, ultrasound all with unknown results. The patient was hospitalized from 13Apr2021 to 20Apr2021 for drug hypersensitivity, skin burning sensation, erythema, skin exfoliation, burning sensation, contusion, wound. Outcome of all events was unknown except for erythema , burning sensation and contusion which was not recovered.
53 2021-01-03 redness After got vaccinated, I walked out of the clinic to monitoring area approximately 15 walking steps, ... Read more
After got vaccinated, I walked out of the clinic to monitoring area approximately 15 walking steps, I felt a little off balance but I was able to make to the chair and sat down. Few seconds later, my heart beat increased faster and faster, my neck turned red. I called for help, they gave me some apple juice to drink and talked to me. About 5 minutes later, my heart beat went back to normal rate and my redness turned back to normal skin color. I only had a little vertigo symptom but I was able to manage myself. About 2 hours later, symptoms disappeared and I was back to my normal health
53 2021-01-03 itchy skin Employee reports to this writer that within 2 minutes of vaccine recieved she experienced dizziness,... Read more
Employee reports to this writer that within 2 minutes of vaccine recieved she experienced dizziness, felt presyncopal,, facial flushing, throat pressure, had elevated BP, itchy cheeks, nausea, chest pressure. Went to ER where they treated her like she had an anxiety attack. No epi given. Patient consulted with her own private ENT?allergist Dr. the next day who states it sounded like a reaction and prescribed Xyzal
53 2021-01-03 rash papular, injection site pain, injection site reaction I developed a raised rash on my left arm at injection site , had chills and nausea and lots of tende... Read more
I developed a raised rash on my left arm at injection site , had chills and nausea and lots of tenderness at injection site at 3 am (1/1/21) following injection. The nausea had resolved when I woke up, the rash subsided throughout the day as did the chills. The most distressing event began on 1/1/2021 , that being sneezing, runny nose and watery eyes which continued and got much worse over the next two days, despite taking sudafed as often as possible. No other cold or flu symptoms were present and it felt like allergies although I have never had any sort of seasonal allergies. I finally took Zyrtec for it the evening of 1/3/21 and the symptoms stopped. Congestion, light sensitivity remain. I am reluctant to take another dose due to drowsiness side effect. Hoping symptoms will all be gone by tomorrow.
53 2021-01-03 rash Pateint recieved COVID19 (Pfizer-BioNTech) vaccine on 12/30/2020 and statrted to develop a rash on h... Read more
Pateint recieved COVID19 (Pfizer-BioNTech) vaccine on 12/30/2020 and statrted to develop a rash on hands and sole of her feet onsetting 01/01/2021. Per patient, she took OTC allergy medication and applied OTC Cortizone onto hands and feet. Pateint denies sypmptomes of headcaches, fever, diarrhea, or nausea.
53 2021-01-04 injection site pain Immediately after receiving vaccine, she felt pain in her left deltoid, followed by a spasm in her l... Read more
Immediately after receiving vaccine, she felt pain in her left deltoid, followed by a spasm in her left trapezius, and headache. She experienced a warm sensation travelling down her left arm. She described a feeling of muscle spasms in her left upper and lower extremity and was unable to bear weight on her left lower extremity due to the altered sensation. She endorsed acute nausea and vomiting. She was transferred from vaccine clinic to emergency department at 1420. Patient received diphenydramine 12.5mg IV @ 1722, prochlorperazine 10mg IV @1733, Lactated Ringers 250mL IV bolus @ 1733, ondansetron ODT 4mg @1445. Patient was diagnosed with an acute anxiety attack in the setting of a novel vaccine administration. She was discharged at 1854.
53 2021-01-04 rash, itchy rash On 12/28 started with itchy rash on left side of body. Arm, hand, leg, foot. Then started on lips ... Read more
On 12/28 started with itchy rash on left side of body. Arm, hand, leg, foot. Then started on lips and inside mouth. Did go to left arm. Started on prednisone 12/31 prescribed by my PCP. Using pepcid and Zyrtec as well as benadryl cream. Have completed 5 days of 30mg prednisone and 1 day of 20mg prednisone and rash remains. Continues to itch. Mouth is better but left side of body no better. Did have shot in left arm. Have changed nothing and no new food. Spoke to several doctors at the hospital that I work at and they are worried that it is from covid vaccine.
53 2021-01-04 vaccination site redness, vaccination site pain, vaccination site swelling Recurrence of redness, swelling, pain at injection site/Site reaction is identical to initial reacti... Read more
Recurrence of redness, swelling, pain at injection site/Site reaction is identical to initial reaction occurring on days 2 and 3; Recurrence of redness, swelling, pain at injection site/Site reaction is identical to initial reaction occurring on days 2 and 3; Recurrence of redness, swelling, pain at injection site/Site reaction is identical to initial reaction occurring on days 2 and 3; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration in the right arm on 19Dec2020 at 10:15 AM in a hospital at a single dose for COVID-19 immunization. Medical history included asthma and GERD. The patient was not pregnant at the time of vaccination and had no known allergies. The patient had no other vaccine in four weeks, had no COVID-19 diagnosis prior to vaccination, and was not tested for COVID-19 post vaccination. Concomitant medication included omeprazole (PRILOSEC). On 27Dec2020 at 18:00, the patient experienced a recurrence of redness, swelling, and pain at injection site measuring 5.5 cm x 5.6 cm occurring on day 9 post injection. Site reaction was identical to the initial reaction occurring on days 2 and 3 of Dec2020, which resolved by day 4. The patient received no treatment for the events. Outcome of the events was not recovered/not resolved. Information about the lot/batch has been requested.
53 2021-01-04 rash The next day a rash appeared on my forearms and now is on my ankles, calves and scalp.; Severe heada... Read more
The next day a rash appeared on my forearms and now is on my ankles, calves and scalp.; Severe headache; chills; flu like symptoms; This is a spontaneous report from a contactable other healthcare professional (patient). A 53-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), intramuscularly at left arm on 18Dec2020 at 14:00 at single dose for covid-19 immunization at workplace clinic. Medical history included hypolipidaemia, allergic to sulfa drugs (hives), allergy to adhesive (severe skin blistering). There was non other vaccine in four weeks and no other medications in two weeks. The patient previously took naproxen (NAPROSYN) and amoxicillin clavulanic acid (AUGMENTIN ) and was allergic to both drugs, and experienced anaphylaxis for naproxen. The patient experienced severe headache, chills and flu like symptoms the night after the shot on 18Dec2020. The next day on 19Dec2020 at 10: 00 AM a rash appeared on her forearms and was on her ankles, calves and scalp at time of the report. No treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not resolved.
53 2021-01-04 rash Tingling lips Sore throat Burning in chest Rash Headache Neck stiffness SOB
53 2021-01-04 vaccination site pain fever; Diarrhea; headache; chills; feeling unwell; Joint pain; injection site pain; tiredness; This ... Read more
fever; Diarrhea; headache; chills; feeling unwell; Joint pain; injection site pain; tiredness; This is a spontaneous report from a contactable consumer. A 53-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot EK5730), intramuscular (Dose number 1, Arm left) on 23Dec2020, 13:45 at single dose for COVID-19 immunization. Medical history included diabetic, thyroidectomy, hysterectomy, tonsillectomy, and Known allergies: Sulfa. Concomitant medication included zolpidem, levothyroxine, and pantoprazole from unspecified dates for an unspecified indication. The patient experienced fever, diarrhea, headache, chills, feeling unwell, joint pain, injection site pain, and tiredness on 23Dec2020 13:45. No treatment for AE was given. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 since vaccination. Outcome of the events was not recovered. Events were reported as non-serious.
53 2021-01-04 hives urticaria on the chest and leg; This is a spontaneous report from a contactable physician (patient).... Read more
urticaria on the chest and leg; This is a spontaneous report from a contactable physician (patient). A 53-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 16Dec2020 21:00 at a single dose for COVID-19 immunization at the workplace clinic. Medical history included sulfa allergies. Concomitant medication included ibuprofen. The patient had not received other vaccine within 4 weeks prior to the COVID vaccine. The patient experienced urticaria on the chest and leg on 24Dec2020 20:00. Outcome of the event was not recovered; no treatment was given for the event. The patient was not diagnosed with COVID prior vaccination and has not been tested for COVID post vaccination. Information on the lot/batch number has been requested.
53 2021-01-05 injection site pain Chills, muscle/joint pain, headache, injection site pain, fever 103.9; Chills, muscle/joint pain, he... Read more
Chills, muscle/joint pain, headache, injection site pain, fever 103.9; Chills, muscle/joint pain, headache, injection site pain, fever 103.9; Chills, muscle/joint pain, headache, injection site pain, fever 103.9; Chills, muscle/joint pain, headache, injection site pain, fever 103.9; Chills, muscle/joint pain, headache, injection site pain, fever 103.9; Chills, muscle/joint pain, headache, injection site pain, fever 103.9; This is a spontaneous report from a contactable Nurse (Patient). A 53-years-old female patient (no pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Ej1685) , via an unspecified route of administration on 22Dec2020 11:00 at first single dose at arm left for covid-19 immunisation . Medical history included iodine allergy. Concomitant medication included fish oil. The patient experienced Chills, muscle/joint pain, headache, injection site pain, fever 103.9 on 22Dec2020 21:00. Therapeutic measures were taken as a result of events was Ibuprofen. The outcome of events was recovered with sequelae. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination
53 2021-01-05 injection site warmth, injection site redness, injection site pruritus, injection site swelling Woke in middle of night with chills fever and severe body aches that lasted until 2100 on 12/29/2020... Read more
Woke in middle of night with chills fever and severe body aches that lasted until 2100 on 12/29/2020. Arm at injections site red swollen, hot to touch and itchy.
53 2021-01-05 rash intense rash both arms, neck and upper torso. Treatment: steroid injection by provider, benadryl, Pe... Read more
intense rash both arms, neck and upper torso. Treatment: steroid injection by provider, benadryl, Pepcid Outcome: next morning symptoms gone.
53 2021-01-06 injection site reaction Approximately 2 hours after the vaccine she reported a "spot on her arm" where the vaccine had been ... Read more
Approximately 2 hours after the vaccine she reported a "spot on her arm" where the vaccine had been given, a headache and back ache. She did go to the chiropractor on 1/4, but states it did not help. She saw an allergy specialist on 1/5. As of 1/7/20 0830am she still had a headache.
53 2021-01-06 injection site redness, injection site pain, injection site swelling Injection site pain, tiredness, headache, chills, feverish (masked because of hot flashes), injectio... Read more
Injection site pain, tiredness, headache, chills, feverish (masked because of hot flashes), injection site swelling, injection site redness, nausea, swollen lymph nodes, sneezing, runny nose, dizziness and weakness, and slight chest pressure. Symptoms came and went but the palm sized redness and swelling at the injection site with extreme itching continues to this day. Used cold compresses, topical lotion for allergies, and Vaseline but nothing helped. Will try Benadryl.
53 2021-01-06 injection site bruising, injection site pain Very achy and tired the following day. very tender at injection site for three days following inject... Read more
Very achy and tired the following day. very tender at injection site for three days following injection. Bruising at injection site.
53 2021-01-07 redness, skin warm, rash Developed a fine rash across her forehead and chest. Cheeks were firey red and warm to the touch. ... Read more
Developed a fine rash across her forehead and chest. Cheeks were firey red and warm to the touch. Rash lasted a couple of days.
53 2021-01-07 itchy skin, rash macular, hives, redness Entered post-monitoring area at 1750, notified RN of prior itching and hives post first dose COVID-1... Read more
Entered post-monitoring area at 1750, notified RN of prior itching and hives post first dose COVID-19 vaccination. Reported that she had taken Benadryl 50mg PO after first vaccination. Pt reported today 1/7/20, she took medication prior to COVID-19 vaccination: Pepcid 40mg PO at 1626. Benadryl 25mg PO at 1626. 1810: pt c/o scalp itching, visible redness to itchy area on scalp. BP 158/84 (101), HR 82, regular rhythm, SpO2 97%, RR 18, Temp=97.5F 1812: 25mg Diphenhydramine HCL oral solution given PO for itching to scalp. 1818: BP 159/93 (108), HR 78, regular rhythm, SpO2 98%, RR 17, Temp =98 F 1822: Splotchy redness noted to pt's L lower arm, no itching. Redness noted to L upper chest with pt c/o itching to L upper chest area, R neck, nose and R toes itching. Pt denies difficulty breathing, swallowing. SpO2=98% 1830: BP 172/84 (105), HR 82, regular rhythm, SpO2 100%, RR 16, Temp=97.5 F Pt denies any new areas of itching, scalp, R toes, R neck and R chest area still itchy. No c/o difficulty swallowing or breathing. No throat clearing. 1837: pt notes improvement in scalp and nose itching. Redness to L arm and chest improved. 1845: BP 165/80 (102), HR 85, regular rhythm, RR 16, SpO2=99%, Temp =98.2 F Pt c/o itching again to R side of scalp with redness noted to scalp. 1850: 25mg Diphenhydramine HCL oral solution given PO for itching and redness to scalp. 1900: BP 153/87 (104), HR 85, regular rhythm, RR 12, SpO2=98%, Temp=97.6 F Pt reports mild scalp itching with some improvement since second dose of diphenhydramine. No other itching or redness noted. 1915: BP 171/86 (107), HR=80, regular rhythm, RR 12, SpO2=99%, Temp=97.4 F pt reports mild itching to L scalp and L chest, no significant redness noted. 1930: Pt denies worsening symptoms, no additional itching or redness. Gave pt discharge instructions to not exceed 100mg of Diphenhydramine in a 4 hour period. Recorded times and amounts of diphenhydramine given during post vaccine monitoring period. Pt denies feeling drowsy and is comfortable driving home. Directed patient to call emergency services from home with any worsening of rash or trouble breathing, feeling faint, or any other concerning symptoms. Pt's husband will be at home with pt, aware of additional monitoring needed post vaccine.
53 2021-01-07 itchy skin Felt severe itching pins needles on arms, wrists, chest & neck.
53 2021-01-07 vaccination site pain Headache; Sore arm; Swelling of the feet; This is a spontaneous report from a contactable consumer (... Read more
Headache; Sore arm; Swelling of the feet; This is a spontaneous report from a contactable consumer (patient herself). This 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 23Dec2020 at single dose for COVID-19 immunisation. She was working as a receptionist in a nursing home. Age at vaccination was 53-year-old. No relevant medical history and concomitant medications were provided. On unknown date after vaccination, the patient developed headache, sore arm, and swelling of the feet. The outcome of the events was unknown. Information on the lot/batch number has been requested.
53 2021-01-07 redness My arm is rather red and huge; It is just red and swollen and warm; My arm is rather red and huge; I... Read more
My arm is rather red and huge; It is just red and swollen and warm; My arm is rather red and huge; It is just red and swollen and warm; My arm is rather red and huge; It is just red and swollen and warm; This is a spontaneous from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELO140), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. Medical history included hypertension. Concomitant medication included lisinopril for hypertension. On an unknown date, her arm was rather red and huge almost looks like a, not a Hematoma but its about that big. She didn't feel bad otherwise. It was just red and swollen and warm. The outcome of the event was unknown.
53 2021-01-07 injection site redness, injection site pain, injection site swelling, injection site warmth Upper left arm at injection site red, swollen, warm and pain. Area swollen approximately 7cm.
53 2021-01-07 vaccination site pain felt really tired; sore arm/ arm was sore to touch and to lift it up/ hurt to touch; chills; fever; ... Read more
felt really tired; sore arm/ arm was sore to touch and to lift it up/ hurt to touch; chills; fever; body aches; snoring bad; freezing/ can't get warm; shaking; felt terrible; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the right arm on 28Dec2020 13:15 at a single dose for COVID-19 immunization. She has had the Coronavirus before and wanted to know if previously having the virus might make her side effects worse. She had COVID 19. She got her positive result on 06Aug2020. Her husband had it too. She knows what it is like. She didn't have to go to the hospital, but she had a severe enough case. She had the fever, dry cough, body aches, nausea, and poops. She has been getting body aches after having COVID really intense. She gets tired very easily. She had fibromyalgia was diagnosed more than 10 years ago and ongoing, before the year 2000; acid reflux was diagnosed five or six years ago; high blood pressure was diagnosed back in 2007; high cholesterol; wheezing for a couple of years and depression. The patient was also taking a water pill. Concomitant medication included omeprazole ongoing for acid reflux, hydrochlorothiazide (HYDROCHLOROTH, 25 mg) ongoing, losartan 100 mg ongoing, desvenlafaxine 75 mg ongoing for depression, montelukast 10 mg ongoing for wheezing, atorvastatin calcium ongoing for cholesterol. When asked for the lot number the patient said that she thinks it is EL1284 but it could possibly be ELI284. On 28Dec2020, the patient felt really tired, has a sore arm with chills, fever and body aches. The same day she got the vaccine she had felt fine. She came home and did a few things. She sat down for a minute and then it was like wham. She told her husband she was done. She went to sleep fast and slept for a couple of hours. She went to work the next morning and her arm was sore to touch and to lift it up. Sometimes when you get the flu shot it is like that too. She does not have any red marks where it was injected. She only knows where it was because it hurt to touch. She got really tired at work about 11:30AM. Her body started aching. She was being tested twice a week for Corona COVID. She had just been tested on 28Dec2020 morning before the vaccination and was negative. On an unspecified in Dec2020, she was freezing and shaking. She cannot get warm. It was like that for a couple of hours. Usually her temperature runs low. It was up to 100.1 degrees Fahrenheit which is high for her because she usually is on the lower end. She felt really ugh.The symptoms after the vaccine reminded her of when she had COVID. She had a low fever and body aches and felt terrible. Her boss wanted to know if she had the flu. The patient does not think so because it would be ironic the day after she gets the shot. She was assuming it was the side effects from this. She further clarified wham as that she was really tired and it came over her really quick. She sat in the chair and got a blanket. Her husband said she was snoring bad (28Dec2020). Two hours later the dogs woke her up and she thought it was the middle of the night. It wasn't it was early. On unspecified date in Dec2020, she had a bout and her body started aching. A day after, she does not feel that bad, does not have fever and her body was not aching. That night when she got home she could not sleep on her arm because it was sore. The next day was when it was hard to lift it. She had the injection in the right arm, which is the arm she uses. It was still sore to touch. She has fibromyalgia. She is not sure if that is why she is aching. She is not sure if that kicked it in high gear. The vaccine was administered in a Long Term Care Center. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The events did not result to emergency room nor physician visit. The outcome of the event fever and body aches recovered on an unspecified date in Dec2020; outcome for all other events was unknown. Information on the lot number has been requested.
53 2021-01-07 vaccination site pain mild pain at the injection site; tiredness; chills; headache; feeling unwell; This is a spontaneous ... Read more
mild pain at the injection site; tiredness; chills; headache; feeling unwell; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received bnt162b2 (BNT162B2; Pfizer-Biontech Covid-19 Vaccine also reported as vaccine A (Pfizer Ultracold); lot number: EH9899; expiration date: unknown), via an unspecified route of administration left arm on 22Dec2020 09:15 at a single dose for covid-19 vaccination. Medical history included anxiety and depression. The patient has no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had other medications received within 2 weeks of vaccination. The patient most recent COVID-19 vaccine was administered a hospital. It was reported that 7 hours after vaccination (22Dec2020 04:15 PM [reported as 04:00PM]), the patient experienced mild pain at the injection site, tiredness, chills, headache, and feeling unwell. All resolved within 12 hours after sleep (23Dec2020 04:15). The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The outcome of the events was recovered on 23Dec2020 04:15.
53 2021-01-07 vaccination site pain neck pain; fatigue; possible low grade fever; muscle ache; injection site pain; heart pounding and s... Read more
neck pain; fatigue; possible low grade fever; muscle ache; injection site pain; heart pounding and shakiness; heart pounding and shakiness; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection in the right arm on 29Dec2020 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included seasonal allergies and prior Covid diagnosis. Concomitant medications were unknown. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. On 30Dec2020 at 06:30, the patient experienced neck pain, fatigue, possible low grade fever, muscle ache, injection site pain within 16 hours of vaccination; heart pounding and shakiness within an hour of vaccination (29Dec2020 15:30). Treatment was provided for the events neck pain, fatigue, possible low grade fever, muscle ache, injection site pain, heart pounding and shakiness included acetaminophen (TYLENOL) and ibuprofen. The outcome of the events neck pain, fatigue, possible low grade fever, muscle ache, injection site pain, heart pounding and shakiness was recovered. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
53 2021-01-07 rash papular, rash no reaction or side effects at time of injection; then 5 days later on 1/4 developed red bump on rig... Read more
no reaction or side effects at time of injection; then 5 days later on 1/4 developed red bump on right forearm that progressed to rash on both forearms, upper legs and torso; no itching pain, swelling of diff breathing
53 2021-01-08 injection site swelling 1/6/21 - Started with a headache that night and then 1/7/21 had severe headache, swollen lymph nodes... Read more
1/6/21 - Started with a headache that night and then 1/7/21 had severe headache, swollen lymph nodes left inguinal, fever of 102.3F, diaphoresis, chills, flushed face, change of taste and baseball sized swelling to injection site.
53 2021-01-08 injection site pain Significant burning with admin of first shot. Approx 3.5 hours after shot I could not move my arm at... Read more
Significant burning with admin of first shot. Approx 3.5 hours after shot I could not move my arm at the shoulder. This was more than muscle soreness but being unfamiliar with Covid vaccine, I just rode it out. This lasted 2 days. Since then, my shoulder joint has not been the same with sl limited ROM and persistent pain. This improved signif over the 3 weeks until my 2nd Covid vaccine 1/7/21. This is what tipped me off that the first shot was not correct. #2 did not burn at all with administration or cause any limited ROM. Typical deltoid soreness sl more than a tetanus shot, and general "flu like sxs" that lasted < 24 hours.
53 2021-01-08 injection site pain, injection site swelling Swelling on my neck shoulder axillary and chest on same side as injection site along with swelling a... Read more
Swelling on my neck shoulder axillary and chest on same side as injection site along with swelling and pain at the injection site And under my arm. I have also had insomnia.
53 2021-01-09 injection site pain Multiple episodes of dizziness, coming and going. Arm hurt upon movement starting shortly after midn... Read more
Multiple episodes of dizziness, coming and going. Arm hurt upon movement starting shortly after midnight after received and still hurting, joint pain and headache began early AM 01/09/21. All have ended except pain at injection site and joints still achy.
53 2021-01-09 injection site pain Pain at injection site, fever, sweating and worsening headache
53 2021-01-10 rash (1) First vaccine - slight effects of Covid symptoms. (2) Second vaccine - Headache, slight fever (t... Read more
(1) First vaccine - slight effects of Covid symptoms. (2) Second vaccine - Headache, slight fever (took tyenol) -Sat am - swollen tongue when I woke up. Took benydril, swelling went down. tongue bled - (brush teeth, scrap tongue) -Sun - semi swollen tongue, rash lower abdomin. R am front area by under arm.
53 2021-01-10 injection site pain 1/8/21 AM headache over the eye, injection site sore arm; PM body aches, chills and shivering, fever... Read more
1/8/21 AM headache over the eye, injection site sore arm; PM body aches, chills and shivering, fever 107., joint pain --over the counter ibuprofen no relief, weakness in legs. 1/9/2021 body aches and fever resolved. Fatigue, weakness and joint pain, Tylenol --some relief. Swollen lymph nodes in left armpit and soreness; low back pain, shooting hip pain.
53 2021-01-10 injection site swelling, injection site warmth, injection site pain 5am on 1/7 woke up with chills, bodyaches, fever, lethargy and headache. Lasted through day, temper... Read more
5am on 1/7 woke up with chills, bodyaches, fever, lethargy and headache. Lasted through day, temperature up to 101.5. On 1/8, temperature resolved, still bodyaches. On 1/9, symptoms resolving, but at 12:00pm temperature of 99.9 and fatigue. On 1/10 right deltoid where vaccine was administered, sight is warm to touch and swollen, painful.
53 2021-01-10 injection site pain Body aches, chills, injection site soreness
53 2021-01-10 injection site swelling, injection site pain Low grade fever, HA, fatigue, pain and swelling at the injection site. Tylenol and Motrin with impr... Read more
Low grade fever, HA, fatigue, pain and swelling at the injection site. Tylenol and Motrin with improvement.
53 2021-01-10 rash, rash papular, hives, rash with redness, skin warm, redness Started as a red raised rash under my arms and my waistline; rash turned to hot to touch; raised red... Read more
Started as a red raised rash under my arms and my waistline; rash turned to hot to touch; raised red large hives all over my body including my face/head; numbness to my hands/feet/chest area; the SOB started; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EU9231), via an unspecified route of administration in the left arm on 30Dec2020 at 08:30 as a single dose for COVID-19 immunization. Medical history included hypothyroidism and chronic low back pain. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), baclofen (MANUFACTURER UNKNOWN), and etodolac (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took miconazole nitrate (MONISTAT) on unknown dates for an unknown indication and experienced drug allergy. On 31Dec2020 at 10:00, the patient started with a red raised rash under her arms and waistline and as the day progressed the rash turned hot to touch with raised red large hives all over her body including her face/head. By 23:00 on 31Dec2020, the patient had already taken 3 doses of diphenhydramine (BENADRYL) which was not effective. Then, later on 31Dec2020, shortness of breath started with numbness in the hands/feet/chest area. Her daughter took her to the emergency room. She was started on intravenous diphenhydramine, dexamethasone, and famotidine (PEPCID). The medications took time to work but they did resolve her shortness of breath and the hives subsided to mild redness. She was sent home and given the following medications to take: diphenhydramine 50 mg every 4 hours, methylprednisolone (MEDROL DOSE PAK), cetirizine (ZYRTEC) daily, and famotidine (PEPCID) daily. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the red rash, rash was hot to touch, shortness of breath, and numbness, were reported as recovered with lasting effects; while that of the hives was recovering as they still flared up if she did not take the medications every 4 hours. The reporter assessed all the events as non-serious.; Sender's Comments: The reported shortness of breath together with red rash was probably related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE together with rash was probably related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), due to temporal relationship and clinical course. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees and Investigators, as appropriate.
53 2021-01-10 redness chest pressure; tightness /pressure in throat; Face red; BP 186/90; within 2 min. of injection had n... Read more
chest pressure; tightness /pressure in throat; Face red; BP 186/90; within 2 min. of injection had near syncope that would come in waves every 2-3 minutes; Headache; rapid HR; Chills; mild cough; Dizziness; fatigue; This is a spontaneous report from a non-contactable health care professional nurse, the patient. A 53-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), in the right arm on 28DEC2020 08:15 as a single dose, for COVID-19 vaccination. Facility where the most recent COVID-19 vaccine was administered was a Hospital. Medical history included asthma and gastroesophageal reflux disease from an unknown date and unknown if ongoing. Known allergies include Tape, Walnuts, and Cat hair. Concomitant medication received within 2 weeks of vaccination included acyclovir [aciclovir] (ACYCLOVIR [ACICLOVIR]), ferrous gluconate, herbal nos, vitamins nos (FLORADIX), lansoprazole (PREVACID), cholecalciferol (VITAMIN D [COLECALCIFEROL]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. On 28DEC2020 08:15 within 2 min. of injection had near syncope that would come in waves every 2-3 minutes, face red, chest pressure, tightness /pressure in throat, headache, BP 186/90, rapid HR. The patient Spent 1 hour in ER. Later in day 28Dec2020, continued to have dizziness, chest pressure, chills, headache, fatigue. This continued for 4 days and had mild cough. The adverse events resulted in an emergency room (ER) visit. and Physician Office Visit. Treatment included Xyzal which relieved majority of symptoms. Laboratory test and procedures on 28Dec2020 include Electrocardiogram (EKG) with normal results, Blood Pressure Measurement 186/90 and Heart Rate Rapid. Treatment was given for chest tightness, throat tightness and red face and No treatment was given for chills, cough, dizziness, fatigue, headache, heart rate increase, blood pressure high and near syncope. The clinical outcome of near syncope that would come in waves every 2-3 minutes, face red, chest pressure, tightness /pressure in throat, headache, BP 186/90, rapid HR, dizziness, chest pressure, chills, headache, fatigue, mild cough was recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported face red, chest pressure, tightness /pressure in throat, blood pressure increased (BP 186/90), near syncope and the administration of BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
53 2021-01-11 injection site pruritus, injection site warmth, injection site redness, injection site swelling A vasovagal response occurred after shot, after sitting for 25 min, I ate lunch. I left facility 1 ... Read more
A vasovagal response occurred after shot, after sitting for 25 min, I ate lunch. I left facility 1 hour later. After 2 hours of the shot, the left arm began to be noticeably sore. 12 hrs post vaccine, I had flu-like symptoms. 24 hrs post vac, flu-like symptoms continued and the injection site had a visibly 2" swollen, red warm circle and raised area; also, I experienced considerable lymph node soreness in left underarm and under jaw (neck area) and itchiness at injection area. 36 hrs post vaccine, the flu-like symptoms subsided, but the injection site continued to grow to 3" red, warm and swollen area. Also I continued to have the itchiness, sore lymph nodes in the left arm (injection arm). Today is 48 hours post vac and I continue to have the red, raised, warm and itchy swollen circle at the injection site with soreness in the lymph node glands on left arm.
53 2021-01-11 injection site tingling Approximately 5 min after administration are is tingling, then got light headed. Next AM at 0700 wa... Read more
Approximately 5 min after administration are is tingling, then got light headed. Next AM at 0700 was extremely tired. When getting out of bed in AM blacked out and fell to the floor. Was able to get up but head was cloudy all day long. She felt very sore and head hurt all day. The next am had headache.
53 2021-01-11 redness, rash Day after receiving dose, experience a red bump on knee. Day after that additional 10-12 red bumps o... Read more
Day after receiving dose, experience a red bump on knee. Day after that additional 10-12 red bumps on both legs, forearms and 1 on forehead. Very itchy and painful. Used calmine lotion. As of today 1/12/21 symptoms improving.
53 2021-01-11 rash Developed over all body rash on 1/9/2021
53 2021-01-11 skin warm, redness, hardening I have a red silver dollar sized hard lump that is red and warm
53 2021-01-11 injection site hardening, injection site mass, injection site redness, injection site warmth I have a silver dollar size hard lump at injection site, it is red and warm.
53 2021-01-11 injection site pain Insatiable hunger, sore injection area. Hunger lasted for four days. Soreness at injection site la... Read more
Insatiable hunger, sore injection area. Hunger lasted for four days. Soreness at injection site lasted about 12 hours
53 2021-01-11 injection site pruritus Patient reported symptoms of itching at injection site, denied any other symptoms. Patient stayed f... Read more
Patient reported symptoms of itching at injection site, denied any other symptoms. Patient stayed for 30 minute observation, at observation completion patient reports she was also feeling slightly dizzy and lightheaded, reports those symptoms were occurring intermittently throughout 30 minute wait. Patient offered oral fluids (water/juice), and to stay a little longer, patient refused, reports she is fine to go home. Patient left observation on her own.
53 2021-01-11 shingles Shingle type pain burning; Shingle type pain burning; Shingle type pain burning; tingling; very sens... Read more
Shingle type pain burning; Shingle type pain burning; Shingle type pain burning; tingling; very sensitive from left flank down toward mid buttocks slightly toward anterior area; This is a spontaneous report from the Medical Information Team. A contactable nurse reported that a 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK9231, via intramuscular route of administration in the left arm, from 24Dec2020 08:15 at a single dose for COVID-19 immunization. Patient had no other medical history (reported as "none"). Concomitant medication included melatonin, calcium and bupropion hydrochloride (WELLBUTRIN). The patient is not pregnant. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 27Dec2020 09:00, the patient experienced shingle type pain burning, tingling and very sensitive from left flank down toward mid buttocks slightly toward anterior area. The outcome of events was reported as "not recovered". Therapeutic measures were taken as a result of events included motrin, tylenol and lidocaine. Patient was unable to go to work for a few days. No follow-up attempts are possible. No further information is expected. Information on the batch number has been obtained.
53 2021-01-12 itchy skin, redness 1ST VACCINATION PRODUCED NO SYMPTOMS AND WAS ADMINISTERED ON 12/21/20 2NS VACCINATION WAS APPROX. 6:... Read more
1ST VACCINATION PRODUCED NO SYMPTOMS AND WAS ADMINISTERED ON 12/21/20 2NS VACCINATION WAS APPROX. 6:30 PM ON 1/11/21 AND SYMPTOMS BEGAN WITH BEING AWAKENED BY FEELING ITCHINESS ON STOMACH AT APPROX 01:30 A.M. ON 1/13/21. PATIENT (I) OBSERVED BUMPINESS AND REDNESS COVERING ENTIRE STOMACH, BACK OF NECK AND ITCHINESS DOWN THIGHS AND ALONG UNDER SIDE OF ARM. TOOK BENADRYL OTC AND WENT BACK TO BED. AWOKE FOR WORK AT 04:30 AND SYMPTOMS ARE BETTER. NO SHORTNESS OF BREATH OR OTHER ALLERGY RELATED SYMPTOMS
53 2021-01-12 injection site pain After patient received Covid 19 second dose experienced fever for 4 days, severe joint pain, nausea,... Read more
After patient received Covid 19 second dose experienced fever for 4 days, severe joint pain, nausea, significant abdominal pain and abdominal cramping with nausea for 3 days, headache, body aches, fatigue. Unable to work . Injection site pain was minimal lasting 1 day.
53 2021-01-12 redness Experienced intense nausea and dizziness within 25 minutes of injection; tachycardia, increased bloo... Read more
Experienced intense nausea and dizziness within 25 minutes of injection; tachycardia, increased blood pressure; skin redness with blotches on face and neck; uncontrollable shaking; chills. These diminished to tolerable level within 30 minutes after onset. Evening of injection: nausea, vomiting, fatigue, muscle cramping. Next day: nausea, light headedness
53 2021-01-12 injection site swelling, injection site inflammation, injection site pain PAIN INJECTION SITE,HEADACHE,CHILLED,FEVER, SWELLING INYECCION SITE AND INFLAMATION IN GANGLIOS.
53 2021-01-12 rash with redness, injection site swelling, injection site pain, rash Red rash on left hand (a little on the right hand) and leg, left side of face under ear across the j... Read more
Red rash on left hand (a little on the right hand) and leg, left side of face under ear across the jaw line to under the chin, malaise, large muscle spasms and cramps, chills and shaking, soreness and swelling at injections site, burning in face and lips, and severe unexplained drop in blood sugar (56) that was very slow to bring back up.
53 2021-01-13 itchy skin, rash with redness, blister 1/4/21 within 4 hours after receiving vaccine sole of right foot in the arch area began to itch. Mo... Read more
1/4/21 within 4 hours after receiving vaccine sole of right foot in the arch area began to itch. Morning of 1/5/21 sole of left foot in arch area began to itch. Upon a visual check a red rash is present approximately 1.5"-2" in diameter on the soles of both feet in the arch area. 1/6/21 blisters formed in rash area of the right foot. On 1/8/21 upon patient visiting her dermatologist, the rash was ruled out as not being caused by a bacterial infection or fungal infection. Dermatologist prescribed an antihistamine oral medication and a steroid cream. 1/9/21 patients reports burning and itching increased and she used a frozen foot roller to treat the burning and itching. 1/10/21 Patient states that itching and burning subsided and discontinued use of steroid cream. Patient continues to take oral antihistamine (Hydroxyzine HCL 25mg) prescribed by dermatologist . Patient reports there have been no changes in soaps or detergents being used and no changes in behavior prior to vaccination and therefore, patient and doctor can, but without certainty, conclude that the rash is a result of the COVID-19 vaccination. 1/11/21 patient took pictures of rash and are available for viewing. As of 1/14/21 rash still present but itching has stopped. This event is a non-severe adverse event. Patient is scheduled to receive second dose of vaccination on 1/25/21. Patient has been advised to take antihistamine prior to receiving second dose of vaccination and again 12 hours following the 2nd dose of vaccination.
53 2021-01-13 rash, rash with redness, rash vesicular, itchy skin 1/4/21 within 4 hours of patient receiving 1st dose COVID-19 vaccination, itching began on sole of r... Read more
1/4/21 within 4 hours of patient receiving 1st dose COVID-19 vaccination, itching began on sole of right foot in arch area. Morning of 1/5/21 itching began on sole of left foot in arch area. Patient look at both feet and noticed a red rash on soles of both feet in arch area approximately 1.5" - 2" in diameter. 1/6/21 blisters developed on right foot in rash area. 1/8/21 patient went to dermatologist; the dermatologist ruled out bacterial and fungal infections. Dermatologist prescribed a topical steroid lotion and an oral antihistamine (Hydroxyzine HCL 25mg). 1/9/21 patient reported severe burning and itching of both feet and self-treated with a frozen foot roller which successfully subsided the burning and itching. 1/10/21 discontinued use of steroid lotion. Continues to take oral antihistamine. 1/11/21 blisters are gone but rash is deep red and still exists as of today without itching or burning.
53 2021-01-13 injection site swelling, injection site redness, injection site pain Chills, Fatigue, Fever, injection site pain, redness and swelling starting 12.23.2020 I experience i... Read more
Chills, Fatigue, Fever, injection site pain, redness and swelling starting 12.23.2020 I experience increase of temperature and fatigue.
53 2021-01-13 injection site pain, injection site pruritus FIRST DOSE- FEELING HOT, CHILLS, TIREDNESS, MILD HEADACHE AND GENERAL BODY PAIN SECOND DOSE-FEVER, ... Read more
FIRST DOSE- FEELING HOT, CHILLS, TIREDNESS, MILD HEADACHE AND GENERAL BODY PAIN SECOND DOSE-FEVER, CHILLS, SEVERE HEADACHE, ITCHY IN THE VACCINATION AREA AND PAIN IN THE VACCINE ARM AND RADIATES UNDER THE ARMPIT TO THE BREAST AND DIARRHEA
53 2021-01-13 itchy skin Fever; wide-spread body pain; hot flashes; intense, unrelenting itching on underarm and down arm on ... Read more
Fever; wide-spread body pain; hot flashes; intense, unrelenting itching on underarm and down arm on side of injection with no rash; fatigue; This is a spontaneous report from a contactable other hcp (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 1284) intramuscularly at right arm on 06Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included known allergies to opiate derivatives and penicillin. Concomitant medication included clopidogrel, sertraline, simvastatin. The patient previously received first dose of bnt162b2 (lot number: ELC5730) intramuscularly at right arm on 18Dec2020 13:00 at single dose for COVID-19 immunization. The patient experienced fever; wide-spread body pain; hot flashes; intense, unrelenting itching on underarm and down arm on side of injection with no rash; fatigue, all on 07Jan2021 01:30. No treatment received. This is a non-serious report. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
53 2021-01-13 injection site pain I experienced soreness at the sight of injection, lymph nodes swollen and sore under left arm, body ... Read more
I experienced soreness at the sight of injection, lymph nodes swollen and sore under left arm, body aches, chills, tiredness. I took 2 Aleve before injection and Benadryl 25mg at 9p after injection.
53 2021-01-13 rash Patient experienced rash shortly after administration. Felt hot. Patient took zyrtec. Was having a... Read more
Patient experienced rash shortly after administration. Felt hot. Patient took zyrtec. Was having a little bit of difficulty breathing. Symptoms except rash resolved after 30 minutes of observation. Patient discharged home from the vaccination clinic.
53 2021-01-13 itchy rash, rash Pt noted rash on (L) knee, progressed to both thighs, lower back and both arms. Now also on bith arm... Read more
Pt noted rash on (L) knee, progressed to both thighs, lower back and both arms. Now also on bith arms, upper back and ears, and both legs. Very itchy.
53 2021-01-13 hives, skin discolouration, itchy skin Received the first dose of the vaccine on Dec 30, 2020 which was a Wed. By that Sat night I was very... Read more
Received the first dose of the vaccine on Dec 30, 2020 which was a Wed. By that Sat night I was very itchy. On Sunday I had hives on my upper legs, stomach, buttocks and my ears were swollen and purple. went to urgent care 1/2/2021. Gave me prednisone 40mg for 5 days and triamcinolone cream.
53 2021-01-14 sensitive skin, injection site swelling, redness 3:00 PM injection site pain swelling resolved within 48 hours 7:00 PM Skin redness sensitivity on ch... Read more
3:00 PM injection site pain swelling resolved within 48 hours 7:00 PM Skin redness sensitivity on chest, abdomen right trunk resolved within 6 hrs. 9:00 PM chills, body aches, nausea resolved within 48 hrs 1:50 AM. Diarrhea resolved within 12 hours 2:00 AM. Vomiting multiple times resolved within 30 minutes
53 2021-01-14 itchy skin At 1:16PM patient complaints of pruritus, but patient said feeling ok. At 1:35PM continue with pruri... Read more
At 1:16PM patient complaints of pruritus, but patient said feeling ok. At 1:35PM continue with pruritus Benadryl 50ml IM were administrated. Vital signs Oxygen saturation 95%, HR 85bpm, BP 155/91mmHg, Dxt 119 and RR 12 rpm. At 1:45pm patient complaint of fatigue, an Rapid Response (RR) code for anaphylactic reaction was activated. Patient received Epinephrine 0.3mg IM (1 dose), Solu-Cortef 200mg IM (1 dose) and was transferred to the ER per anaphylactic shock protocol. Vitals signs at ER were 132/76mmHg, RR 14rpm, Osat 99% and HR 83bpm.
53 2021-01-14 vaccination site redness, vaccination site warmth Chills; Body ache; Fatigue; redness and hot about 1-3 inches below injection site; redness and hot a... Read more
Chills; Body ache; Fatigue; redness and hot about 1-3 inches below injection site; redness and hot about 1-3 inches below injection site; patient received the second dose in less than 21 days from the first dose; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EJ0142), intramuscular in the left arm on 05Jan2021 at 08:00 AM (at the age of 53-year-old) as a single dose for COVID-19 immunization. Medical history was none. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient previously received the first dose of BNT162B2 intramuscular on 19Dec2020 at 19:00 PM, lot number: EJ1685 at the age of 53-year-old for COVID-19 immunization in the left arm. The patient did not receive any other vaccines within four weeks prior to the second vaccination (except the first vaccination). On 05Jan2021 at 22:00 PM the patient experienced chills, body ache, fatigue, redness and hot about 1-3 inches below injection site. The patient took Motrin for chills, body ache, fatigue, redness and hot about 1-3 inches below injection site. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the chills, body ache, fatigue, redness and hot about 1-3 inches below injection site was not recovered.
53 2021-01-14 injection site pain, injection site swelling, injection site nodule Day 1- RUE injection site tender Day2- RUE Large knot at injection site, tenderness. Fatigue Day 3- ... Read more
Day 1- RUE injection site tender Day2- RUE Large knot at injection site, tenderness. Fatigue Day 3- Right Axillary lymph nodes swelling, grapefruit size, painful. Edema from injection site to fingertips with numbness to 3,4,5 digits. Fatigue and headache. Day 4- RIGHT sided lymph nodes swelling, palpable to neck, axillary and groin. Severe fatigue. Headache. Edema still complete to RUE- with numbness to fingers. Grapefruit sized axillary, slightly improved. NO FEVER, COUGH, DYSPNEA
53 2021-01-14 rash, hives Hives across face and upper torso, arms.
53 2021-01-14 vaccination site pain Nausea; fast heart rate; low grade temp (99.4-100); headache; body aches; soreness at site; This is ... Read more
Nausea; fast heart rate; low grade temp (99.4-100); headache; body aches; soreness at site; This is a spontaneous report from a contactable Nurse (patient herself). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 13:00 (Lot number: EK5730) at SINGLE DOSE (first dose, left arm); and via an unspecified route of administration on 07Jan2021 13:00 (Lot number: EK9231) at SINGLE DOSE (second dose, left arm) for COVID-19 immunization. Medical history included hypertension, high cholesterol, Graves disease, and Known allergies: Sulfa from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 since vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the vaccine at hospital. Concomitant medication included hydrochlorothiazide, atorvastatin, amlodipine from unspecified dates for unspecified indications. The patient experienced nausea, fast heart rate, low grade temp (99.4-100), headache, body aches, soreness at site on 08Jan2021 06:00. The patient underwent lab tests and procedures which included temp 99.4-100 and heart rate fast on 08Jan2021. Treatment was not received for adverse events. Event outcome was recovering. The reporter assessed the events as non-serious.
53 2021-01-15 injection site pain, injection site hardening Chill, terrible headache, noisy sound in ears, body aches, swollen lymph node at left armpit is very... Read more
Chill, terrible headache, noisy sound in ears, body aches, swollen lymph node at left armpit is very big, injection site is harder. Lower back at kidney sites are so painful. Weakness. No energy to lift up arms or legs. Have difficult to get up and get out of bed to get medicine or food. So sleepy, maybe because Tylenol 500mg q4h to help for pain but reduce just little from 10 down to 8 for a short time enough to get out of bed to get something. Ice pack at armpit, heat pat at lower back but just reduce the pain from 10 down to 9 only. No appetite. Eat lentil and rice porridge but indigestible and have to take Pepcid. All symptoms prolong until Friday 1/15/2021 around 1pm. I pushed myself hard to get up to drive to employee health for testing which I missed on Thursday due to unable to get up. After that the symptoms down to moderate that I able to report CDC. I wonder why 2 dose is so horrible to me.
53 2021-01-15 hives Mild hives and wheezing one hour after second dose of vaccine. Employee health provider administered... Read more
Mild hives and wheezing one hour after second dose of vaccine. Employee health provider administered 25 mg Benadryl IM with relief. I have needed to use albuterol daily since which is unusual for me.
53 2021-01-16 itchy skin, redness, hives Hives on both arms redness itching burning
53 2021-01-16 rash Within 15 mins of the inj. started feel fuzzy, under conscious sedation, warm sensation going up the... Read more
Within 15 mins of the inj. started feel fuzzy, under conscious sedation, warm sensation going up the right arm and neck and right ear. The left arm felt like battery acid, hurt super bad. Felt like an outer body experience. Was given Benadryl. Was having a problem clearing her throat. Felt weird by her bellybutton, felt like she had on a corset on. Rash developed at sternum and bellybutton. Went over to her ER at work. The knee to the hip felt like she had cement on them. Her tongue started to swell. She was wheeled up to tramum2. She blackout at some point. Her body was doing one thing and her mind another. She had EpiPen stat. Right was twitching like Parkinson's. After 1 1/2 she started feeling a little better. 69/43 bp recorded. The next few days she felt like she had Mono.
53 2021-01-17 itchy skin For 3 to 4 days I've been feeling itchy from the inside. I am allergic to shell fish and it's the sa... Read more
For 3 to 4 days I've been feeling itchy from the inside. I am allergic to shell fish and it's the same feeling I get when I eat shell fish. I've been taking Benadryl. Not sure if this is a side effect but I haven't eaten anything to make me feel this way.
53 2021-01-17 hives Hives 60 hours after the vaccine with no other side effects
53 2021-01-17 itchy skin Hx Covid infection Had Covid vaccine #1 - no problems Within 1 hr after Covid vaccine #2 progressed ... Read more
Hx Covid infection Had Covid vaccine #1 - no problems Within 1 hr after Covid vaccine #2 progressed to SOB, pruritis throat tickle TxT-ed self with Benadrl but symptoms persisted Went to ED txt with Bendryl, prednisone, zyrtec.
53 2021-01-17 redness neck lymph node swelling; then 30 hours after receiving vaccine hands turned red and burned, pain an... Read more
neck lymph node swelling; then 30 hours after receiving vaccine hands turned red and burned, pain and swelling in arm pits. currently have increased paresthesia arms, hands, legs and feet
53 2021-01-18 injection site redness Fever up to 101.0, body aches, chills, fatigue, weakness, redness at injection site, tender at injec... Read more
Fever up to 101.0, body aches, chills, fatigue, weakness, redness at injection site, tender at injection site, swollen lymph nodes in neck, axilla, L breast, headache that started at 6 am the following day. I took Tylenol which did help fever and body aches. I had symptoms until 1/11/21 and started feeling better at 11 am.
53 2021-01-18 injection site redness, injection site mass Patient describes a red, raised bump on the injection site, along with headache and fatigue.
53 2021-01-18 itchy skin, redness Redness and itchy
53 2021-01-18 injection site redness, injection site pain headache, body aches, fever, nausea, fatigue, injection site pain and redness, joint pain, not feeli... Read more
headache, body aches, fever, nausea, fatigue, injection site pain and redness, joint pain, not feeling well
53 2021-01-19 rash ? headache ? muscle pain ? chills ? joint pain nausea swollen lymph nodes (lymphadenopathy) Swellin... Read more
? headache ? muscle pain ? chills ? joint pain nausea swollen lymph nodes (lymphadenopathy) Swelling of your face and throat ? A fast heartbeat ? A bad rash all over your body ? Dizziness and weakness
53 2021-01-19 injection site pain Headache, body aches, low grade fever (100.6), fatigue, injection site tenderness
53 2021-01-19 rash, hives, itchy skin Hives beginning at 4 pm on January 17 and progressed to severe itching and swelling. Benadryl and Fa... Read more
Hives beginning at 4 pm on January 17 and progressed to severe itching and swelling. Benadryl and Famotidine taken. Admitted to ED at 4 am on January 18, Prednisone given. Symptoms were improving and discharged at 7 am the same day. Hives and itching were worse and facial edema and rash noted on night of January 18. Treatments included Benadryl and Famotidine. Morning of January 19, 40 mg Prednisone and Benadryl every 4-6 hours. Morning of January 20, hives and rash and itching persists on stomach, legs, arms, and ears. 40 mg of Prednisone and Benadryl. (Present time - hives, rash, and itching still persists with less severity)
53 2021-01-19 injection site pain Initial headache within approximately 10 hours of injection, then body aches, insomnia, injection si... Read more
Initial headache within approximately 10 hours of injection, then body aches, insomnia, injection site soreness, fatigue, slight mental fog.
53 2021-01-19 redness, itchy skin, skin swelling Started having some blurry vision on the night of 01/17/2021 which lasted for 45 mins to 1 hour. The... Read more
Started having some blurry vision on the night of 01/17/2021 which lasted for 45 mins to 1 hour. The next day on 01/18/2021 at about 1445 started having some itchiness on the face[ cheeks, forehead and around lips] with chills on and off. My face became little puffy and swollen with redness. By the evening, I also ended up with high temperature 100 degree and started having body pain , mainly on the lower back . Took 600 mg Ibuprofen along with Vitamin C 1000 mg and Zinc 1 tablet at night. All my symptoms resolved by 01/19/2021 noon.
53 2021-01-20 rash Low grade fever 99.9 and aches and back pain and chills and headache and rash in armpit neck and sho... Read more
Low grade fever 99.9 and aches and back pain and chills and headache and rash in armpit neck and shoulder areas bilaterally.
53 2021-01-20 vaccination site pain Migraine; Mild pain at injection site; This is a spontaneous report from a contactable other healthc... Read more
Migraine; Mild pain at injection site; This is a spontaneous report from a contactable other healthcare professional (HCP, patient). A 53-year-old female patient (pregnant: No) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 4178) Intramuscular on 08Jan2021 09:15 AM at left arm at single dose for COVID -19 immunization in Hospital. Medical history was none. No Known allergies. Concomitant medication in two weeks included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). No other vaccine in four weeks. Patient receive the first dose of bnt162b2 (lot number: EK5730), intramuscularly on the left arm on 18Dec2020 at 13:15 at single dose for COVID-19 immunization and experienced injection site soreness (Day 1 and Day 2) and mild headache (Day 2). Patient experienced mild pain at injection site (Day 1 and Day2, 08Jan2021 12:00 PM) and Migraine (Day 2, 08Jan2021 12:00). COVID was not tested post vaccination. No treatment received. Patient was recovered from the events in Jan2021.
53 2021-01-20 itchy rash, rash Within 3 hours of receiving the vaccine left shoulder pain and in particular inability to raise arm ... Read more
Within 3 hours of receiving the vaccine left shoulder pain and in particular inability to raise arm (behaved like a deltoid injury or bursitis) as pain on both lateral and forward flexion and extension. While it was the worse in the first 24-48 hours it still persists over one week later requiring decreased mobility, tylenol or ibuprofen for relief . The discomfort has, however, never fully gone away. Also approximately 1 1/2 days later I developed an erythematous pruritic drug rash over my trunk (back and front). This developed within 12 hours of my first series. It has since completely resolved and was not a particular bothersome issue. Just a bit pruritic.
53 2021-01-21 rash About the 35 minutes later became nausea and threw up, faint and blood pressure 190/106 she was sen... Read more
About the 35 minutes later became nausea and threw up, faint and blood pressure 190/106 she was sent to ER at time of admission blood pressure was going down and back to normal within hour and gave anti- nausea medicine . Blood pressure every :15 for hour 128/76 event resolve . Ondansetron 4 mg Face and chest rash 24 hours later Benadryl 25 mg
53 2021-01-21 hives Approximately five minutes of receiving the second vaccine broke out in hives everywhere started exp... Read more
Approximately five minutes of receiving the second vaccine broke out in hives everywhere started experiencing throat tingling. Was taken to ER. I am a nurse at hospital Was given Solu-Medrol and Benadryl IV in ER
53 2021-01-21 injection site pain Received dose on 1/20/2021 at 0818 by 1400 had a horrible headache. At 2100 started having body ache... Read more
Received dose on 1/20/2021 at 0818 by 1400 had a horrible headache. At 2100 started having body aches all over body. Injection site pain as well. On 1/21/2021 at 0500 began having chills and running a fever of 102.4. The head ache subsided around 1800. The body aches and fever were gone by 0700 on 1/22/2021. At this point (1/22/2021 1450) just exhausted, but no other aches or pains. During the time of the head ache initially took Tylenol which did nothing. Then took a low dose of Ibuprofen which took an edge off.
53 2021-01-24 rash 20 mins after the injection, my BP increased to 193/113 ( no h/o HTN), pulse was 134, flushing and a... Read more
20 mins after the injection, my BP increased to 193/113 ( no h/o HTN), pulse was 134, flushing and a rash across my chest, headache, nausea, numbness/tingling in both hands and lightheaded.
53 2021-01-24 itchy skin, rash Four days ago the patient received her 2nd coronavirus vaccine. She received at the hospital pot. Sh... Read more
Four days ago the patient received her 2nd coronavirus vaccine. She received at the hospital pot. She received her 2nd Pfizer vaccine. She tolerated her 1st vaccine dose without incident. She did not have any problems approximately 15 minutes after her 2nd dose and she was then released to drive away. About 30 minutes after her 2nd dose she developed nonspecific symptoms of shortness of breath and a sensation of something sticking in her throat. She presented to the emergency department. She did not receive epinephrine. She was monitored and received intravenous fluids and diphenhydramine. She notes ongoing itching with rash and which she describes as exacerbation of asthma. She has known asthma with frequent exacerbations. She has been hospitalized numerous times in the past for asthma exacerbation. Now that it has been several days since her vaccination and she is still having rash and difficulty with her asthma we have discussed initiation of low-dose steroids for ongoing improvement.
53 2021-01-24 injection site warmth, injection site redness, injection site swelling, injection site mass My arm was red, swollen, hot to touch and swelled up about 1 inch around the injection site. I still... Read more
My arm was red, swollen, hot to touch and swelled up about 1 inch around the injection site. I still have about a pea size knot there. It doesn't bother me unless I bump that spot.
53 2021-01-24 injection site redness, injection site swelling, injection site mass VACCINE 1: SWELLING, REDNESS AT INJECTION SITE, KNOT UP TO APPROX 1 INCH DIAMETER ALL THE WAY AROUND... Read more
VACCINE 1: SWELLING, REDNESS AT INJECTION SITE, KNOT UP TO APPROX 1 INCH DIAMETER ALL THE WAY AROUND INJECTION (SITLL HAVE PEA SIZED KNOT AT INJECTION SITE) VACCINE 2: SWELING, REDNESS AT INJECTION SITE
53 2021-01-24 injection site pain, injection site warmth pain at injection site- 24 hours warmth at injection site- 24 hours fatigue- 24 hours
53 2021-01-25 redness Chills/shivering; fever at 102°F; Headache; sweating; Arm is sore and red; Arm is sore and red; Thi... Read more
Chills/shivering; fever at 102°F; Headache; sweating; Arm is sore and red; Arm is sore and red; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EL0142, expiry date not reported), via an unspecified route of administration on 11Jan2021 11:30 at a single dose in the left arm for Covid-19 immunization (as patient works in a nursing home and wanted to get it). Medical history included ongoing asthma and had COVID back in Apr2020 to an unknown date. There were no concomitant medications. The patient previously had flu shot and had arm red and sore. Patient had a reaction after receiving her Covid shot yesterday at 11:30 AM. Patient mentioned that she woke up this morning (12Jan2021) at around 3 AM with chills, a headache and fever at 102-degree Fahrenheit and felt that she has to move her legs every time to feel better. She has asthma but stated that her breathing was fine. Patient wanted to know if this was normal and when this will go away. She called her doctor and left a message to let them know. She had COVID back in Apr2020, but got the vaccine yesterday, which she wanted. She was unsure what was going on. She was also shivering and cannot settle down, like her legs. She just has a massive headache with chills, shivering, and some sweating (12Jan2021). Her arm was also red and sore (12Jan2021). It was like she gets with the Flu shot, but she never has had any other symptoms with the flu shot. The events were reported as non-serious. Therapeutic measures were taken as a result of chills/shivering, fever at 102-degree Fahrenheit, headache, and arm was sore and red. Patient took Tylenol this morning when she woke up at 3 AM. She did not fall asleep until 5 AM. Then she got up at 7 AM and took some more. She will take more at 11 AM. The outcome of the events chills/shivering, fever at 102-degree Fahrenheit, headache, sweating, and arm was sore and red was not recovered.
53 2021-01-25 hives, itchy skin, redness, skin irritation Experienced Pruritus, redness, skin irritation, hives on bilateral arms, chest, hands Treated with D... Read more
Experienced Pruritus, redness, skin irritation, hives on bilateral arms, chest, hands Treated with Diphenhydramine 12.5 mg IV, Pepcid 20 mg IV, SoluMedrol 125 mg IV, Normal Saline x 1000 ml
53 2021-01-25 itchy skin Itching on the right knee and both legs below the knees. Swollen spot below right knee that itches.... Read more
Itching on the right knee and both legs below the knees. Swollen spot below right knee that itches. Right eye is swollen. I took allergy eye medicine , a 24 hour tablet of Allegra, and put Cortizone 10 on my legs below the knees. As of 1/26/2021 - the medicine has stopped the itching, but eye is still slightly swollen.
53 2021-01-25 skin irritation, redness, itchy skin, hives Pruritus, redness, skin irritation, hives on bilateral arms, chest, hands. Treated with Diphenhydram... Read more
Pruritus, redness, skin irritation, hives on bilateral arms, chest, hands. Treated with Diphenhydramine 12.5 mg IV, Pepcid 20 mg IV, SoluMedrol 125 mg IV, Normal Saline IV solution x 1000 ml
53 2021-01-26 injection site pain Extreme pain the left arm at Injection site along with swelling of the lymph nodes under the left a... Read more
Extreme pain the left arm at Injection site along with swelling of the lymph nodes under the left arm. Whole body inflammatory response. Treatment: Ice, Tylenol and Hydrocodone. Called physicians office to inform. Awaiting call back if anything needs to be done.
53 2021-01-26 injection site swelling, injection site pain, injection site rash I was flushed, my arm hurt, palpitations, dizziness, foggy brain, fast heart rate, fever, vomitting,... Read more
I was flushed, my arm hurt, palpitations, dizziness, foggy brain, fast heart rate, fever, vomitting, nausea, headache, stuffiness, congestion, swelling on the arm at the injection site, pain and rash around the injection site.
53 2021-01-26 rash elevated BP : 193/113; Tachycardia 134 BPM; bad headache; numbness and tingling in both hands; numbn... Read more
elevated BP : 193/113; Tachycardia 134 BPM; bad headache; numbness and tingling in both hands; numbness and tingling in both hands; nausea; rash across the top of my chest; sore muscles in legs; This is a spontaneous report from a contactable nurse. A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, via intramuscular route of administration in the left arm, on 12Jan2021 10:30 at SINGLE DOSE for covid-19 immunization. Medical history included asthma, sinusitis and migraine. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), albuterol, estradiol, norethisterone acetate (ESTRADIOL AND NORETHINDRONE), vitamin d3, zinc, paracetamol (TYLENOL) and diphenhydramine hydrochloride (BENADRYL). The patient previously took erythromycin, levaquin, biaxin and cefzil (on unspecified dates) and experienced allergy. The patient started having reactions after 20 mins (12Jan2021, 10:45am): a bad headache, elevated BP: 193/113 (no history of hypertension), tachycardia 134 BPM, numbness and tingling in both hands, nausea, and a rash across the top of the chest. Since it was administered in a workplace drive-thru clinic, there was a 15-30 mins post vaccine monitoring. She was taken inside for further evaluation and monitoring with no changes after 30 mins. EMS was called for transport to the closet hospital that wasn't on diversion. Her allergist was consulted by the treating ER physician and was later discharged with prescriptions for the following: Epipen, prednisone for 5 days, and pepcid. Follow-up with allergist in 3-5 days and PCP. Patient was still recovering however headache was and sore muscles in legs were still present. The outcome of events headache was and sore muscles in legs was not recovered whereas patient was recovering from all other events. Therapeutic measures taken as result of the events included Benadryl, Pepcid, Zofran, Tylenol, 1L Saline bolus, EKG, lab work, monitoring on a pulse ox, frequent BP. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.; Sender's Comments: Based on the compatible time association, the reported events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
53 2021-01-27 itchy skin, rash maculo-papular, rash macular 12/28 received COVID-19 vaccine left deltoid. This was complicated with momentary (about 30 sec) l... Read more
12/28 received COVID-19 vaccine left deltoid. This was complicated with momentary (about 30 sec) lightheaded and some pruritis, although patient continued with work (rounding on service). Self treated with tylenol. She noted two spots on her left arm (pictures emailed to me), self-treated with motrin. 12/29 in the arm she believed the spots on her left wrist were more pronounced, with new spots on her forearm. Round maculopapular back left of spine 12/19 in am. Self treated with claritin. Called the reaction line and evaluated by Dr. on Thursday as all symptoms progressed. Simmered down over the weekend. Last claritin or any antihistamine was 6 days ago. Had COVID with positive PCR in April 2019. Still with positive antibodies, measured repeatedly as part of participation in program. Persistent loss of taste and smell. No history of known miralex exposure. Has not had a colonoscopy before. Minimal use of personal care products/lotions. Received annual flu vaccine without complications. Never history of anaphylaxis. Allergic reaction to COVID19 vaccine with diffuse cutaneous symptoms; not classical IgE mediated reaction No evidence of clear anaphylaxis to COVID-19 vaccine (or any other injectable). Patient received their second dose of vaccine on 1/19 - 30 minutes of monitoring instead of 15 minutes.
53 2021-01-27 vaccination site pain, vaccination site redness, vaccination site rash, vaccination site itchiness Flu like symptoms; All joints hurt/ joints were painful; Severe pain in left arm I got injection in/... Read more
Flu like symptoms; All joints hurt/ joints were painful; Severe pain in left arm I got injection in/left arm was very painful and it was up underneath my armpit and down my arm; rash few days later and it's been itching; redness; Sunburn; Has sort of a "wound" (not clarified) on the injection "site wise"; arm is feeling itchy; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284 and expiry date: 30Apr2021), via an unspecified route of administration in left arm on an unspecified date at single dose for COVID-19 immunization. Medical history included haemochromatosis and GERD from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient stated, "I got the Injection, the second injection on Monday and Tuesday night I got the typical flu like symptoms. My joints were painful. I had severe pain in my left arm that I go the injection in and today like all day, my arm is feeling itchy on 14Jan2021 but I really didn't have any like redness around it but now there is like half of the side like redness on my shoulder. It feels like kind of a sunburn and has sort of a "wound" (not clarified) on the injection "site wise" (not clarified). I have been taking some Advil and I took some Benadryl the first night and I took the "Mucinex" (not clarified) (unspecified medication) it's like a "cough" medicine. The arm is getting as the days have gone on. It's just like first night the day after I got flu like symptoms, so like all of my joints hurt. The left arm was very painful and it was up underneath my armpit and down my arm and then that part improved but the left arm is now developing a rash few days later and it's been itching, like really itching." The patient considered that BNT162B2 is related to the events. The outcome of the event "pain in the left arm" was recovering while the outcome of the remaining events was unknown.
53 2021-01-27 rash Rash and fever 100.8F
53 2021-01-27 rash, itchy skin Rash and itching on torso and neck; Rash and itching on torso and neck; This is a spontaneous report... Read more
Rash and itching on torso and neck; Rash and itching on torso and neck; This is a spontaneous report from a contactable physician who reported for herself, a 53-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL0140) at the hospital, via an unspecified route of administration in the left arm, on 12Jan2021 at 09:15 at the age of 53 years, at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no COVID prior vaccination, and was not COVID tested post vaccination. The patient was not pregnant. Concomitant medications included ospemifene (OSPHENA), vitamins and ibuprofen (ADVIL). Patient had no other vaccines in four weeks. The patient previously took and had known allergies to Gentamycin Opath Drops and hydroxychloroquine. The patient received the first dose of BNT162B2 with lot number: EJ1685 at the age of 53 years, in the left arm on 21Dec2020 at 07:00 PM for COVID-19 immunization. The patient experienced rash and itching on torso and neck 48 hours after injection on 14Jan2021 at 20:00. Therapeutic measures taken as a result of rash and itching on torso and neck included Benadryl. The outcome of the events was not recovered.
53 2021-01-28 hives 1-2 hives on face near mouth (outside) scratchy, dry throat ER doctor had the nurse administer a s... Read more
1-2 hives on face near mouth (outside) scratchy, dry throat ER doctor had the nurse administer a steriod shot (methylPREDISolone (Medrol (pak)) and I was given famotidine (Pepcid pill). A prescription was called into my pharmacy (famotidine and methylPREDNISolone)
53 2021-01-28 rash, skin warm, redness At 6: 28 pm patient reported that arm felt warm. Arm was reddened and had rash. Vitals taken every 5... Read more
At 6: 28 pm patient reported that arm felt warm. Arm was reddened and had rash. Vitals taken every 5 minutes. 50 mg IM Benadryl administered. Observed patient for 1 hour. No further intervention needed. Patient went home with husband.
53 2021-01-28 rash Fever; joint pain left side; Rash on legs; headache; This is a spontaneous report from a contactable... Read more
Fever; joint pain left side; Rash on legs; headache; This is a spontaneous report from a contactable other healthcare professional (hcp; patient for herself). A 53-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EL3247, expiry date not reported), via an unspecified route of administration in the left arm on 13Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included hypothyroidism, HTN (hypertension), migraines, and blepharitis. The patient had no known allergies. The patient was not pregnant at the time of the vaccination. The patient had no COVID prior to vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), metoprolol tartrate, lisinopril, colecalciferol (VIT D3), fish oil, and "mul" as reported. The first dose of BNT162B2 (brand Pfizer, lot EL1284) for COVID-19 immunization was administered on 22Dec2020 at 05:30 pm in the left arm. The patient had no other vaccines in four weeks. On 13Jan2021 08:45 pm, the patient experienced fever, joint pain left side, rash on legs and headache. No treatments received in response to the events reported. The patient was not tested for COVID post vaccination. The events fever, joint pain left side, rash on legs and headache were recovered on an unknown date in Jan2021.
53 2021-01-28 itchy skin feeling itchy from the inside; This is a spontaneous report from a contactable other HCP (patient). ... Read more
feeling itchy from the inside; This is a spontaneous report from a contactable other HCP (patient). A 53-year-old female patient started to receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number /expiration date: unknown), via an unspecified route of administration, on 11Jan2021 01:00 PM (at the age of 53 years old) as a single dose on left arm for COVID-19 immunisation at a hospital facility. Relevant medical history included High blood pressure, diabetes, known allergies: shellfish (onset dates unknown). Past drug history included known allergies: silva on unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Jan2021, the patient stated that for 3 to 4 days she has been feeling itchy from the inside. She is allergic to shellfish and the feeling she was having was similar to how she felt if she ate shellfish. She hadn't eaten anything out of the ordinary to make her felt this way. The patient received treatment for the event which included diphenhydramine (BENADRYL). The outcome of the event headache was not recovered. Information on the Lot/Batch number has been requested.
53 2021-01-28 injection site pain, injection site warmth, injection site redness injection site warmth, pain and redness
53 2021-01-29 hives, itchy skin Itchiness all over the body, hives, and head rush
53 2021-01-29 rash, itchy rash, rash papular, rash with redness Mild red raised itchy rash face and bilateral forearms with mild scratchy throat.
53 2021-01-30 skin warm ? Jan 21st, 2 hours after vaccine headache. 12 pm right side of back hurting last 2 hours, 3 pm nec... Read more
? Jan 21st, 2 hours after vaccine headache. 12 pm right side of back hurting last 2 hours, 3 pm neck hurting lasts 2 hours.6pm feet are burning hot to the touch. ? Jan 22, 12 am Arrhythmias, racing heart rate, uncontrollable shaking, throat is feeling sore and difficulty swallowing. I go to the ER . While waiting to see a doctor my symptoms subside. Dr. prescribes an epi-pen. Explains that they do not know about the vaccine. ? Jan 23, 3am uncontrollable shaking, neck hurting feet burning. 4am nausea, headache still continues. ? Jan 24, massive headache continues, nausea, diarrhea, I go to Urgent Care Center. They do a blood test must wait a few days for results. ? Jan 25, Massive headache continues, uncontrollable shaking ? Jan 26, 2am, headache continues, uncontrollable shaking, burning feet, blood pressure 164/103. Back to Urgent care. Add blood pressure meds. ? Jan 29, 12 am Shaking, blood pressure168/85 ? Jan 31st Sunday 7pm, Muscles tightening up in lower body, chest pain Symptoms ongoing, Doctors do not know enough about the vaccine to treat the problem.
53 2021-01-31 injection site pain Bad headache, body aches, chills, fatigue, injection site pain, malaise, new joint and muscle pain
53 2021-01-31 rash with redness Left Axilla/Underarm pain; Left Axilla/Underarm swelling; lymph node swelling; pain in neck.; Red ra... Read more
Left Axilla/Underarm pain; Left Axilla/Underarm swelling; lymph node swelling; pain in neck.; Red rash on both arms, chest.; This is a spontaneous report from a contactable nurse (patient). A 53-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via an unspecified route of administration on 26Dec2020 14:00 at single dose in left arm for COVID-19 immunization. Medical history included complete thyroidectomy in 2000 and known allergies included Sulfa. Concomitant medications included losartan, levothyroxine, thyroid (ARMOUR THYROID). The patient didn't receive other vaccine in four weeks. The patient had no covid prior vaccination and no covid tested post vaccination. The patient experienced left axilla/underarm swelling/pain, lymph node swelling/pain in neck. Red rash on both arms, chest on 27Dec2020. The patient did not receive the treatment for events. The outcome of the events was unknown. Information on the lot/batch number has been requested.
53 2021-01-31 rash Rash on arm & neck Given benadryl at walk in clinic
53 2021-02-01 rash, hives, itchy skin Employee reported that she began dry, burning lips and neck which started day after covid vaccine ad... Read more
Employee reported that she began dry, burning lips and neck which started day after covid vaccine administered. On day 2 following vaccine, employee reported lips began to swell and rash and hives developed on neck and chest. Lip swelling resolved on 1/31/2021 and employee still has rash on chest and neck, but is improving. Employee was using Benadryl cream for rash and itching and was also taking Benadryl orally 50 mg at bedtime and was taking Claritin during day. Did not have to seek emergency treatment but did miss 1 day of scheduled work. Employee is also reporting fatigue and pain in joints. Has a hx of lupus and RA and believes vaccine may have caused a flare.
53 2021-02-01 skin tightness, itchy skin Facial swelling, itching, tightness, eyelid dropping
53 2021-02-02 hives patient developed hive from hair line to waist, pt went to urgent care and was instructed to take di... Read more
patient developed hive from hair line to waist, pt went to urgent care and was instructed to take diphenhydramine and given steroid cream to treat hives
53 2021-02-03 itchy skin DROWSY ITCHY THROAT (STARTED HERE) ITCHY NOSE (PROGRESSED HERE) GENERALIZED ITCHING EVERYWHERE (ENDE... Read more
DROWSY ITCHY THROAT (STARTED HERE) ITCHY NOSE (PROGRESSED HERE) GENERALIZED ITCHING EVERYWHERE (ENDED HERE) NUMB LIPS AND TONGUE THROAT HOARSE LEFT ARM ACHE
53 2021-02-03 injection site pain, injection site nodule Knot under the right arm. Soreness if moved a certain way. It is the size of an egg.
53 2021-02-03 rash first shot my arms and neck muscles went numb for several hours Second time my legs were in severe ... Read more
first shot my arms and neck muscles went numb for several hours Second time my legs were in severe pain and hard to make move-could barely walk. This lasted for about 8 hours. I had a small fever, my left leg and ankle swelled for several days and hurt mildly. I had a rash on my neck and body. I had fatigue like theonset of a fibro attack both times but second shot was much worst than first.
53 2021-02-04 vaccination site warmth, vaccination site swelling Area of injection site has become very large, swollen, hot to touch, and firm in the middle; Area of... Read more
Area of injection site has become very large, swollen, hot to touch, and firm in the middle; Area of injection site has become very large, swollen, hot to touch, and firm in the middle; Area of injection site has become very large, swollen, hot to touch, and firm in the middle; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 53-year-old female patient received second dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on her left arm on 17Jan2021 12:45 at single dose for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included piroxicam (PAXIL), thyroid (ARMOUR THYROID), both from an unspecified date for unspecified indication. The patient previously took the first dose of bnt162b2 on 27Dec2020 at 01:00 PM on her left arm for covid-19 immunisation. On 17Jan2021 at 14:00, the patient experienced that the area of injection site has become very large, swollen, hot to touch, and firm in the middle. The events were reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
53 2021-02-04 itchy skin Headache 3-5/10 for DAYS 1-5 Itchiness of the face, scalp and right hand DAYS 1-5 Itchiness of lips... Read more
Headache 3-5/10 for DAYS 1-5 Itchiness of the face, scalp and right hand DAYS 1-5 Itchiness of lips and tongue DAY 1 and DAY 5 Bilateral Hip and Knee pain DAYS 1 and DAYS 3-5 Flank Pain DAYS 3-5
53 2021-02-04 injection site pain Injection site pain radiating down into the elbow, up the shoulder and into the neck. L arm was sore... Read more
Injection site pain radiating down into the elbow, up the shoulder and into the neck. L arm was sore first week but worsened the 2nd week and is not having mobility issues with terrible constant pan.
53 2021-02-04 injection site warmth, injection site redness, injection site mass, injection site pruritus, injection site rash Nausea, headache, severe muscular and joint aches, night sweats, weird dreams, golf ball size red c... Read more
Nausea, headache, severe muscular and joint aches, night sweats, weird dreams, golf ball size red circle at injection site warm to touch, itchy with lump under skin.
53 2021-02-04 itchy rash, rash Slightly itchy and painful generalized rash around my entire torso and up my neck. Some itchiness i... Read more
Slightly itchy and painful generalized rash around my entire torso and up my neck. Some itchiness in my limbs but no visible rash. Pt took Benadryl 25mg PO without any relief. 5 Feb: rash is spreading around chest area lower abdomen and around back side. No reports of dyspnea.
53 2021-02-05 itchy skin, skin warm Very sore Large itchy lump size of egg on day 3 LRge itch lump size of baseball day 4 Hot to the to... Read more
Very sore Large itchy lump size of egg on day 3 LRge itch lump size of baseball day 4 Hot to the touch
53 2021-02-06 hair loss After the first dose of the Pfizer COVID-19 vaccine on 1/13/21 I notice some thinning of my hair. Af... Read more
After the first dose of the Pfizer COVID-19 vaccine on 1/13/21 I notice some thinning of my hair. After the second dose on 2/3/21 my hair loss accelerated dramatically. It is unknown whether I will go completely bald and/if hair will regrow.
53 2021-02-07 rash, hives 2 day after getting the Pfizer vaccination, I broke out in hives and rashes all over my entire body.... Read more
2 day after getting the Pfizer vaccination, I broke out in hives and rashes all over my entire body. There was NOTHING abnormal prior to the shot.
53 2021-02-07 injection site redness, injection site swelling After second dose chills after 24 hours, severe abdominal pain, aches, swelling and redness to left... Read more
After second dose chills after 24 hours, severe abdominal pain, aches, swelling and redness to left arm, extreme fatigue
53 2021-02-07 hives Developed acute hives followed by itching of the throat. Epinephrine auto injector 0.3mg administer... Read more
Developed acute hives followed by itching of the throat. Epinephrine auto injector 0.3mg administered IM. Patient remained stable. EMS called, evaluated patient. Patient declined transport.
53 2021-02-07 itchy skin SWELLING OF THE FACE AROUND BOTH EYES WITH ITCHING AND LIPS SWOLLEN AROUND SUNDAY MORNING AT 2:00 ... Read more
SWELLING OF THE FACE AROUND BOTH EYES WITH ITCHING AND LIPS SWOLLEN AROUND SUNDAY MORNING AT 2:00 AND BECAME WORSE LATER THAT MORNING. EXTREME TIREDNESS. TOOK BENADRYL TO RELIEVE THE ITCHING AND SWELLING.
53 2021-02-07 rash, vaccination site pain fatigue; chills; headache; a rash from her face to her waist; fever; pain at injection site; This is... Read more
fatigue; chills; headache; a rash from her face to her waist; fever; pain at injection site; This is a spontaneous report from a contactable nurse reporting for herself. A 53-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: not reported), via an unspecified route of administration on 20Jan2021 at a single dose on the right arm for COVID-19 immunization. Medical history included gluten sensitivity; she develops a rash when she eats gluten. Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was either EJ7685 or EJ1685, expiry date: not reported), via an unspecified route of administration on 30Dec2020 at a single dose on right deltoid for COVID-19 immunization and experienced pain at injection site; patient was 53-year-old at the time of vaccination. The patient received the second dose of the COVID vaccine on 20Jan2021. On 21Jan2021, she experienced fatigue, fever, chills, headache, which have resolved. However, on 21Jan2021 later in the evening she broke out in a rash. She reported that she is gluten sensitive. She asked if there is any gluten involved in the 2nd dose and if they do grow anything for the serum that might be gluten contained. The patient also experienced pain at injection site with second dose on 21Jan2021. She experienced fever, chills, headache and fatigue. She has a rash from her face to her waist. She has a gluten sensitivity and develops a rash when she eats gluten. She didn't see it on the information sheet. She is wondering if any aspect of the vaccine was grown containing grain. She will be seeing her doctor on Monday. She has a fever where she takes her temperature on the skin that is elevated with the rash. She does not have a fever on the areas that she does not have a rash. She noticed the rash late on 21Jan2021. She had a long sleeve on during the day. She still has chills at night. The patient reported the events as non-serious. Outcome of the event fatigue was recovered on 22Jan2021, of headache was recovered on an unspecified date, in Jan2021 of chills and pain at injection site was recovering, while outcome of other events was unknown.
53 2021-02-07 vaccination site pain sore arm at vaccination site; This is a spontaneous report from a contactable consumer (patient). A... Read more
sore arm at vaccination site; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (BNT162B2), lot number: EL1283, via an unspecified route of administration Left arm from 23Jan2021 14:15 to 23Jan2021 14:15 at SINGLE DOSE (first dose) for COVID-19 immunisation. Medical history included asthma and penicillin allergy. Concomitant medication included montelukast sodium 10 mg tab, fluticasone propionate, salmeterol xinafoate (ADVAIR), albuterol [SALBUTAMOL]. The patient experienced sore arm at vaccination site on 23Jan2021 15:00 with outcome of recovering. The patient is not pregnant at the time of vaccination. No treatment was received for the event.
53 2021-02-08 itchy rash, rash 2/5/2021 S/O: Patient endorses 2-day history of rash of trunk, lower extremities, feet. Rash is pru... Read more
2/5/2021 S/O: Patient endorses 2-day history of rash of trunk, lower extremities, feet. Rash is pruritic. Started on torso and then spread peripherally to involve back, legs. Spares face. Itching improved with Benadryl. She is 10 days status post second dose of COVID-19 vaccine. She denies lip/tongue swelling, fever, chills, cough, wheezing, dyspnea. Patient denies any history of allergies or adverse vaccine reactions. A/P: 1. Chilblain-like lesions of multiple toes R23.8 -Rash concerning for pseudochilblains associated with COVID-19 infection. -Patient otherwise with no signs of Covid infection. -Suspect adverse drug reaction to vaccine. -We will send patient for PCR testing to rule out active infection. 2. Pruritic rash L28.2 -Suspect drug reaction. Recommend continue antihistamine twice BID. -Rx Medrol Dosepak 2/6/2021 COVID Test Negative 2/8/2021 Patient states her rash is gone, toes are improving, and Medrol Dosepak is working well.
53 2021-02-08 injection site warmth, injection site nodule, injection site redness, injection site pain, injection site pruritus After receiving my vaccine, I had the normal arm soreness and low grade fever but the following day ... Read more
After receiving my vaccine, I had the normal arm soreness and low grade fever but the following day my fever went up to 102 even after taking Advil every 6 hours. On the 3rd day my arm continued to be sore and my fever continued but was between 100.7 and 101.4. On day 4 my fever started going down to 99 for the day but my arm continued to be sore where the injection was and my armpit was sore as well like something was swollen. Day 5, today, my fever finally broke but my arm has a red circle and knot where the injection was given, its still very sore and also itches and warm to the touch. Every time I raise it up, I get shooting needles in the area of the shot. I have severe fatigue and sweats when I get up to walk anywhere and I feel exhausted. I called and spoke to the nurse who spoke to my Dr. listed on this form. She told me all of my symptoms were normal and said that if I started throwing up or my arm got worse to call back. I was not asked to come in to have anyone look at my arm or see if there is something else going on with the symptoms I am having.
53 2021-02-08 shingles Full blown case of facial Shingles, involving right eye, right ear, and scalp can send pictures if ... Read more
Full blown case of facial Shingles, involving right eye, right ear, and scalp can send pictures if you wish
53 2021-02-08 injection site pain her voice is still a little raspy; had a hard time speaking; fibrillation in her heart, and that fel... Read more
her voice is still a little raspy; had a hard time speaking; fibrillation in her heart, and that felt rapid; fatigue/tired; sluggish; nausea; she was not feeling well; Dry throat; injection site pain; This is a spontaneous report from a contactable consumer reporting for self. This 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1280) on 24Jan2021 at 0.3 ml single by injection to left upper arm for COVID-19 immunisation (reported as works in assisted living). Medical history and concomitant medications were not reported. The patient received the vaccine on 24Jan2021, Sunday morning, then 6 hours after started feeling injection site pain, it was really sore, but she packed it with ice that night and it was very slight now. She worked the following morning (25Jan2021), and was sluggish, fatigue, and tired. Also nausea (started in the afternoon), it was slight, she was not feeling well. She experienced fibrillation in her heart, and that felt rapid, that comes and goes. Also dry throat on 25Jan2021, not sore, just dry. Her voice was still a little raspy, not like it was yesterday, she had a hard time speaking, when talk and dry throat. The outcome of injection site pain was recovering, sluggish, fatigue/tired, nausea was not recovered, outcome of other events was unknown.
53 2021-02-09 vaccination site pain Chills; Body aches; Injection arm began to hurt; Body tremble; Armpit very painful; Arm pit swelling... Read more
Chills; Body aches; Injection arm began to hurt; Body tremble; Armpit very painful; Arm pit swelling; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 23Jan2021 (11:45) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included early diabetes and high blood pressure. Concomitant medications included valsartan, sitagliptin (JANUVIA) and rosuvastatin. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140; Expiration date was not reported) on 02Jan2021 (when the patient was 53 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 23Jan2021 (19:00), the patient had chills; body aches; injection arm had begun to hurt; body tremble; armpit was very painful; and armpit was swelling. The patient had no fever. The patient had taken paracetamol (TYLENOL) as treatment for the reported events. The outcome of the events, 'chills', 'body aches', 'injection arm had begun to hurt', 'body tremble', 'armpit was very painful' and 'armpit was swelling', was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested post-vaccination.
53 2021-02-09 vaccination site pain Moderate-severe pain in her large leg muscles; moderate pain in arm at injection site for a few days... Read more
Moderate-severe pain in her large leg muscles; moderate pain in arm at injection site for a few days; This is a spontaneous report from a non-contactable nurse (patient) received via a Pfizer sales representative. A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Dec2020 and experienced moderate pain at injection site and fatigue. In Jan2021, the patient experienced moderate-severe pain in her large leg muscles for at least 24 hours and moderate pain in arm at injection site for a few days. The patient outcome of the events was recovering. No follow-up attempts are possible, information about batch number cannot be obtained.
53 2021-02-09 vaccination site pain pain at injection site from first dose; This is a spontaneous report from a contactable Nurse (patie... Read more
pain at injection site from first dose; This is a spontaneous report from a contactable Nurse (patient). A 53-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Lot # either EJ7685 or EJ1685) at single dose at right deltoid on 30Dec2020 for Covid-19 immunisation. Medical history included gluten sensitivity and developed a rash when she ate gluten. The patient's concomitant medications were not reported. The patient experienced pain at injection site from 1st dose on 31Dec2020. The outcome of event was recovered on 02Jan2021. Information about Batch/Lot number has been requested.
53 2021-02-10 redness There is a little redness around it, but it hasn't went into bruising yet.; in between her shoulder ... Read more
There is a little redness around it, but it hasn't went into bruising yet.; in between her shoulder and neck area a nodule that is about 2cm in diameter. It is hard and painful; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunization (based on contact with COVID positive patients). The patient had no medical history. There were no concomitant medications. She got the initial injection 06Jan2021 (at the age of 53 years old), in her upper left arm. Two days later, she noticed a huge bruise. She had bruising on various parts of body. The first bruise she noticed on the 08Jan2021. It was probably about 3.5 in. in length 2 in. in width. It didn't necessarily have a shape. She had a large bruise on her right buttock. Two days later, she noticed a similar in size bruise on the front of her right thigh. Then a a couple days later, she noticed three quarter size bruises on her right arm (2 on the inner part of arm, and 1 on the outer, both on upper arm). The very next day, she developed the same sizing bruise. It was about the same size on her left upper arm. Just the one. There were no other side effects besides the bruising. There was no itching or redness, no skin, respiratory, or neurological issues. She received the 2nd vaccine yesterday, 27Jan2021. She didn't have a prescribing doctor. She got it based on contact with COVID positive patients. The day before the vaccine, 26Jan2021, she noticed a 4 inch reddened area with a two centimeter nodule inside that bruise. Today (28Jan2021), the day after the vaccine, she now has, on her left side, in between her shoulder and neck area a nodule that was about 2cm in diameter. It was hard and painful. There was a little redness around it, but it hasn't went into bruising yet. This is how the other ones started. There was a little redness and a bruise appeared. All of the bruises didn't have nodules. The nodule is present now. The initial bruises have begun to heal. They were not as dark as they were. The one that was noticed the day before yesterday is beginning to darken. They started out red and then turn black and blue. The one she noticed today 28Jan2021 is just the nodule. No discoloring has occurred yet. She can't answer seriousness yet because she doesn't know how serious it is yet. She also had numbness and tingling in her right thumb and was having some chest discomfort after the initial injection that is still ongoing. That chest discomfort prompted her to go to urgent care on 08Jan2021. She had an abnormal EKG 08Jan2021. They told her to follow up with a cardiologist so she did. She saw the cardiologist on Monday 25Jan2021. He did an EKG and ECHO. The EKG was abnormal, but the doctor was unable to determine when the heart attack occurred. He also ran labs. He did a Troponin to see if anything was acutely going on, and a D Dimer to evaluate her clotting factors. Both were negative. He recommended a CT scan. She is scheduled for a CT scan this Saturday for a Heart Coronary Calcium Score testing. Causality was not provided by the patient and was also unable to provide seriousness. The outcome of the events was unknown. Information on the lot/batch number has been requested.
53 2021-02-11 hives PATIENT REPORTED SYNCOPE TO CHILDHOOD IMM., BUT NOT RECENT FLU SHOT. PATIENT WAS OBSERVED TO BE FINE... Read more
PATIENT REPORTED SYNCOPE TO CHILDHOOD IMM., BUT NOT RECENT FLU SHOT. PATIENT WAS OBSERVED TO BE FINE FOR 20 MINUTES POST-VACC. SHE WAS ON HER WAY HOME AT 50 MINS. POST-VAC WHEN SHE BECAME UNCONSCIOUS, UNRESPONSIVE, & PRESENTED W/HIVES. SHE WAS TREATED AT EMERG. DEPT. AFTER 90 MIN, SHE IS CONSCIOUS & IMPROVING.
53 2021-02-14 injection site pain Initially, soreness around injection site. Backaches. Then the next few days, I realized, I was havi... Read more
Initially, soreness around injection site. Backaches. Then the next few days, I realized, I was having a flare up of sjogrens. Dry mouth and dry eyes were worse. Dry cough, chest discomfort was the most difficult to deal with and GERD issues got worse
53 2021-02-14 rash Rash, lightheadedness, weakness and tingling, throat closing, elevated blood pressure
53 2021-02-14 redness, skin discolouration Started pink about 1cm first day post. 3cm second day post. Fifth day post was 8cm-10cm and 9n sixth... Read more
Started pink about 1cm first day post. 3cm second day post. Fifth day post was 8cm-10cm and 9n sixth day post was grayish with red ring around it. I have pictures.
53 2021-02-14 bruising, skin mass, redness reddened area with bruising with nodule; reddened area with bruising with nodule; numbness and tingl... Read more
reddened area with bruising with nodule; reddened area with bruising with nodule; numbness and tingling in right thumb; numbness and tingling in right thumb; EKG abnormal; large bruise on right buttock/right thigh/right arm; Chest discomfort; Heart attack; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 06Jan2021 (at the age of 53-years-old) at a single dose for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient experienced electrocardiogram (EKG) abnormal and large bruise on right buttock/right thigh/right arm on 08Jan2021; numbness and tingling in right thumb on 10Jan2021; reddened area with bruising with nodule on 26Jan2021; chest discomfort and heart attack in Jan2021. The clinical course was reported as follows: Two days later after vaccination, she noticed bruising on various parts of body. The first bruise she noticed on the 08Jan2021. It was probably about 3.5 inches in length 2 inches in width. The patient stated that it did not necessarily have a shape. She had a large bruise on her right buttock. Two days later, she noticed a similar in size bruise on the front of her right thigh. Then a couple days later, she noticed three quarter size bruises on her right arm (two on the inner part of arm, and one on the outer, both on upper arm). The very next day, she developed the same sizing bruise. It was about the same size on her left upper arm. There were no other side effects besides the bruising. There was no itching or redness, no skin, respiratory, or neurological issues. The day before her second dose, on 26Jan2021, she noticed a 4 inch reddened area with a two centimeter nodule inside that bruise. The patient stated that the initial bruises began to heal. They are not as dark as they were. They were reported to have started out red and then turned black and blue. The patient also had numbness and tingling in her right thumb. She was having some chest discomfort after the initial vaccination that is still ongoing. The chest discomfort prompted her to go to urgent care on 08Jan2021, where she had an abnormal EKG on 08Jan2021. The patient was told to follow up with a cardiologist. The patient saw the cardiologist on 25Jan2021, where he did an EKG and ECHO. The EKG was abnormal and ECHO with unknown results on 25Jan2021, but the doctor was unable to determine when the heart attack occurred. The cardiologist also ran labs: a troponin to see if anything was acutely going on, and a D Dimer to evaluate her clotting factors; both were negative on 25Jan2021. The cardiologist recommended a computerised tomogram (CT) scan, which was still scheduled at the time of report. The clinical outcome of large bruise on right buttock/right thigh/right arm, chest discomfort, numbness and tingling in right thumb, and reddened area with bruising with nodule was not recovered and of heart attack and EKG abnormal was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
53 2021-02-15 rash Immediate dizzy, nausea, malaise, fatigue; After 72 hours painful chapped lips, canker sore and blee... Read more
Immediate dizzy, nausea, malaise, fatigue; After 72 hours painful chapped lips, canker sore and bleeding gums. Rash on chest area.
53 2021-02-17 vaccination site pain Injection site was moderately sore; I felt extremely tired and fatigued; chilled to the bone alterna... Read more
Injection site was moderately sore; I felt extremely tired and fatigued; chilled to the bone alternating with hot spells; This is a spontaneous report from a contactable consumer. A 53-year-old female consumer reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL8982), into the left arm on 29Jan2021 at 10:30 at single dose for COVID-19 immunization. Age at vaccination 53 Years. The patient had received first dose of BNT162B2 on 09Jan2021. The patient had no allergies to medications, food, or other products. Medical history was none. Concomitant drugs included Prozac daily and Lyrica one daily. The patient reported that the injection site was moderately sore. The main side effect started 24 hours post shot. She felt extremely tired and fatigued as well as chilled to the bone alternating with hot spells. No body aches. No other effects. No treatment was received. Resolved in 24 hours.
53 2021-02-17 vaccination site pain This is a spontaneous report from a non-contactable nurse (patient herself). This 53-year-old female... Read more
This is a spontaneous report from a non-contactable nurse (patient herself). This 53-year-old female nurse received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, in Dec2020 at a single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. After the first shot she had moderate pain at injection site for a few days, and fatigue for at least one day. The events were assessed as non-serious. Both events resolved on unknown date. No follow-up attempts are possible. No further information is expected. Information about lot/batch cannot be obtained.
53 2021-02-18 rash A rash occurred 1 hour after administration of the vaccine, started on my left arm and progressed to... Read more
A rash occurred 1 hour after administration of the vaccine, started on my left arm and progressed to my head and torso and arms. Went to urgent care which gave me prednisone to take for 4 consecutive days and to take Benadryl with the prednisone
53 2021-02-18 rash, hives A rash/hives that started on my left arm and progressed to both hands and arms then my torso, (front... Read more
A rash/hives that started on my left arm and progressed to both hands and arms then my torso, (front and back), head and ears. I went to urgent care and they gave me a prescription for prednisone and also take over the counter Benadryl for 4 days.
53 2021-02-18 itchy skin Initially experienced severe B elbow pain on anterior side that resolved within 48 hours. Noted that... Read more
Initially experienced severe B elbow pain on anterior side that resolved within 48 hours. Noted that clothing seemed tight- especially underwear, bras, and shirts, arms and breasts visibly swollen on both sides. Breasts itchy. Some shortness of breath noticed that was surprising x3 during week. I am 1 week post vaccine and put 2+2 together this AM. Initially thought that I must have put something in the dryer for too long, but EVERYTHING fits tightly. I recently had shoulder surgery and purchased clothing that was loosely fitting and It is now tight. My BP on home machine is 133/86, which is generally normal for me. No fever. Fatigued all week that could be attributed to this or heavy workload. Generally feel good. Distal extremities normal in size.
53 2021-02-21 injection site mass, injection site swelling, injection site pain About 12 hours later I had a mild headache, body aches, chills that lasted another 18 hours. 36 hour... Read more
About 12 hours later I had a mild headache, body aches, chills that lasted another 18 hours. 36 hours after the shot I felt a lump under my left armpit and there was visible swelling about the length of my fist. The lump was sore and pain could be felt with touch and with squeezing my arms across my breasts. 4 days after the shot, the lump under my arm isn't very painful but there is still some swelling.
53 2021-02-22 hives, redness, itchy skin 1st vaccine: Patient reports hives 4-6 hrs later, took Benadryl, itching stopped within 24 hrs, spot... Read more
1st vaccine: Patient reports hives 4-6 hrs later, took Benadryl, itching stopped within 24 hrs, spots remained (upper calf to her knee) 2nd vaccine: talked with her doctor who agreed it was a good idea to preload with Benadryl, she stated that she took several doses for 24 hours after vaccine and thought she was still in the clear. Wed 2/17 hives started at work, itching arms and legs, noticed hives/spots left elbow, several both hips, a few more on legs near previous spots from 1st dose, both fingers swollen and red with some bumps, felt "unwell" and achy "grumpy" for 24-48 hours- took Benadryl, could not take Benadryl 2/19/21 because she had to work, itching is better 2/19 and she feels okay, spots remain.
53 2021-02-22 injection site pain 2/19/21 – 6:30 pm start feeling fatigue. Right arm carpel tunnel started twitching randomly and fre... Read more
2/19/21 – 6:30 pm start feeling fatigue. Right arm carpel tunnel started twitching randomly and frequently. This continued all evening and all the next day. 2/20/21 – Woke with fatigue, upper arm pain round injection site, muscle pain randomly over body, joint pain in previous arthritic sites. Continued all day randomly. General feeling of tiredness or unwell. Evening the pain worsed, muscles contracting around spine creating spinal pains and severe headaches. 2/21/21 – Woke feeling tired but better. 2/22/21 – In the evening started feeling pain in spine and muscles in middle to upper back and cervical region. Lymph nodes under jaws and side of neck are painful and inflamed. 2/23/21 – woke up feeling better.
53 2021-02-23 injection site pain 2/17 ; STARTED WITH CONGESTION/RUNNY NOSE AROUND 4:00 ; BY AROUND 5-6PM STARTED WITH CHILLS; HAD T... Read more
2/17 ; STARTED WITH CONGESTION/RUNNY NOSE AROUND 4:00 ; BY AROUND 5-6PM STARTED WITH CHILLS; HAD TWO BOUTS OF DIARRHEA THAT NIGHT; ARM OF INJECTION SITE HURT; WOKE UP AT 4:30 AM WITH HEADACHE ; STILL HAD CHILLS. EVERY JOINT IN BODY HURT; WOKE UP AROUND 10AM WITH CHILLS AND STILL HEADACHE; WALKING FELT LIKE MY LEGS WEIGHED 100 LBS A PIECE. I WAS VERY TIRED THE WHOLE DAY. STARTED GETTING ENERGY AROUND 7 PM ON 2/18. JOINTS STILL ACHY BUT NOT AS BAD.
53 2021-02-23 injection site pain I had pain at the injection site which started about 2 hours after the shot. (I had had this after ... Read more
I had pain at the injection site which started about 2 hours after the shot. (I had had this after the first shot as well, but it happened faster this time and was a little more severe). About 12 hours after the injection, I started to feel feverish, and went to bed - fever seemed to spike during hours 12-16 post-injection. (I did not take my temperature because I was in bed and really not feeling well.) I had chills, sweating, muscle aches, restless sleep, and a headache. I remained feverish most of the next day and had a migraine level headache the entire day; temperature reads were in the 100-101 degree range for the entire next day, until about 10pm (a full 24 hours after the onset of symptoms, 36 hours from injection.), when it went down to 99 degrees, and then finally seemed to subside.
53 2021-02-23 injection site swelling Soreness and swelling at injection site(beginning overnight) lightheadedness/dizziness, slight short... Read more
Soreness and swelling at injection site(beginning overnight) lightheadedness/dizziness, slight shortness of breath(just before noon the following day)
53 2021-02-24 itchy skin, injection site pruritus, injection site warmth Itchy hot skin at sight of injection and on both arms, hands and left shoulder turning into itchy ... Read more
Itchy hot skin at sight of injection and on both arms, hands and left shoulder turning into itchy spots with a scab in the middle. Started early morning after two days. Less itchy but still apparent. Also top of head itchy.
53 2021-02-24 redness, itchy skin, skin burning sensation, blister Pfizer COVID-19 vaccination.
53 2021-02-24 injection site pain Sharp headache, fever, muscle pain (very sharp pain in the legs), loss of appetite, stomach pain, ch... Read more
Sharp headache, fever, muscle pain (very sharp pain in the legs), loss of appetite, stomach pain, chills, sleepiness, severe pain in the arm of the vaccine, thirst, constant desire to urinate.
53 2021-02-25 hives, sensitive skin, itchy skin I received my first injection of the COVID-19 vaccine on 12/28/2020 and the second dose on 01/12/202... Read more
I received my first injection of the COVID-19 vaccine on 12/28/2020 and the second dose on 01/12/2021. Starting Friday February 5, I developed severe itching on my back that occurred during sleep only. The itching continued for the next several nights. I had to remove my bra in order to obtain any sleep. After removing the bra, the itching eventually stopped. I tried several bras, but all caused itching at bedtime only. Now, itching is occurring on other parts of my body. Hives and itching have developed on my back, chest, inner thighs and both hands. The itching is relieved by applying lotion. My skin is super sensitive to elastics (in most bras) and other items. I'm only reporting this just in case other people have experienced the same sensitivities. I don't believe the vaccine caused the itching and hives; but instead just hastened or exacerbated something already in my body.
53 2021-02-25 vaccination site pain Left arm very sore up through left neck; Left arm very sore up through left neck; This is a spontane... Read more
Left arm very sore up through left neck; Left arm very sore up through left neck; This is a spontaneous report from a contactable consumer (patient). This 53-year-old non-pregnant female patient received the first dose of BNT12B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9264) via an unknown route of administration in the left arm on 26Jan2021 (at the age of 53-years-old) at 3:30 PM as a single dose for COVID-19 immunization. The patient's medical history included hypertension and penicillin allergy, both from unknown dates and unknown if ongoing. The patient's concomitant medications included hydrochlorothiazide, valsartan (DIOVAN HCT) from an unknown date for an unknown indication; amlodipine from an unknown date for an unknown indication; fish oil from an unknown date for an unknown indication; and vitamin B complex (VITAMIN B 50) from an unknown date for an unknown indication. The patient previously took levofloxacin (LEVOQUIN) on an unknown date for an unknown indication and experienced allergies; and influenza vaccine on an unknown date for an unknown indication and experienced pain. The patient had not received any other vaccines in the 4 weeks prior to the COVID vaccine. The patient reported experiencing left arm very sore up through left neck; not red just aching and pain through the first night post injection. The patient reported being still sore on day two; much more pain than flu shot previous experience. The event was reported as non-serious and did not require hospitalization. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen. The clinical outcomes of left arm very sore up through left neck were recovering. It was also reported the patient was not diagnosed with COVID-19 prior to vaccination and that the patient had not been tested for COVID-19 since vaccination. No follow-up attempts are possible. No further information is expected.
53 2021-02-25 itchy skin Patient received vaccine at 0935 and reported approximately 10 minutes after vaccine experienced itc... Read more
Patient received vaccine at 0935 and reported approximately 10 minutes after vaccine experienced itching to arms and face, progressing to the Bilateral arms and back. Alerted observation staff @ 25 minutes and patient was taken to the first aid station. Patient denies any SOB, Swelling, no CP and Patient is A & O x 3, VSS at B/P 1238/76, HR 76, RR 18, SaO2 at 95% on RA. 1025-Itching had improved. 1030-B/P 126/68, HR 80, RR 16, SaO2:96% on RA. 1045-Itching improved but residual itching continues-repeated Benadryl 25mg Oral liquid. 11:00-Observed patient for 45 minutes and discharged patient after itching had improved with instructions for the patient to follow up with PCP. Patient communicated understanding and had no further question prior to discharge home today. 1019- Patient given Benadryl 25 mg Oral liquid.
53 2021-02-25 vaccination site mass Raised swollen lump at injection site; muscle and joint aches; muscle and joint aches; fatigue; head... Read more
Raised swollen lump at injection site; muscle and joint aches; muscle and joint aches; fatigue; headache; nausea; lack of appetite and energy; lack of appetite and energy; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 10Feb2021 13:00 at a single dose for COVID-19 immunization. Medical history included known allergies: Sulfa, High blood pressure, arthritis, obese, anxiety, depression. Concomitant medication included lamotrigine, duloxetine hydrochloride (CYMBALTA), ropinirole hydrochloride (REQUIP) and unspecified blood pressure meds. On 12Feb2021, the patient experienced raised swollen lump at injection site, muscle and joint aches, fatigue, headache and nausea, lack of appetite and energy. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Since the vaccination, the patient has been tested for COVID-19, nasal swab on 04Dec2020: negative. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was not recovered. Information on the lot/batch number has been requested.
53 2021-02-26 injection site pain About 30 minutes after the injection I had a burning sensation in the back of my throat and slight c... Read more
About 30 minutes after the injection I had a burning sensation in the back of my throat and slight congestion and wheezing that lasted about 3-4 hours but subsided after taking an antihistamine. No other symptoms or problems other that soreness at injection site the next morning.
53 2021-02-26 blister, redness Painful red blistered toes muscle aches and fatigue developed approximately 18 days after vaccine ac... Read more
Painful red blistered toes muscle aches and fatigue developed approximately 18 days after vaccine accompanied by painful sensory neuropathy. Covid test on 2/12/21 negative. Pain and rash persisted and worsened. I saw my primary doctor on 2/19/21 because my rheumatologist had left her practice. He checked my circulation and prescribed prednisone course to be taken if problem worsened. I waited another week because I am reluctant to take prednisone and was then advised by my friend who is a rheumatologist that I should go ahead with the steroid. This rash resembled the "Covid toes " phenomenon that has been reported in response to the actual Covid 19 viral infection and the neuropathic pain in my feet was very uncomfortable. I started prednisone course 40 mg QD on 2/26/21 with some improvement so far after one day.
53 2021-02-26 rash, itchy skin Rash to face, upper arms, lower back and ankles Itchiness to face, and lower back 50mg of Diphen... Read more
Rash to face, upper arms, lower back and ankles Itchiness to face, and lower back 50mg of Diphenhydramine to Right deltoid
53 2021-02-26 hardening, injection site pain These symptoms were from the 2nd dose. Tenderness at injection site, fever, body aches, vomiting, se... Read more
These symptoms were from the 2nd dose. Tenderness at injection site, fever, body aches, vomiting, severe headache, fatigue, weakness - 3 days duration
53 2021-02-27 injection site swelling, injection site pruritus Moderate and mild site swelling X7 days, itching at site. size of a quarter, raised- not as big as... Read more
Moderate and mild site swelling X7 days, itching at site. size of a quarter, raised- not as big as it was the day after vaccination (size of a small egg) pain only with pressure to sight, including laying on it itching around raised area started 2/23.
53 2021-02-28 itchy skin, rash At around 0800 am on 2/27/2021, I started experience some slight itching around my right forearm. I ... Read more
At around 0800 am on 2/27/2021, I started experience some slight itching around my right forearm. I proceeded to take my morning shower and in the shower the itchiness felt to have intensified. Within an hour of showering, I noticed the itchiness was so severe and I started developing generalized rash and hives. I took Benadryl 25 mg at around 0900am, contacted my doctor. During the break out, I was concerned that my airway might be affected, but thankfully I did not experience any throat itchiness or respiratory distress. After speaking with my doctor, I took another dose of 25mg Benadryl. I was instructed to take 50 mg of Bendaryl every 6 hours for the next 2-3 days. The rash completely resolved later in the day, around 1:00pm, but i continued to take benadryl for the next 2 days.
53 2021-02-28 injection site redness, injection site pain First muscle soreness at site of injection, then severe redness at site, cherry electric red and pin... Read more
First muscle soreness at site of injection, then severe redness at site, cherry electric red and pink, severe muscle aches, severe joint aches, severe headache, diarreah, dizzyness, the extreme rapid heart rate of 205 BPM. SEVERE SVT, SUPREVENTRICULAR TACHYCARDIA lasting from 9 p.m. Friday evening through the a.m. until I was transported from Urgent Care via Paramedics to Emergency Hospital. I was given an IV of a Medicine to restart my heart twice. I felt like I was dying.
53 2021-02-28 rash Rash face and neck; This is a spontaneous report from a contactable Other Health Professional that r... Read more
Rash face and neck; This is a spontaneous report from a contactable Other Health Professional that reported for herself. A 53-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL8982 on 22JAN2021 15:00, as single dose (at the age of 53 years) via unspecified route in left arm for COVID-19 immunisation. The patient medical history was none. Concomitant medication was not reported. The patient was not pregnant at the time of vaccination. There were no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. On 26Jan2021 at 06:00 the patient experienced Rash face and neck. The patient received treatment (Benadryl and aloe). The outcome rash face and neck are recovering. The case was reported as non-serious by the reporter.
53 2021-02-28 redness Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers in... Read more
Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL3247, unknown expiration), via an unspecified route of administration in right arm on 19Jan2021 at a single dose for COVID-19 immunization in a workplace clinic. Medical history included hypothyroidism, idiopathic thrombocytopenic purpura (ITP), and previously administered dermal fillers in Jun2020. The patient has no allergies to medications, food, or other products. Concomitant medications included levothyroxine, tamoxifen, and vitamin D. The patient also received her first dose of BNT162B2 (lot number: EJ1685, unknown expiration) for COVID-19 immunization in right arm on 29Dec2020. The patient experienced swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness on 21Jan2021. The patient received steroids and antihistamines. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient recovered from the events on unspecified date. The events were assessed as non-serious. No follow-up attempts are possible. No further information is expected.
53 2021-02-28 shingles shingles
53 2021-02-28 vaccination site pain, vaccination site swelling, vaccination site redness, vaccination site itchiness swelling and soreness at the injection site; soreness at injection site; red, and a little swollen a... Read more
swelling and soreness at the injection site; soreness at injection site; red, and a little swollen at the injection site; felt itchy at the injection site; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249 and expiry date: unknown), intramuscular on the right arm near shoulder on 19Jan2021 09:00 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. There were no other vaccine received within 4 weeks prior to COVID vaccination. After she got a tetanus shot (probably needs another since it had been ten years) her arm/ muscle was sore. Patient had typical swelling and soreness at the injection site on Jan2021that went away within a couple of days and then did not have any symptoms. Then today all of a sudden it felt sore, red, and a little swollen at the injection site again. It has been more than a week since the symptoms initially resolved and now they have reemerged. It felt itchy at the injection site, it had a raised red area that was itchy on Jan2021. She did go running this morning and has been running several times, she went running the day after she got the vaccine. Events did not require emergency room nor a visit to the physician's office, and no treatment was given. Outcome of the events was unknown.
53 2021-03-01 redness Mild tingling sensation over the arm and redness over left hand right after receiving her second dos... Read more
Mild tingling sensation over the arm and redness over left hand right after receiving her second dose of Covid 19 vaccine. Adverse reaction occurred during observation. Benadryl 2 tabs (25 mg each) oral administered. Patient observed for 45 mins. Symptoms cleared. Patient left home verbalizing feeling safe and cleared of any symptoms.
53 2021-03-02 itchy skin, hives, skin warm, redness Hives, bumps in the whole body, red and warm skin, itchy and swelling
53 2021-03-03 itchy skin, injection site pruritus Itching - left hand, injection site, and upper left back. BPs 146/91 (pulse, 86), 140/89 (pulse 76).... Read more
Itching - left hand, injection site, and upper left back. BPs 146/91 (pulse, 86), 140/89 (pulse 76). O2 sats 97%, 96%. Benadryl 25 mg PO given.
53 2021-03-03 redness, itchy skin March 2, 2021 1. At vaccination site, severe itchiness, dizzy, felt really hot, sweaty. Nurse too... Read more
March 2, 2021 1. At vaccination site, severe itchiness, dizzy, felt really hot, sweaty. Nurse took blood pressure 120 over 80. Stayed for 1/2 hour (9:10-9:41 a.m.). 2. Drove to work . All symptoms persisted, entire body turned bright red (like sunburn), extreme shaking. Checked in with school MA (nurse) . Blood pressure 140 over 80. Temperature 100. Extreme agitation and heightened senses. 3. sent me to Urgent Care seen at 11:35 a.m.. Same symptoms persisted. Blood pressure 143/94. Temperature 98.8. Was prescribed 2 Benedryl now, 1 every 4-6 hours as long as have itching. 2 at night for next 7 days. Prescribed Prednisone (10 mg) 4 one day, 4 next day - decrease dosage for 8 days. 4. Took prednisone- heightened senses, agitation increased. Migraine. Outer body exhausted, inner pure adreneline that would not decrease. March 3, 2021 1. Most symptoms lessened. Went to work . Checked in with MA (nurse) and told her that I wanted to stop the prednisone. She recommended that I take the dose. Took 4 tablets (10 mg) at 9:40 a.m. Heightened senses (light, sound, touch, taste), agitation, shakiness. brought me to in . Doctor told me to stop the prednisone as I have a history of anxiety. Exhaustion, heightened senses, agitation remained the rest of the day. March 4, 2021 1. Lessened symptoms. Four 20-minute recurrence episodes between the hours of 9 a.m. and 5 p.m.
53 2021-03-03 hives, rash, rash with redness The morning after the vaccine, patient got red hives and rashes all over face. Reduced by noon.
53 2021-03-04 itchy skin, injection site pruritus Patient c/o itchy all over.. First injection site and then all over. Red: Vitals 132/86, O2 99, P66,... Read more
Patient c/o itchy all over.. First injection site and then all over. Red: Vitals 132/86, O2 99, P66, R 13/ No c/o shortness of breath or any other issue. Given Benadryl at 920am. At 945 feeling better.
53 2021-03-04 itchy skin Patient prophylactically premedicated with 50MG/1ML Benadryl IM to right gluteus without complicatio... Read more
Patient prophylactically premedicated with 50MG/1ML Benadryl IM to right gluteus without complication due to previous covid pfizer vaccination response. Vaccine administered 1455; 1505 onset itching to right ear and scalp; 1513 symptoms ceased; 1525 continued no adverse reaction thus patient cleared to leave.
53 2021-03-05 rash papular, itchy skin, rash with redness, rash, skin warm, hives Itching on both arms and lower back/buttocks, hives and rash. Rash then extended over entire body (e... Read more
Itching on both arms and lower back/buttocks, hives and rash. Rash then extended over entire body (except for below the knees and only mildly on face). Extreme itchiness, hot to the touch, red, raised.
53 2021-03-06 injection site pain Waves of nausea every few hours for about 24h after injection. Also tenderness upon touching injecti... Read more
Waves of nausea every few hours for about 24h after injection. Also tenderness upon touching injection site for same amount of time.
53 2021-03-07 rash, injection site pain, itchy skin I took one Aleve for my arm Pain near the injection site. Then I got a Rash and itch that traveled d... Read more
I took one Aleve for my arm Pain near the injection site. Then I got a Rash and itch that traveled down my left side, my throat started to feel funny so I took a Benedryl. Then my cheeks felt like they were hot and tingly.
53 2021-03-07 redness Symptoms: throat swelling, lips swelling, face turned red, racing heart and blood pressure, feeling... Read more
Symptoms: throat swelling, lips swelling, face turned red, racing heart and blood pressure, feeling faint. This happened 10 minutes after shot was given. Benadryl shot was given in arm and didn't help and then epipen was administered. Then taken to ER and given Decadron and Pepcid. Was monitored for 4 hours and sent home.
53 2021-03-07 itchy skin This is patient's second vaccine. Within 10 minutes of vaccination, she developed generalized pruri... Read more
This is patient's second vaccine. Within 10 minutes of vaccination, she developed generalized pruritis. No rash. No progression of symptoms. After 40 minutes, itching began to abate and she was asymptomatic at 70 minutes. No intervention was required and she was discharged home with instructions to call 911 if any new symptoms. Also advised her to seek allergist evaluation prior to any more mRNA vaccines.
53 2021-03-08 rash, hives 12 hours after receiving vaccine, rash appeared on lower legs with raised welts. This lasted 9 days.... Read more
12 hours after receiving vaccine, rash appeared on lower legs with raised welts. This lasted 9 days. 16 hours after vaccine, wheezing, chest tightness and throat tightness which improved after 4 days using Benadryl and Pepcid. Visited Dr. on 2/12/2021 and was prescribed an Epi pen, oral and topical steroids.
53 2021-03-08 itchy skin Vaccine was admin. at 1310 via LPN. Pt. then waited until 1325 in the clinic waiting room per Protoc... Read more
Vaccine was admin. at 1310 via LPN. Pt. then waited until 1325 in the clinic waiting room per Protocol for observation of serious adverse reaction to vaccine. At 1325, pt. reported feeling well and left the clinic. After returning to her private vehicle from vaccine clinic, pt. states that she noticed her face was flushed and her tongue "felt funny." At 1337, the pt. returned to the front entrance of hospital reporting that she thought she may be having a reaction to the vaccine. Pt. was immediately taken to the ED for evaluation. According to the patient, she was given 50 mg IV Benadryl and observed for a short time. Her symptoms of tongue swelling, itchiness with no hives, mild numbness/tingling in extremities bilat., tingling at top of head all resolved. Pt. was then discharged to home with a prescription for Prednisone and instructed to return to ED with any new/worsening symptoms. Pt. also instructed to f/u with PCP regarding advice for admin. regarding second dose of Covid-19 vaccine.
53 2021-03-08 injection site pain Within First 15 minutes neck and shoulder pain on side of injection site Injection site soreness in... Read more
Within First 15 minutes neck and shoulder pain on side of injection site Injection site soreness in right arm and shoulder Nausea Headache Aggression/frustration
53 2021-03-09 injection site mass Starting shortly after the injection she had severe left arm pain. Symptoms have varied over the las... Read more
Starting shortly after the injection she had severe left arm pain. Symptoms have varied over the last 2 months, but she has noticed decreased ROM in the shoulder, pain sleeping on the left side at night, a lump at the site of the injection and ongoing pain. She has taken Aleve and ibuprofen intermittently with some relief.
53 2021-03-09 redness Throat felt scratchy gave 50mg/mL IM benadryl. Face swelled up and turned red and her chest hurt. ... Read more
Throat felt scratchy gave 50mg/mL IM benadryl. Face swelled up and turned red and her chest hurt. Gave 0.3mg epipen vastus lateralis. Brought patient to ER via wheelchair
53 2021-03-09 rash the next morning I discovered a rash about 3-6 inches long on my arm that spread to my chest and rib... Read more
the next morning I discovered a rash about 3-6 inches long on my arm that spread to my chest and ribcage and on the inside of my arm and possibly my back. low grade fever 99.1. fatigued. the rash is quite possibly in my eye. (feels like pink eye or a sty)
53 2021-03-10 injection site swelling, injection site redness, injection site pruritus, injection site pain Swelling. Redness pain itchy at injection site
53 2021-03-10 injection site pain injection pain, nausea, dizziness, headache immediately following injection pain, swelling in undera... Read more
injection pain, nausea, dizziness, headache immediately following injection pain, swelling in underarm 2 days following injection Continues to be problematic
53 2021-03-10 injection site pain pain and swelling in underarm area of same arm where received vaccination. This started approximatel... Read more
pain and swelling in underarm area of same arm where received vaccination. This started approximately 36 hours after vaccination. Has continued for more than 24 hours. Still swollen and sore at this time. Injection site is also still sore, but not severe, and no swelling or redness at the injection site.
53 2021-03-10 hives patient chest broke out in hives. gave 10ml benadryl and hives went down
53 2021-03-11 itchy skin Flushed face, neck and itchy face(8 hours) started 30min. after vaccination Fever(48hours) starting ... Read more
Flushed face, neck and itchy face(8 hours) started 30min. after vaccination Fever(48hours) starting 03/07/2021 Body aches(48 hours) Chills(48 hours) starting 03/07/2021 Severe Headache(36 hours) started 30 min. after vaccination.
53 2021-03-11 itchy skin Itching all over, while being evaluated by EMS, patient began seizing-transported to nearest ER.
53 2021-03-11 rash, rash papular, hives, itchy skin MONDAY MARCH 8, 2021 , had itching and hives on back, thighs, legs , arms and stomach. They would co... Read more
MONDAY MARCH 8, 2021 , had itching and hives on back, thighs, legs , arms and stomach. They would come and go. On Tuesday it contined and the bumps on legs and thighs were raised. Went to clinic, where I was given a prednisone shot and it helped. All hives cleared within 24 hours. Today March 12th saw my regular doctor and he suggested I report incident. To see if 2nd dose should be administered on schedule.
53 2021-03-11 injection site pain Pain at the injection site?pain and weakness all over?feel the cold
53 2021-03-11 injection site pruritus Patient experienced itching on right arm she took diphenhydramine about 15 minutes after the vaccina... Read more
Patient experienced itching on right arm she took diphenhydramine about 15 minutes after the vaccination.. EMS was called vitals HR 88 BP 183/100 sitting BP 182/78 standing. Patient waited in garage 10 minutes to see if symptoms resolve. Released against medical advise.
53 2021-03-11 rash, itchy rash Rash on leg and arms itching and bumpy
53 2021-03-11 injection site pain Severe soreness, pain at injection site started 10 hours post vaccination , dull aching, low grade f... Read more
Severe soreness, pain at injection site started 10 hours post vaccination , dull aching, low grade fever (101), chills, exhaustion, headache started 17 hours post vaccination. Treatment included rest, drinking fluids, Tylenol.
53 2021-03-12 rash macular I woke up today with an unusual headache very early. Around 2 hours later when I went to take a sho... Read more
I woke up today with an unusual headache very early. Around 2 hours later when I went to take a shower, I noticed an unusual, splotchy rash on my left knee. I have CRPS in this limb and initially assumed it had something to do with that, but once I inquired in my support group I was shown pictures and articles of rashes much like mine as a sign of CRPS. I have had a stuffy nose since before my vaccine and it was just that (had a negative covid test). I schedule a test for 12:51 today.
53 2021-03-12 rash Rash covering both arms, has continued to spread and worsen after 2nd shot, starting to spread to ot... Read more
Rash covering both arms, has continued to spread and worsen after 2nd shot, starting to spread to other parts of body.
53 2021-03-12 injection site pain headache and fatigue for 24 hours Pain in my underarm for 5 days Injection site pain for 2 days musc... Read more
headache and fatigue for 24 hours Pain in my underarm for 5 days Injection site pain for 2 days muscle sorness for 3 days
53 2021-03-13 injection site pain, redness It was painful the injection at all point but I didn?t complaint as I was able to support the paint ... Read more
It was painful the injection at all point but I didn?t complaint as I was able to support the paint in my 15 min wait my pain in the arm was what I consider strong but still able to support, 25 min after the injection I started hot flash and redness in face and neck, The reaction was only 5% of the reaction I experimented with Chemo so I knew I was ok and I did not have to run to the medical center again. In the hour after the injection the paint in the arm intensified and it was from the base of the neck to the lower back, during the weekend I lost some moved of my arm and I took Tylenol every 8 hours as per the post vaccine indicator, and slept a lot as I was too tired and having a little of running nose, by the Monday (72 hrs) w Most of the hot flashes and running nose stopped and the pain was under my pain threshold and I managed to reduce Tylenol only to one before bed time, however last night pain intensity and arm movement reduce again. i will be calling my primary doctor on Monday to review
53 2021-03-14 rash with redness, itchy skin, rash papular, rash I received the 1st vaccine on March 4th. Only had a sore arm. Then on March 10th I woke up before 2:... Read more
I received the 1st vaccine on March 4th. Only had a sore arm. Then on March 10th I woke up before 2:00 that morning itching all over. At 6:30 am I was covered in painful rash from behind my knees to my shoulders. It itches and hurts. I went to immediate care at which time they gave me a steroid shot, antihistamine tablets and a cream. Today it got so painful I went back to immediate care and was given a shot of epinephrine and given an epipen. The rash is raised and deep red. Very itchy and painful. It is now on my hands as well and they are stiff and swollen. Both doctors that I seen suggested going to regular physician before taking second dose of vaccine
53 2021-03-14 rash macular Patient felt mouth tingling with 1st dose & red scattered rash next day. After second dose next day... Read more
Patient felt mouth tingling with 1st dose & red scattered rash next day. After second dose next day symptoms of body aches/joint pain, severe headache, neck back pain, fever 101. Heart palpitations.
53 2021-03-14 hives Started with migraine, fever, chills after three hours of injection, night two same, night three sam... Read more
Started with migraine, fever, chills after three hours of injection, night two same, night three same, four night histamine levels were high and developed hives on back and chest area, fever, five night same, sixth night shortness of breath, fever, seventh night shortness breath, fever. Night eight same, tenth day went to urgent care x-ray lung had fluid and pneumonia . 12 day blood pressure was 80/50 and admitted in ER.
53 2021-03-14 vaccination site pain also developed a minor runny nose/occasional nasal congestion that has persisted for at least 3 days... Read more
also developed a minor runny nose/occasional nasal congestion that has persisted for at least 3 days (this might also be due to extreme cold weather in my area currently); also developed a minor runny nose/occasional nasal congestion that has persisted for at least 3 days (this might also be due to extreme cold weather in my area currently); mild pain/soreness at the site of injection evening and following day post vaccination; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration (at the age of 53-years-old) on 27Jan2021 11:30 at a single dose in left arm for COVID-19 immunization. Medical history type 2 diabetes. Concomitant medication included metformin (METFORMIN), colecalciferol (VITAMIN D), omega-3 fatty acids (OMEGA-3 FATTY ACIDS), multivitamins with minerals [umbrella term] (CENTRUM) and ''tumeric". The patient previously took azithromycin and experienced drug allergies. The patient experienced mild pain/soreness at the site of injection evening and following day post vaccination, on 27Jan2021 23:00, also developed a minor runny nose/occasional nasal congestion that has persisted for at least 3 days (this might also be due to extreme cold weather in my area currently) on 28Jan2021. No treatment received for the adverse events. The outcome of the events was recovered. The events were assessed as non-serious. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was at Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
53 2021-03-15 injection site redness, itchy skin 3/9/21: 1:05pm: Nerve-like pain immediately neck to fingertip. 5pm--extreme arm soreness for 3 days;... Read more
3/9/21: 1:05pm: Nerve-like pain immediately neck to fingertip. 5pm--extreme arm soreness for 3 days; less extreme soreness still present at 7 days. 3/10/21: 2am: fever, chills, body aches, headache, fatigue, weakness for 48 hours. 3/13/21: golf ball sized redness at site of shot, intermittent itchiness/soreness
53 2021-03-15 rash with redness, itchy rash Burning in the arm of injection. Slight red rash, itchy. Tingly lips, fever, headache. Went away in ... Read more
Burning in the arm of injection. Slight red rash, itchy. Tingly lips, fever, headache. Went away in two days
53 2021-03-15 itchy skin, rash Rash (mild) arms and back. Itchy. Evaluated by EMS- Refusal to Transport
53 2021-03-15 rash, itchy skin Small bumps covering both legs front and back. Painless. Colorless with some mild itching.
53 2021-03-15 hives, itchy skin, rash The patient is having severe allergic reactions all over her body with lots of hypes. This started o... Read more
The patient is having severe allergic reactions all over her body with lots of hypes. This started on 3/12/2021 around 7 PM. The patient was then given Benadryl allergy over the counter medication along with calamine lotion to help with the rashes and itchiness. We tried giving the same medication for 36 hours after that we decided to take the patient to Urgent care on 3/14/2021. The doctor took a look at the patient and prescribed prednisolone storied to help the patient with rashes and hypes. Till today 3/16/2021 the patient is still suffering from the same severe allergic reaction. The Patient doesn't have insurance and also has low income she is worried about the expenses that's costing her now.
53 2021-03-16 injection site pain As soon as I got to my car in the parking garage my left knee started hurting, like aching. Went to... Read more
As soon as I got to my car in the parking garage my left knee started hurting, like aching. Went to the store when I got home my left ankle and the top of my left foot started to hurt. Fell asleep took a nap and woke up and my whole body hurt left arm was really hurting. Woke up Sunday morning and whole body hurt X10! Back, knees, hands, wrists, fingers, shoulders, shoulder blades, neck, left arm. Woke up Monday and could hardly move right arm and this is Wednesday and it still hurts, hands and wrists still ache, not as bad but still do. It seems like it really got to my joints, which I already have issues with but since the shot the issues have increased X10.
53 2021-03-16 injection site pain Pain at the site , sore throat chill
53 2021-03-16 redness Patient received Pfizer vaccine at 1526. Patient at 1535 started to c/o of scratchy/tingling throat... Read more
Patient received Pfizer vaccine at 1526. Patient at 1535 started to c/o of scratchy/tingling throat. Patient verbalizing well. Skin color perfused. Lead site RN at bedside. 1540 Vital signs BP 120/70, P85, R 20 pulse ox 97 percent. Patient states no history of allergies, calming reassuring patient. Patient states it might be anxiety. Breath sound auscuctated clear bilaterally. 1550: Education to patient by RN. Patient to be observed for 30 minutes. Patent refused 911 call. Patient drinking water. Patient states no distress, discomfort to throat resolved. 1556 BP 120/88, P74, R16, pulse ox 98 percent. 1605: Patient given education- instructed if any reoccurrence to call 911. Patient states understanding. Patient signed to understanding. Patient remains awake, alert, oriented x 4. Skin color perfused w/d to touch. Patient ambulatory on discharge with steady gait.
53 2021-03-17 itchy skin Hallucinating; I feel like my body is having a Allergic reaction; lot of pain all over my body; chil... Read more
Hallucinating; I feel like my body is having a Allergic reaction; lot of pain all over my body; chills; funny taste; dizziness; itchy feelings; tired; discomfort; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6202, expiry date not reported), via an unspecified route of administration administered in arm right on 26Feb2021 14:00 as single dose for covid-19 immunisation. Medical history included hypertension and known allergies: arrhythmia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced hallucinating, lot of pain all over her body, chills, funny taste, discomfort, dizziness and feel like her body is having a allergic reaction and itchy feelings and tired on 27Feb2021 01:00. The patient did not recover from the events.
53 2021-03-17 itchy skin My eyes, face and neck were very swollen. My eyes hurt really bad and my vision was blurry. Face a... Read more
My eyes, face and neck were very swollen. My eyes hurt really bad and my vision was blurry. Face and neck itchy.
53 2021-03-18 hives, rash Bumps on left arm and part of my back. Turned into small welts. Benadryl was used for the itching an... Read more
Bumps on left arm and part of my back. Turned into small welts. Benadryl was used for the itching and ice. I called Teledoc and send photos. Methylprednisolone was prescribed.
53 2021-03-19 injection site redness, injection site inflammation, injection site pruritus, injection site warmth Developed rash (red, raised, warm, itchy) on left arm in area where shot was received. Symptoms dev... Read more
Developed rash (red, raised, warm, itchy) on left arm in area where shot was received. Symptoms developed 1 week after shot was received. Treating with anti-itch cream and icing arm.
53 2021-03-19 itchy rash, rash, pain of skin Developed rash on abdomen - front, back, and sides. Rash is a little itchy and at times painful. I... Read more
Developed rash on abdomen - front, back, and sides. Rash is a little itchy and at times painful. It feels like I am getting stung by something every once in awhile.
53 2021-03-19 itchy rash, rash with redness, rash On March 13th developed itchy, red rash on left side of chest, neck, arm, elbow and wrist. Self... Read more
On March 13th developed itchy, red rash on left side of chest, neck, arm, elbow and wrist. Self-treating with hydrocortisone cream. Chest and neck has subsided as of 3/18/2021. Wrist and elbow still itchy and inflamed.
53 2021-03-20 rash Developed a rash (three spots on the inner part of the lower left arm. It did not bother me (no itc... Read more
Developed a rash (three spots on the inner part of the lower left arm. It did not bother me (no itching or burning). There was no treatment. It went away on it?s own the next day.
53 2021-03-20 hives Hives all over body trunk (not extremities)
53 2021-03-20 injection site pain, injection site swelling Pain and swelling at injection site - ongoing. Fatigue and tiredness - ongoing.
53 2021-03-21 injection site swelling, injection site pain Follow up on report 370952: 03/21 arm pain & swelling at injection site - swelling increased, pain t... Read more
Follow up on report 370952: 03/21 arm pain & swelling at injection site - swelling increased, pain the same, now itchy. 03/21 as with the first shot (Report: 315416), today I developed increased heart rate (I have SVT but controlled with meds), upper abdominal pain, cramping, diarrhea, bloating, inability to eat/drink without stomach pain. It took me 3 weeks to get back to almost normal but to me it appears both shots causes gastrointestinal issues or aggravates existing issues like IBS (which I have). 03/22: At the time of this submission, the heart rate is back to normal, the arm pain & swelling is not as bad but still there. The itching has gone away. The gastrointestinal issues are ongoing.
53 2021-03-21 injection site hardening, injection site warmth, injection site redness Lump, redness, and heat in injection site on the day after the second shot. The second day after t... Read more
Lump, redness, and heat in injection site on the day after the second shot. The second day after the shot developed swelling in the neck on left side between neck and shoulder area. Third day lymph node swelling and pain when swallowing. Arm still red, swollen and hot on third day after the shot. I have iced down both area which has not helped. I contacted occupational health as I work at a hospital and received the vaccine there. I was told to contact my PCP, which I did and am waiting to hear back.
53 2021-03-21 injection site pain Patient immediately felt pain/burning on injection site, and started having muscle pain the next day... Read more
Patient immediately felt pain/burning on injection site, and started having muscle pain the next day and continues to have muscle pain. The pain occurs when she retracts her left arm behind her back.
53 2021-03-21 injection site redness, injection site pain, injection site swelling Severe chills, fever of 101, nausea/vomiting, extreme thirst, headache, body aches (joint pain), Inj... Read more
Severe chills, fever of 101, nausea/vomiting, extreme thirst, headache, body aches (joint pain), Injection site pain/swelling/redness, fatigue. These symptoms started with sever chills about 12 hours after the vaccine dose. It was like being hit by a freight train. With ibuprofen I was able to reduce the fever for a short time, but the side effects continued for 2 days (until 3/20/2021 7pmish). the injection site pain/swelling/redness continued for another 2 days (until 3/22/2021).
53 2021-03-21 hives, itchy skin Woke on 4th day after first vaccine with nausea, vomiting, headache, fatigue, lethargy, dizziness, w... Read more
Woke on 4th day after first vaccine with nausea, vomiting, headache, fatigue, lethargy, dizziness, weakness. In the evening, hands, wrists, feet, and ankles began itching and showing large, red welts; took Benadryl. Woke on 5th day, itching and red welts began spreading all over body, including head and ears. Continued taking zyrtec, benadryl, and cortisone, which helped somewhat. On 6th day, these medications were not controlling the itching and welts/hives. By evening, all was worsening and throat was swollen. Went to ER on night of 3/18/21, where I received IV treatment to stop the reaction. ER also prescribed 4 days of prednisone and recommended that I not take the second Covid-19 vaccine.
53 2021-03-22 skin warm, dry skin 1600: Patient c/o feeling increased heart reae, resting HR 57 usually, Now currently 92 and 110 bpm,... Read more
1600: Patient c/o feeling increased heart reae, resting HR 57 usually, Now currently 92 and 110 bpm, flushing. PMHx: SVT, Asthma Meds: Flonase, Flovent, HRT, Levothyroxine Allergies: Sulfa Patient A & O x 4, skin pink, warm and dry, able to tolerate water well. B/P: 192/118, 173/108, 158/100 Provider on duty cleared patient to leave and instructed patient to follow up with PCP for b/p monitoring. Patient communicated understanding and was discharged home.
53 2021-03-22 injection site vesicles, rash with redness, injection site warmth, injection site hardening Erythematous, warm, hard, circumferential rash noted on the deltoid region of the LUE. There is one ... Read more
Erythematous, warm, hard, circumferential rash noted on the deltoid region of the LUE. There is one blister noted in this area. Good pulses.
53 2021-03-22 skin swelling FACE BEGAN TO TINGLE THEN TONGUE BEGAN TO SWELL. I WAS FINDING IT TO BE AN EFFORT TO TAKE IN A BREAT... Read more
FACE BEGAN TO TINGLE THEN TONGUE BEGAN TO SWELL. I WAS FINDING IT TO BE AN EFFORT TO TAKE IN A BREATHE. OVER THE NEXT 48 HOURS MY OTHER AREAS WHERE I HAD BEEN BITTEN BY FIRE ANTS AND A HORNET STING BEGAN TO SWELL AGAIN AND MORE BENADRYL AND PEPCID
53 2021-03-22 hives, redness, skin burning sensation, itchy skin I stayed at the facility for about ten minutes and didn?t have an issue. They wanted me to stay long... Read more
I stayed at the facility for about ten minutes and didn?t have an issue. They wanted me to stay longer but a homeless person was coughing on me maliciously. I had an epipen and a cellphone with me and walked 3 or so blocks home. On the way home, I noticed my forearm was red and felt hot, though not the side that got the shot and I had a single hive. I thought maybe I had scratched myself. I came home, and my face was very flushed and my skin started burning and itching, mostly my scalp and face, but also my body. I had already taken Pepcid and Xyrtec for allergies I had in the early morning. I added Singulair and Benadryl. I would have called 911 if my breathing had been impaired but I was not asthmatic. The symptoms resolved by later that day after a few hours but I do not believe I will be getting another shot as allergies are often worse on second exposure. It was scary though considering I was already in strong allergy meds. I had some asthma later that night and the following day but not bad. Was very fatigued and dizzy all day.
53 2021-03-22 injection site warmth, injection site redness, injection site swelling, injection site pain My arm is red and raised at injection site. It is very tender to touch and painful. Also feels hot.
53 2021-03-22 shingles Outbreak of Shingles 2 days after vaccine
53 2021-03-22 rash, skin spots Symptoms began on 3/9. She presented to urgent care on 3/11 with petechial rash on both legs and ar... Read more
Symptoms began on 3/9. She presented to urgent care on 3/11 with petechial rash on both legs and arms, purpuric bruising on bottom lip, and mild nosebleeds x 2 days. Transferred on 3/11 to Hospital for lab work due to suspicion of idiopathic thrombocytopenic purpura, and found to have a platelet count <2. Treated with IVIG from 3/11 to 3/12. Platelets normalized by follow-up testing on 3/18, confirming the diagnosis of ITP.
53 2021-03-23 pain of skin, skin burning sensation Continuous right side headache starting February 14, 2021. Right side headache, scalp burning & sens... Read more
Continuous right side headache starting February 14, 2021. Right side headache, scalp burning & sensitivity, orbit pain, right temple pain, pain at base of skull, forehead pain & sensitivity. right eye discomfort
53 2021-03-23 injection site pain Headache, joint pain in knees, fingers and neck; tenderness at injection site, fatigue, cough, scrat... Read more
Headache, joint pain in knees, fingers and neck; tenderness at injection site, fatigue, cough, scratchy throat
53 2021-03-23 itchy skin Patient c/o itching all over, vitals stable. Patient given 50mg Benadryl. She felt fine after 30 min... Read more
Patient c/o itching all over, vitals stable. Patient given 50mg Benadryl. She felt fine after 30 minutes and discharged.
53 2021-03-24 redness, skin warm 1. Within the hour started feeling lightheaded and on and off feeling like I was going to faint but ... Read more
1. Within the hour started feeling lightheaded and on and off feeling like I was going to faint but didn?t 2. Also feel flushed across my cheeks face that sort of feels hot/prickly -you can visibly see it red across my cheeks 3. Headache Today is day 4 and my lightheaded feeling is worse and I am feeling nauseous and headache is worse.
53 2021-03-24 injection site pain Pfizer-BioNTech COVID-19 Vaccine EUA 24-48hrs after: injection site pain spread to whole-body muscle... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA 24-48hrs after: injection site pain spread to whole-body muscle & joint pain, tiredness, headache, coughing, sneezing, copious/choking amounts of mucous from nose & throat, nausea, vomiting, diarrhea, lightheaded/dizzy, chills/fever (99.1-99.3F), sweating, chest pressure & back pain on left side from waist to neck, difficulty breathing, severe insomnia. 48-72hrs after: all of the above EXCEPT coughing/sneezing/mucous/vomiting/diarrhea. Soft stools w/loss of bowel control. Growing anxiety due to chest pressure/back pain on left side from waist to neck, difficulty breathing & severe insomnia.
53 2021-03-24 skin warm warm and tingly resolved within minutes after symptoms started
53 2021-03-25 skin spots, bruising Easy bruising, petechiae, gum bleeding, aches and joint pains
53 2021-03-25 hives, redness Hives over arms legs torso Patches of red
53 2021-03-25 rash Patient was covered in head to toe rash. She tried OTC Benadryl, oatmeal bath and creams. Ended up g... Read more
Patient was covered in head to toe rash. She tried OTC Benadryl, oatmeal bath and creams. Ended up getting a seriod injection in office and prescription sent to pharmacy
53 2021-03-25 injection site pain Sore left upper arm for a few days, aching in shoulders and neck 1st 24 hours, very slight headache
53 2021-03-26 redness 03/23/21 Redness of face, neck, anxiety, rapid heart rate. 03/24/21 Vomiting, red dots on my face ... Read more
03/23/21 Redness of face, neck, anxiety, rapid heart rate. 03/24/21 Vomiting, red dots on my face especially around my eyes and slight swelling of my eyes, weakness.
53 2021-03-26 hives Client waited for 15 minutes after vaccine, said she felt "off," but proceeded to her car. Once in h... Read more
Client waited for 15 minutes after vaccine, said she felt "off," but proceeded to her car. Once in her car she noticed she was red, flushed, had one hive on her chest. AT 2:20 She proceeded back into the building and was taken to the emergency area for observation. 2:30 pm, she had bilateral redness in cheeks, BP 138/85, 97% O2, 74 HR., red spot on chest. 2:47pm 97% O2, BP 178/98. 2:55 BP 182/102, Dr called for consultation. Dr. gave verbal order to proceed with IM Benadryl, and monitor for another 15 minutes to see if epi pen was indicated. 3:01, Benadryl given IM in left deltoid. Lot# 080012, expiration: 08/2022. 3:03 O2 97%, HR 80. 3:04, patient became panicked that she could not swallow, Nurse administered Epinephrine autoinjector into left thigh. Lot # 0FM534, Expiration: 9/2022. EMS called 3:06pm. Vital signs stable, client reported feeling cold and had chills. Client reported ease in swallowing almost immediately. Client taken to hospital around 3:15.
53 2021-03-26 rash, hives Painful outbreak of hives all, on the same side of the body I received the vaccination
53 2021-03-26 injection site pain, injection site redness Redness and pain at injection site, headache, chills, low fever (99.9F), extreme fatigue, joint pain... Read more
Redness and pain at injection site, headache, chills, low fever (99.9F), extreme fatigue, joint pain. All symptoms manageable at home, all symptoms gone after 48 hours.
53 2021-03-27 itchy rash 3/26/21 itchy rash across face / cheek bones 3/28/21 itchy rash down neck
53 2021-03-27 rash Bumps that appear in 3 first site right foot on top 2 nd location right arm above elbow in back 3r... Read more
Bumps that appear in 3 first site right foot on top 2 nd location right arm above elbow in back 3rd location left arm above hand in rear 4 th location stomach 5 th location left shoulder
53 2021-03-28 hives, injection site warmth Hives to chest and arms, Swollen left neck lymph node, diarrhea, injection site warm
53 2021-03-28 rash papular, rash vesicular, injection site reaction, rash, hives I received the 2nd dose on March 24th around 1:30. The 25th I became extremely tired and extremely c... Read more
I received the 2nd dose on March 24th around 1:30. The 25th I became extremely tired and extremely cold. That lasted throughout the night and into the next day where I could not work. I then felt fine, but on Friday evening my right arm throbbed and ached and nothing I took would relieve the achiness and pain. I then developed a raised rash that started around my injection site and has worked it's way to my thumb and pointer finger on my right arm only, They keep multiplying and are raising like hives with little water blisters. They are painful and feverish.
53 2021-03-30 hives COVID-19 confirmed by positive COVID-19 test; high levels of histamine; hives on back and chest; sho... Read more
COVID-19 confirmed by positive COVID-19 test; high levels of histamine; hives on back and chest; shortness of breath; blood pressure of 80/50; pneumonia; fever; chills; migraine; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205, expiry date: unknown), via an unspecified route of administration in the right arm, on 26Feb2021 14:30, as single dose, for covid-19 immunization, at a health department. Medical history included known allergies to latex and egg whites. The patient did not have COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive other vaccines in 4 weeks. On 26Feb2021 at 17:00, 3 hours after the vaccine, the patient experienced fever, chills and migraine which went on for 4 nights (as reported). On 03Mar2021 (reported as "fifth night"), the patient started to have high levels of histamine, hives on her back and chest and shortness of breath for three days (as reported). In Mar2021 (reported as "by the weekend"), the patient went to urgent care, underwent x-ray of chest, and had pneumonia. In Mar2021 (reported as "Monday"), the patient came back with blood pressure of 80/50 and was sent to the emergency room (ER). It was reported that the events pneumonia, fever, chills, migraine, high levels of histamine, hives on back and chest, shortness of breath and blood pressure of 80/50 required physician office and emergency room visits; treatment for these events included fluids, potassium and antibiotics (unspecified). On 06Mar2021, the patient underwent COVID nasal swab which resulted to positive. The patient recovered from events fever, chills and migraine on 02Mar2021; and from high levels of histamine, hives on her back and chest and shortness of breath on 06Mar2021. The outcome of the events pneumonia, "blood pressure of 80/50" and "COVID-19 confirmed by positive COVID-19 test" was unknown.
53 2021-03-30 rash Rash; This is a spontaneous report from a contactable consumer or other non health professional (pat... Read more
Rash; This is a spontaneous report from a contactable consumer or other non health professional (patient). A 53-years-old-female consumer received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9261), via an unspecified route of administration in the left arm on 01Feb2021 at 15:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Relevant medical history and concurrent conditions included allergy to penicillin, allergy to sulfa and Autoimmune deficiency. Prior Vaccinations (within 4 weeks) medical history included Shingles Oct2020 and flu. other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. History of all previous immunization with the Pfizer vaccine was not considered as suspect. Her weight was 158-160lbs. Prior to the vaccine, she had a rash that popped up a week before. Her doctor told her to keep taking Zyrtec DM and take Benadryl orally. Caller mentioned a one time occurrence with shortness of breath, and she took Benadryl and that helped. That incidence had nothing to do with the vaccine. She only has a rash when she is allergic to something she has taken internally. She doesn't know what the original rash was from. She thinks it was from using expired deodorant. It was expired for 2 years. She developed the rash under her arms. She was on prednisone for 5 days, and the rash went away. She was fine. Then, 4-5 days later, she could get the vaccine. Then, she received the Pfizer vaccine on 01Feb2021 (Monday), and on 03Feb2021 (Wednesday) she had a rash all over again. It was worse than it was before. She doesn't know if it was related. It was just on her torso/side. When the break out did happen, she had some on her leg too, She was very allergic to sulfa. She was wondering if the Pfizer vaccine breaks down into a sulfaride when it was in the body. She doesn't know whether to get the second vaccine or not. When she was in her 20s, she was on a birth control pill, and she had an allergic reaction to it. The pharmacist said the ingredients in it break down into sulfarides even though sulfa isn't an ingredient. So she as wondering if this was the same. She doesn't have the name, NDC, lot, or expiration for the birth control. She was allergic to sulfa, and she doesn't want it to happen to someone else. She works for the public She got the vaccine at (Address). Her director put them all in line to get the vaccine because she deals with the public. It happened over the weekend. The doctor didn't want to do an oral prednisone this time because of the vaccine. So she gave her a hydrocortisone cream to use on the rash. She thinks it was 2.5. It was like a prickly rash. She could feel it. If she wears something loose then she doesn't feel it. She took a bath with Aveeno oatmeal which aggravated more because of the heat. No details from the Aveeno was provided . She hasn't used creams or perfume since Friday. The rash had gone away with cortisone cream. This time it came back a lot stronger than before. She has pictures if Pfizer would want them. She was wondering if she should get the second dose? She was scheduled for the second dose on 22Feb2021. Relevant tests included the list other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebrospinal fluid culture, bacterial sero-type, diagnostic imaging, (e.g., chest X-ray, MRI): no PSCC communication: The caller was provided Medical Information's number of #, option 3, and placed in queue due to high call volumes. The outcome of event rash was recovering.
53 2021-04-08 injection site pain site of injection, LUA, muscle soreness and unable to life L arm. Still unable to life left arm com... Read more
site of injection, LUA, muscle soreness and unable to life L arm. Still unable to life left arm completely without pain. I'm a nurse, so doing my own physical therapy. BUT, main issue has been daily headaches. I've had more headaches in the last 3 months since vaccine, then I have had in my entire life. no treatment except Tylenol or ibuprofen. Although, the other day I had a severe headache, with visual disturbance, vertigo with dizziness and nausea. Was treated at local ER for possibly stroke. MRI showed no issues. I am now diagnosed with migraines.
53 2021-04-09 vaccination site pain Growing anxiety; Injection site pain; Muscle & joint pain; Muscle & joint pain; Tiredness; Headache;... Read more
Growing anxiety; Injection site pain; Muscle & joint pain; Muscle & joint pain; Tiredness; Headache; Coughing; Sneezing; Copious amount of mucous from nose/throat; Copious amount of mucous from nose/throat; Nausea; Vomiting; Diarrhea; Chills; Lightheaded/dizzy; Fever (99.1-99.3F); Sweating; Chest pressure; Back pain on left side from waist to neck; Difficulty breathing; Severe insomnia; Soft stools with loss of bowel control; Soft stools with loss of bowel control; This is a spontaneous report from a Non-contactable consumer (herself reporting). This 53-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EP7534, Expiry date: Not reported) via an unspecified route of administration in left arm on Mar2021 as a single dose for COVID-19 immunisation. The patient was allergic to mycin,neosporin/bacitracin. The patient's medical history and concomitant medication were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID prior vaccination. After 24 to 48 hours of vaccination the patient experienced injection site pain spread to whole-body muscle & joint pain, tiredness, headache, coughing, sneezing, copious amount of mucous from nose/throat, nausea, vomiting, diarrhea, lightheaded/dizzy, chills/fever (99.1-99.3F)/sweating, chest pressure and back pain on left side from waist to neck, difficulty breathing, severe insomnia. After 48 to 72 hours of vaccination the patient experienced Soft stools with loss of bowel control. Growing anxiety due to chest pressure and back pain on left side from waist to neck, difficulty breathing and severe insomnia and all the above events except coughing, sneezing, mucous, vomiting and diarrhea and the patient was sent to emergency room/department or urgent care and hospitalized for one day. The patient received IV, EKG (electrocardiogram), blood panels, X-ray, Ibuprofen, Ativan (lorazepam) as treatment for the events. The patient underwent unknown COVID test post vaccination in ER (emergency room) which shown negative result. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
53 2021-04-11 hives Started cephalexin for a bad foot infection..had taken it in past with zero issues...within 30 minut... Read more
Started cephalexin for a bad foot infection..had taken it in past with zero issues...within 30 minutes had horrible lung on burning clenched up fire, gasping and coughing for breath, hives all over me reaction.
53 2021-04-15 redness, bruising, skin spots received her 2nd dose of Pfizer on 4/8@8:32am, was given discharge information, education and direct... Read more
received her 2nd dose of Pfizer on 4/8@8:32am, was given discharge information, education and directed to our monitoring area. About 8:40am the clinic RN, went to assess the patient as she began to feel nauseated, began dry heaving without vomiting, had generalized redness, then complained of feeling light headed. She passed out so the RN eased her to the floor. A Rapid Response(RR) was called and the patient was moved to the stretcher. VS were taken and at about 8:50am the RR team arrived and assumed care. Once they arrived the patient began to seize. She was taken to the ER where she had another seizure. She remained in a post-ictal state for most of her stay at our facility.
53 2021-04-22 hives Big welp little bigger than a silver dollar ( I have a photograph).
53 2021-04-23 hair loss hair was thinning; This is a spontaneous report from a contactable nurse. This 53-year-old non-pre... Read more
hair was thinning; This is a spontaneous report from a contactable nurse. This 53-year-old non-pregnant female nurse reported for herself that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK4176), via an unspecified route of administration on 13Jan2021 14:30 (Age at vaccination is 53 year) on left arm at single dose for COVID-19 Immunization at workplace clinic. The patient also received second dose on 03Feb2021.Patient medical history included diabetes, hypertension, hypothyroid, obesity, allergies to Sulfa drugs. Concomitant medications included acyclovir, atorvastatin, amlodipine and levothyroxine (Other medications in two weeks). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, patient had not tested for COVID-19. After the first dose of the COVID vaccine patient noticed that her hair was thinning. It was unknown at this time if the damage would be permanent. The outcome for the event was unknown. No follow-up attempts are possible. No further information is expected.
53 2021-04-24 rash rash covering most of torso; Passed out; unable to hold urine; diarrhea; extremely weak; sweating pr... Read more
rash covering most of torso; Passed out; unable to hold urine; diarrhea; extremely weak; sweating profusely; temp of 101; trembling uncontrollable; freezing; terrible headache; lethargic; This is a spontaneous report from a contactable consumer (who is also the patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8732), via an unspecified route of administration in the left arm, on 07Apr2021 10:30, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies and was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) received at age 53 years, via an unspecified route of administration in the left arm, on 16Mar2021 11:00, for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. On 08Apr2021 at 03:30, the patient woke up trembling uncontrollable and was freezing. She had a terrible headache. At about 04:30, the patient got out of bed to get some Advil and go to the bathroom. She almost got to the bathroom but was unable to hold her urine and had sudden diarrhea as soon as she sat down. She then became extremely weak and passed out. She was sweating profusely and had a temp of 101. She took Tylenol and Advil and her temp broke an hour or two later. She then had a headache and was lethargic all day on 08Apr2021. On 09Apr2021, the patient felt much better but reported she was still weak, she also had a rash covering most of her torso. Treatment for the events trembling uncontrollable, freezing, terrible headache and temp of 101 included Tylenol and Advil. No treatment was taken for the remaining events. The outcome of extremely weak was not recovered; and the outcome of the remaining events was recovering.
53 2021-04-26 vaccination site itchiness, itchy skin, hives pneumonia; tching and small bumps like hives on arm I got injection in and shoulder; itching and sma... Read more
pneumonia; tching and small bumps like hives on arm I got injection in and shoulder; itching and small bumps like hives on arm I got injection in and shoulder/Maybe a dozen in total from elbow to back of shoulder; itching and small bumps like hives on arm I got injection in and shoulder/Maybe a dozen in total from elbow to back of shoulder; Extremely dizzy within minutes after (I had already filled out the Vsafe & noticed dizziness when I was done); they gave me an orange tasted awful; made me stay for a little over hour.; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (lot number: EW0150), via an unspecified route of administration in arm left on 06Apr2021 15:45 at single dose for COVID-19 immunisation. Medical history included multiple sclerosis (MS), horseshoe kidney, chronic obstructive airways disease (COAD), hypertension, and low potassium. The patient's concomitant medications were not reported. The patient previously took glatiramer acetate (COPAXONE), and interferon beta-1a (AVONEX) and experienced drug allergy. On 06Apr2021 16:15, the patient experienced extremely dizzy within minutes after (patient had already filled out the Vsafe and noticed dizziness when was done) and was given an orange tasted awful, which made her stay for a little over hour. Patient did not feel good so went home. A few hours later, patient noticed itching and small bumps like hives on arm she got injection in and shoulder. Maybe a dozen in total from elbow to back of shoulder; still a bit dizzy 6 days later bumps starting to go away. Patient thought she had COVID a year before but was tested 23 days after she got sick and had pneumonia. Outcome of the events was not resolved.
53 2021-04-28 rash Began with rash, severe body aches, loss of smell and taste, brain fog, unsteadiness, nausea, diarrh... Read more
Began with rash, severe body aches, loss of smell and taste, brain fog, unsteadiness, nausea, diarrhea that eventually led to dehydration and finally colitis that resulted in ER visit for fluids; sent home; next day, passed out at home, back to ER and was admitted for the colitis.
53 2021-04-28 skin discolouration cardiac arrest; on the ground turning purple and lifeless/ immediate risk of death from the event; s... Read more
cardiac arrest; on the ground turning purple and lifeless/ immediate risk of death from the event; she had no pulse; on the ground turning purple and lifeless; This is a spontaneous report received from a contactable consumer. A 53-year-old female patient (reporter's mother) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6200), administered in left arm on 24Feb2021 (at the age of 53-year-old) at single dose for COVID-19 immunisation. The vaccination facility type was reported as other. The patient was not pregnant. The patient's medical history was reported as none. No known allergies were reported. The patient had not had COVID prior vaccination. The patient's concomitant medications were not reported. No other vaccine was administered in four weeks. It was reported that on 13Mar2021 08:15 exactly 17 days after reporter's mother received her first Pfizer vaccine she had a cardiac arrest, luckily reporter was with her when this happened and he/she called immediately and followed the steps of cardiopulmonary resuscitation (CPR) etc. When the emergency team arrived she had no pulse and they used the defibrillator on her 4 times. The entire day they did not know if she would survive. She was sedated and tested, they got the news that she had survived and there was not brain damage. The doctors had no clue what the cardiac arrest was caused by, she had no prior health conditions and the tests show nothing to what could have caused this event (no blood clots, no clogged arteries etc.). The only thing that changed leading up to the event was her receiving her first vaccine. Luckily reporter was there when this happened or else she would in fact be dead. She now had a defibrillator implanted and reporter had a post-traumatic stress from the traumatic event and witnessing his/her mom on the ground turning purple and lifeless. They need answers. The events resulted in emergency room/department or urgent care. The events were reported as serious since resulted in hospitalization and life-threatening illness (immediate risk of death from the event). Treatments were received for the events and they were reported as multiple lifesaving treatments, tests, and defibrillator implant. The patient underwent lab tests and procedure which included COVID test (negative) on unspecified date post vaccination. The outcome of the events was resolved for the event "she had no pulse" and resolved with sequel (reported as recovered with lasting effects) for all other events.
53 2021-04-29 injection site pain Fatigue Injection site soreness (2nd time experiencing this symptom. The first was 24 hours after ... Read more
Fatigue Injection site soreness (2nd time experiencing this symptom. The first was 24 hours after 2nd vaccination) I am almost 4 months out from my second dose. I experienced a soreness and tenderness to the touch of the vaccination site in my right upper arm. I have also experienced intermittent joint pain.
53 2021-04-30 bruising big knot there and now its black and blue and it's also like ball/could be a blood clot on her hand;... Read more
big knot there and now its black and blue and it's also like ball/could be a blood clot on her hand; Headache; sickness; felt like little vomit; not having a very good appetite; feeling like sinusy; feeling little nauseas; bruise on the top of her hand and then that bruise move to left part of her upper hand; This is a spontaneous report from a contactable consumer (patient) reported that a 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727), via an unspecified route of administration on 08Apr2021 (at the age of 53-years-old) as a single dose for covid-19 immunisation. The patient medical history included cardiovascular disease. She has had open heart surgery, a double bypass when she was 44. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Mar2021 (at the age of 53-years-old) for covid-19 immunisation, and experienced face got swollen and got red and she think she got wet nose right there swelling a little bit same time her face swollen. Additional medical history included anxiety and depression. Concomitant medications included acetylsalicylic acid, ascorbic acid (ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]; atorvastatin; midodrine; metoprolol; clopidogrel; ranolazine; meclozine hydrochloride (MECLIZINE HCL); hydrocortisone; glyceryl trinitrate (NITROGLYCERIN); zinc sulfate (ZINC SULPHATE); gabapentin; colecalciferol (VITAMIN D [COLECALCIFEROL]); and paracetamol (ACETAMINOPHEN); all were taken for an unspecified indication, start and stop date were not reported. Additional concomitant medications included duloxetine taken for depression and anxiety; and alprazolam (XANAX) taken for anxiety; both start and stop date were not reported. On 13Apr2021 5 days after the second vaccination, the patient experienced headache every single day with sickness and felt like little vomit and not having a very good appetite at all. She was feeling "sinusy" but she don't have any sinus issues and then she was feeling little nauseas and then her right hand for some reason she got bruise on the top of her hand and then that bruise move to left part of her upper hand and gotten a big knot there and now its black and blue and it's also like ball; her husband and she think that could be a blood clot on her hand. The outcome of the events was unknown.
53 2021-05-04 rash, dry skin, hives, rash papular, itchy skin, redness the right arm is roughly 2" bigger than the left arm around it.; inflamed; Thought it was dry skin. ... Read more
the right arm is roughly 2" bigger than the left arm around it.; inflamed; Thought it was dry skin. That area is prone to dry skin.; pretty tired; shortness of breath; chest pain; rash/rash around right arm; Redness in right arm at mastectomy site, and warm to touch; Welts; red bumps; Itching; Nauseated; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the second dose of BNT162B2, via an unspecified route of administration in left deltoid on 19Apr2021 14:30 at single dose for COVID-19 immunisation. Medical history bipolar disorder, breast cancer, and slightly high blood pressure. Patient had a right mastectomy and had lymph nodes removed from the right side. In the spring, when everyone was mowing grass and it was real humid outside, she got welts on her body. It was temporary and went away. Patient would get really itchy. Concomitant medications included letrozole for breast cancer (the tumor in her breast was powered by hormones. This drug suppressed hormones) from 2017 and ongoing, omeprazole for constant heartburn from an unspecified date and ongoing, propranolol hydrochloride (PROPANOLOL) for anxiety from 2016 and ongoing, clonazepam for anxiety from 2016 and ongoing, and venlafaxine hydrochloride (EFFEXOR) for bipolar disorder from an unspecified start date and ongoing. Patient previously received the first dose of BNT162B2 in left deltoid on 29Mar2021 11:30 for COVID-19 immunisation and was really tired after the first vaccine. When she was a kid, her doctor put her on steroids. Never happened after age 12. Patient also got the influenza vaccine (flu shot) a couple of years before. The patient experienced redness in right arm at mastectomy site, and warm to touch, welts, red bumps, itching, and nauseated on 20Apr2021. Patient had a right mastectomy and had lymph nodes removed from the right side. In the area where that occurred, it had become red, inflamed, and a little welty. Not all of the welts were raised, they look like they were in the skin. There was redness and it was like someone scratched her and was kind of itchy. She took 2 diphenhydramine hydrochloride (BENADRYL). Patient was very sensitive to allergies, but was not allergic to anything. Sometimes she broke out in welts in the spring. Patient got the injection in the left side but the reaction was occurring in the right side. Patient was pretty tired, but she was concerned about the rash. Patient was concerned that the right arm was roughly 2" bigger than the left arm around it. Patient had been measuring the circumference, because nurses were paranoid about things like that. It was usually not 2" more around. Patient woke up this around 10:00 am. Around roughly 12:20 pm, or probably 10 after 12, she looked in the mirror and said there it was. She noticed the itching and thought it was dry skin. That area was prone to dry skin. The welty points of redness that were raised. It looked like someone had scratched across the area. It was red, and might be the end of one red scratchy area might be a bump. It looked like, if were to put hand where the nipple used to be and open up the area. That would all be covered. It included the upper arm and the inside of the shoulder, like the front side of the shoulder. It was raised and welty redness. Not all areas were raised and was bumpy. It was all pretty red and warm to the touch. The itchiness started more after she saw it, which was terrible. Patient took diphenhydramine hydrochloride because she was concerned about an allergic reaction. She also had scheduled medications that she took in the morning. Patient took 50 mg diphenhydramine hydrochloride this morning. Patient took at 12:10 pm when noticed these things. At first, she didn't think anything, she didn't think like it was the Pfizer shot or anything. It was just a normal day. Diphenhydramine hydrochloride had done nothing for the welts yet. Patient then felt kind of nauseated. It started when we first got on the phone. She couldn't put her finger on it. Patient went to the emergency room last Monday. The incident had nothing to do with any vaccine. She had chest pain and shortness of breath. They drew all of the labs. If she wanted to know if anything in the labs was different from then and now, she could. Everything was normal. She got an inhaler. They though it might be related to all of her allergies. The only way she would go see a doctor, is if she saw that the arm was getting much bigger, like it grew 2" more. If she had a hard time breathing, she would call 911. Patient had rash around right arm on 20Apr2021, in area of past breast mastectomy. Patient first noticed itching and the redness around 12:20 pm on 20Apr2021. Had gotten progressively worse. Patient did not see in the emergency department and was not hospitalized. Patient was not admitted to an Intensive Care Unit. Multiorgan were involved. Patient just noticed new area that formed. There were lines coming out of the area and came below the sleeve line. The red rash was spreading. It looked like something invisible scratched it. There was a triangle of three dots with a little scratch mark below the sleeve. There was another dot area on the forearm that itches, just like the other stuff did. Stomach had been feeling a little jumpy. Patient had already eaten breakfast. It was not horrible. Patient would watch it and drink ginger ale. Patient was asking what parameters should be for calling 911. She was home alone. This was not life threatening but if it turned into something bigger or if she noticed getting a bigger rash, she might have to call 911. Outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
53 2021-05-06 skin mass Body is full of bumps was reported as worsened / bumps are on body from stomach to inner thighs/ It ... Read more
Body is full of bumps was reported as worsened / bumps are on body from stomach to inner thighs/ It is spreading all over arms; The bumps are spreading. It is painful. She is off work. She cannot even work. She got the steroid pills; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 16Apr2021 09:00 (Lot Number: EP7534) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (Lot number: EP6455) at 9 am on 26Mar2021, administered in arm right for COVID-19 immunization. Clinical course: After vaccination, her body was full of bumps (also reported as body is full of bumps was worsened). She had to go the emergency room, and they gave her steroid pills. It was not clearing up from the steroid pills. She had to leave work today. She went to the clinic today, and they gave her a steroid shot. The bumps were on her body from her stomach to her inner thighs. This all started on 16Apr2021 after the second vaccine. It was spreading all over her arms. The bumps were spreading. It was painful. She was off work. She could not even work. She got the steroid pills, Methylprednisolone on 18Apr2021. She started with 6 tablets and decrease by one tablet per day for 6 days. The events required to visit emergency room and physician office. No prior vaccinations received within 4 weeks. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer. The event seriousness was provided as unspecified by reporter. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.
53 2021-05-06 bruising she will bruise in the drop of a hat; This is a spontaneous report from a contactable registered nur... Read more
she will bruise in the drop of a hat; This is a spontaneous report from a contactable registered nurse (the patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL3249), via an unspecified route of administration in the left deltoid on 13Jan2021 13:00 (at the age of 53-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: Von Willebrand's disease: diagnosed from when she was 8-years-old- when she was baby she went in for cleft palate repair and they gave her aspirin and she almost didn't survive, when she went for tooth removal the dentist suggested she get tested; mitral valve prolapse: diagnosed from when she was 13 or 15-years-old; Treacher-Collins' syndrome: diagnosed at birth. The patient had no family history. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EK5730), via an unspecified route of administration in the right deltoid on 22Dec2020 13:00 (at the age of 52-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. No other vaccine was administered on the same date as the Pfizer vaccine. The patient had a history of Von Willebrand disease, but since getting her second vaccine dose on 13Jan2021, she has noticed that she has been bruising more easily, since Mar2021. This has continued for over a month now. It had never been an issue before. She didn't bruise easily, but since she got the vaccine, she noticed she will bruise in the drop of a hat (Mar2021). In the last couple of months, she has had bruises that she didn't have any idea where they came from. She noticed more bruising a month or a month half ago on the inside of the right forearm. Then probably two or three weeks ago, she noticed bruises on both her right and left thighs. Then yesterday, she went to give blood from the right anti cube, and she got a bruise from that. The bruises on her thighs were still there. She had her physical yesterday with her primary healthcare professional who stated he had seen a couple of people with this side effect. She asked whether she should get a booster third dose when it becomes available. The patient considered the event bruise in the drop of a hat to be medically significant. The outcome of the event was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Bruise cannot be excluded. The medical history of Von Willebrand's disease may provide a plausible alternative explanation for the event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
54 2020-12-31 redness Raised red area, that did not itch but became a circle of scabs
54 2021-01-01 injection site pain, injection site swelling, injection site redness Within 24 hours of receiving vaccine, I became very dizzy , had severe weakness, nausea, severe head... Read more
Within 24 hours of receiving vaccine, I became very dizzy , had severe weakness, nausea, severe headache, muscle and joint pain, chills, fever (temperature-102.8),and exhaustion. Redness, pain, and swelling at injection site that has continued to worsen even after 48 hours. Could not perform regular activities of daily living. I could not drive home from work the day after the injection because the adverse reactions were getting more severe, especially after the 24 hour mark. Treatment: treated my symptoms at home with medications (I am a nurse), after researching possible adverse reactions. I figured there was not anything someone else would to treat me besides treat my symptoms.
54 2021-01-03 injection site pain Arm Pain at injection site - pleased to report nothing else. Thank you
54 2021-01-03 injection site pain I got Pfizer vaccine on 12/29. Had muscle soreness at site, Stomach cramp same day after 35 mins of ... Read more
I got Pfizer vaccine on 12/29. Had muscle soreness at site, Stomach cramp same day after 35 mins of shot. Mild lower back pain that evening (vaccine on left arm and pain on same side). On 12/30 soreness was only to palpation. Rhinorrhea all day long, took NyQuil, moderate back pain, took naproxen and did some back stretches. On 12/31 no sore arm but little tender. Increased back pain , used back brace , took naproxen not that much help though. used heat pack finally fall asleep around 3 am. on 01/01/2121 around 6 am woke up with excruciating left lower back pain, could not move, get off the bed. took a while to get off the bed. Have to drag my legs very slowly to walk. Went to ER. X-ray did not show anything. In ER took Narco 5 and Baclofen. MD thinks that it might not be side effects of vaccine. But I wonder, I never had left lower back pain before. Taking Baclofen and Advil TID since 0101/2021. 01/04 still in pain. increase pain after 6-7 hours after meds. Sitting or standing more than 30 mins Increases pain. Going to see PMD today
54 2021-01-03 rash Received first dose of Pfizer vaccine on December 28th in left upper arm. On the afternoon of Decemb... Read more
Received first dose of Pfizer vaccine on December 28th in left upper arm. On the afternoon of December 30th a rash was identified on my torso. It was not very itchy, took few doses of Benadryl and was resolved next day. May I receive the second dose scheduled in few weeks?
54 2021-01-03 injection site pain got localized pain for a few days on my left arm from injection site, I developed malaise, headache... Read more
got localized pain for a few days on my left arm from injection site, I developed malaise, headache, a fever 101.8 the day after the injection, fever subsided that night. Headache went away the 2nd day of vaccination.
54 2021-01-04 rash with redness, hives, itchy skin Developed multiple erythematous patches/hives to R lower abdomen covering an area of approximately 1... Read more
Developed multiple erythematous patches/hives to R lower abdomen covering an area of approximately 17cmx28cm in size. Patches are erythematous, pruritic and appear to have a central clearing. Pt tried applying a topical anti-fungal cream initially, but it did not help. Also applied a regular topical emollient which also did not help.
54 2021-01-04 skin warm, injection site nodule, redness, bruising Fever began on 24th around 10 with chills. Took Tylenol for low grade fever about 12:30 pm. Subsided... Read more
Fever began on 24th around 10 with chills. Took Tylenol for low grade fever about 12:30 pm. Subsided for 6 hours and then 6:30 that evening it returned at 100.7. Again 6 hours later, fever was 100.4. Christmas day, still had fever around 100. Then again that afternoon. Lymph node swelling underneath the arm. The site of the injection I had a large knot. Very swollen, small bruise, hot, and red. No streaking or red lines. Lymph node underneath the arm was about the size of a ping pong. I did not want to go to the ER. I called the nurse line and was triaged over the phone. I was instructed to take BP and pulse and gave numbers over the phone. BP was a little elevated, but nothing to extreme. I pretty much stayed laying down. It sucked the life out of me. I used hot compress and cold compress on site of the injection. It was late Saturday evening when I decided to see a change in the size of the lymph node. By Sunday, the 27th, there was no fever. Not even on Saturday. By Sunday, the lymph node had subsided as well. I did get a headache, but it was like a nagging headache. My left shoulder in the muscle area towards the neck area, I had soreness.
54 2021-01-04 hives Itchy eyes and hives on most of body that started 2 hours after injection. I took 50mg of Benadryl ... Read more
Itchy eyes and hives on most of body that started 2 hours after injection. I took 50mg of Benadryl and that put me to sleep. When I woke the hives were gone but I still itches another day. I took Claritin which did not help. When I got home from work I took 25mg of Benadryl which took care of symptoms. Eyes have been itchy off and on still.
54 2021-01-04 vaccination site pain Left arm pain - mild; Mild lightheadedness; This is a spontaneous report from a contactable nurse (p... Read more
Left arm pain - mild; Mild lightheadedness; This is a spontaneous report from a contactable nurse (patient herself). A 54-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; lot number: EK9231, expiration date unknown), via an unspecified route of administration on the left arm on 28Dec2020 at 11:15 at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included hypertension (HTN), obesity, hypothyroid, allergies to penicillin (PCN), and was diagnosed (Dx) with an unknown virus in Feb2020. Concomitant medications included chlorthalidone (CHLORTHALIDONE), levothyroxine sodium (SYNTHROID), olmesartan medoxomil (BENICAR), atenolol, and minoxidil (PANT). The patient previously took levofloxacin (LEVAQUIN), gatifloxacin (TEQUIN), and morphine and experienced allergies from all these medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020, the patient experienced left arm pain - mild and mild lightheadedness. The reporter assessed the events as non-serious. The patient did not receive any treatment for the events. The outcome of both the events was unknown.
54 2021-01-04 hives hivers on lower back to side and left leg; joint stiffness over entire body; This is a spontaneous r... Read more
hivers on lower back to side and left leg; joint stiffness over entire body; This is a spontaneous report from a contactable pharmacist. A 54-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; lot number: ett9899, expiration date: unknown), intramuscularly on the left arm on 17Dec2020 at 10:45 at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included hypertension, diabetes, tachycardia, diverticulitis, and known allergies to pimentos. Concomitant medications included metformin and metoprolol tartrate (LOPRESSOR). The patient previously took valaciclovir hydrochloride (VALTREX) and experienced allergies to it. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced hivers on lower back to side and left leg and joint stiffness over entire body on an unspecified date in Dec2020 with hive improvement several days later. The patient received diphenhydramine (BENADRYL) and paracetamol (TYLENOL) orally from the emergency room as treatment for the events. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were assessed as non-serious. The patient recovered from the events "hivers on lower back to side and left leg and joint stiffness over entire body" on an unspecified date in Dec2020.
54 2021-01-05 redness 20 minutes after receiving the vaccine, patient felt her lips swelling. She then noticed facial swel... Read more
20 minutes after receiving the vaccine, patient felt her lips swelling. She then noticed facial swelling and chest tightness. She then developed erythema to her chest area. She immediately was evaluated. Denies any SOB or difficulty breathing. Denies any itching or hives.
54 2021-01-05 rash macular, itchy skin, injection site pruritus Approximately 10 minutes after injection tingling in right hand, red splotchy skin on palm of hands ... Read more
Approximately 10 minutes after injection tingling in right hand, red splotchy skin on palm of hands and forearms. Approximately 15-20 minutes after injection. Tingling in feet and lower extremities. Thirty minutes after injection slight itching at injection site. Approximately 1 1/2 hours after injection splotchy red skin inside both thighs and mild generalized itching. At 2:00 pm that day of injection tingling began in face with slight swelling in cheeks. Itching lasted 3 days. Currently intermittent itching since Monday 01/03/2021.
54 2021-01-05 skin hardening LARGE AMOUNT OF SWELLING WITH FIRM MASS ON THE UNDERSIDE OF HER ARM, STARTED 5 DAYS POST INJECTION ... Read more
LARGE AMOUNT OF SWELLING WITH FIRM MASS ON THE UNDERSIDE OF HER ARM, STARTED 5 DAYS POST INJECTION , WENT TO WALK IN AND WAS PRESCRIBED STEROIDS AND ANTIBIOTIC, NO IMPROVEMENT AS OF 2 DAYS LATER
54 2021-01-05 itchy rash PATIENT RECEIVED VACCINE ON DEC 18TH. ON DEC 30, PATIENT BEGAN EXPERIENCING HAND AND JOINT PAIN THA... Read more
PATIENT RECEIVED VACCINE ON DEC 18TH. ON DEC 30, PATIENT BEGAN EXPERIENCING HAND AND JOINT PAIN THAT SPREAD TO ENTIRE UPPER BODY. SHOOTING PAINS UP HER NECK AND DOWN HER ARMS. DEVELOPED ITCHY RASH ALL OVER UPPER BODY AS WELL AS HEADACHE AND SWOLLEN LYMPH NODES. CRP WAS 3.6 AND SED RATE 25. COVID TEST WAS NEGATIVE. PATIENT PUT ON MEDROL DOSE PACK AND SYMPTOMS RESOLVED IN 5 DAYS
54 2021-01-05 itchy rash, rash patient received vaccine on dec 18th. on dec 30th patient started experiencing extreme hand and joi... Read more
patient received vaccine on dec 18th. on dec 30th patient started experiencing extreme hand and joint pain and had to take analgesics. Pain radiated through her upper body and at times was shooting. she was unable to perform ADLs. She then developed an itchy rash all over her upper body as well as a headache and swollen lymph nodes. Covid test was negative, CRP was 3.6 and sed rate was 25. all other labsl WNL, symptoms resolved after 5 days
54 2021-01-05 injection site pain positive COVID-19 test with symptoms; positive COVID-19 test with symptoms, tested for COVID (PCR); ... Read more
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms, tested for COVID (PCR); night sweats; Soreness at injection site; slight temp 99.5 degrees/her temperature was 101 degrees Fahrenheit/it was 102.5 degrees Fahrenheit/99 degrees Fahrenheit and then 98 degrees Fahrenheit; Tiredness she related to giving blood; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) via intramuscular on 19Dec2020 15:45 on left deltoid at a single dose for prevention as frontline health worker at hospital (COVID-19 immunisation). The patient donated blood on 18th and no antibodies were present then. The patient was a former smoker and quit 2 or 3 years ago. Patient diagnosed Osteoporosis in 2015, benign heart arrhythmia in 2005. The patient took 70 mg alendronate sodium (FOSAMAX) once weekly and just a regular OTC daily multivitamin. Caller reported she was having the covid vaccine on 19Dec2020 and began having fever, night sweats, loss of taste and smell and then tested positive for covid. The patient received the Pfizer COVID 19 vaccine through work on 19Dec2020. She received it at 3:45 pm and should have taken temperature before, but she was afebrile the day before because she donated blood. At 7pm, she had slight temp 99.5 degrees Fahrenheit and by 10:30, her temperature was 101 degrees Fahrenheit and she still felt fine. She was surprised that it was that. She woke up at 2:30 am on 20Dec2020 and took her temperature and it was 102.5 degrees Fahrenheit. She took 2 Tylenol and went back to bed and felt fine. By morning it was 99 degrees Fahrenheit and then 98 degrees Fahrenheit a little later. She has been afebrile since then. She was a little tired because she gave blood and though it was related. She does not know if it was a side effect or not. It was not significant tiredness and was just not having energy in the evening of 19Dec2020. She also had soreness at injection site that night after 22:00 and the next day. It did not bother her until she woke up in the middle of night, and she noticed her left arm was sore. She received the vaccine at 3:45pm and started with low grade fever at 6:30 pm, earlier stated at 7:00 pm. There was no prescriber. She tested for COVID (PCR) on Saturday, 26Dec2020 at 14:50and it came back positive 28Dec2020 18:45. At 10pm on 19Dec2020, her temperature was 101 degrees Fahrenheit. If she had not been monitoring her temperature, she would not have known. She has been Afebrile since morning of 20Dec2020. Tiredness she related to giving blood and the holidays. She was a little stressed about the holidays and running around. It was very mild. Soreness at injection site was during the night after 10pm when she went to bed. On Wednesday, 23Dec2020, she woke up congested, sniffly, sneezy, with a runny nose. This persisted through Wednesday night. Her sense of taste was off. She had no problem with that on Tuesday. She had some horrible smell at work she recalled, so she knew her sense of smell was fine. On Thursday, 24Dec2020, she had no sense of taste or smell. She could not smell a pine candle. She was congested on Thursday and called employee health on 24Dec2020. This both improved and persisted. She is still congested but it has improved. She has never had a complete loss of sense of taste or smell before. Mild cough started yesterday morning. On the night of 20Dec2020, and 21Dec2020, she developed night sweats. She had not had any night sweats before this since menopause and she woke up really wet. The patient was not hospitalized and not admitted to an Intensive Care Unit. NO ER or physician's office required. She did not know if she was exposed on the day of the vaccine or if a couple of days later if the fever is from the vaccine. She stated what are the chances she goes 10 months and is super careful and then gets the vaccine and test positive. The patient did not display clinical signs at rest indicative of sever systemic illness. The patient did not require supplemental oxygen nor receive mechanical ventilation. No Multiorgan failure. The patient did not receive any additional therapies for COVID- 19. No initiation of new medication or other treatment or procedure. Not any preexisting diseases worsen during the SARS-CoV2 infection. She would like to know if there is a chance of false positive for this. It would just be her luck to be 10 months and not getting it. She has not gone anywhere without her N95 and then gets the vaccine and gets COVD. She wears mask and face shield at work always. She also wanted to know if she should get the second dose. The outcome of the event slight temperature was recovered on 20Dec2020 and the other event was recovering.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.
54 2021-01-06 injection site pain Headache, Myalgia, Diarrhea, NauseaVomiting, injection site soreness initially, then on the 30th ar... Read more
Headache, Myalgia, Diarrhea, NauseaVomiting, injection site soreness initially, then on the 30th arm was very sore, runny nose, shoulder/neck aches, severe N/V/D, severe fatigue Narrative: Did not need to seek medical care. Stayed at home.
54 2021-01-06 itchy rash Rash (pruritic) was first noticed the morning after injection. Started on one wrist and expanded thr... Read more
Rash (pruritic) was first noticed the morning after injection. Started on one wrist and expanded throughout arm. Started the same way on the other arm a few hours later. By the evening, the rash encompassed both arms and started at both ankles. After 24h, the rash was over all 4 extremities. Took benadryl (50mg once) without effect on rash.
54 2021-01-06 injection site pain pain/swelling at injection site (expected) worsening of regular joint pain in addition to new joint ... Read more
pain/swelling at injection site (expected) worsening of regular joint pain in addition to new joint pain ocular migraines (had aura 3 or 4 times that next week, this is something I do not experience frequently, hadn't had one for at least 15 years prior to the vaccine
54 2021-01-07 vaccination site pain Arm pain at injection site; This is a spontaneous report from a contactable other healthcare profess... Read more
Arm pain at injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 54-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: unknown, unspecified route on 28DEC2020 12:45 (at the age of 54-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was none. The patient did not have allergies to medications, food, or other products. Concomitant medication included ergocalciferol (VIT D), calcium (CALCIUM). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 28DEC2020 03:45, the patient experienced arm pain at injection site. The event arm pain at injection site did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the event. Outcome of the event arm pain at injection site was recovered. Since the vaccination, the patient had been tested for COVID-19. Covid test type post vaccination = Nasal Swab, Covid test date on 30Dec2020 and result was negative. Information on lot/batch number has been requested.
54 2021-01-07 rash, itchy skin At night I felt fatigue and palpitations and could not sleep. Next morning the palpitations and fati... Read more
At night I felt fatigue and palpitations and could not sleep. Next morning the palpitations and fatigue went away but I start with a rash and very itchy and noticed my face swelling up. I took some prednisone I had home and Benadryl and went to the ER. They monitored me and medicated me and told me to keep with the Benadryl. On the 24th I started with the rash and on the 26th no more rash. My second dose is scheduled on the 13th and I will see my PCP on the 12th to decide if I should have the second dose. I am not allergic to anything and thought I would die on 12/24. I was swelling up in less than a minute after I woke up it was awful. I also have a consultation with an allergist on Tuesday before the vaccine.
54 2021-01-07 vaccination site pain Complained arm where she received vaccine was getting sore and very heavy.; Complained arm where she... Read more
Complained arm where she received vaccine was getting sore and very heavy.; Complained arm where she received vaccine was getting sore and very heavy.; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer sales representative. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at arm on 04Jan2021 morning at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received COVID vaccine this morning (04Jan2021) and complained arm where she received vaccine was getting sore and very heavy. The events took place after use of product. She took Tylenol and stated that she feels better. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
54 2021-01-07 vaccination site pain Fatigue; Fatigue; got pain in her arm/ pain in her arm at the injection site; got pain in her arm/ p... Read more
Fatigue; Fatigue; got pain in her arm/ pain in her arm at the injection site; got pain in her arm/ pain in her arm at the injection site; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at Right Upper Arm on 03Jan2021 (around 9:15 to 9:30AM) at single dose for COVID-19 immunization. Medical history included ongoing lupus (diagnosed about 2-1/2 years before 04Jan2021) and fatigue with lupus. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient said later in the evening of 03Jan2021, she got pain in her arm she got the COVID-19 Vaccine. She received her first check-in call after receiving the COVID-19 Vaccine, and at that time she had no pain in her arm. She clarified the pain in her arm at the injection site started in the evening of 03Jan2021. On 04Jan2021 she had fatigue. She stated she got fatigue sometimes with her lupus. No treatment received for the adverse events. No emergency room or physician office involved. The patient reported she saw her rheumatologist and had blood work done. The outcome of pain in arm at the injection site was recovering, of fatigue was not recovered. The information on the batch number has been requested.
54 2021-01-07 vaccination site pain Injection site pain; Tiredness; Muscle pain; Chills; Fever; Nausea; Feeling unwell; This is a sponta... Read more
Injection site pain; Tiredness; Muscle pain; Chills; Fever; Nausea; Feeling unwell; This is a spontaneous report from a contactable nurse, the patient. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EJ1685, Expiration 31Mar2021) solution for injection in the left arm on 02Jan2021 (at the age of 54-years-old) as a single dose for COVID-19 vaccination. There was no medical history. There were no concomitant medications. On 03Jan2021 at 02:00, the patient experienced injection site pain, tiredness, muscle pain, chills, fever, nausea and a feeling of unwell. Treatment was provided for the events injection site pain, tiredness, muscle pain, chills, fever, nausea and a feeling of unwell included ibuprofen. The outcome of the events injection site pain, tiredness, muscle pain, chills, fever, nausea and a feeling of unwell was unknown. There was no physician office/ emergency room visit.
54 2021-01-07 injection site redness Patient reported red injection site, itchy throat and cough while being monitored. Patient was taken... Read more
Patient reported red injection site, itchy throat and cough while being monitored. Patient was taken to emergency department for evaluation.
54 2021-01-07 vaccination site pain Some muscle soreness around injection site. Started about 10 hours after injection and lasted about ... Read more
Some muscle soreness around injection site. Started about 10 hours after injection and lasted about 24 hours; This is a spontaneous report from a contactable other health care professional. A 54-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 31Dec2020 11:30 at single dose, at left arm for COVID-19 immunization. Medical history included arthritis. On 31Dec2020 21:30, it was reported that the patient experienced some muscle soreness around injection site. Started about 10 hours after injection and lasted about 24 hours. The patient did not receive treatment for the event. The outcome of the event was recovered. Information about lot/batch number has been requested.
54 2021-01-07 itchy skin, rash Starting on the second day after vaccine I started to get itchy, first my arms and back and eventual... Read more
Starting on the second day after vaccine I started to get itchy, first my arms and back and eventually all over. On the third day I started to see pumps on my itchy skin. I started to take benadryl 25mg on the 26th and 27th. Doubled the dose to 50mg at night time for 5 days. Took medicated baths and Sarna cream, along with benadryl cream. The symptoms started to subside. I took only benadryl 25mg on January 2nd and 3rd. Now I am still somewhat itchy but only using topical creams. I do have seasonal eczema and dry and itchy skin in the winter but this was definitely something more than my winter symptoms.
54 2021-01-07 vaccination site swelling, vaccination site pain Starting to get really achy; Temperature is 101.7/ fever; Not feeling well; Injection site swelling;... Read more
Starting to get really achy; Temperature is 101.7/ fever; Not feeling well; Injection site swelling; Injection site pain; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at a single for COVID-19 immunization. Medical history were reported as none. The patient's concomitant medications were not reported. On 31Dec2020, the night patient's arm didn't get sore till the night and it started swell at the injection site. Patient knew that the site pain was to be expected. On an unknown date, as the day progressed, patient started to get really achy and had a temperature of 101.7 when checked, she was just not feeling well. Outcome of the events was unknown Information on batch number has been requested.
54 2021-01-07 injection site pain Symptoms - ? EE reports she received her vaccine during work yesterday and then worked until approxi... Read more
Symptoms - ? EE reports she received her vaccine during work yesterday and then worked until approximately 8:00 PM. EE reports arm soreness and pain at injection site. EE reports she woke up around 04:00 with flu like symptoms, body aches (reporting so bad she is barely able to get out of bed), fever (Tmax 101.4). + runny nose, congestion and headache. EE reports + exposure to pt with only wearing surgical mask approx. 3 weeks, and was contacted by EH and was considered low-risk and not scheduled for testing. Last day of work and shift - ? yesterday left work at approx. 8:00 PM Home remedies? - Tylenol at 0700, 600 mg ibuprofen at 11:30 Any improvement? - none Recommendation? After completely algorithm, EE meets criteria to be COVID tested and removed from work at this time. EE provided with EH command center and instructions to notify them need for COVID-19 testing. EE educated to notify his manager. EE verbalized back understanding and denied further questions at this time.
54 2021-01-07 vaccination site pain arm pain (unspecified) following the injection; shoulder and neck stiffness; Pain was bilateral shou... Read more
arm pain (unspecified) following the injection; shoulder and neck stiffness; Pain was bilateral shoulders earlier; Neck is till sore, midline to posterior; This is a spontaneous report from a non-contactable nurse (patient herself that works at the surgical center of the hospital). A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EX9231, expiry date: Apr2021), via an unspecified route of administration on 03Jan2021 at a single dose as Covid-19 vaccine. The patient's medical history and concomitant medications were not reported. Patient received flu vaccine on 29Oct2020. On 03Jan2021, the nurse reported some arm pain (unspecified) following the injection and shoulder and neck stiffness after going to sleep that night. The nurse reported that her arm pain resolved the next day. On 03Jan2021, pain was bilateral shoulders earlier, now subsiding. Neck was till sore, midline to posterior. The event arm pain (unspecified) following the injection was recovered on 04Jan2021. The patient was recovering from shoulder and neck stiffness and "pain was bilateral shoulders earlier". The outcome of the event neck was till sore, midline to posterior was not recovered. No follow-up attempts are possible. No further information is expected.
54 2021-01-07 vaccination site redness, vaccination site swelling dizziness; severe weakness; fevers of 102.8; muscle and body aches; muscle and body aches; chills; c... Read more
dizziness; severe weakness; fevers of 102.8; muscle and body aches; muscle and body aches; chills; cold-clammy skin; headache; exhaustion; nausea; Redness and swelling at injection site that is still getting more severe after 48 hours; Redness and swelling at injection site that is still getting more severe after 48 hours; This is a spontaneous report from a contactable nurse reporting for self. A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EH9899, intramuscularly from 30Dec2020 13:00 (age at vaccination: 54 years old) at single dose in left arm (dose 1) for COVID-19 immunization. There was no other vaccine administered in the 4 weeks prior to COVID vaccination. The patient was not pregnant. Medical history included hypertension, arthritis, degenerative disc, CRPS/RSD, thyroid cancer, thyroidectomy during 2007, and Crohn's disease. Known allergiesincluded insect stings and environmental allergies. The patient had COVID prior to vaccination. Concomitant medication included thyroid (THYROID); ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN); hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ); meloxicam (MOBIC); vitamin D; alpha lipoic acid (ALPHA LIPOIC ACID); duloxetine hydrochloride (CYMBALTA); and pantoprazole sodium sesquihydrate (PROTONIX). Within 24 hours of receiving COVID vaccine, the patient experienced dizziness, severe weakness, fevers of 102.8, muscle and body aches, chills, cold-clammy skin, headache, exhaustion, and nausea, from 31Dec2020 at 08:00. These continued to worsen over the next 24 hours. Redness and swelling at injection site that was still getting more severe after 48 hours. The patient was unable to drive home from work the day after injection due to adverse reactions getting worse throughout the day. The patient self-treated at home with medications (not further specified). The outcome of the events dizziness, severe weakness, fevers of 102.8, muscle and body aches, chills, cold-clammy skin, headache, exhaustion, nausea, and redness and swelling at injection site were not recovered. The events were reported as non-serious. The patient was not COVID-tested post-vaccination.
54 2021-01-07 rash right arm started tingling about 15 minutes after vaccine. Rash started on left wrist/forearm area. ... Read more
right arm started tingling about 15 minutes after vaccine. Rash started on left wrist/forearm area. Took Benadryl and Zyrtec...symptoms subsided.
54 2021-01-09 injection site pain I woke up the next morning with fever, fatigue, aches and feeling faint. I didn't take my temperatur... Read more
I woke up the next morning with fever, fatigue, aches and feeling faint. I didn't take my temperature, I went back to bed after taking Advil until I woke up at 2pm, then took Tylenol. By 4 pm I felt much better. My injection site was much more sore than the first dose.
54 2021-01-09 hives Urticaria, treated with diphenhydramine, pepcid, prednisone. Improved.
54 2021-01-10 rash "1/10/21 I go the 2nd shot. My blood pressure dropped and they had to lay me down. It went to 90/40... Read more
"1/10/21 I go the 2nd shot. My blood pressure dropped and they had to lay me down. It went to 90/40, I broke out in a rash on my neck, I am achey all over today 1/11/21"
54 2021-01-10 rash with redness, itchy rash, rash 10days after receiving vaccine developed an anaphylactic allergy after eating shellfish which I was ... Read more
10days after receiving vaccine developed an anaphylactic allergy after eating shellfish which I was never allergic to. I developed a red itchy rash over the entire body with throat tightening. Went to ER where I was treated with H1 H2 blockers steroids. After being treated and observed for a few hours I re developed the rash and symptoms again requiring further treatment and observation.
54 2021-01-10 injection site pain Apart from normal reactions like pain in injection site, headache, myalgias, on about fourth day, pa... Read more
Apart from normal reactions like pain in injection site, headache, myalgias, on about fourth day, patient starts seeing a cloud-like blurry vision, intermittently, during the day.
54 2021-01-10 injection site pain Developed chills and rigors lasting approximately 15 minutes. Followed by fatigue also had arm pai... Read more
Developed chills and rigors lasting approximately 15 minutes. Followed by fatigue also had arm pain at injection site which subsided after episode of rigors.
54 2021-01-10 injection site pain Extreme headache and nausea. Headache started on 1/8/21 about 6pm and lasted a couple of hours. Sat... Read more
Extreme headache and nausea. Headache started on 1/8/21 about 6pm and lasted a couple of hours. Saturday 1/9, just had tenderness to injection site until 1030pm when the headache returned. Hurt to move my head. Woke up on 1/10, extreme headache and nausea. Hurt to move head and was nauseated whenever I bent over.
54 2021-01-11 injection site pain I had four visual migraines followed by a migraine headache and my PCP prescribed me some meds that ... Read more
I had four visual migraines followed by a migraine headache and my PCP prescribed me some meds that helped. A little soreness at the injection site nothing extraordinary. I had the vax on a Monday and the last migraine I had was maybe on Friday the same week. I received the second dose yesterday and now I have a headache, low grade fever (99.9F about 8AM this morning) and body aches. Just treating myself at home. The headaches I have now are different, in a difference place in my head, they are lighter, it feels more like the headache you have when you have fhe flu.
54 2021-01-11 injection site pain Severe splitting headache for 3 days Flushing for 2 days Burning feeling at the injection site right... Read more
Severe splitting headache for 3 days Flushing for 2 days Burning feeling at the injection site right after injection for 2 days Moderate Pain at the injection site for 5 days Muscle weakness and aches, mild for 2 days Difficulty with concentration Feeling tired for a few weeks
54 2021-01-11 injection site rash employee received the first COVID vaccine in her left arm. The following morning she woke up with a... Read more
employee received the first COVID vaccine in her left arm. The following morning she woke up with a rash on her left arm that spread to her neck. She has been managing it with antihistamines, has not missed work and is contacting her PCP today
54 2021-01-11 injection site pain, pain of skin headache within 4 hours (not severe) arm pain (site of injection within 4 hours) lasted through 12/3... Read more
headache within 4 hours (not severe) arm pain (site of injection within 4 hours) lasted through 12/30 next morning - chills, muscle pains (sharp/fast) entire day 12/30 fatigue entire day 12/30 skin hurt (especially in shower, felt like water was burning my skin) entire day 12/30
54 2021-01-11 hives pt had periorbital swelling within 20 minutes of vaccination to urticaria, no new sob, has asthma an... Read more
pt had periorbital swelling within 20 minutes of vaccination to urticaria, no new sob, has asthma and had some mild sob day before vaccine
54 2021-01-11 rash rash on her belly and torso area; Left arm soreness; This is a spontaneous report from a contactable... Read more
rash on her belly and torso area; Left arm soreness; This is a spontaneous report from a contactable nurse (patient). A 54-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1686) via an unspecified route of administration in left arm on 28Dec2020 11:15 at single dose for COVID-19 immunisation. There was no medical history. The patient only takes vitamins; has no underlying conditions. There were no concomitant medications. 20 years ago, the patient had flu like symptoms after the Flu vaccine. Last vaccine was a Tetanus shot 8-10 years ago. The patient received COVID-19 vaccine through hospital on 28Dec2020 at 11:15 in left arm. Left arm soreness noticed in morning on 29Dec2020. Forty-eight hours later (15:00 on 30Dec2020) had a rash on her belly and torso area. Rash was no where else. Is due to get second dose on 18Jan2021. She wants to know if it is OK to receive second dose. Clarified she is referring to the Pfizer COVID-19 Vaccine. Clarified soreness was noticed only in the injection arm. Was noticed in morning. Noticed rash at 15:00 on 30Dec2020. She took benedryl x 3 doses and the rash and symptoms were gone on 31Dec2020. Event outcome of rash on her belly and torso area was recovered on 31Dec2020, while for others was unknown.
54 2021-01-12 shingles I developed a severe case of Shingles.
54 2021-01-12 vaccination site swelling, vaccination site redness, vaccination site pain headache; muscle pain; chills; fever; injection site redness and swelling; injection site redness an... Read more
headache; muscle pain; chills; fever; injection site redness and swelling; injection site redness and swelling; Injections site pain; tiredness; This is a spontaneous report from a contactable nurse (patient herself). A 54-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via intramuscular on 05Jan2021 10:30 in left arm at single dose for covid-19 immunization. Medical history included hypothyroidism, arthritis, hypertension, eczema. Prior to vaccination, the patient was diagnosed with COVID-19. The patient was known allergies: daptomycin and cefdinir (OMNICEF). The most recent COVID-19 vaccine was administered was in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included clonidine, levothyroxine sodium (SYNTHYROID), ibuprofen. The patient experienced injections site pain, tiredness, headache, muscle pain, chills, fever, injection site redness and swelling on 06Jan2021 11:00 with outcome of recovering. Since the vaccination, the patient had not been tested for COVID-19. No treatment received for the adverse event. Events were reported as non-serious.
54 2021-01-13 injection site pain Arm soreness; Huge headache; Low grade fever (99.5); Felt cold, couldn't get warm; chills; Stabbing,... Read more
Arm soreness; Huge headache; Low grade fever (99.5); Felt cold, couldn't get warm; chills; Stabbing, shooting pain in right parotid glands; General feeling of unwellness; This is a spontaneous report from a contactable nurse. A 54-years-old female patient started to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EL0142, on 06Jan2021 (at the age of 54-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included chronic granulomatous disease. Concomitant medication were unspecified. The patient previously received the first dose of BNT162B2, Lot number: EK5730, on 17Dec2020, administration time: 08:00 AM, in the left arm for covid-19 immunization. The patient previously took Oxacillin and Levaquin and experienced allergies. The most recent COVID-19 vaccine was administered in the workplace clinic. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 07Jan2021 09:30, the patient experienced arm soreness, huge headache, Low grade fever (99.5), Felt cold, couldn't get warm, chills, Stabbing, shooting pain in right parotid glands and General feeling of unwellnessThe events arm soreness, Huge headache, Low grade fever (99.5), Felt cold, couldn't get warm, chills, Stabbing, shooting pain in right parotid glands and General feeling of unwellness did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events. Outcome of the events arm soreness, Huge headache, Low grade fever (99.5), Felt cold, couldn't get warm, chills, Stabbing, shooting pain in right parotid glands and General feeling of unwellness was recovered. Since the vaccination, the patient has not been tested for COVID-19.
54 2021-01-13 injection site redness, injection site rash Rash and redness around injection site Arm soreness Chills Fever
54 2021-01-13 injection site pain Site pain; Shoulder pain
54 2021-01-13 hives c/o dizziness, SOB, hives, "flushed"
54 2021-01-13 itchy skin itching, moderate itching, no rash, mostly on torso and legs /started on right leg and has worsened ... Read more
itching, moderate itching, no rash, mostly on torso and legs /started on right leg and has worsened and spread; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1686), intramuscular on 05Jan2021 10:30 at single dose on left upper arm as Covid vaccine. Medical history included hypertension from an unknown date and unknown if ongoing. There were no concomitant medications. The patient stated that she was inoculated on 05Jan2021 with the COVID-19 vaccine at 10:30 AM in left upper arm. On 07Jan2021 (this morning), she was having a side effect that was not listed on information provided to her. She was itching, moderate itching, no rash, mostly on torso and legs and has taken some hydroxyzine 50mg to see if that would help stop the issues. Patient had a call with PCP today as well, started on right leg and has worsened and spread. Patient works in human resources for one of the hospitals. which is why she was able to get the vaccine. Patient had no pain at injection site or any other issues. Outcome of the event was not recovered (reported as "itching was reported as worsened"; ongoing).
54 2021-01-14 hives Hives within 2 hours and then onset of Tachycardia lasting 36 hours on and off.
54 2021-01-14 injection site redness, rash, injection site swelling Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Rash (oth... Read more
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Rash (other than injection site)-Medium, Systemic: Chills-Mild, Systemic: Increase in BP to 184/91; symptoms lasted 1 day
54 2021-01-14 injection site pain Soreness at the injection site x2 days Headache x1day Right eye upper lid (spasms/weakness, feels as... Read more
Soreness at the injection site x2 days Headache x1day Right eye upper lid (spasms/weakness, feels as if my upper lid gets stuck, lasting only a few seconds, not painful and doesn't affect my vision). It occurs intermittently throughout the day and began approx. 2 hours after receiving the injection.
54 2021-01-14 hives, injection site pruritus, rash WITHIN MONITORING TIME PERIOD, PT. COMPLAINED OF INJECTION SITE ITCHINESS AND OVERALL BODY HIVES. ... Read more
WITHIN MONITORING TIME PERIOD, PT. COMPLAINED OF INJECTION SITE ITCHINESS AND OVERALL BODY HIVES. NO OTHER COMPLAINTS. EMS ON SITE.
54 2021-01-15 skin warm Low grade fever, severe joint pain and headache 16 hours post injection. Headache for over 72 hours.... Read more
Low grade fever, severe joint pain and headache 16 hours post injection. Headache for over 72 hours. Large swollen right supraclavicular lymph node noticed at 72 hours post injection. Painful and warm to touch approx size golf ball. Entire right clavicle swollen and painful.
54 2021-01-16 rash, shingles painful rash. appears to be shingles
54 2021-01-17 rash papular, itchy rash Dose #1 ER5730 12/30/2020. From day 1 post injection 2 - repeat symptoms of extreme SOB on ambulati... Read more
Dose #1 ER5730 12/30/2020. From day 1 post injection 2 - repeat symptoms of extreme SOB on ambulation - worse than with #1. RR 36+ O2 sat stayed at 93 or above with ambulation. HR in supine position 70 w/in 10-15 seconds of ambulation greater than 105. On day 6 post injection, with bagging up a bag of garbage (bending over and picking things up with a spilt can) I had to sit down I was that SOB. HR 130 on pulse ox - O2 sat. 94-95. Day 7 post injection - ER work up for PE - negative, chf evaluation - negative. no pneumonia or cardiomegaly on CTA. CBC all w/in normal limits except on diff - lymph 0.5 above normal range only. CMP ok as well. BMP and trops normal. Day 9 diffuse itchy rash has developed, even worse now on day 10. Raised, blanching, papules - no pustules/vesicles noted. Trunk presentation spreading to extremities. leg signifiant more populated than arms. Rash now on tops and bottoms of feet. Minimal spots on dorsal hands and none on palms. Extremely itchy. + Celiac patient (Dx- genetically 7-8 years ago, symptoms for over 10) and + Hashimotos patient (29 years). No recent gluten exposure resulting in GI response. (I can get bowel incontinence with cross contamination. ) I'm taking Synthroid as prescribed. Since I'm in the CD8 peak days (9-11)- can this just be some type of autoimmune storm since it was a viral vaccine? No history of any problems with my yearly influenza vaccine.
54 2021-01-17 itchy skin ITCHING, NO RASH. TOOK CLARITIN
54 2021-01-18 injection site pain Arm sore at injection site for a few days. I noticed several days later that my neck (part between ... Read more
Arm sore at injection site for a few days. I noticed several days later that my neck (part between neck & shoulder) was swollen. I had a few lumps. I had swollen lymph nodes.
54 2021-01-18 injection site pruritus, injection site pain, itchy skin For 24 hours after my shot I had a severe headache, body aches, and exhaustion. For the first 12 hou... Read more
For 24 hours after my shot I had a severe headache, body aches, and exhaustion. For the first 12 hours after the shot my entire body itched. The injection site hurt immediately and still hurts four days later. My entire arm is achy and hurts to move. I?ve never had my arm hurt like this after a shot and I haven?t been pampering my arm. I?ve been purposely working it in hopes that would lessen the soreness.
54 2021-01-18 vaccination site redness, vaccination site swelling Injection site swelling and redness; Injection site swelling and redness; Low grade fever; Nausea; T... Read more
Injection site swelling and redness; Injection site swelling and redness; Low grade fever; Nausea; This is a spontaneous report from a contactable nurse reporting for herself. A 54-year-old female patient received bnt162b2 (BNT162B2) (Lot# EJ1686, Exp date 31Mar2021), via an unspecified route of administration, on 05Jan2021, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. The patient experienced injection site swelling and redness, low grade fever and nausea all on 06Jan2021 with outcome of unknown. Therapeutic measures were taken as result of the events and included treatment with a 1000 mg Tylenol. The events were considered related (source of assessment: primary source reporter, method of assessment: global introspection).
54 2021-01-18 injection site warmth, injection site pain, injection site swelling, injection site nodule The injection site became swollen, tender and developed a knot that was feverish. An icepack was ap... Read more
The injection site became swollen, tender and developed a knot that was feverish. An icepack was applied to the area. By 4PM, the site was softer with decreased swelling and pain. She went home. One day later, the site continues to be swollen.
54 2021-01-18 bruising sore arm for 24-48 hours...like a bruise, but it didn't keep me from doing anything.
54 2021-01-19 redness Face (cheeks, forehead, chin) red (sunburn look) and swollen. Occurred several hours after re... Read more
Face (cheeks, forehead, chin) red (sunburn look) and swollen. Occurred several hours after receiving vaccine.
54 2021-01-19 itchy skin Facial itching 25mins after administration
54 2021-01-19 rash Rash, SOB, Flushing, fever, severe Chills, HA, Dizziness, Tachycardia , Muscle pain/weakness, chest ... Read more
Rash, SOB, Flushing, fever, severe Chills, HA, Dizziness, Tachycardia , Muscle pain/weakness, chest pain, palpitations--Treated with EpiPen onsite, Ambulance--Epi/O2/Monitoring---ER IV benadryl/ IV Solumedrol/ IV dexamethasone--Sent home 5 hrs later with oral benadryl and predinsone
54 2021-01-19 injection site pain Sore right arm where I received the shot. Swelling and soreness in my shoulder. Sore neck.
54 2021-01-19 injection site swelling Swelling to armpit on side of injection, low grade fever persisting
54 2021-01-20 injection site pain Injection site pain, headache, tiredness, muscle pain, chills, nausea, feeling unwell, sweating, diz... Read more
Injection site pain, headache, tiredness, muscle pain, chills, nausea, feeling unwell, sweating, dizziness. After 45 minutes it subsided enough, except the nausea, so that I could go to the recovery area where I remained for a few more minutes. I then felt well enough to drive myself home.
54 2021-01-20 rash Rash on the inner side of the arms, both left and right (size if a palm) and under the breasts. Stre... Read more
Rash on the inner side of the arms, both left and right (size if a palm) and under the breasts. Stretch marks-like swelling in the same area. After 30 min the symptoms have disappeared.
54 2021-01-20 injection site pruritus, injection site redness, injection site swelling Red raised warm 2inch diameter circle around injection site; last 7 days post injection. Started it... Read more
Red raised warm 2inch diameter circle around injection site; last 7 days post injection. Started itching 4 days post injection. ibuprofen
54 2021-01-20 rash, rash Systemic: Rash (other than injection site)-Medium
54 2021-01-21 injection site pain Low grade fever; Headache; Stomach ache; body ache; metallic taste in mouth; sore arm at injection s... Read more
Low grade fever; Headache; Stomach ache; body ache; metallic taste in mouth; sore arm at injection site; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EKQ231), via an unspecified route of administration at the left arm on 11Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. On 11Jan2021, patient experienced metallic taste in mouth, which was reported as worsened and sore arm at injection site. On 12Jan2021within about an hour after vaccination, the patient experienced lowgrade fever that was slowly going up, headache, stomach ache, & body ache. The patient has not recovered from the events.; Sender's Comments: Based on the time association, the reported events are possibly related to suspect BNT162B2 administration in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
54 2021-01-21 injection site pain SORENESS AT SIGHT, NO ENERGY/ SWOLLEN LYMPH NODES
54 2021-01-21 redness Two hours after the injection both of my leg seized. The muscles so tight that I was unable to walk... Read more
Two hours after the injection both of my leg seized. The muscles so tight that I was unable to walk (like a spasm). There was no twitch the a muscular contraction that left me unable to walk properly (the left side seem to be the tightest side of by body) . I also had bilateral jaw pain (not sure if its was because I was in so much pain in the legs that I was clenching my teeth) I also had slight numbness on by left face and by the evening I had redness on my left cheek but it went away. My face still has a bit of muscle sensitivity (tingling sensation) near the mouth and jaw.
54 2021-01-21 redness, itchy skin redness, swelling and slight itchiness to left arm
54 2021-01-21 injection site pain temp 100.2-100.6/fever/chills, body aches, injection site L.arm very sore/heavy/painful
54 2021-01-22 injection site redness, injection site pain, injection site mass Arm was a little sore at injection site on 12/30/20, day of injection. Woke up 12/31/20 and had a ni... Read more
Arm was a little sore at injection site on 12/30/20, day of injection. Woke up 12/31/20 and had a nickel-sized lump/redness. Lump lasted about 2 days then disappeared on 1/3/21. On 1/7/21 axilla was tender and occasionally painful, On 1/8/21 lump and tenderness returned to injection site at 1:00pm. At 6:30pm that day site had a 50 cent piece lump which was red, raised and warm. Took Benadryl. Area was slightly more red and tender am of 1/9/21. so called MD and antibiotic ordered. Arm is slowly improving each day. Axilla is still painful. Had a similar reaction to Tdap 20 years ago which was treated as cellulitis. No known hx. of COVID, but had classic COVID symptoms in December when she tested negative.
54 2021-01-23 itchy skin, rash, hives The day after injection I had the normal soreness of left arm, achiness , and fatigue that lasted al... Read more
The day after injection I had the normal soreness of left arm, achiness , and fatigue that lasted all day. At approximately 6:00 pm I noticed some red spots on my abdomen and by 10:00 pm the rash/hives had spread all over my abdomen. The next morning (Friday 1/22/21) it had spread to my chest and back areas and small areas on my legs. A PA recommended I take Zyrtec and Pepcid. I called my PCP's offices and they recommended I continue doing that. Saturday I continued to have rash all over and itchiness and some soreness. I went to an Urgent Care at 5:30 pm) and the PA there gave me a shot of epinephrine and called in a Rx for a stronger antihistamine. Today, Sunday (1/24/21) I still have the rash/hives. I'm not sure what Rx was called in, I have to pick it up this morning.
54 2021-01-24 injection site swelling, injection site pain Extreme pain with swelling of left upper arm at injection site. Pain and swelling continues down arm... Read more
Extreme pain with swelling of left upper arm at injection site. Pain and swelling continues down arm to hand. Started 1/20/2021 and continues to worsen. Pain unbearable.
54 2021-01-24 hardening Fever, body aches, lump on arm, nausea, headache less than 24 hours, treated with meds
54 2021-01-24 injection site pain Headache, Injection site pain, Tiredness, Joint pain, Chills
54 2021-01-24 rash, skin burning sensation, skin warm I had a sore arm for the day and then it was gone. Sunday morning, I woke with my face hot and red w... Read more
I had a sore arm for the day and then it was gone. Sunday morning, I woke with my face hot and red with a rash on my chin, forehead and left cheek. The second week, my chin started burning and my face was covered in a dermatitis rash. I saw the dermatologist for this.
54 2021-01-24 injection site pain On 1/8/21 received dose and had nausea <1 hour; Left shoulder pain. Swelling in pm and pain continu... Read more
On 1/8/21 received dose and had nausea <1 hour; Left shoulder pain. Swelling in pm and pain continued x 4 days, then, local tenderness persisted for additional week. Onset of HA 1/18/21 through 1/25/21 for 6 of the 7 days, for a few hours duration and relieved with Aleve qd to BID. On 1/22/21 noticed Left shoulder muscle weakness, visible atrophy of muscle and dull pain in shoulder/ arm and neck. Clicking in the joint with rotation movement. Spoke to Director of Rehab and advised to contact CDC and seek medical care. Call placed to PCP 1/23/21 with office closed for weekend. Due to non-urgent symptoms, opted to wait for appointment on Monday. Continued pain and symptoms through the weekend with feeling of instability in the shoulder. Spoke to CDC for Q/A on 1/24/21 and sought medical attention with appointment for care on 1/25/21.
54 2021-01-24 itchy skin patient developed itching throughout her body approximately 25 minutes after administration. She was... Read more
patient developed itching throughout her body approximately 25 minutes after administration. She was observed for 15 minutes. No hives developed. This itching came and went
54 2021-01-25 injection site pain I felt good all day till about 130am then I started feeling very uncomfortable. I had positive Covid... Read more
I felt good all day till about 130am then I started feeling very uncomfortable. I had positive Covid-19 and I was having some of those symptoms- very painful headache, terrible lower back pain , very tired, upset stomach and sore at injection site. I couldn't get comfortable . I started taking 3 Tylenol ES, Ibuprofen 800mg, and Pepto Bismol at same time every 4 hours. After about 18 hours I started feeling normal. The testing site told me some people are having reactions.
54 2021-01-25 vaccination site redness, vaccination site mass, vaccination site pain, vaccination site warmth axillary was tender and occasionally painful; 50 cent size lump on the side of her arm at injection ... Read more
axillary was tender and occasionally painful; 50 cent size lump on the side of her arm at injection site that was raised, warm, red, and tender at the injection site; 50 cent size lump on the side of her arm at injection site that was raised, warm, red, and tender at the injection site; 50 cent size lump on the side of her arm at injection site that was raised, warm, red, and tender at the injection site; 50 cent size lump on the side of her arm at injection site that was raised, warm, red, and tender at the injection site; patient received the covid vaccine on the 30Dec had a sore arm; This is a spontaneous report from a contactable pharmacist. A 54-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 30Dec2020 at single dose on the arm for COVID-19 immunization. The patient medical history included "had classic symptoms of COVID, but had a negative COVID test" on Dec2020. Concomitant medications were not reported. The patient previously had a Tetanus vaccine 23 years ago. After receiving patient spiked a fever 101 and cellulitis at the site. Reporter explained she is not 100 percent sure. She is not sure if the nurse used the DTap abbreviation and truly administered the Tetanus shot. Reporter indicated she is not sure which preparation patient got. Patient received the vaccine on 30Dec2020 and her arm was sore that day when went to bed. The next morning (31Dec2020) the site was tender. She then noticed a nickel size (as reported) red lump that had disappeared on 03Jan2021 (The next day she had tenderness and redness that went away after two days). Patient noticed the 50 cent size (as reported) lump on the side of her arm at injection site that was raised, warm, red, and tender at the injection site the morning of 31Dec2020, an exact time was not specified. On 07Jan2021 he had a 50 cent size lump on the side of her arm at injection site in arm received injection that was raised, warm, red, and tender at the injection site. On 07Jan2021 her axillary was tender and occasionally painful. On 08Jan2021 it returned to injection site at 1. That day at 6:30 PM on 08Jan2021 she had an area she had a 50 cent size area that was raised, red, and warm. She took Benadryl the next day. The morning of 09Jan2021 she woke up and had more redness tenderness in her arm, therefore, she called her doctor. Her doctor ordered an antibiotic. On 11Jan2021 they entered in the follow-up notes she had slow improvement even though the axillary area is still painful. Reporter explained it sounds like events are slowly improving, they are not completely resolved. Reporter stated it is so weird that the sore arm went away, disappeared, and then came back again. The final outcome of the events was recovering. The adverse events di not require a visit to the emergency room or physician office. The events were as assessed as non-serious by reporter. The causality of events was considered as related by reporter. Information on the Lot/Batch number has been requested.
54 2021-01-25 vaccination site pain fatigue; headache; muscle ache; injection pain site; This is a spontaneous report from a contactab... Read more
fatigue; headache; muscle ache; injection pain site; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: El1283; expiration date: unknown), via an unspecified route of administration right arm on 12Jan2021 17:15 at SINGLE DOSE for covid-19 immunization. Medical history included diabetic, high blood pressure, high cholesterol, ADHD (attention deficit hyperactivity disorder), anxiety, depression and IBS (irritable bowel syndrome). The patient has no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included lovastatin (LOVASTAT), bupropion hydrochloride (BUPROPION HCL XL) and networking 750mg. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the Pfizer Covid 19 vaccine in a hospital. The patient experienced fatigue, headache and muscle ache and injection pain site on 13Jan2021 06:00 PM (18:00). The patient did not received treatment for the adverse events. The events were reported as non-serious. The patient has not been tested for COVID-19 since vaccination. The outcome of the events was recovering.
54 2021-01-26 injection site warmth, injection site redness, injection site rash, redness I had a bullseye rash about 7cm circular and 5 inches below the injection site that was red and hot.... Read more
I had a bullseye rash about 7cm circular and 5 inches below the injection site that was red and hot. It was there for two days and went away. I had a 2.5cm hot spot on my chin and the left cheek saw red and hot.
54 2021-01-26 redness, rash I had a red hot rash on my face that lasted about a week. During the night, I woke to my face cover... Read more
I had a red hot rash on my face that lasted about a week. During the night, I woke to my face covered all over after being clear at bedtime.
54 2021-01-26 itchy skin I received the vaccine last Jan. 5, 2021 @ 240pm. I had fever and chills, running nose, itchy lower ... Read more
I received the vaccine last Jan. 5, 2021 @ 240pm. I had fever and chills, running nose, itchy lower part of my body. I took Tylenol every 6hrs. and zyrtec. It took 3 days, feeling better.
54 2021-01-26 injection site hardening, injection site warmth, injection site swelling, injection site redness I received the vaccine on 1/25/2021 at 11:00 A.M. and felt fine all day and evening. I began feeling... Read more
I received the vaccine on 1/25/2021 at 11:00 A.M. and felt fine all day and evening. I began feeling body aches and ran a low grade fever of 100 around 5:00 P.M. on 1/26/2021. The injection site has a lump about the size of a quarter, red and warm to the touch. I took two Tylenol at 9:30 P.M. on 1/26/2021 and went to bed. I awoke at 7:30 A.M. on 1/27/2021 feeling fine, but he injection site is still swollen, red and warm to the touch.
54 2021-01-27 injection site swelling, injection site pruritus, injection site redness She noticed redness, itchy swelling around the injection site, along with a sore arm and a shotty ly... Read more
She noticed redness, itchy swelling around the injection site, along with a sore arm and a shotty lymph node in the right axilla
54 2021-01-27 injection site numbness, injection site tingling The patient reported numbness, tingling, and heaviness in vaccinated arm which travelled up neck, to... Read more
The patient reported numbness, tingling, and heaviness in vaccinated arm which travelled up neck, to eyelid and side of face. This prompted a visit to urgent care and urgent care sent the patient to the ED for stroke rule-out. The ED did not believe patient was experiencing a stroke and administered 10 mg of IM decadron. The patient's symptoms resided overnight but the next day developed red bumps all over upper palate of mouth. The patient went to her PCP which did not test for strep at this time. The red bumps developed into ulcers with white heads and the patient went back to the PCP which performed a rapid strep test which was negative. The PCP was concerned for mono due to lymph node swelling. The patient's palate has improved slightly but they still feel fatigued.
54 2021-01-27 rash body rash over stomach, back and left side of neck area.; This is a spontaneous report from a contac... Read more
body rash over stomach, back and left side of neck area.; This is a spontaneous report from a contactable other hcp report self. This 54-year-old not pregnant female patient receive second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration in left arm on 15Jan2021 13:00 at single dose for covid-19 immunization. Medical history included osteoporosis and overactive bladder, lactose intolerant. Patient not diagnosed with COVID-19 prior to vaccination. Concomitant medications within 2 weeks include omeprazole (PRILOSEC), fesoterodine fumarate (TOVIAZ), Vitamin D3, cyanocobalamin (VITAMIN B12), lactobacillus nos (CULTURELLE). Patient received first dose of bnt162b2 (lot number: EK9231) in left arm on 28Dec2020 12:30 PM. No other vaccines within 4 weeks prior to the COVID vaccine. Approximately 48 hours after injection on 17Jan2021 09:00 AM, patient developed body rash over stomach, back and left side of neck area. Symptoms persisting over the last 10 hours and continuing. Outcome of event was not recovered. No treatment received for the adverse event. Patient has not tested for COVID-19 post to vaccination.
54 2021-01-27 itchy skin fatigue nausea headache pruritis
54 2021-01-27 itchy skin received her first COVID-19 vaccine today at 4:40 PM. Approximately 25 minutes after her vaccine sh... Read more
received her first COVID-19 vaccine today at 4:40 PM. Approximately 25 minutes after her vaccine she developed itching throughout her body. She was first observed in her seat in the lobby for 5 min. Patient was then directed to a triage room where we observed her for another 15 minutes. She did not develop any SOB, CP, dizziness, oral itching, difficulty swallowing, fatigue or malaise. Patient was well-appearing throughout this time. Her lungs were clear and heart rate was regular. She never developed hives or other rash. She was offered Benadryl IM and declined due to the excess in drowsiness and because we only had an IM dose. After approximately 45 minutes from time of vaccination patient departed in good condition. Her symptoms never progressed. She did state that her itching came and went, making it less likely that this was an allergic reaction. She stated that her epi-pen was at home and she lives 15 min away. I asked her to take Benadryl upon arriving home and she agreed.
54 2021-01-28 hives, itchy skin Patient felt anxious, flushed, and itchy. She reports hives over her chest and feeling lightheaded,... Read more
Patient felt anxious, flushed, and itchy. She reports hives over her chest and feeling lightheaded, though this was likely secondary to anxiety. Denies any other symptoms, SOB, throat swelling, abdominal pain, or nausea.
54 2021-01-28 vaccination site pain her body felt uncomfortable; had pain at injection site for a little bit; muscle soreness/muscle sor... Read more
her body felt uncomfortable; had pain at injection site for a little bit; muscle soreness/muscle soreness in left arm at injection area after receiving the second dose; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse (patient) reported that a 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302, expiration date: May2021), intramuscular on 12Jan2021 09:00 at 0.3 mL, single on left arm for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient received her first dose of BNT162B2 on 22Dec2020 around 08:15am to 08:30 am, intramuscular injection in left arm. The dose she received was 0.1ml (lot number: EH9899). The patient received flu shot on Nov (no year reported). The patient experienced headache on 12Jan2021 and muscle soreness on 13Jan2021 in left arm at injection area after receiving the second dose. Her headache was not very strong. It was mild headache since she took Tylenol. She clarified it recovered completely as of yesterday (14Jan2021). When querying seriousness, she states it was a normal side effect so she did not think it is serious. She reported her body felt uncomfortable, and she cannot explain what it was happening, she did not have shortness of breath or diarrhea or anything. States it was like she got flu vaccine and had pain at injection site for a little bit. She received the flu vaccine in Nov (no year reported) and she does not know the name of the flu vaccine. The patient recovered from headache and muscle soreness/muscle soreness in left arm at injection area after receiving the second dose on 14Jan2021. Outcome of the rest of the events was unknown.
54 2021-01-28 injection site pain pt states she has sore left arm around the injection site and looks like she had two injection marks... Read more
pt states she has sore left arm around the injection site and looks like she had two injection marks. Pt states she has had headaches and pain in the clavicle area with swelling in her lymph nodes on the left side.
54 2021-01-29 itchy skin 20-30 minutes post vaccine, some prickling/tingling around nose and mouth, with some facial flushing... Read more
20-30 minutes post vaccine, some prickling/tingling around nose and mouth, with some facial flushing. Did not progress, waxed and waned. Had more flushing later, took benedryl. Went to Urgent care, advised benedryl to continue, but did not feel there was any cause for concern. Day after injection, mild flushing at times, and diffuse mild itching including scalp, face, particularly borders, and general arms, legs, torso. No rash, hives, and itching not aggressive, just mild. Persisted for about a week. Feel anxiety may have played role. Continued with benedryl. Had telehealth visits with PCP and with allergist. Resumed taking zyrtec daily with additional dose in pm- symptoms resolved. Not felt to be "serious" reaction by either MD, feel it is ok to have 2nd dose.
54 2021-01-29 injection site pruritus, skin discolouration, injection site redness A red area appeared at injection site on 01/23/21 at 8 A.M. The reddened area was an inch in diamet... Read more
A red area appeared at injection site on 01/23/21 at 8 A.M. The reddened area was an inch in diameter. Now the reddened area is 2 1/2 inches in diameter. It has darkened center and is very itchy, especially at night.
54 2021-01-30 injection site hardening, injection site pain, injection site warmth Severe headache (migraine) lasting 16 hours, nausea and vomiting, fever 101 for 6 hours, severe fati... Read more
Severe headache (migraine) lasting 16 hours, nausea and vomiting, fever 101 for 6 hours, severe fatigue, body aches, injection pain hot and very sore and hard.
54 2021-01-31 vaccination site pain Exhaustion/ Felt more exhausted; Lightheadedness/ Light headed; Nausea/ Nauseous; Sore throat/ Throa... Read more
Exhaustion/ Felt more exhausted; Lightheadedness/ Light headed; Nausea/ Nauseous; Sore throat/ Throat is really sore too/ there is pressure there; Injection site soreness; Loss of appetite; Not feeling well; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL324) via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunisation. Medical history included COVID-19 in Oct2020 and she had a mild case. The patient had no other medical history. There were no concomitant medications. The patient got the vaccine yesterday (reported as 18Jan2021, clarification pending) at work in the afternoon. Yesterday, she felt fine, except for the normal injection site soreness. Today on 18Jan2021, she felt more exhausted. At work started feeling kind of lightheaded. She was kind of nauseous and stuff. Over all, she was not feeling well. She didn't have a prescribing doctor. She got it done at her place of work. This morning when she woke up she noticed the exhaustion. Being light head started about an hour or half or so, maybe 2 hours ago. The nausea, she first noticed about 1 hour to 2 hours ago. Her throat was really sore too. She first noticed that this morning, and it had persisted. It was like a sore throat but there was pressure there. She took Ibuprofen for the injection site soreness. She had experienced a loss of appetite. She ate this morning and didn't have much to eat. She was also usually hungry by now, and she hadn't ate. All she ate was some protein bar because she was nauseous, but the symptoms hadn't subsided from eating. She got the vaccine because she was an essential worker. She worked with people with disabilities. She was looking at symptoms and figured she should call and see if this throat issue she was having would make it severe. She wasn't having trouble breathing or face swelling or anything. She just couldn't tell if her throat was just sore or swollen too. There was no investigation assessment. The outcome of event normal injection site soreness was recovering, outcome of event not feeling well was unknown, outcome of other events was not recovered.
54 2021-01-31 itchy skin, hives, rash, redness On 1/17/21 after 3 days, starts itching on left arm then next day few scattered rashes on both ar... Read more
On 1/17/21 after 3 days, starts itching on left arm then next day few scattered rashes on both arm.. on 1/22/21 redness both lower extremity no itchiness. Then on 1/25/21 rashes appears on both upper thigh,,still with few rashes on both upper arms and lower leg..1/29/21 with rashes + itchiness. 1/31/21. Pronounced Rashes on both upper arm , both legs up to inguinal area , raised rashes at the back of both knees plus severe itchiness. Went to hospital, Dr. said it is not due to vaccine because it supposed to not last x 2 weeks for the rashes if it?s from vaccine. Dx: urticaria. Dr dismissed the fact that it all started when I got the vaccines
54 2021-01-31 vaccination site pain, injection site tingling, injection site redness, injection site swelling, injection site warmth Pfizer-BioNTech COVID-19 Vaccine EUA Patient reported symptoms beginning on 1/28/2021 after receivi... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Patient reported symptoms beginning on 1/28/2021 after receiving COVID vaccine on 1/27/2021. States that she had had increasing pain in her LUE, where she received the vaccine. States that there is discoloration and redness, warmth, and mild swelling around the injection site. Additionally reports tingling radiating from the injection site to her finger tips. Pt referred to emergency department and was treated for L shoulder pain consistent with localized inflammation secondary to recent vaccination
54 2021-01-31 rash fever, nausea, rash all over body, painful swollen knees and hands, and shortness of breath. She ha... Read more
fever, nausea, rash all over body, painful swollen knees and hands, and shortness of breath. She had an eppy-pin she used.
54 2021-01-31 vaccination site pain fever; chills; joint pain; headache; tiredness; injection site pain; This is a spontaneous report fr... Read more
fever; chills; joint pain; headache; tiredness; injection site pain; This is a spontaneous report from a contactable pharmacist (patient). A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: unknown) intramuscularly at right arm on 11Jan2021 13:15 at single dose for COVID-19 immunization. Medical history included hashimoto's. No known allergies. There were no concomitant medications. The patient received the first dose of bnt162b2 (lot number: unknown) intramuscularly at right arm on 21Dec2020 13:15 at single dose for COVID-19 immunization. Basically, patient felt like she was hit by a mack truck. She had fever, chills, joint pain, headache, tiredness and injection site pain, all on 12Jan2021 01:00. No treatment received. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the events was recovered on an unspecified date in Jan2021. Information on the lot/batch number has been requested.
54 2021-02-01 injection site pain Fever X24 hours at 100.0, pain at site 48 hours, headache 24 hours, muscle aches X 48 hours and fati... Read more
Fever X24 hours at 100.0, pain at site 48 hours, headache 24 hours, muscle aches X 48 hours and fatigue X 48 hours
54 2021-02-01 itchy skin, redness GENERALIZED ITCHINESS AND C/O THROAT FILLIING A BIT TIGHT. REDNESS AT TRUNK/LEGS/BREAST.
54 2021-02-01 hives Severe hives, heartburn,
54 2021-02-01 pain of skin kind of fainted; Body feels tender and skin feels tender to touch; dizziness; Weakness; Fatigue; Hea... Read more
kind of fainted; Body feels tender and skin feels tender to touch; dizziness; Weakness; Fatigue; Headache; Chills; Left arm hurting really bad; A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 18Jan2021 07:15 at single dose in left arm for covid-19 immunisation. Medical history included menopause from May2020 and ongoing (She is going through menopause, which started 7 months ago). There were no concomitant medications. Received call from consumer regarding the Pfizer BioNtech COVID vaccine. She had first vaccine yesterday morning and is experiencing some side effects. It looks like it was prescribed by a pharmacist, but she is not able to see the name and does not have any contact details to provide. She signed up at the online thing for reporting. Her arm is much better this morning. She woke up at 03:00 with the headache and still has it. Dizziness and weakness started 06:30 this morning. She kind of fainted. She was walking from one room to the next and she just gave out. It has improved and she is not really dizzy any more. She is having a little fatigue though. Chills began at 06:30 and they come and go. She is going through menopause and it could have something to do with it. She was unable to answer outcome for this. She just wants the headache to stop. She has not been able to do anything today. She is going through menopause, which started 7 months ago. She would like to know if there is something she can take for the headache. AE Details and time of onset: Left arm hurting really bad 18:00. When she first got it, she did not feel it. As the day progressed, she could feel the pain. Headache 03:00. Dizziness and weakness 06:30. Fatigue 06:30. Chills 07:00-07:30. She layed down at that point. Body feels tender and skin feels tender to touch 09:00. NO ER or physician's office required. No prior Vaccinations (within 4 weeks). The outcome of the event dizziness was resolved, Chills was unknown, Headache was not resolved, while the outcome of the other events was resolving. Information on the lot/batch number has been requested.
54 2021-02-01 itchy skin, rash tingling and numbness in right arm itching and rash around left wrist
54 2021-02-02 injection site pain Mild pain at injection site Moderate chills severe headache and nausea
54 2021-02-02 itchy skin On 1/28/2021, I woke from my sleep with legs cramps and muscle pain. I went to the toliet to urinat... Read more
On 1/28/2021, I woke from my sleep with legs cramps and muscle pain. I went to the toliet to urinate and began to have multiple bowel movement. I began to feel nauseated and very cold with shortness of breath and my heart racing. I cleaned up, washed my hands and proceeded to check my temperature it read 91.5, I continue to check it and it continue to read 91.5. I drank water and orange juice thinking it was my blood sugar. I began to feel dizzy but did not want to lay flat on my bed due to the shortness of breath. My heart rate was 120. I checked my blood pressure it was 180/120. I was fearful of shock. I continued to pace and warm up with blankets and a space heater. I took a warm bath and my temperature increased to 97.7. I continued to feel my pulse racing. I called Dr. office and got an appointment to see her 8:30 am 1/29/2021. She checked my vitals signs B/P - 143/87, P 80, T 98.1 O2Sat 99, heart and lungs. She did labs and urinalysis. She prescribed Clonidine 0.1mg TID take if BP greater 160/90 and Allergra 180 mg QD prn for itch and reaction. I will return to see her 2/5/2021.
54 2021-02-02 hives Ten minutes after injection felt lightheaded/dizzy with brief periods of feeling alternately "hot an... Read more
Ten minutes after injection felt lightheaded/dizzy with brief periods of feeling alternately "hot and cold". Then felt some chest tightness with some difficulty breathing but no wheezing, She felt the tightness sensation on her chest. EpiPen administered once with transient improvement of symptoms but then recurred then administered EpiPen again. Thinks she saw some hives on her chest. Taken by ambulance and administered diphenhydramine 50mg Taken to the ER with no rash, upper/lower respiratory symptoms noted. EKG and cardiac workup negative. Patient discharged after 4 hours after improvement of symptoms with no other treatment given. Serum tryptase sent and 6.4mcg/mL.
54 2021-02-02 rash rash to arm, shoulder area, and back
54 2021-02-02 itchy skin, rash swelling lips; numbness; rashes in the face and legs; high blood pressure; itching; nauseas; diahrre... Read more
swelling lips; numbness; rashes in the face and legs; high blood pressure; itching; nauseas; diahrrea; palpitation; Headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 54-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 14Jan2021 13:15 at single dose at left arm for covid-19 immunization. Medical history included known allergies: sulfas, codeine, latex. Concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. After 22 minutes received the vaccine on 14Jan2021: started swelling lips, numbness, rashes in the face and legs, high blood pressure, itching and headache, nauseas and diarrhea, until now still felling palpitation and headache. The adverse events resulted in emergency room/department or urgent care. Patient received treatment famotidine 20 mg, epinephrine for events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. Outcome of events palpitation and headache was not recovered, and outcome of other events was recovered with lasting effects in Jan2021. Information of lot/batch number has been requested.; Sender's Comments: The reported events swelling lips, numbness, rashes in the face and legs, high blood pressure, itching, nauseas and diarrhea, palpitation and headache, were causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
54 2021-02-03 rash macular, redness 10-15 minutes after injection splotchy redness forearms, palm of hands. Approximately 1 hour after i... Read more
10-15 minutes after injection splotchy redness forearms, palm of hands. Approximately 1 hour after injection splotchy redness both legs. Approximately 2 hours after injection tingling around neck, tingling in lips and swelling and tingling right side of face and voice change hoarseness.
54 2021-02-04 itchy skin, rash Developed rash on arms and front of legs with severe itching. She was placed on Medrol dose pack by ... Read more
Developed rash on arms and front of legs with severe itching. She was placed on Medrol dose pack by PCP then hospitalized 1/27/21-1/29/21.
54 2021-02-04 blister Patient reports with 1st shot had arm pain described as mild and not interfering with daily activiti... Read more
Patient reports with 1st shot had arm pain described as mild and not interfering with daily activities. Patient reports with second shot, within 5 hours had arm pain, malaise, headache, and nausea. At 7 hours symptoms increased in severity limiting activity. Also had chills and body aches. Unable to sleep overnight, felt feverish. On day 2 had difficulty working due to migraine headache, unrelieved by migraine medication. On day 3 migraine remained present but was less severe, modifications needed to continue working. On day 4 had worse migraine and nausea, unable to work. Developed itchy blisters, at least 12 to inner thighs, also on belly and back. Took OTC allergy medication, no worsening or additional spread of blisters following this.
54 2021-02-04 rash bilateral leg paralysis; nauseous; hardly walk; muscles were so tight/jaws felt locked, like a tight... Read more
bilateral leg paralysis; nauseous; hardly walk; muscles were so tight/jaws felt locked, like a tightness; numbness on the left side of [her] face, right under the eye; temporary rash she had on the left side of her face, under her cheek; toes crowded back; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose "on the left side" for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She stated feeling nauseous right after the shot and mentioned not eating breakfast. She described having bilateral leg paralysis which she also qualified as locked to the point where she could hardly walk. She added that her leg muscles were so tight that her toes crowded back. She then explained having numbness on the left side of her face, right under the eye and that her jaws felt locked, like a tightness. She specified she didn't know if she really felt tightness in her jaws because of the intensity of her bilateral leg paralysis. She then described a temporary rash she had on the left side of her face, under her cheek. She said her experience occurred two hours post injection on 21Jan2021 and was resolved in Jan2021 after taking a muscle relaxer. She asked if shellfish is in the vaccine. Information about lot/batch number has been requested.
54 2021-02-07 vaccination site pain Chills; Fever; Heart racing; ached from head to toe/body soreness; FLU LIKE FEELING; Could not sleep... Read more
Chills; Fever; Heart racing; ached from head to toe/body soreness; FLU LIKE FEELING; Could not sleep and mind was racing; her mind was racing; Soreness at the injection site; Tension headache with pressure; This is a spontaneous report from a contactable consumer reported for herself. A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on left arm on 20Jan2021 12:30 at SINGLE DOSE for covid-19 immunisation. Medical history included none. There were no concomitant medications. The patient received the vaccine on Wednesday, 20Jan2021. This was her first dose. She had the vaccine at 12:30 PM. Right after the vaccine she waited her 15-20 minutes and was fine. These things did not start till later. She was not sick prior to getting the vaccine. 8 hours after, around 8:30 PM she had a tension headache with pressure that went all through the night and let up around 21Jan2021 10 AM. Around 12 AM Thursday morning on 21Jan2021, she had chills, fever, and a racing heart. She ached from head to toe/body soreness. It was a flu like feeling. Then they all got better around the same time 21Jan2021 evening. The racing heart was not enough to need 911. It worried her but was not enough. She also could not sleep and her mind was racing. She thinks it was because what was going on with her racing heart. It was making her head pound. She finally was able to sleep last night on 21Jan2021 around 8:30 PM and slept until 4:30 AM this morning on 22Jan2021. The doctors said if she was not better by tomorrow they would work her in to see her. But she is much better today. She also had soreness at the injection site on 20Jan2021. She knew that was normal though. She is still sore but overall is better. It felt like there was an invasion in her body. She is a little scared now for the second dose. She is unsure if she wants to get it. She asks, do you recommend getting the second dose after she had all of these side effects? It worries her. The heart is the main thing. That worried her the most. Outcome of the event tension headache with pressure, chills, fever, heart racing, ached from head to toe/body soreness, flu like feeling was recovered on 21Jan2021, outcome of the event could not sleep and mind was racing was recovered on 22Jan2021, outcome of the event soreness at the injection site was not recovered.
54 2021-02-07 vaccination site pain arm injection site pain(soreness); ran a fever of 101; Body aches; stuff nose; This is a spontaneous... Read more
arm injection site pain(soreness); ran a fever of 101; Body aches; stuff nose; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route on 21Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient is not pregnant. The patient had received the first dose of the same vaccine on unknown date. On 21Jan2021 the patient experienced arm injection site pain, ran a fever of 101, body aches and stuff nose. The outcome of the events was reported as recovering. The patient did not receive any treatment for the events. The patient had not been tested for COVID post vaccination. No COVID prior vaccination. The events were assessed as non-serious. Information on the lot/batch number has been requested.
54 2021-02-07 redness both of her legs seized. The muscles so tight that I was unable to walk (like a spasm); The muscles ... Read more
both of her legs seized. The muscles so tight that I was unable to walk (like a spasm); The muscles so tight that I was unable to walk/ just a muscular contraction that left me unable to walk properly (the left side seem to be the tightest side of by body); like a spasm; bilateral jaw pain; slight numbness on by left face; face still has a bit of muscle sensitivity (tingling sensation) near the mouth and jaw; redness on my left cheek; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on the left arm on 21Jan2021 09:15 at a single dose for COVID-19 immunization. Medical history included shellfish allergy. Concomitant medications included received within 2 weeks of vaccination but were not reported. The patient previously took codeine and experienced allergy. On 21Jan2021 11:30, both of her legs seized. The muscles so tight that she was unable to walk (like a spasm). There was no twitch just a muscular contraction that left her unable to walk properly (the left side seem to be the tightest side of by body). The patient also had bilateral jaw pain (not sure if it was because she was in so much pain in the legs that she was clenching my teeth). She also had slight numbness on by left face and by the evening she had redness on her left cheek but it went away. Her face still had a bit of muscle sensitivity (tingling sensation) near the mouth and jaw. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Events were reported as non-serious. Outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
54 2021-02-07 injection site pain next day fever and palpitations. Coming and going for days. on 2/4/2021 started having LLE and RLE... Read more
next day fever and palpitations. Coming and going for days. on 2/4/2021 started having LLE and RLE numbness and tingling. Went to ED given hx of CVA. Testing all normal. Started to resolve 2 hours later. Continues to have pain at injection site (today is 2/8/2021)
54 2021-02-09 rash, skin spots Severe thrombocytopenia (Platelets = 5) and diffuse petechial rash to trunk and extremities
54 2021-02-10 skin spots Patient received dose 1 of COVID-19 vaccine on 1/15/2021 and dose 2 on 2/5/2021. Approximately 1 wee... Read more
Patient received dose 1 of COVID-19 vaccine on 1/15/2021 and dose 2 on 2/5/2021. Approximately 1 week after the 1st dose, patient said she developed a rash. On presentation on 2/10/21, the rash appeared to be petechial in nature. Prior to coming to the hospital, the patient had blood work done at her ALF and was told she had zero platelets and she was sent to the hospital. Admission labs at the hospital on 2/10 also showed zero platelets and immune thrombocytopenia is suspected.
54 2021-02-10 itchy rash, rash with redness dry and reddened rash; the rash is so itchy and swollen; the rash is so itchy and swollen; This is a... Read more
dry and reddened rash; the rash is so itchy and swollen; the rash is so itchy and swollen; This is a spontaneous report from a contactable Nurse. A 54-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot # EL9261) vaccine , via an unspecified route of administration in the left shoulder on 18Jan2021 at single dose for Covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. The patient received the first dose of BNT162B2 vaccine on 28Dec2020. The patient experienced dry and reddened rash in the anterior side of her neck in the shape of her thyroid. on 22Jan2021 with outcome of not recovered , the rash is so itchy and swollen on 22Jan2021 with outcome of not recovered. The reported events were considered Important Medical Events. The patient used her son's eczema cream, clarified as "Elcom" or "Elecom" but the events worsened.; Sender's Comments: Based on the available information, a possible contribution of the drug to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
54 2021-02-11 hives, itchy skin Patient reports itching, and hives. Epi Pen administered and patient escorted to the ED She did rece... Read more
Patient reports itching, and hives. Epi Pen administered and patient escorted to the ED She did receive epi prior to arrival but required no epi in the ED. She received corticosteroids. She was monitored for period time with no deterioration of symptoms. She is discharged stable condition she will complete prednisone and use Benadryl as needed
54 2021-02-12 cellulitis, rash, redness Cellulitic Sweet's syndrome of lower extremity. Significant LLE erythema and pain out of proportion ... Read more
Cellulitic Sweet's syndrome of lower extremity. Significant LLE erythema and pain out of proportion to exam that has continued to progress despite broad-spectrum antibiotics, now s/p OR cut down x3 with no e/o necrotizing fasciitis. Initially most c/f infection/cellulitis, however in discussion with ID, rheum, and derm and given progression of rash in s/o broad spectrum Abx and negative tissue cultures, now most suspicious for cellulitic variant of Sweet's syndrome (SS). Pathology report w/neutrohpliic inflammation w/evidence of ischemia, w/o evidence of infection, c/w Sweets Syndrome. While this is a rare disorder, it primarily occurs in the setting of recent infection or malignancy. Currently working up potentially triggers. Infectious work up thus far negative. Hematologic malignancy most often linked with SS, given new and worsening pancytopenia, will consult heme for recommendations for additional work up. Other potential triggers include vaccinations (question about COVID vaccine recently) and often idiopathic. Maintain of treatment for SS is steroids, dermatology currently managing dosing.
54 2021-02-14 injection site pain A pressure/low burning sensation down the lateral rear side of my left leg. I have not felt this pai... Read more
A pressure/low burning sensation down the lateral rear side of my left leg. I have not felt this pain sensation there so intensely since before my back operation in October 2018. The intense sensation lasted from Sunday 07 FEB through Tuesday 09 FEB 2021, when it started to slowly wane. The inoculation site also had minimal pain. Emailed my PCP and my orthopedic surgeon.
54 2021-02-15 injection site pain Employee received Covid19 vaccine on 01/13/2021 at 8:30 am and at 9:30 am she began having, pain an... Read more
Employee received Covid19 vaccine on 01/13/2021 at 8:30 am and at 9:30 am she began having, pain and burning to her left arm at the sight of the vaccine. Two days later she was unable to lift her left arm due to the severe pain which continues until now.
54 2021-02-15 skin discolouration, redness patient came back in after four or more hours from vaccine administration with complaint of redness ... Read more
patient came back in after four or more hours from vaccine administration with complaint of redness on her fingertips. no itching, shortness of breathe noted. did assess that patient had additional redness and some slight swelling on the left hand as well. Patient received the vaccination in that arm.
54 2021-02-16 injection site redness, injection site pain, injection site warmth, skin infection at injection site, injection site pruritus Cellulitis at injection site with warmth, redness and pain. Continues even today but swelling is goi... Read more
Cellulitis at injection site with warmth, redness and pain. Continues even today but swelling is going down and it is not as red but it itches.
54 2021-02-16 rash The day after I just had an aching body and slight fever. Then about 3 days after I woke up with a ... Read more
The day after I just had an aching body and slight fever. Then about 3 days after I woke up with a horrible rash on my wrist, torso and legs and the next morning I now have it on my face and neck. I went to the doctor on the 15th and he prescribed me Prednisone 10mg and was told to take zyrtec along with Pepcid twice a day and Benydryl at nite. It is now the 17th and I still have rash.
54 2021-02-17 rash, itchy skin Full body itching at bed time. Woke up with full body rash & itching. Took systemic antihistamine (g... Read more
Full body itching at bed time. Woke up with full body rash & itching. Took systemic antihistamine (generic Allegra).
54 2021-02-18 injection site redness Erythematous circular rash with surrounding white clearing close to injection site
54 2021-02-18 rash, redness, itchy skin, hives Rash began on day 5. itching and redness. whelts, no blisters.
54 2021-02-18 injection site pain Sore Arm at injection site; Fatigue - within a few hours of receipt; Headache within 12 hours; Chill... Read more
Sore Arm at injection site; Fatigue - within a few hours of receipt; Headache within 12 hours; Chills and joint pain within 15 hours - all over within 18 hours total
54 2021-02-19 rash Felt like heart racing, POx & VS stable. Patient had cortisone shot 2 days prior with rash
54 2021-02-21 rash with redness, rash Almost immediately got a very bad headache and nausea. About 30 minutes later I got foggy in the he... Read more
Almost immediately got a very bad headache and nausea. About 30 minutes later I got foggy in the head. Within an hour, I felt exhausted. I went to sleep until about 7pm and when I woke up I felt really nauseous and still very tired. I had a little broth and went back to sleep. on 02/19/2021 at 1am I woke up feeling really hot and had horrible body aches. Even my joints hurt. I took my temperature and it was only 99.2 but my temperature usually runs 97.4 or 97.6. I woke up on 02/20/2021 and my left eye was crusted over just like the first vaccine. My body aches and nausea lasted until 02/20/2021. In the evening of 02/20/2021 I noticed about 10 little red bumps in various places on my body. (2 on left arm, one on back neck in hairline, two on upper back, one on chest, two on left leg, one on lower back and one on left buttock. Today is 02/22/2021 and I am still feeling fatigued. It's not as bad as it was over the weekend but I am still tired. My arm was much sorer with this injection.
54 2021-02-21 dry skin Approximately 15 minutes post-vaccination (0830), pt started feeling dizzy, nauseous and had one epi... Read more
Approximately 15 minutes post-vaccination (0830), pt started feeling dizzy, nauseous and had one episode of emesis. Vital signs at 0830 were bp:184/108, p:112, SpO2:99%. At this time pt was flushed, skin was hot and dry. Vitals at 0835 were bp:179/124, p: 92. Pt began feeling chest pain. Vitals at 0840 were bp: 182-108, p:86. Emergency services were called and pt was transferred to local ED.
54 2021-02-21 rash with redness, rash, skin warm Hot red rash first appeared behind knees, then on elbows, the on knees and shins, then by sitting bo... Read more
Hot red rash first appeared behind knees, then on elbows, the on knees and shins, then by sitting bones and then ankles over the course of a week. Prednisone was prescribed and helped.
54 2021-02-21 dry skin, injection site pruritus, itchy skin Itching at injection site and sporadic itching in multiple areas of body. Itching, very dry skin cen... Read more
Itching at injection site and sporadic itching in multiple areas of body. Itching, very dry skin centralized on face starting Friday, February 19 around 5 PM. It continues. Benadryl 25 mg taken by mouth.
54 2021-02-22 itchy skin, rash macular C/o feeling itchy on arms, neck, knee. No rash noted at injection site or on arms. Blotchy essential... Read more
C/o feeling itchy on arms, neck, knee. No rash noted at injection site or on arms. Blotchy essential noted neck right clavicle area. Denies pain, SOB, dizziness, nausea. P76. Checked by EMT. EMT instruct ti take oral benadryl when she gets home. Client stated that perfums,perfume, lotions can set off itchy feeling when shesmells perfume.
54 2021-02-22 rash with redness Patient developed red rash neck, chest and arms. Bilateral Eye swelling. Chest tightness. Denied dif... Read more
Patient developed red rash neck, chest and arms. Bilateral Eye swelling. Chest tightness. Denied difficulty breathing. Benadryl 25mg IM administered and transferred to Emergency Room for further treatment.
54 2021-02-23 redness 0825 Feeling Shaky skin little red, Pfizer 2nd dose. 0835 Cheeks feeling flushed. Benadryl 50mg give... Read more
0825 Feeling Shaky skin little red, Pfizer 2nd dose. 0835 Cheeks feeling flushed. Benadryl 50mg given orally. 0842 Cheeks feeling better arms, still flushed NO SOB,NO CP NO NAUSEA 854am Reports no worsening symptoms 910 Feeling better released to go home.
54 2021-02-23 itchy skin, hives Hives/swelling/puritis (of head/face, neck, chest, arms) and elevated blood pressure. IM Benadryl at... Read more
Hives/swelling/puritis (of head/face, neck, chest, arms) and elevated blood pressure. IM Benadryl at vaccination site IM steroid and prescription for steroids in ED
54 2021-02-23 itchy skin Waited 15 minutes as required and left. At 20-25 minutes as I was driving my mouth began to severely... Read more
Waited 15 minutes as required and left. At 20-25 minutes as I was driving my mouth began to severely itch. Arrived home, and took Benadryl which lessened the itch and it was almost gone by 2am on 2/24/2021.
54 2021-02-23 injection site pain, injection site swelling fever, - up to 102, chills, headache, muscle aches, joint aches, tiredness, injection site pain and... Read more
fever, - up to 102, chills, headache, muscle aches, joint aches, tiredness, injection site pain and swelling, swollen lymph nodes in underarms- more pronounced in arm where shot was received.
54 2021-02-24 skin discolouration, redness, injection site mass, cellulitis COVID-19 Vaccine Pt received vaccine 1/7/2021 and discharged to home. Pt endorsed one day of nausea... Read more
COVID-19 Vaccine Pt received vaccine 1/7/2021 and discharged to home. Pt endorsed one day of nausea, headache, fatigue, and chills following vaccination. On Monday 1/11/21, pt woke up to a large, red, discolored, warm, grapefruit-sized lump on her arm at site of injection. PA at clinic she worked with was curbsided, who said it might be cellulitis. Pt called her PCP who issued prescription for cephalexin 500 mg cap PO TID x 10 days on 1/11/2021. After 2 days of therapy, pt reports lump is still red, discolored, and grapefruit-sized, but is no longer warm. 2/2/21: Pt received 2nd dose of COVID vaccine without issue.
54 2021-02-24 injection site pain I noticed a slight swelling of my palms near the wrists on the following morning of my first dose of... Read more
I noticed a slight swelling of my palms near the wrists on the following morning of my first dose of the Covid vaccine. I took a dose of pseudoephedrine and the swelling went down. Other reactions were tiredness and injection site pain.
54 2021-02-25 hardening, itchy skin Fatigue and chills the first 24 hours then itchy, swollen bump on arm at day 7, 8 ,9 ( still swollen... Read more
Fatigue and chills the first 24 hours then itchy, swollen bump on arm at day 7, 8 ,9 ( still swollen currently at day 9)
54 2021-02-26 injection site hardening, injection site pruritus, injection site redness, injection site warmth 3x4 inch raised, warm, red swelling about 3 inches distal to the vaccination site. Purritic. Present... Read more
3x4 inch raised, warm, red swelling about 3 inches distal to the vaccination site. Purritic. Present for 3 days before slowly resolving.
54 2021-02-27 injection site pain, injection site pruritus, injection site redness, injection site mass No side effects the day of the 1st vaccination. On Sunday 2/21, I wok up with an extremely sore ar... Read more
No side effects the day of the 1st vaccination. On Sunday 2/21, I wok up with an extremely sore arm at injection site and it felt like there was a knot the size of a golf ball underneath my skin. On Monday, 2/22 I developed a large red circle around the injection site which grew in size along with the sore "knot" growing in size. The red circle was not an outline. It was a large red circle completely filled int. The circle grew to about 3.5 - 4 inches in circumference and itched. It peaked on 2/24. The size of the circle and the "knot" started to reduce and by 2/28 the circle was gone and only a slight tightness at the injection site remained. We took a photo on the "peak" day.
54 2021-02-27 redness Red arm half way down , still 4 days post injection
54 2021-02-28 itchy skin Itchy, and heart racing turned over care to AMR was given oral Benadryl transported to hospital.
54 2021-02-28 itchy skin, hives Within 5 minutes of vaccine I developed a tight cough. By 10 minutes I was wheezing, coughing and i... Read more
Within 5 minutes of vaccine I developed a tight cough. By 10 minutes I was wheezing, coughing and it was difficult to inhale deeply, was itchy with few hives, lips and tongue were tingling and I became dizzy. I was sent to the ER and received IV Benadryl, IV pepcis and an IV steroid along with an Albuterol breathing treatment. Heartrate 110-115 pulse ox 94% prior to meds and breathing treatment. BP not done. Symptoms resolved but by 1200 were all back. At that time I was given Epinepherine IM. Symptoms resolved by 1pm. Discharged from hospital by 4pm. By 5pm face numb and tingling from cheekbones to mandible. Resolved within 24hrs. Since then, I have had episodes of facial numbness and tingling, hives and overall itching, lip/tongue tingling and bronchoconstriction(not with exercise)
54 2021-03-01 injection site pain, injection site pruritus, injection site redness Friday, Feb 26th 2021-About a hour after shot I had joint pain in my elbow and wrist. I took Tyleno... Read more
Friday, Feb 26th 2021-About a hour after shot I had joint pain in my elbow and wrist. I took Tylenol 1 hour prior to the shot and 6 hours afterwards. No redness or pain Friday evening. I had insomnia Friday night and did not fall to sleep until 5am. Saturday, Feb 27th, 2021- I woke up with joint pain to my elbow and wrist. Arm was extremely sore. I did not eat until 4pm and I took Tylenol then, Once I started moving my arm felt better and the joint pain went away. Trouble sleeping Saturday night. Fell asleep around 4am. Sunday, Feb 28th- Work up and arm wasn't as sore. Noticed around 1pm I had a red spot under the vaccine spot where I was injected. It was red and painful, about the size of 2 nickels put together. I took more Tylenol that evening and was ok. Monday, March 1st- I noticed the red spot had gotten bigger. It wasn't as itchy and was not bothering me. Around 8pm, I noticed the spot was bigger and itchy. I toke a Tylenol and Benadryl and about midnight put an ice pack on the redness for 15 min intervals. I did this 3 times. I outlined the red spot, which is now as big as a orange to see if it was spreading. Tuesday, March 2nd - Noticed no spread at 8:30am. Site beginning to itch. At 12 noon, taking a Benadryl and Tylenol after eating lunch.
54 2021-03-01 itchy skin Pt experienced mild transient pruritus to various locations of body "moving from legs to arms then h... Read more
Pt experienced mild transient pruritus to various locations of body "moving from legs to arms then head" but not all at once. Onset 3-5 minutes after receiving vaccination. Pt reports occasionally experiences pruritus when anxious and this vaccine appointment was a source of anxiety. Denies flushing, SOB, headaches. Pt alert and oriented. No problems with ambulation. Pt taken to quieter location. Pt declined diphenhydramine nor zyrtec on site. After 30 minute observation time after vaccination, pt's, sx's diminishing and pt refused transport to hospital for further evaluation, signing refusal form. Pt stating her husband is in parking lot and will transport her home.
54 2021-03-02 redness, rash with redness, itchy skin Pt c/o redness to face and chest and lightheadedness. Rash noted on checks, neck, and upper chest n... Read more
Pt c/o redness to face and chest and lightheadedness. Rash noted on checks, neck, and upper chest noted. Pt denied SOB, difficulty breathing, or chest heaviness. C/O mild itching. Pt declined referral to ER. Given 50 mg of oral Benadryl per protocol. Husband to drive home. Encouraged pt to call PMD and alert to reaction. Instructed to go to ER or call 911 if difficulty breathing develops or s/s worsen.
54 2021-03-03 injection site pain 10 minutes after the first dose, I developed a severe headache and a sharp increase in blood pressur... Read more
10 minutes after the first dose, I developed a severe headache and a sharp increase in blood pressure. My blood pressure returned to normal within 40 minutes but I had a persistent headache for 19 days. After second dose, the headache returned with greater severity and my PCP had to prescribe a course of prednisone to help reduce the pain. There was no blood pressure change with the second dose. I also had profound fatigue and was in bed for 48 hours after both doses. My current condition is that the headache and swelling has resolved on right side of temple after 3 days on prednisone but I still have selling and pain, though reduced on left side. I also had typical pain at site injection and received both doses in my right arm.
54 2021-03-03 injection site redness, rash, injection site pain, injection site swelling Fever (101 degrees); chills; dizziness; extreme fatigue; headache; body aches; pain, swelling, redne... Read more
Fever (101 degrees); chills; dizziness; extreme fatigue; headache; body aches; pain, swelling, redness and itching at injection site; red, lacy rash on torso - all symptoms began within 20 hours of vaccine and subsided gradually by 48 hours after vaccine - no treatment other than rest
54 2021-03-03 injection site pain I experienced soreness and pain at the injection site. I also felt very tired/fatigue with severe ... Read more
I experienced soreness and pain at the injection site. I also felt very tired/fatigue with severe neck, shoulder pain with a minor headache.
54 2021-03-04 injection site pain No adverse reactions other then pain in the injection site and being tired then last night 48 hours ... Read more
No adverse reactions other then pain in the injection site and being tired then last night 48 hours later my eye was twitching. Today it 72 hours later eye twitching again and then this afternoon my bottom lip began to tingle. Called the Urgent care they said come in and I did and the said it is bells palsy and gave me steroids and another drug to take
54 2021-03-05 redness, itchy skin 3/6/21 5:07am, woke with red, swollen face like a shellfish allergy reaction. Top of chest right bel... Read more
3/6/21 5:07am, woke with red, swollen face like a shellfish allergy reaction. Top of chest right below neck was red. Face and red area of chest itchy. Went to quick care, received steroid injection and prescriptions for hydroxyzine and prednisone.
54 2021-03-05 itchy skin 5 minutes after vaccine, patient began to feel like her throat was tightening/ closing and that it ... Read more
5 minutes after vaccine, patient began to feel like her throat was tightening/ closing and that it was difficult to swallow. She also reported feeling like her tongue was swelling mildly. She felt mild itching but denied rash, chest pain, or difficulty breathing. Also denied nausea, vomiting, abdominal pain. She received 50 mg of IM Benadryl and was observed until an ambulance arrived to transfer her to an emergency department. She felt better after the Benadryl. Reports a history of similar reaction to eating berries.
54 2021-03-05 injection site redness, injection site pruritus Moderate amt redness.& Itching to site and knot the size of a ping pong ball initially. At this time... Read more
Moderate amt redness.& Itching to site and knot the size of a ping pong ball initially. At this time now the size of a marble with small amt itching.
54 2021-03-06 injection site pain Symptoms occurred with 2nd covid dose. Pfizer lot number is unclear and may not be correct due to s... Read more
Symptoms occurred with 2nd covid dose. Pfizer lot number is unclear and may not be correct due to sloppy handwriting. Days 1-5 with increasing left arm soreness at injection site. Also increasing left wrist joint pain, left elbow joint pain, and left shoulder joint pain. Day 5 and 6 were the worst for joint pain. Very uncomfortable. No fevers. Day 7 with swollen left arm pit and swollen left breast. Arm pit and breast with mild pains and painful to touch or move. Joint pains subsiding . Days 8 -14 continues with the same symptoms of left arm pit swelling, left breast swelling and pains. No skin discoloration and no warmth. No change in swelling , discomfort or pain from days 8-14, but not any better. Can?t wear bra or do yoga.
54 2021-03-07 shingles I broke out with shingles on the left side of my neck, along the left jawbone, behind and in my left... Read more
I broke out with shingles on the left side of my neck, along the left jawbone, behind and in my left ear.
54 2021-03-09 injection site pain, rash, itchy skin, injection site rash Injection site was sore for 2 days; however, 5 to 6 days later, I developed a rash on the upper left... Read more
Injection site was sore for 2 days; however, 5 to 6 days later, I developed a rash on the upper left arm. I took Benadryl but that did not alleviate the rash or itching. The rash turned hard on the upper left of my arm and then smaller rashes ran down the arm. Today, March 10, I notice a rash beginning on the upper part of my right arm near the injection site. I have applied topical Benadryl cream to the rash which helps with the itching but the rash does not go away; instead it feels like small bumps underneath the skin.
54 2021-03-09 itchy rash, rash Severe rash and itching on right arm and around fingers. Steroid shot
54 2021-03-09 skin peeling Skin peeled, inflammation and soreness that has dried by the second shot
54 2021-03-09 itchy skin, hives difficulty inhaling; cough; hives; tongue and lips tingling; tongue and lips tingling; itching; This... Read more
difficulty inhaling; cough; hives; tongue and lips tingling; tongue and lips tingling; itching; This is a spontaneous report from a contactable nurse reporting for herself. A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL 3246/expiration date: not provided), via an unspecified route of administration, on 15Jan2021 at 08:00 (at the age of 54 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL1284/expiration date: not provided), via an unspecified route of administration, on 26Dec2020 at 10:00 (at the age of 54 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included exercised induced asthma, and psoriatic eczema. The patient had known allergies to penicillin, fentanyl, and levofloxacin (LEVAQUIN). Concomitant medication included levothyroxine sodium (SYNTHROID) and atorvastatin (LIPITOR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 15Jan2021 at 08:15, the patient experienced difficulty inhaling, cough, hives, itching, tongue and lips tingling. The events resulted in an emergency room visit. The patient received treatment for these events which included treatment epi: IV fluids, IV benadryl, Pepcid, Solumedrol then IM. The outcome of the events difficulty inhaling, cough, hives, itching, tongue and lips tingling was recovered with lasting effects (sequel) on an unspecified date in 2021. Since the vaccination, the patient had not been tested for COVID-19.
54 2021-03-09 itchy skin, hives hives all over the body 2 days after the vaccine, severe forearm pain bilateral from elbow down and ... Read more
hives all over the body 2 days after the vaccine, severe forearm pain bilateral from elbow down and was unable to write or lift anything for 3-4 days . pain has improved but still has hives very itchy
54 2021-03-10 injection site pain Lightheadedness on 3/5/21 Soreness at vaccine site Shortness of Breath Body Chills Fatigue Weakness... Read more
Lightheadedness on 3/5/21 Soreness at vaccine site Shortness of Breath Body Chills Fatigue Weakness Headache
54 2021-03-10 injection site pain Severe headache, arm soreness at injection site, vomiting in first 24 hours, nausea, fever up to 102... Read more
Severe headache, arm soreness at injection site, vomiting in first 24 hours, nausea, fever up to 102 but consistently at 100 for approximately 48 hours, weakness and fatigue. Headache lasted to third day but less severe.
54 2021-03-10 injection site swelling, injection site nodule, injection site warmth Symptoms began about 12 hours after the 2nd shot. (The first one I just was lethargic for a couple o... Read more
Symptoms began about 12 hours after the 2nd shot. (The first one I just was lethargic for a couple of days and had a big knot at the injection site.). I had a terrible headache for about 36 hours and had zero energy for 2 days. I had night sweats the first night. Then I had a swollen, hot arm from left shoulder to elbow for 24 hours. It decreased some, but the knot remained for about 4 days. The symptoms were a lot less than the 2nd shingles shot I got in the fall. And certainly the symptoms were a lot better than the virus itself!
54 2021-03-11 rash, itchy skin Cold sore, mouth sores, itchy burning eyes, abdominal rash, itchy skin head to toe, vertigo, dry cou... Read more
Cold sore, mouth sores, itchy burning eyes, abdominal rash, itchy skin head to toe, vertigo, dry cough, shortness of breath, traveling leg pain, development of ear infection, dizziness
54 2021-03-11 itchy skin Developed mild itching over all skin surface including scalp about 20 minutes post vaccine administr... Read more
Developed mild itching over all skin surface including scalp about 20 minutes post vaccine administration. No rash. Administered Benadryl 50mg orally. Vital signs stable with PO2 @ 99% & Pulse 62-64, regular. Itching subsided and she was discharged to her husband @ noon. She was instructed to contact her hematologist to inform of this event.
54 2021-03-11 pain of skin First I had chills and quite violent shaking. I then got a fever and felt muscle aches, joint pain a... Read more
First I had chills and quite violent shaking. I then got a fever and felt muscle aches, joint pain and my skin hurt. I also had a headache on and off. Sleep was almost impossible due to being uncomfortable, and I had thoughts racing through my head. I also had lack of appetite, but not nausea.
54 2021-03-11 sensitive skin Flu-like symptoms including: chills/shivering, headache, joint pain, skin sensitivity, exhaustion - ... Read more
Flu-like symptoms including: chills/shivering, headache, joint pain, skin sensitivity, exhaustion - lasted about 9 hours and then all symptoms were gone.
54 2021-03-11 hives Tingling in mouth started Wednesday (3/10) and hives and little trouble breathing. Patient took Bena... Read more
Tingling in mouth started Wednesday (3/10) and hives and little trouble breathing. Patient took Benadryl and Inhaler. THursday patient still using Benadryl and used Prednisone. Saw MD Friday 3/12. Getting better now.
54 2021-03-11 rash tingling in tongue and lips, rash on neck, certizine given 10mg
54 2021-03-12 injection site pain Extreme ache at injection site started an hour after injection. Within a few hours my entire body s... Read more
Extreme ache at injection site started an hour after injection. Within a few hours my entire body started aching. The next day I could barely get out of bed and function. I also could not sleep. Aches lasted for two days.
54 2021-03-12 injection site redness, injection site pruritus, vaccination site warmth, injection site hives Patient complained of itchiness, hives, redness, and hotness on her right arm(same arm of vaccine) a... Read more
Patient complained of itchiness, hives, redness, and hotness on her right arm(same arm of vaccine) after receiving the vaccine. Zyrtec 10 mg given at 1647. After 15 minutes patient symptoms improved. Patient sent home per MD.
54 2021-03-13 injection site pain Fatigue, nausea, headache, pain at injection site, pain in right side of my neck and swollen muscle ... Read more
Fatigue, nausea, headache, pain at injection site, pain in right side of my neck and swollen muscle and lymph gland in right front collar bone. All symptoms were within hours of administration except the swollen lymph gland. The gland was about 36 hours after administration. I have not pursued treatment at this point.
54 2021-03-13 injection site numbness, injection site swelling, injection site tingling pt was anxious about getting the shot, stated she's diabetic with heart condition pre vaccine. dose ... Read more
pt was anxious about getting the shot, stated she's diabetic with heart condition pre vaccine. dose approx 1:20, at 1:28 said her arm was going numb and declined water and food. 1:33 continued tingling numbness of left arm and jawline, she again declined food and water. 1:43 hot, sweaty, ache in chest and rapid pulse feeling. called ems, gave water and crackers, 1:48 bp between 103/80 Pulse 94 to 127/79 pulse 86. 1:55 bp 156/113 pulse 88. said her arm was tingly and face going numb, feeling her heart flutter. when EMS arrived she said her blood glucose was 286 this am and she took Humalog then. normal bp 130s/80s pulse in 90s. Tx to hospital, FU 3/12&3/14 said she had throat closing and vax site numb and swollen
54 2021-03-14 rash Fever, severe chills and fatigue, headache, body aches, pain in left arm, full body hot rash. Began... Read more
Fever, severe chills and fatigue, headache, body aches, pain in left arm, full body hot rash. Began on the afternoon 3/14/21, became severe in the evening, into 3/15/21. Symptoms have improved, but are still present, I have been in bed for 24 hours.
54 2021-03-14 itchy skin Hives and itchiness, dizziness and weakness, lip and tongue swelling, cough, throat swelling, troubl... Read more
Hives and itchiness, dizziness and weakness, lip and tongue swelling, cough, throat swelling, trouble swallowing, difficulty breathing, confusion, chills, difficulty speaking.
54 2021-03-14 itchy skin Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Additional Details: Patient c/o... Read more
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Additional Details: Patient c/o itching in right throat, right neck, along left hair line. Patient took own hydroxyzine 50 mg.
54 2021-03-15 injection site pain Extreme fatigue. Slept. Felt better. Moderate soreness at injection site. Soreness continues 2nd da... Read more
Extreme fatigue. Slept. Felt better. Moderate soreness at injection site. Soreness continues 2nd day.
54 2021-03-15 rash My lips started to tingle (same reaction as cobalt allergy before my lips swell). I asked if I coul... Read more
My lips started to tingle (same reaction as cobalt allergy before my lips swell). I asked if I could take benadryl (which I brought with me). The person watching us texted someone and they came in and looked at me, asked me what was happening, took my blood pressure and said to take 2 benadryl. I told the nurse I only take one benedryl when this happens. She said take 2 benadryl. I did take 2 benadryl 12 minutes after my vaccine. My blood pressure went up. They called an ambulance and I went to the Hospital. My blood pressure was 176/105 at 11:50 am. While I was in the ER, I took a selfie and noticed that I had a rash. No one mentioned that earlier so I am guessing that is why they had me take 2 benadryl. At the ER I was put on an IV - NS .09% 1000ML at 12:27 pm. Then at 13:04 I was given Pepcid 40 MG/NS 250 ML IV at 500 ml/hr intravenous. At 1:12 pm my blood pressure was 138/96 and at 2:31 pm it was 135/70. My rash went away then. Up until last week I have been taking benadryl and/or pepcid everyday since the vaccine. I would still get a rash. I have not had the rash for about 5 days.
54 2021-03-15 rash, hives Rash and welts started on both ankles - front and back; spread up legs to knees over period of week;... Read more
Rash and welts started on both ankles - front and back; spread up legs to knees over period of week; lasted for 2 weeks and 3 days until prednisone.
54 2021-03-15 injection site pain Soreness at injection site on the first day, around 24 hours later developed all over aches, lighthe... Read more
Soreness at injection site on the first day, around 24 hours later developed all over aches, lightheadedness, chills, and weakness to the point of not being able to ambulate. This lasted for two days, then started getting extremely swollen, sore lymph nodes under left arm to the point of not being able to tolerate wearing a bra along with dizziness and nausea. This has persisted for two days so far.
54 2021-03-15 rash slight rash on arm and legs, sore throat, nausea, severe chills, severe headache, jaw ache, tirednes... Read more
slight rash on arm and legs, sore throat, nausea, severe chills, severe headache, jaw ache, tiredness,
54 2021-03-16 injection site pruritus, itchy skin, injection site redness Patient's reaction(s) noted during COVID vaccine observation period: 0754, patient complaints of fe... Read more
Patient's reaction(s) noted during COVID vaccine observation period: 0754, patient complaints of feeling itchy and reddness at injection site, runny nose. No hives noted. 0754: 126/67, 98% O2, 77 HR 0805: 118/66, 98% O2, 75 HR; still c/o itchiness and redness at injection site, post-nasal drip 0820: Pt stated that she is feeling itchy in mouth and is having thicker post-nasal drip. Code Medic called and at bedside within a minute. Taken via wheelchair to ED and pt remained awake and alert. Patient reports previous anaphylactic reaction after receiving the flu shot. Discharged home from ED 1000
54 2021-03-16 skin warm feeling of warmth and swelling on the face
54 2021-03-17 rash, skin burning sensation Received the vaccine and within a minute or two felt very dizzy and heart was beating so fast. My li... Read more
Received the vaccine and within a minute or two felt very dizzy and heart was beating so fast. My lips were tingling and my arms and legs felt suddenly so tired. They monitored me in the reaction tent for 45 minutes until I could sit up and walk. By the time I got home I had a burning rash on my neck and my voice was suddenly hoarse as if I was sick. Just rested and symptoms slowly subsided over the day. I must be hypersensitive to something because this is the third time I have had a reaction like this. The others were with the fly shot. Folks took good care of me.
54 2021-03-18 hives Broke in Hives twice.
54 2021-03-18 rash, rash vesicular I have been feeling tired since the vaccine and have had a chronic low-grade headache since as well.... Read more
I have been feeling tired since the vaccine and have had a chronic low-grade headache since as well. Things have been okay until a couple of days ago. I am a fanatic about skincare. I developed a water blister-type rash on the right side of my chin ( not in my mouth). The very next day, my neck started to hurt, and I noticed that my lymph node is swollen on the right side of my neck, just under my jaw. The blisters have crusted over, but my chin and a bit of my cheek are swollen.
54 2021-03-18 itchy skin Waited 30 minutes felt ok. Got in car 10 minutes later. Slowly began to feel Throat was swelling, f... Read more
Waited 30 minutes felt ok. Got in car 10 minutes later. Slowly began to feel Throat was swelling, face was swelling and very red and hot. I took Benadryl with me just in case. Called doctor she said take the Benadryl and call 911. I took 2 pills 25mg each and three puffs from my rescue inhaler. We face me prednisone and more Benadryl . Oxygen level was good just throat was. Tight and I was very itchy. Now 8 hours later systems came back took 2 mire Benadryl while I?m typing starting to feel better.
54 2021-03-19 injection site swelling, injection site redness, injection site pruritus Almost 2 weeks after vaccine my injection site started to itch and then became red and swelled to th... Read more
Almost 2 weeks after vaccine my injection site started to itch and then became red and swelled to the size of a softball and has gotten bigger overnight. I have a bad headache and a lot of fatigue .
54 2021-03-20 itchy skin, pain of skin, rash At around 7pm, the symptoms started first with diarrhea. 10-20 minutes later, she started sneezing a... Read more
At around 7pm, the symptoms started first with diarrhea. 10-20 minutes later, she started sneezing a lot. She took a Claritin, then took a shower. In the shower, she began feeling itchy everywhere, especially in the face. She developed hives around the body (3-4 small patches on underarm, legs). There was also a hive patch on her left eyelid, which started as a small bump, but worsened while she was in the shower. It grew bigger, taking up half of her eyelid. She came out of the shower 10-15 minutes after she began sneezing. 20 minutes after that, her body hives subsided but the eye hive worsened further. The hive took up her entire left eyelid and the eye was swollen nearly shut. Before going to bed (9:30pm), she took a Benadryl. The eye was still swollen in the morning but less so than the night before. Now, 24 hrs after the symptoms began, the eye hive has almost entirely subsided. She feels less severe symptoms now, like fatigue and scalp tenderness.
54 2021-03-20 injection site swelling Fever 100.7; muscle aches; headache; swelling at injection site; This is a spontaneous report from a... Read more
Fever 100.7; muscle aches; headache; swelling at injection site; This is a spontaneous report from a contactable other health professional. A 54-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via Intramuscular route of administration on Right arm on 06Feb2021 12:30 at single dose for covid-19 immunisation administered at Public Health facility. Medical history was none. Known allergies include Tetracyclines. Concomitant medications include advil [ibuprofen] (IBUPROFEN); dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL), bromazepam (NIQUIL); paracetamol (TYLENOL) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). On 06Feb2021 13:30, patient experienced Fever 100.7, muscle aches, headache, swelling at injection site. The patient did not receive any treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Covid has not been tested post vaccination. The seriousness was reported as non-serious. The outcome of the events was recovering. Information on the lot/batch number has been requested.
54 2021-03-20 itchy skin, injection site pain Itching, , severe headache, swelling or lump under right armpit with severe pain, pain in area of ... Read more
Itching, , severe headache, swelling or lump under right armpit with severe pain, pain in area of injection , chest pain , runny nose, chills, fever, nausea, fatigue, muscle and body aches especially on right side.
54 2021-03-21 skin burning sensation, itchy skin, rash Persistent itching/burning rash on both hands.
54 2021-03-21 injection site rash, injection site bruising, injection site bleeding, injection site irritation, hives, injection site pain, rash Progress Notes PA-C (Physician Assistant) ? ? Family Medicine Cosign Needed Expand AllCollapse All ... Read more
Progress Notes PA-C (Physician Assistant) ? ? Family Medicine Cosign Needed Expand AllCollapse All COVID VACCINE CLINIC 3/22/2021 Date: 3/22/2021 MRN: 3150851 Subjective Patient is a 54 y.o. female who was seen at Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience hives. She denied difficulty breathing, difficulty swallowing, wheezing and throat tightness. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms, respiratory distress and skin changes. ALLERGY REVIEW OF SYSTEMS: Patient complains of hives (1 hive on chest) Patient denies chills, facial swelling, cough, chest tightness, shortness of breath, wheezing, dizziness and headaches Previous Reactions: Denies prior reaction to vaccines Objective Vitals Vitals: 03/22/21 0828 03/22/21 0846 BP: (!) 153/87 (!) 141/69 Pulse: 52 SpO2: 100% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema. Comments: No swelling or lips or tongue. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Skin: General: Skin is warm and dry. Comments: +erythematous hive on anterior chest. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Assessment/Plan Treatment included: antihistamines Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Systemic reaction (hypoglycemia, hypotension, generalized rash) Encouraged patient to take benadryl prior to getting her second vaccination. PA-C Electronically Signed 3/22/2021 8:55 AM
54 2021-03-22 injection site pain Arm and vaccination site not sore until this morning, but tolerable. Felt very sleepy starting at ar... Read more
Arm and vaccination site not sore until this morning, but tolerable. Felt very sleepy starting at around 5:30pm yesterday. Had a good night sleep but very tired and sleepy this morning. Low energy.
54 2021-03-22 blister, shingles, rash, rash vesicular The night of the injection I had a headache and chills no fever. In the morning my headache was a m... Read more
The night of the injection I had a headache and chills no fever. In the morning my headache was a migraine no energy and a rash on forehead. My evening my head was on fire and blister formed on rash. My ear was ringing and hurt It was painful to swallow. Went to ER and was Dx with shingles was prescribed valtrex 1gram q8 hours and lotramin lotion
54 2021-03-23 injection site pain Dizziness; fatigue; sleeplessness; very sore at injection site
54 2021-03-23 shingles The day after vaccine thigh pain, 5 days after vaccine, thighs start have Shingles Visit doctor on 3... Read more
The day after vaccine thigh pain, 5 days after vaccine, thighs start have Shingles Visit doctor on 3/22/21, doctor prescribes medicine ? Zovirax?
54 2021-03-23 injection site warmth, injection site hardening, injection site pain Woke the morning of March 18th with tenderness, warmth and mild induration at my post 9 day Pfizer ... Read more
Woke the morning of March 18th with tenderness, warmth and mild induration at my post 9 day Pfizer Covid vaccine injection site, so of course googled it, and came upon an article regarding late reaction following Covid vaccine. My second dose is scheduled for April 6th (do not know why they scheduled it for 28 days vs. 21) and intend on receiving it, as suggested in the article. 54 y.o. female History seasonal allergies, hives with sulfa and clindamycin Dose 1 - received March 9th - Day 9 reaction (no reaction immediately post vaccine) Left arm Local symptoms - tenderness, warmth, mild induration Size - 6cm X 4cm Systemic symptoms - mild malaise Treatment - 3 Advil and 50mg of Benadryl
54 2021-03-24 injection site warmth About 30 minutes after, arm and face became really hot. Then it turned into tingling, pins and needl... Read more
About 30 minutes after, arm and face became really hot. Then it turned into tingling, pins and needles along my whole left side. I am still having this as of today 3/25/21
54 2021-03-24 rash, rash with redness Arm was sore as expected. Red spots developed on chest first. They do not itch or hurt. I didn?t ... Read more
Arm was sore as expected. Red spots developed on chest first. They do not itch or hurt. I didn?t notice that the spots were all over the torso - back, abdomen, breast, and I may have some on scalp. My allergy Dr described as fixed drug eruption and said the spots look like nummelar dermatitis - even though no itching. She prescribed Triamcinolone and I just started using. I first went to my internist and she had no clue what it was or how to help. I?ve never had anything like this ever - the only thing I?ve done differently in the last 3 weeks was getting vaccinated. No way I?m getting the second dose.
54 2021-03-24 injection site pain Injection site pain for one week after vaccination Tiredness and Fatigue for one day after vaccinati... Read more
Injection site pain for one week after vaccination Tiredness and Fatigue for one day after vaccination Nausea and Vomiting. Vomited 4 times over the course of 6 hours. Slept for 5 hours and felt better. Swollen lymph nodes for 3 days after vaccination.
54 2021-03-24 itchy skin The day after my second dose of the Pfizer vaccine, I experienced chills, severe body aches, stomac... Read more
The day after my second dose of the Pfizer vaccine, I experienced chills, severe body aches, stomach upset, vomiting. I had loss of sensitivity in my right thigh area that comes and goes. I also have brain fog, joint aches that overwhelming. Subsequently, I had Covid tests through my PCP which were negative but I had symptoms that mimicked Covid symptoms. My PCP recommended I go to the ER and I was admitted for two and a half days. They monitored my heart, did lab work, liver test. I continue with headaches that are more profound. I still have loss of strength in my right thigh, which is intermittent, comes and goes. I still have itchiness on my right thigh and leg with loss of sensation lasting from three to five hours. I will be seeing a neurologist next month.
54 2021-03-24 vaccination site pain delirous as if I was hungover; delirous as if I was hungover; felt on the brink of fainting; chills;... Read more
delirous as if I was hungover; delirous as if I was hungover; felt on the brink of fainting; chills; joint pain; pain at the injection site; lethargic; dry cough; severely nauseous; could not eat; serious fogginess; General malaise; fatigued; a debilitating headache; did not feel comfortable driving; weak; hurt in my chest; slept the whole day; This is a spontaneous report from a contactable consumer. A 54-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in the left arm on 05Mar2021 at 13:30 (Batch/Lot Number: EN6202) at 54-years-old as a single dose for COVID-19 immunization; administered in a hospital. The patient did not receive any other vaccine within four weeks of the suspect vaccine. Medical history included hypertension, and acne from an unknown date and unknown if ongoing. The patient did not have COVID prior to the vaccination. Concomitant medications included hydrochlorothiazide, olmesartan medoxomil (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; isotretinoin (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported. The patient previously took (ceftriaxone sodium) ANCEF, start and stop date were not reported, and experienced drug allergy. On 06Mar2021 at 04:00 (as reported), the patient experienced: delirious as if i was hungover (medically significant), felt on the brink of fainting (non-serious), chills (non-serious), joint pain (non-serious), pain at the injection site (non-serious), lethargic (non-serious), dry cough (non-serious), severely nauseous (non-serious), could not eat (non-serious), serious fogginess (non-serious), general malaise (non-serious), fatigued (non-serious), a debilitating headache (non-serious), did not feel comfortable driving (non-serious), weak (non-serious), hurt in my chest (non-serious), slept the whole day (non-serious); with no treatment received. The clinical course was reported as follows: The patient reported that on the first night (as reported) she had chills, joint pain and pain at the injection site. The next day (as reported) she was lethargic and was severely nauseous to the extent she could not eat. The patient also experienced serious fogginess, felt delirious as if she was hungover. The patient felt general malaise and a debilitating headache all day. The patient was fatigued to the extent she did not feel comfortable driving. The patient was so weak, that she felt on the brink of fainting. That evening, the patient slept the whole night through, except when she would awake with a dry cough that hurt in her chest. This cough was not as persistent and intense but was lasting even now. The patient slept the whole day and was just now beginning to feel as if she had recuperated from the vaccine four days later. The clinical outcome of the events was recovered with sequelae on an unspecified date (also reported as "recovered with lasting effects"). The patient was not tested for COVID post vaccination.
54 2021-03-24 hives, skin discolouration, itchy skin, hair loss severe fatigued/fatigue; red eyes; fever; Darkened skin in face; Itchy scalp and subsequent hair; ha... Read more
severe fatigued/fatigue; red eyes; fever; Darkened skin in face; Itchy scalp and subsequent hair; hair loss; headaches; Anaphylaxis; hives; itching breathing, lips, throat impacted; itching breathing, lips, throat impacted; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm on 23Feb2021 at 01:00 PM (at age of 54-year-old) as SINGLE DOSE for covid-19 immunisation, Lot Number: EN6198. First vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 03Feb2021 in Left arm for COVID-19 immunisation, Lot number: EL8982. Medical history was not reported. Patient did not receive any other medications within two weeks prior to the vaccination. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Patient had no COVID prior vaccination. Patient was not tested for Covid post vaccination. On 23Feb2021 within 20 mins patient experienced anaphylaxis, hives, itching breathing, lips, throat impacted. On 23Feb2021 at 02:00 PM (also reported as over next week) patient experienced severe fatigued; red eyes; fever; darkened skin in face; subsequent results, Itchy scalp and subsequent hair; seeing hair loss continuing and fatigue, headaches ongoing thus far. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatments received included Anaphylaxis medicine, intravenous (Iv) administration; prescript. Patient had not recovered from the events, at the time of the report.
54 2021-03-25 hives Dystonia of right foot/dystonia of neck wryneck; left foot and groin flare of patient dermatomyositi... Read more
Dystonia of right foot/dystonia of neck wryneck; left foot and groin flare of patient dermatomyositis; Nausea; wryneck; flare of the complex regional pain syndrome condition in left arm, left foot & groin flare of dermatomyositis; weakened muscles; Hives on face and neck; intercostal pain; Sternum pain; flare of the patient crps complex regional pain syndrome condition in left arm, left foot; This is a spontaneous report from a contactable Other HCP (patient). A 54-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; E19266), via intramuscularly on 20Feb2021 at 11:30 (at the age of 54-year-old) as a single dose in left arm for COVID-19 immunisation. The patient medical history included Sjogren's, dermatomyositis, crps complex regional pain syndrome, known allergies (unspecified). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The concomitant medication included thyroid (ARMOUR THYROID), pancrelipase (ZENPEP), cynara cardunculus (ARTICHOKE), oenothera biennis oil (PRIMROSE OIL), calendula officinalis, carotenoids nos, crocus sativus, phospholipids, ribes nigrum (MACUGUARD OCULAR SUPPORT), cyanocobalamin (VIT 12), iron, folic acid (FOLATE), retinol acetate (VITAMIN A), ergocalciferol (VITAMIN D), calcium, magnesium and zinc. On 20Feb2021, at 23.30 the patient experienced nausea upon Injection for about an hour and dystonia of neck wryneck and it was reported to vaccine staff, dystonia of right foot, flare of the patient crps complex regional pain syndrome condition in left arm, left foot and groin flare of patient dermatomyositis, weakened muscles, hives on face and neck, after vaccination following morning: intercostal and sternum pain. The patient received zyrtec and azelastine nasal spray as a treatment for the events. The outcome of events was recovered on an unknown date in 2021.; Sender's Comments: Based on vaccine-event chronological connection a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, as appropriate.
54 2021-03-25 skin tightness Lip swelling beginning 48 hours following 1st dose of vaccine. Lips swollen, tight, dry and mildly i... Read more
Lip swelling beginning 48 hours following 1st dose of vaccine. Lips swollen, tight, dry and mildly itchy. Little bumps around the edges of both upper and lower lips.
54 2021-03-25 injection site pain Severe pain in left arm outside of injection, move down the whole arm to the bottom arm was numb for... Read more
Severe pain in left arm outside of injection, move down the whole arm to the bottom arm was numb for over 12 hours. Left side of the neck pain, left lymph node glands under the arm severely swollen, earache and left side, and extreme fatigue. Now 43 hours later after the injection I can move my arm but still cannot touch the site of the injection, left ear still hurts, left side of neck still painful but better. Can now lift arm above had but still feels very heavy. The lymph node glands under her left arm has reduced in size but still sore to the touch. I?ve been taking ibuprofen for the last two days to help with the discomfort.
54 2021-03-25 itchy skin Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: A... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Dizziness / Lightheadness-Medium
54 2021-03-25 rash The morning after the vaccine, I woke up with rash, swelling and inflammation everywhere that I have... Read more
The morning after the vaccine, I woke up with rash, swelling and inflammation everywhere that I have eczema and psoriasis. I took prednisone and the symptoms lasted about 24 hours.
54 2021-03-26 injection site swelling 19th Mar - Day 1 - Slight tightness at the area of injection 20th Mar - Day 2 - no symptom 21st Mar ... Read more
19th Mar - Day 1 - Slight tightness at the area of injection 20th Mar - Day 2 - no symptom 21st Mar - Day 3 - no symptom 22nd Mar - Day 4 - no symptom 23rd Mar - Day 5 - no symptom 24th Mar - Day 6 - irritated throat after dinner 25th Mar - Day 7 - Sore throat, ear ache, full body and joints ache, temperature between 99 and 101, spoke to NP, was ordered Covid test 26th Mar - Day 8 - Sore throat (throat hurts while swallowing), body & joints ache, feverish (no fever), 27th Mar - Day 9 - Sore throat (throat hurts while swallowing), body & joints ache, feverish (no fever),
54 2021-03-26 injection site warmth, injection site swelling, injection site pain 8 hours after injection: aching left arm, sore at the injection site. 24 hours after injection, ach... Read more
8 hours after injection: aching left arm, sore at the injection site. 24 hours after injection, aching left arm, hot lump at the injection site, headache, fever of 99.5, tiredness. Symptoms lasted about 12 hours.
54 2021-03-26 injection site pain Pain at the injection site, feeling tired, a little bit unwell, chills, loss of appetite
54 2021-03-26 rash vesicular Rash that looked like tiny blood blisters, neck down.
54 2021-03-26 injection site pruritus, injection site swelling, injection site redness Redness, swelling, intense itching at injection site. Benadryl helps but it comes back when the bena... Read more
Redness, swelling, intense itching at injection site. Benadryl helps but it comes back when the benadryl wears off. It is ongoing so I don't know how to answer question 20. I will answer "yes".
54 2021-03-26 itchy skin, skin burning sensation Woke up from sound sleep at approximately 3:30AM on 3/ 27 /221 due to severe scalp burning and itch... Read more
Woke up from sound sleep at approximately 3:30AM on 3/ 27 /221 due to severe scalp burning and itching. Symptoms continued throughout the day. At 7pm n same day seen by Urgent Care practioner previously noted.
54 2021-03-27 redness, hives, skin warm 4 days after getting my second dose, I broke out in hives all over my body. they were not itchy, jus... Read more
4 days after getting my second dose, I broke out in hives all over my body. they were not itchy, just red and hot. This has never happened before in my life, so I called 911.
54 2021-03-27 cellulitis 6 days after vaccine, Previous site for cellulitis infections reoccurred and needed antibiotic treat... Read more
6 days after vaccine, Previous site for cellulitis infections reoccurred and needed antibiotic treatment.
54 2021-03-27 injection site pain High fever 103 to moderate fever 100 continuously over 48 hours. Pain at injection site immediately ... Read more
High fever 103 to moderate fever 100 continuously over 48 hours. Pain at injection site immediately after shot. Underarm swelling began at 36 hours after vaccine.
54 2021-04-03 vaccination site pain, vaccination site swelling, vaccination site redness High Fever (103); chills; body aches; headache; nausea; fatigue; pain at injection site; injection s... Read more
High Fever (103); chills; body aches; headache; nausea; fatigue; pain at injection site; injection site swelling and redness; lymphadenopathy; injection site swelling and redness; This is a spontaneous report from a contactable consumer(patient). A 54-year-old female (non-pregnant) patient received second dose of BNT162B2 (Solution for injection, Lot number: EL9269, Expiration date: unknown), in left arm on 11Feb2021 at 03:30 PM, at single dose for COVID-19 immunization. The patient historical vaccine included first dose BNT162B2 (lot number: EL8982) left arm on 21Jan2021, at single Covid-19 immunization. Patient medical history and concomitant medications were not reported. After second shot Patient experienced High Fever (103), chills, body aches, headache, nausea, fatigue, pain at injection site, injection site swelling and redness, lymphadenopathy on 12Feb2021 at 09:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event was recovered.
54 2021-04-03 vaccination site pain covid test result=Positive; covid test result=Positive; Fever 103; chills; muscle ache; joint pain; ... Read more
covid test result=Positive; covid test result=Positive; Fever 103; chills; muscle ache; joint pain; nausea; extreme headache; injection site pain; tiredness; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on 20Jan2021 08:45 (lot number: E18982) as single dose at the age of 54 years old, for COVID-19 immunisation. Medical history included interstitial cystitis, palpitations, high cholesterol and covid-19. The patient was not pregnant at the time of vaccination. Concomitant medications included pentosan polysulfate sodium (ELMIRON), metoprolol, oxybutynin, rosuvastatin and Vit (unspecified); all taken for an unspecified indication, start and stop date were not reported. The patient previously took levaquin and experienced allergies. No other vaccines received four weeks prior to COVID vaccination. On 11Feb2021 02:30, the patient experienced fever 103, chills, muscle ache, joint pain, nausea, extreme headache, injection site pain, and tiredness. No treatment was given for these events. On 18Mar2021, the patient's COVID-19 test (nasal swab) was positive. The patient recovered from fever 103, chills, muscle ache, joint pain, nausea, extreme headache, injection site pain, and tiredness on unspecified date. Outcome of the COVID-19 test positive was unknown.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported event "covid test result=Positive" cannot be completely excluded based on temporal association. This case will be re-assessed when additional information becomes available.
54 2021-04-11 rash Patient is a 54 y.o. female who presents with concern for allergic reaction. Patient received her s... Read more
Patient is a 54 y.o. female who presents with concern for allergic reaction. Patient received her second Covid vaccine today. Shortly after this she felt very faint and almost passed out. She then developed a rash over her chest and felt like had a scratchy throat that was slightly swollen to her. She was given 1 dose of IM epinephrine with significant improvement in symptoms. She states he does have a history of allergy to strawberries as well as bees. Last time she had very she developed hives and vomited. She is feeling significantly better now no significant shortness of breath and her throat feels better. No nausea or vomiting or diarrhea at this time. Patient otherwise fairly healthy with no major medical problems.
54 2021-04-11 rash Saturday March 13 Evening . Stroke symptoms, facial drooping, weakness in legs, difficulty walking, ... Read more
Saturday March 13 Evening . Stroke symptoms, facial drooping, weakness in legs, difficulty walking, speech difficulty, loss of use of left arm, rash on hands. TPA administered. Situation resolved. Hospitalized 4 days. Note: My brother who resides in a different state suffered a stroke March 12. He also received the Pfizer vaccine date unknown.
54 2021-04-18 rash Stroke symptoms; Facial drooping; weakness in legs; difficulty walking; speech difficulty; loss of u... Read more
Stroke symptoms; Facial drooping; weakness in legs; difficulty walking; speech difficulty; loss of use of left arm; rash on hands; This is a spontaneous report from a contactable consumer (patient herself). A 54-year-old female patient received BNT162B2(Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, at age 54 years, administered in the right arm on 10Mar2021 11:15 (Batch/Lot Number: EN6199) as single dose for COVID-19 immunization. Relevant medical history include Hashimoto's thyroiditis from an unspecified date, allergies to shellfish and tree nuts. Patient is not pregnant. Patient did not have COVID prior to vaccination. Concomitant medication include levothyroxine sodium (SYNTHROID). No other vaccines administered in four weeks. Patient previously took amoxicillin and cefalexin and experienced allergies. The patient historically took first dose of BNT162B2 (lot number: EM9810) at age 53 years on 17Feb2021 at 10:45 AM on the right arm for COVID-19 immunization. On 13Mar2021 at 19:45, evening, patient experienced stroke symptoms, facial drooping ,weakness in legs, difficulty walking, speech difficulty, loss of use of left arm, rash on hands. Treatment for the events was TPA. The patient was hospitalized for 4 days. COVID was not tested post-vaccination. Vaccination facility type was at a public health department. The outcome of the events was recovered on an unspecified date.
54 2021-04-24 pain of skin passed out; trouble flexing her right hand open and closed; not feeling well, she feels very bad; so... Read more
passed out; trouble flexing her right hand open and closed; not feeling well, she feels very bad; sores in her mouth and nose; sores in her mouth and nose; anal hemorrhoid sores; had difficulty speaking, with her words; has been dropping things, she has broken glass; her eye felt heavy and her eye was drooping; Dizzy; Fall; Slight fever; Fatigue; extreme pain through right side (right side means her shoulders, neck, torso, arm, and entire leg); first dose given 14Jan2021, and second dose given 07Mar2021; first dose given 14Jan2021, and second dose given 07Mar2021; Shortness of breath; severe nerve pain; Vomiting; had a feeling of urination, like she had to urinate when she didn't, that feeling of urination; Disorientated; eye pain like pins and needles; skin is burning and painful to the touch; Headache; joint and muscle pain; joint and muscle pain; Nausea; horrible lack of appetite/couldn't eat anything other than soup; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program called COVAX US Support. A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 07Mar2021 (Lot Number: EN6204) as single dose for covid-19 immunization. The patient's medical history included history of three spinal surgeries (takes no pain meds, she is not on pain meds, she has never been on or kept taking them); and has "neuropathy and nerve related issues" that were not this bad since ten years ago in 2011, clarified that what she has is not actually neuropathy, something with the peripheral nerve, she says she doesn't remember actual verbiage), since ten years ago in 2011, and the only difference was this vaccination, it was not this bad until this vaccination. She doesn't react well to pharmaceuticals anyway (unspecified). Her medications are that she takes the minimum amount of medications, very minimal (unspecified). There were no concomitant medications. There was no other products. Also, she has not had any other recent vaccinations or started any new medications. For past drug, she didn't take anything other than 5mg of zolpidem tartrate (AMBIEN) to sleep at night because of her spine. Patient previously also took pregabalin (LYRICA) and was off it, was also on gabapentin or neurontin (patient did not have those medications to provide NDC/LOT/EXP for either of them because she took them back to the pharmacy or turned them in to the police station because she doesn't keep medications in her house if she isn't taking them, and she couldn't take that medication). Historical vaccine included first dose of bnt162b2 on 14Jan2021 (at the age of 54-year-old; Lot Number: EN5318) in Arm Right for covid-19 immunization, and for her first dose the only thing was a sore arm, it was very sore, and she only experienced a slight bit of fatigue after her first dose. She received both doses of vaccine. Her first dose was LOT: EN5318 and was given 14Jan2021, and her second dose was LOT: EN6204 given 07Mar2021. The patient was reporting for Pfizer COVID-19 vaccine, for she was having a horrible reaction to it "45 days" (as reported) after taking 2nd dose, and had been in the ER, and her temperature still hasn't gone back down to her normal, her oral temp is still raised and her rectal is raised even more. She was not feeling well, she felt very bad, she would never get a vaccine again, that is how bad it was. Since "45 days" later she was still having significant pain and trouble flexing her right hand open and closed. For events treatment, she took over the counter Tylenol for fever and pain, strength unknown. Patient said she had not had this kind of disabling symptoms or anything before this vaccination. She had a slight fever almost the whole "45 days". On 08Mar2021, her oral temp was over 98 degrees Fahrenheit when her norm temp being 97.2 or 97.3degrees Fahrenheit. Her rectal temp stayed at 100 degrees Fahrenheit. The next day, actually on the 09Mar2021 (which was two days after her second dose), she had the slight fever, fatigue, and extreme pain through her right side. She said her right side means her shoulders, neck, torso, arm, and entire leg. She also had shortness of breath, and severe nerve pain. She called her primary care provider who said to wait 5 days to be seen. On day 5, or actually the whole five days (reported as in Mar2021), she was in bed and didn't leave her apartment because she was in bed and she was vomiting. On day 2 or within 6 hours of vaccination, she had a feeling of urination, like she had to urinate when she didn't, that feeling of urination was equivalent of having contrast dye (NDC/LOT/EXP: Unknown) put in her IV which makes her feel like she is peeing her pants but she did not, and that feeling has not gone away. On day 5 (11Mar2021), she was dizzy and fell. In Mar2021, she was disorientated and vomiting, she couldn't eat anything other than soup. On day two (Mar2021) she had some kind of eye pain that is still there "45 days later", it feels like pins and needles. Her skin was burning and painful to the touch, she couldn't keep an IV in her when she was in the ER. She was not admitted to the hospital. She was having headaches, and joint and muscle pain. She had nausea and vomiting at different times. She continued to have shortness of breath. She had a horrible lack of appetite. She had sores in her mouth and nose. She had anal hemorrhoid sores. Last night (05Apr2021 )she had a headache that was severe like someone put a knife behind her right eye, and when she got up (06Apr2021) her eye felt heavy and her eye was drooping. She also had difficulty speaking, with her words. She says she had passed out, and had been dropping things, she had broken glass. She has been to a neurologist and a gastroenterologist. She clarified that all of these events were after her second dose, for her first dose the only thing was a sore arm, it was very sore, and she only experienced a slight bit of fatigue after her first dose. None of her doctors know what to do, her gastro doctor was giving her an anti inflammatory suppository and was going to do some tests. She had blood done from neurologist and at the ER and no one knows what to do, they keep referring her to other doctors. She wished someone could explain to her, but no one know and they said it was uncharted territory, they didn't know what to do. She is now back on Lyrica which she was off of but the ER prescribed her 300mg three times a day. She wanted to know what the hell is going on with this vaccine, and that she doesn't think having these side effects "45 days" out is normal. She wanted to be transferred to speak with someone about what to do because her doctor's don't know anything. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
54 2021-04-26 hives, redness, injection site pruritus, injection site redness erythema and pruritis to left arm around immediate site of the vaccine, monitored for 30min and appe... Read more
erythema and pruritis to left arm around immediate site of the vaccine, monitored for 30min and appeared to improve - erythema almost completely resolved, no rash presented anywhere else and pt had no respiratory symptoms and felt fine. Recommended Benadryl 25-50mg if itching persisted and advised follow-up for additional care if symptoms worsened. Called to follow up the next day and check on the pt, had initially improved but then worsened and had redness and hives to both arms, then to back, neck and chest. pt took Claritin (about an hour or more after benadryl) and symptoms improved over several hours - they did not seek additional medical attention and today pt is back to baseline. She never had any wheezing, coughing, swelling or difficulty swallowing - no respiratory symptoms at all. Given the rash worsened to chest and back and symptoms took >4hrs to resolve, recommended she NOT return for her second dose due to increased risk of a more severe allergic reaction. Notified PCP and recommended f/u with PCP for any additional questions or concerns.
54 2021-04-27 injection site bruising, vaccination site pain Felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn'... Read more
Felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe; almost like she couldn't breathe/Difficulty Breathing; Felt funny in her chest, like a really weird, really warm and heavy feeling/ warm feeling in the chest; having an anaphylactic reaction from the vaccine; Respiratory, Wheezing, Difficulty Breathing and Respiratory Distress; Respiratory, Wheezing, Difficulty Breathing and Respiratory Distress; Very sore right arm where she was given the injection; felt like she was punched several times in her arm; Injection site bruising; This is a spontaneous report from a contactable nurse(patient). The nurse reported similar events for herself and her husband. This is the first of two reports. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 54 years of age), dose 1 intramuscular, administered in arm right on 10Mar2021 16:00 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included severe asthma which started as a child and then it went away and then as an adult it got severe around 2010 and ongoing, she was an asthmatic and would panic and start feeling worse. She had ongoing chronic obstructive pulmonary disease (COPD), brain surgery in 2007, low immune system, allergies to cephalosporins, pulmonary and stomach issues; and bradycardia (as her BP usually runs 90/45 and she is bradycardic). Concomitant medications included tiotropium bromide (SPIRIVA RESPIMAT), salbutamol sulfate (PROAIR HFA), fluticasone propionate, salmeterol xinafoate (ADVAIR HFA), salbutamol (VENTOLIN [SALBUTAMOL]), and montelukast (MONTELUKAST), all taken for asthma, chronic obstructive pulmonary disease from an unspecified start date and ongoing; clarithromycin (CLARITIN [CLARITHROMYCIN], omeprazole, phenytoin sodium, azelastine, ipratropium bromide, fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), and ipratropium bromide, salbutamol sulfate (DUONEB), all taken for an unspecified indication from an unspecified start date and ongoing; prednisone taken for an unspecified indication from 2021 and ongoing as she was on this steroid 2 weeks before the vaccine; and azithromycin which she takes prophylactically for her low immune system from an unspecified start date and ongoing. She was on a lot of medications period and most are for her pulmonary and stomach issues. The patient previously took propofol, Versed, Nitrous Oxide, and Percocet wherein the patient had drug hypersensitivity and anaphylactic shock with these; adhesive from nicotine patch made her arm to get red and swollen (Dermatitis contact). She previously took EpiPen for anaphylaxis. It was reported that on 10Mar2021, the patient had the first dose of the vaccine and it felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe. She got her vaccine at a hospital in their clinic and she was transferred from the vaccine clinic to the ER. Stated she was given a shot with an Epi-pen in her thigh at the clinic and transferred to the ER. In the ER, she was given Benadryl and watched for 4 hours. She would state this was medically significant because of airway, breathing, circulation and she felt like she couldn't breathe. She added that it was kind of weird and freaky. She mentioned that along with that, shortly before she was released from the ER, she experienced a very sore arm where she was given the injection. She heard that was very common so she dealt with it. However as the night progressed, it got increasingly worse, it almost felt like she was punched several times in her arm. It probably started between hour 3 and 4 after receiving the vaccine. She added that she had a very sore right arm where she was given the injection; felt like she was punched several times in her arm. It was not serious, just annoying and it was gone 3 days later. She had injection site bruising on 10Mar2021. She stated that she knows this because she was a nurse, but a lot of times, people experienced this reaction when they are given Dilaudid wherein they get a warm feeling in their chest, so they push it really slow and dilute it with saline so it doesn't have the respiratory factor. She stated that this was kind of what the feeling was like for her and it was scary because she didn't expect it. She stated that the ER team that assessed her said, because she wasn't used to that feeling, she may have had a panic attack and that may have made it worse. After she was treated, she spoke with her husband and he had the shot two minutes before her and he had the same feeling but he didn't freak out and didn't want to appear weak. Stated he told her he had the same feeling and it lasted 5 minutes and then it went away. Stated since she got scared, it made it worse. She doesn't know if she had a panic attack that made it worse. She stated that of course her husband didn't tell her that until she was out of the ER, that it does go away. That made her feel better because she wasn't the only one that experienced that. States he didn't say anything about it, because he was worried about her, he said it was a warm feeling in the chest and not being able to breathe but he didn't want to say anything because she was an asthmatic and would panic and start feeling worse. She mentioned that they weren't going to let her get the second dose, so she went to an allergy doctor and told them what happened and about her husband having the same reaction and because she was severely immunocompromised. Stated the hospital said they were not giving her the second dose unless an allergist says it is safe and sets a protocol and he had to write a letter to the hospital. Stated she was pre-medicated 24 hours before the vaccine with 50mg Benadryl, 50mg Benadryl the day of the shot and 50mg of Benadryl two days after the shot. Stated she will have full immunity on 14Apr2021. She added that she had a pulmonary doctor, brain cancer doctor, ENT doctor, stated they don't know if it was caused by the vaccine, but they are pretty sure she had a reaction but they can handle it with pre-medicating her. She received the second vaccine on 31Mar2021. She mentioned that she was happy to be able to get her second shot. She stated that at first they didn't want to give it to her because of her reaction but she kept calling. So she went to a hospital to saw an allergist and he had to sign off that it was safe to give her the second shot and under what circumstances. Stated she had the letter from the hospital that she was seen by them and she needed to be pre-medicated and it had to be given at a hospital that had the ability to intervene quickly and she needed to be watched for at least 30 minutes after the vaccine. She mentioned that to go through what she went though, and not be able to get would have been disappointing. Because of her immune system, it is important to get the shot and there was a way around the reaction which worked for her. She added that even having an anaphylactic reaction from the vaccine, she was able to recover quickly. Stated with having asthma, COPD and a low immune system, she may not recover from Covid. It makes sense they evaluated it and came up with a solution and a pre medication protocol and when and how long and she was still able to get the shot because it is important. Answers to follow up questions indicated that on 10Mar2021, the patient had the first dose of the vaccine and it felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe. She was given the shot and getting ready to get out of the chair and her husband was about to sit down for his shot. Stated she would say the time of the course of the reaction was within under 5 minutes of her injection. The patient required medical intervention with Epi-Pen, Benadryl, and Duo-Neb. The patient was not hospitalized because she was immunocompromised, it was better to watch herself at home and because she had an Epi Pen at home in case she has that sort of reaction returning over a 72 hour period. Stated they instructed her husband and told them if she felt any different to come back to ER. She was not admitted to the ICU. Organ involvement included: Respiratory, Wheezing, Difficulty Breathing and Respiratory Distress. The event required initiation of new medication or other treatment or procedure including Epi-Pen, Benadryl, DuoNeb. Patient have a history of previous allergies: Medication Allergies to Cephalosporins, Anesthesia medications: Propofol, Versed, Nitrous Oxide, Percocet: Anaphylactic shock; Adhesive from nicotine patch, caused her arm to get red and swollen. She takes EpiPen as she had previous history of allergies and since she had multiple medication allergies and had a history of quickly going into anaphylaxis, stated her BP usually runs 90/45 and she was Bradycardic. She did not receive any recent vaccines for any other conditions prior to the events being reported. She did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. She has not received any other vaccines around the time of the Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient recovered from 'felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe', Difficulty breathing, and 'warm feeling in the chest' on 10Mar2021; while having an anaphylactic reaction from the vaccine, Respiratory, Wheezing, Difficulty Breathing and Respiratory Distress were recovered on an unknown date; Vaccination site pain recovered on 13Mar2021 and Injection site bruising recovered on 18Mar2021. Therapeutic measures were taken as a result of all events except Vaccination site pain and Injection site bruising. Relatedness of drug to reactions/events: Reaction assessed for events "felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe", 'very sore right arm where she was given the injection; felt like she was punched several times in her arm.' and Injection site bruising: Method of assessment: Global Introspection: Drug result: Related. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, the Company considered all serious and non-serious events as possibly associated to BNT162B2 injection, due to a plausible chronological sequence. Current patient conditions of asthma, chronic obstructive pulmonary disease and allergic diathesis may have been considered as favoring factors in development of reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-2021406773 same reporter and drug, similar events, different patient
54 2021-04-29 rash, skin warm, itchy skin 04/19/2021 at 8:00am woke up with a very bad headache. Temperature of 101.2. Sat in dark room with i... Read more
04/19/2021 at 8:00am woke up with a very bad headache. Temperature of 101.2. Sat in dark room with ice bag on head and use of tylenol. Drank soda and sat quietly. 04/20/2021 7:30 am. Headache gone with fever. Left arm is now very swollen. Hot to touch. Itchy. Achy. And about a 4? wide rash band on my left arm near crease/ elbow. 4-29/2021 rash is still slightly visible but fading. No heat emitting from it.
54 2021-05-04 rash, hives had fine hives on my forehead and also under neath my right eye and cheeks; Initially, while waiting... Read more
had fine hives on my forehead and also under neath my right eye and cheeks; Initially, while waiting posterior neck muscle soreness/ache from of ears downward to top of shoulder, but not affecting shoulder. only neck.; My BP 160s; repeat 1288/60; rash on my forehead; This is a spontaneous report from a contactable Nurse. A 54-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW5318), via intramuscular route, administered in Arm Left on 26Jan2021 at 16:15 as single dose for COVID-19 immunization. Medical history included seasonal allergy, eczema, sinus disorder. Known allergies: PCN, Biaxin, Avelox, shellfish, salmon, latex. Concomitant medications included Gabapentin, levocetirizine, Multi-betic, Zetia, Crestor, Zinc, Super B complex, Biotin, D3. On 26Jan2021 at 16:30 patient experienced Initially, while waiting posterior neck muscle soreness/ ache from of ears downward to top of shoulder, but not affecting shoulder only neck. We waited over 30min. BP is 160s and repeat 1288/60, HR-66, and Sat100% per EMT. Left after over 30min being watched. Upon returning home, Dad noted that I had a rash on forehead. I removed my face mask noted in the mirror that I had fine hives on my forehead and also under neath my right eye and cheeks. On 26Jan2021 Lab data was noted as BP with 1288/60, Heart rate as 66 and oxygen saturation as 100. Treatment have been taken with Benadryl and applied cortisone to face and neck rash that developed. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. The outcome of the events was recovering.
55 2021-01-02 itchy skin, hives 25 minutes after receiving the injection, there was a sudden onset of facial swelling, hives, itchin... Read more
25 minutes after receiving the injection, there was a sudden onset of facial swelling, hives, itching and airway constriction. I had already left the drive-thru vaccination clinic and was driving to the hospital emergency room where I work. I informed my colleagues of my symptoms and was treated for anaphylaxis with IV diphenhydramine and famotidine over several hours. I was given a prescription for a prednisone taper for the next 6 days.
55 2021-01-03 rash Dec. 29: she developed arm soreness and joint pain. Dec. 30: she developed pain in chest area radi... Read more
Dec. 29: she developed arm soreness and joint pain. Dec. 30: she developed pain in chest area radiating towards the back Jan. 01: she noticed a rash in the mid abdomen radiating towards the back. She has been experiencing pain in the affected area.
55 2021-01-03 itchy skin, injection site pruritus itching that started @injection site and then spread across body, facial flushing Administered 50 mg... Read more
itching that started @injection site and then spread across body, facial flushing Administered 50 mg of diphenhydramine orally and continued to observe Patient's husband was called and he took her home after approximately 30 mins.
55 2021-01-04 rash, itchy rash 6 days after my shot, I developed an itchy rash with moderate swelling on face mostly, neck and wris... Read more
6 days after my shot, I developed an itchy rash with moderate swelling on face mostly, neck and wrists. I am not sure of the cause - it was clearly some kind of allergy, possibly a contact allergy, but I am not sure if it is connected to the vaccine or not. I was advised to report it. It was bad enough to have been prescribed prednisone
55 2021-01-04 rash Agitation, Sedation, Anaphylaxis, Rash & HYPOtension
55 2021-01-04 rash, itchy skin All over my back, my butt, my legs; Itching; This is a spontaneous report from a contactable consume... Read more
All over my back, my butt, my legs; Itching; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received bnt162b2 (BNT162B2, Lot: EL0140, Exp:Mar2021), via an unspecified route of administration on 21Dec2020 for first dose at single dose for COVID-19 immunisation. Medical history included blood pressure high and anxiety. Concomitant medication included atorvastatin (LIPITOR [ATORVASTATIN]) for Blood pressure high and an anxiety medicine. The patient experienced itching there was nothing on 25Dec2020, in the morning of 26Dec2020, suddenly had rash all over back, butt, leg, she would like have the rash over body and she knew the reaction like the people like said it was within a couple of hours but this was more than couple of hours it is few days. At the time of reporting, no treatment received, she might go emergency to see if I get good dose of Benadryl. The event outcome was unknown.
55 2021-01-04 vaccination site pain fatigue; Fever/Woke up on 27Dec2020 with 100.5F; some soreness at injection site; This is a spontane... Read more
fatigue; Fever/Woke up on 27Dec2020 with 100.5F; some soreness at injection site; This is a spontaneous report from a contactable healthcare professional (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EK5730), intramuscular on the right arm on 26Dec2020 10:45 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included hypertension. Concomitant medications included lisinopril (LISINOPRIL), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), citalopram (CITALOPRAM), ascorbic acid (VITAMIN C), calcium (CALCIUM), loratadine (LORATADINE) and Sudaphrene pene (as reported). It was mentioned that prior to vaccination, the patient diagnosed was not with COVID-19 and had not been tested for COVID-19 since vaccination. On 26Dec2020 06:00 (as reported), the patient had fatigue, and some soreness at injection site. It was reported that the patient woke up on 27Dec2020 with 100.5 F that lasted most of day until 5 pm. It was mentioned that the patient did not receive any treatment for the events. The patient recovered from fever on 27Dec2020 17:00 while recovering for the remaining events.
55 2021-01-04 itchy skin itching on my left arm, face and neck; This is a spontaneous report from a contactable Other Health ... Read more
itching on my left arm, face and neck; This is a spontaneous report from a contactable Other Health Professional (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: ELO140, via an unspecified route of administration in the arm left, first dose on 28Dec2020 16:15 at a single dose for Covid-19 immunization. Medical history was none, she had no known allergies. There were no concomitant medications. The patient was not pregnant. The patient did not receive any other vaccine within four weeks prior to covid vaccine. She had no covid prior vaccination nor was she tested post vaccination. The patient experienced a little itching on her left arm, face and neck, but other than that, nothing else, all on 28Dec2020 at 04:30 PM with outcome of recovered in Dec2020. No treatment received for the event.
55 2021-01-05 rash with redness, injection site warmth, injection site redness 15 days post vaccine of the (Pfizer Covid vaccine) on 1/6, I developed a 7 x 5 cm erythematous whea... Read more
15 days post vaccine of the (Pfizer Covid vaccine) on 1/6, I developed a 7 x 5 cm erythematous wheal to left deltoid (injection site) - warm to touch without puritus/fevers or chills.
55 2021-01-05 itchy rash Pruritic rash to dorsal hands.
55 2021-01-05 rash, itchy skin Pt experienced rash and itching on arms and legs from 12/23-12/27. Took Benadryl to improve symptoms... Read more
Pt experienced rash and itching on arms and legs from 12/23-12/27. Took Benadryl to improve symptoms.
55 2021-01-05 rash Rash, chest pain, tachycardia, numb tongue, hard to swallow
55 2021-01-05 injection site redness, injection site mass Temperature, cough, chest pressure, fatigue, redness and bump at immunization site
55 2021-01-05 rash, skin warm Within five minutes of the vaccine my face broke out with a rash and was warm to the touch. Doctor ... Read more
Within five minutes of the vaccine my face broke out with a rash and was warm to the touch. Doctor took my blood pressure and it was fine, recommended Benadryl when I got home.
55 2021-01-06 rash, shingles Exactly one week after shot developed pain in back left flank. Over several days it moved to left si... Read more
Exactly one week after shot developed pain in back left flank. Over several days it moved to left side and front. One week later a rash developed. It is diagnosed as shingles. I?m now on Valtrex . I was also working night shift for several months which also may be the cause. I submit this because I?m not stressed. I don?t get sick. Maybe my immunity was suppressed by vaccine.
55 2021-01-06 injection site pain INJECTION SITE PAIN, BREAST PAIN
55 2021-01-06 rash Rash Narrative:
55 2021-01-06 injection site pain Same evening body aches and injection site was painful. In 24 hrs my lymph nodes were swollen, also ... Read more
Same evening body aches and injection site was painful. In 24 hrs my lymph nodes were swollen, also neck and arm pit. I also had headaches and body aches across my shoulder, neck and back.
55 2021-01-06 skin warm, rash, itchy skin, skin burning sensation, hives, redness, rash papular Vaccine administered at 11:15 AM. At 12:00 pm the top of my head became very hot, my face felt hot ... Read more
Vaccine administered at 11:15 AM. At 12:00 pm the top of my head became very hot, my face felt hot and red with raised rash, my scalp became very itchy, my heart felt like it was beating out of my chest and I had pounding in both ears. My bilateral forearms began to itch and then developed hives. I notified my Supervisor that I was having a reaction. I was checked in to ER (where I am an RN). My blood pressure was elevated 180's systolic and my heart rate was 180BPM and short of breath. An IV was started and I was given Normal Saline Bolus, Solu-medrol 125MG and Benadryl 25MG IV. Prior to medications, my throat felt itchy and "tight" but resolved once medication given. The itching and hives continued to spread to my upper back, neck, bilateral feet and behind my bilateral knees. After approximately 1 1/2 hrs itching and hives continued then I was given Pepcid IV and Benadryl 25mg PO which after 40 minutes my itching and hives resolved. I was later discharged home with a prescription of Methylprednisolone 4MG dose pack. Symptoms resolved until approximately 1:30 am on 5/7/2021 when I awoke to pounding in my ears and the feeling once again my heart was beating out of my chest. My heart rate was 132BPM, I became hot and diaphoretic, short of breath. My scalp felt it was on fire and then I broke out in hives. I immediately took Prednisone, benadryl and pepcid. I took a cool shower, got dressed and drove to the hospital down the road and sat in the parking lot just in case my throat became itchy and tight (which it did not). The hives and itching began to resolve after an hour. My heart rate went back to 67BPM and shortness of breath resolved as well. I called Employee Health at hospital and made a report of symptoms.
55 2021-01-06 injection site pruritus within 10 minutes of receiving vaccine pt complained of itchiness on and around injection site, no s... Read more
within 10 minutes of receiving vaccine pt complained of itchiness on and around injection site, no swelling or redness so we gave Benadryl 25mg and pt was fine afterwards. monitored after for 30 minutes with no issues
55 2021-01-07 redness, injection site pain, injection site warmth Erythema and edema in left arm area of administration. Warm and tender to touch and a mild hematoma ... Read more
Erythema and edema in left arm area of administration. Warm and tender to touch and a mild hematoma formed in the puncture site.
55 2021-01-07 vaccination site pain Fatigue; Migraine; Body aching everywhere including joint and muscle everything; General aches, pain... Read more
Fatigue; Migraine; Body aching everywhere including joint and muscle everything; General aches, pain; Headache; Severe muscle pain around the injection site; Severe muscle pain around the injection site; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. Medical history included diabetes mellitus from an unknown date, covid-19 from an unknown date. Concomitant medication included metformin. The patient stated the side effects were initially day one (30Dec2020) was this general aches, pains and headache. It almost started as if it was a Covid itself starting all over again because she had this disease already earlier this year and the headache and general ache and pains and pretty severe muscle pain around the injection site and also the general aches and pain. The second day (31Dec2020) was extreme fatigue, migraine that the never went away, body aching everywhere including joints and muscle everything. It almost felt like the Covid itself all over again. Patient took Motrin essentially around the clock something 6 (intent: 600mg) to 800 mg every 6 hours or so. The outcome of event migraine was not recovered, the other events was unknown.
55 2021-01-07 hives Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling,... Read more
Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; hives on neck; This is a spontaneous report from a contactable health care professional nurse, the patient. A 55-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9844), intramuscular in the left arm on 20Dec2020 13:45 as a single dose, Lot number EK5730 for COVID-19 vaccination. Medical history included ongoing complex regional pain syndrome. The patient previously took Ceftiaxone, tizanidine, vancomycin, triamcinone, duloxetine and experienced drug hypersensitivity. Concomitant medication were taken within two weeks but details not provided. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 20Dec2020 14:00 the patient experienced flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes. No treatment was given for the events. The clinical outcome Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating was recovered.
55 2021-01-07 hives Swelling, bleeding, and warmth immediately after administration. 1/7/21, she broke out in hives and ... Read more
Swelling, bleeding, and warmth immediately after administration. 1/7/21, she broke out in hives and had general body aches, which has continued into 1/8/21.
55 2021-01-07 itchy skin, vaccination site pain, skin reaction left arm and shoulder pain persisted; generalized itching; localized reaction distal to injection si... Read more
left arm and shoulder pain persisted; generalized itching; localized reaction distal to injection site (4 cm in circumference); Nearly debilitating joint, muscle and body aches and pain; Nearly debilitating joint, muscle and body aches and pain; severe headache; chills; night sweats; weakness; dizziness; lethargy; fever; body aches; nausea; Muscle soreness at injection site; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), intramuscularly in the left arm, on 23Dec2020 at 14:30 (at the age of 55-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension, depression, and penicillin allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included atenolol (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ) (MANUFACTURER UNKNOWN), sertraline hydrochloride (ZOLOFT), and simvastatin (MANUFACTURER UNKNOWN). The patient previously took bupropion hydrochloride (WELLBUTRIN) and experienced allergy. The patient did not receive other vaccines within four weeks prior to vaccination. The patient experienced fever, body aches, nausea, and muscle soreness at injection site on 24Dec2020 at 16:00; generalized itching, localized reaction distal to injection site (4 cm in circumference), nearly debilitating joint, muscle and body aches, severe headache, chills, night sweats, weakness, dizziness, and lethargy on 26Dec2020; and left arm and shoulder pain persisted on 03Jan2021. All of the events were reported as non-serious. The events were described as: Within 24 hours (as reported), fever, body aches, nausea, and muscle soreness at injection site occurred. Then within 72 hours (as reported), generalized itching, localized reaction distal to injection site (4 cm in circumference), nearly debilitating joint, muscle and body aches and pain for three days with onset of severe headache, fever, chills, night sweats, weakness, dizziness, and lethargy. On Day 11 (as reported), left arm and shoulder joint pain persisted. The patient underwent lab tests and procedures which included nasal swab: negative on 31Dec2020. The patient did not receive any treatment for any of the events. The clinical outcome of all of the events was recovering.
55 2021-01-07 itchy skin usual right arm soreness, then settled in right wrist area tingling, pain, weakness, and itchy type ... Read more
usual right arm soreness, then settled in right wrist area tingling, pain, weakness, and itchy type feeling in wrist
55 2021-01-07 itchy skin within 5 minutes became lightheaded, flushed, tachycardia , itching in both hands Given Benadryl ... Read more
within 5 minutes became lightheaded, flushed, tachycardia , itching in both hands Given Benadryl 25 mg , Pepcid , solu-medrol
55 2021-01-08 injection site swelling, injection site redness 2 inch area red and swollen around injection site, headache, fatigue, fever Tylenol and ibuprofen ta... Read more
2 inch area red and swollen around injection site, headache, fatigue, fever Tylenol and ibuprofen taken
55 2021-01-08 injection site redness 2 inch red area around injection, fever, aches, fatigue, headache Taking tylenol and ibuprofen
55 2021-01-08 injection site pain Headache started 12/30/2020. Nauseous and dizzy off and on. Arm pain at injection site for 3 days. ... Read more
Headache started 12/30/2020. Nauseous and dizzy off and on. Arm pain at injection site for 3 days. Headache unresolved even after taking headache med, ibuprofen, oxycodone. Nausea and dizziness is intermittent.
55 2021-01-08 rash SkinRash Vaccinated with 2nd dose @ 0942 w/o issue. After she returned to work, c/o rash to chest an... Read more
SkinRash Vaccinated with 2nd dose @ 0942 w/o issue. After she returned to work, c/o rash to chest and arms. At 1500 returned to the immunization clinic. Take to ED for evaluation BP 224/108, 88, 18, 97% O2sat. Narrative: Vaccinated with 2nd dose @0942 w/o issue. 5 hours later at 1500 returned to the immunization clinic with c/o rash to chest and arms and c/o slight H/A. BP elevated. Taken to ED for evaluation BP 224/108, 88, 18, 97% O2sat.
55 2021-01-09 injection site pain Pfizer-BioNTech COVID-19 Vaccine EUA~ 8 hrs after receiving second vaccine, developed severe nausea... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA~ 8 hrs after receiving second vaccine, developed severe nausea & intense vomiting for several hours associated with severe chills and severe myalgia and severe arm pain (though no redness) at vaccine injection site. Vomiting/nausea continued despite Zofran x 2 and lasted ~ 8 hrs. The intense chills and myalgia lasted ~ 48 hrs- symptoms severe enough to keep me in bed for that time. Other than soreness at injection site and mild headache the next day, I had no adverse reaction after first vaccine dosage that was given on 12/21/20
55 2021-01-10 injection site swelling, injection site pain, injection site redness, injection site warmth 1/8/21 tingling/ sensitive/extra warm lips - from 5 mins after injection till 8pm that night 01/08/2... Read more
1/8/21 tingling/ sensitive/extra warm lips - from 5 mins after injection till 8pm that night 01/08/2021 (thought due to wearing mask?) 1/9/21 soreness & heat to injection site - joint pain esp. hands, elbows and wrists; and flu-like symptoms - tired 1/10/21 little redness to site-swollen/soreness & heat still ; joint pain in fingers still not so much in main joints 1/11/21 finger joint pain - lot of redness/soreness/heat/swollen to site of injection ** new symptom sharp pinching pain around site
55 2021-01-10 itchy skin, hives Received Vaccine Jan. 4, 2021 at 2pm. Starting "itching" at 7pm. Went to bed at 9pm and awoke Jan. ... Read more
Received Vaccine Jan. 4, 2021 at 2pm. Starting "itching" at 7pm. Went to bed at 9pm and awoke Jan. 5th (at 7am) with HIVES & ITCHING over upper chest, bilateral arms, upper back area and face. Took OTC Zyrtec 10 mg po and Pepcid 20 mg po. Went to work at 7pm. Took Prednisone 20 mg po at 2am. After working till 7am took Benadryl 25 mg po before going to bed at 8am Jan 6th. Symptoms relived by Wednesday evening.
55 2021-01-10 injection site swelling Tiredness, queasy stomach, low energy, lethargic, headache, swelling and pain at injection site
55 2021-01-10 injection site pain, injection site warmth lips sensitive- tingling/felt warm - right after injection/vaccination till about 8pm ( not sure du... Read more
lips sensitive- tingling/felt warm - right after injection/vaccination till about 8pm ( not sure due to mask or injection) started with soreness/heat to site, joint pain, flu-like symptoms- body aches, tired and headaches. - January 9th. most joint pain gone except to fingers gone. soreness and heat to site of injection. - January 10th finger joints hurt still hurts, site of injection - redness swollen/ heat still - around site a "pinching" pain, which is a new today - Jan11th
55 2021-01-10 injection site redness localized redness at injection site, R arm/hand joint tenderness and pain, over 72 hr. period
55 2021-01-11 skin infection at injection site Developed cellulitis at injection site. It should be noted that injection was to be given intramuscu... Read more
Developed cellulitis at injection site. It should be noted that injection was to be given intramuscularly but the RN who administered it gave to the back of the arm which was likely subcutaneous rather than intramuscular.
55 2021-01-11 rash, redness Employee had an allergic reaction after receiving the covid vaccine 2nd dose. She had rashes and red... Read more
Employee had an allergic reaction after receiving the covid vaccine 2nd dose. She had rashes and redness all over the body
55 2021-01-11 hives Hives on stomach and chest 48 hours after; This is a spontaneous report from a contactable other hea... Read more
Hives on stomach and chest 48 hours after; This is a spontaneous report from a contactable other healthcare professional. A 55-year-old female patient received the first dose of bnt162b2 (lot no. and expiry date unknown), intramuscular in left arm on 02Jan2021 16:15 at single dose for Covid-19 immunization. Medical history included mastocytosis. The patient is not pregnant. The patient's concomitant medications were not reported. The most recent COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 04Jan2021 at 16:00, the patient experienced hives on stomach and chest 48 hours after. No treatment was received for the event. The outcome of the event was recovering. The event was assessed as non-serious. Information on the lot/batch number has been requested.
55 2021-01-11 rash, itchy skin Itching; neck rash; cough; This is a spontaneous report from a contactable nurse. A 55-year-old fema... Read more
Itching; neck rash; cough; This is a spontaneous report from a contactable nurse. A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on the left arm on 27Dec2020 08:15 at a single dose for COVID-19 immunisation. Medical history included hypertension and allergies from IVP dye, sulfa, and iodine. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Concomitant medications included hydrochlorothiazide (HCTZ), lisinopril, and calcium carbonate (CALTRATE). On 27Dec2020 08:30, the patient experienced itching, neck rash and cough. The patient underwent lab tests and procedures which included investigation: unknown results (Pending) on 02Jan2021. Therapeutic measure was taken as a result of the events that included Benadryl. Clinical outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.
55 2021-01-11 itchy skin, rash Rash and itching on arms and legs; Rash and itching on arms and legs; This is a spontaneous report f... Read more
Rash and itching on arms and legs; Rash and itching on arms and legs; This is a spontaneous report from a non-contactable pharmacist. A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK5730), intramuscular, on 22Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The most recent COVID-19 vaccine was administered in a hospital. From 23Dec2020 to 27Dec2020, the patient experienced rash and itching on arms and legs. The patient took diphenhydramine hydrochloride (BENADRYL) to improve symptoms. The events were considered non-serious. The patient recovered from the events on 27Dec2020. No follow-up attempts are possible. No further information is expected.
55 2021-01-12 injection site pain Headache ongoing Chills with no fever ongoing Pain at injection site ongoing Metallic taste in mouth... Read more
Headache ongoing Chills with no fever ongoing Pain at injection site ongoing Metallic taste in mouth right after injection lasted 1 hour or so
55 2021-01-12 itchy skin ITCHY NOSE , BELTCHING, HOT FLADHES, TOUNGUE HAVINESS, TREATED WITH EPI AND BENADRLY
55 2021-01-12 itchy skin Patient began to complain of itching all over body, numbness & tingling of lips. Patient was placed... Read more
Patient began to complain of itching all over body, numbness & tingling of lips. Patient was placed on guerney, O2@ 4L via mask placed, vital signs taken (pulse 81, BP 140/80), O2 sat on 4L via face mask 98%. Patient given epi pen injection @1422 and transported to ED. Upon arrival to ED, patient began to cough.
55 2021-01-12 injection site pain Post injection developed moderate to severe left arm pain - (when laying down unable to lay on that... Read more
Post injection developed moderate to severe left arm pain - (when laying down unable to lay on that arm for 3 days) then developed discomfort and stiffness in left shoulder, left elbow and left wrist that has continued but is slowly resolving. Spoke to Employee Health on 1/12/2021 and had virtual Employee Health consult on 1/13/2021. Treatment was to advised to take Ibuprofen/or Aleve. Discussed if should receive 2nd dose and was advised to receive by Health Care Provider.
55 2021-01-12 injection site pain The day after I received my 2nd Pfizer COVID vaccine (Day 1), I experienced sore muscle at the injec... Read more
The day after I received my 2nd Pfizer COVID vaccine (Day 1), I experienced sore muscle at the injection site and I noticed that the skin in my left flank, left back and Left abdomen felt numb. On Day 2 1/12/21, the numbness got progressively worse and it was noted that there was a marked difference while showering, my upper left hip and thigh were also beginning to get numb. I went into the ED where they took x-rays, gave me steroids (Decadron) and sent me home for follow up within the next 3-5 days. Today, Day 3-1/13/21,My skin still feels numb and less, and the tingling in my left thigh is no longer present. dx"paresthesia," no other concerns as it has not affected my movement or ability to work.
55 2021-01-12 rash to develop a rash yesterday. It started off as large red spots last night, and this morning they are... Read more
to develop a rash yesterday. It started off as large red spots last night, and this morning they are smaller red spots. She said the rash started in her feet and is moving upwards. This morning it is now on her arms. She also said she was having numbness and tingling from the waist down as well. Last night she did take Benadryl. She is not experiencing any other side effects. She did not have this reaction after the first dose. prednisone, benadryl given at urgent care, prescription for prednisone given at Urgent Care
55 2021-01-13 redness, hives, itchy skin Bilateral lower arm urticaria-(below elbow to and including writs.)red, welts, severe itching, requi... Read more
Bilateral lower arm urticaria-(below elbow to and including writs.)red, welts, severe itching, required 10mg prednisone for 3 days to stop itching. Lasted 4 days. Also Left arm pain, 4 days. Fatigue and subjective fever.
55 2021-01-13 itchy skin, rash Burning, itching, painful rash over back, stomach and groin. Rash and swelling in hands and ankles
55 2021-01-13 redness I began to experience a dry throat about 10 minutes after injection - I attributed it to needing a d... Read more
I began to experience a dry throat about 10 minutes after injection - I attributed it to needing a drink. My throat then felt a bit warm and I thought this was due to thirst as well. I left the monitoring area. I was walking to my vehicle and began to feel more of a warm sensation in my throat and not into my upper chest. About 5 minutes after this took place my face became flush and began tingling and feeling sunburned and tight - I looked in the mirror and my cheeks and nose and chin were red and felt extremely warm - I did not have facial swelling that i noticed buy my face felt tingly and like it was sunburned - my eye felt puffy but did not look puffy enough to notice in the mirror. Approximately 30-35 minutes after the immunization, I took 50mg of Benadryl and 1300mg of Tylenol. I felt my symptoms begin to improve about 25-30 minutes after taking the medication - my throat and chest were not as warm. the facial flushing lasted about an hour or hour and a half. The morning after my immunization I did have a scratchy throat - I did not take any further medication - by the afternoon - this is almost gone - still just a little scratchy.
55 2021-01-13 rash I had the vaccine on 1/11 at 11:30AM. I only had a sore right arm on Tuesday. I noticed a full fron... Read more
I had the vaccine on 1/11 at 11:30AM. I only had a sore right arm on Tuesday. I noticed a full front and back body rash that afternoon. It started spreading up my neck and onto my forehead. No other symptoms. I took 25mg of Benadryl that evening. Woke up the next day with improving rash but still visible.
55 2021-01-13 itchy skin Patient got her shot around 11:15am and around 11:45am started feeling itchy down the arm of injecti... Read more
Patient got her shot around 11:15am and around 11:45am started feeling itchy down the arm of injection (left) and itchy in the mouth and numb in the tongue. Came to report to me (lead RPh for clinic) at 11:50am. I spoke with another staff member to get patient 50mg of benadryl. While I waited for the medicine, I inspected the patients arm, face and inside the mouth. No redness, swelling, hives or other signs/symptoms of allergic reaction. Arm looked normal, no discoloration. Same with face and inside mouth. Patient took 50mg Benadryl at 12pm. Patient also stated having sinus issues currently (before vaccination) and has had off/on reactions with flu shot and other vaccines, mainly itching in the arm that was injected and swelling at the injection site (grapefruit size). Patient reported feeling itchiness gone at 12:10pm but still having some numb tongue. By 12:23pm, patient reported feeling completely better and no more numbness in the tongue.
55 2021-01-13 rash Systemic: Rash (other than injection site)-Medium, Systemic: Chills-Mild, Systemic: Exhaustion-Mediu... Read more
Systemic: Rash (other than injection site)-Medium, Systemic: Chills-Mild, Systemic: Exhaustion-Medium, Systemic: Headache-Mild, Systemic: upper body test rash, itchiness around eyes and mouth, she discribed a tingling sension in the back of her throat, verbilized her tongue was swelling; symptoms lasted 1 day
55 2021-01-14 itchy skin, rash with redness 36 Hours later I noticed that I was scratching my knuckles.. Very red and inflamed and tiny bumps ... Read more
36 Hours later I noticed that I was scratching my knuckles.. Very red and inflamed and tiny bumps .. One knuckles on left hand and two knuckles on my right hand
55 2021-01-14 blister, shingles Developed shingles on left side of spine on mid/lower back area. 1.5 inch x .5 inch. I have a histor... Read more
Developed shingles on left side of spine on mid/lower back area. 1.5 inch x .5 inch. I have a history of shingles in 2011. I received the 2 dose shingles vaccine in 2019. I received my second Pfizer dose on 1/11. Developed fatigue and muscle aches on 1/12, then slight headache, muscle weakness, myalgia's and arthralgia on 11/13. Morning of 11/14, woke up and noticed a sore spot/blister on my lower/mid back area. Slowly became more painful (burning sensation). No injury to area or any other reason for blister and pain. 11/15, realized it was shingles.
55 2021-01-14 vaccination site pain Pain at shot location; swelling; chills; headache; body aches; fatigue; This is a spontaneous report... Read more
Pain at shot location; swelling; chills; headache; body aches; fatigue; This is a spontaneous report from a contactable other healthcare professional (hcp). A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) first dose on 18Dec2020 13:00 (lot 121820, expiry date not reported), then second dose on 08Jan2021 15:30 (lot EK9231, expiry date not reported); both intramuscular in the left arm at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient was not pregnant at the time of the vaccination. The patient had no other vaccine in four weeks and no other medications in two weeks. The vaccines were administered in a hospital. On 09Jan2021 06:30, the patient experienced pain at shot location, swelling, chills, headache, body aches and fatigue. Post vaccination, patient had COVID test nasal swab (PCR) on 05Jan2021 and the results was negative. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The patient did not receive any treatments in response to the events reported. The patient was recovering from the events pain at shot location, swelling, chills, headache, body aches and fatigue.
55 2021-01-14 rash Patient received Covid vaccine dose #1 on 12/16/2021. Patient came to work on 12/17/2021 at 6:30am a... Read more
Patient received Covid vaccine dose #1 on 12/16/2021. Patient came to work on 12/17/2021 at 6:30am and noted rash on neck, left arm, legs, and back. Patient was given Benadryl, Claritin, and Solumedrol. Patient was admitted for 23 hours observation. Patient was discharged home on Claritin for 7 days.
55 2021-01-14 rash Reaction delayed - self-care: Day 1 body aches, bad headache, Day 2 sore feet and heel especially, r... Read more
Reaction delayed - self-care: Day 1 body aches, bad headache, Day 2 sore feet and heel especially, rash on right arm. Lymph nodes sore on neck on Day 2.
55 2021-01-14 injection site swelling, injection site redness, injection site bruising Red raised bruise on left arm at injection site not improving since onset of symptoms following vacc... Read more
Red raised bruise on left arm at injection site not improving since onset of symptoms following vaccination.
55 2021-01-15 injection site pain Fever up to 102 degrees pain at site headache chills muscle pain nausea felt unwell Took Tylenol fo... Read more
Fever up to 102 degrees pain at site headache chills muscle pain nausea felt unwell Took Tylenol for fever and aches
55 2021-01-15 injection site pain, injection site swelling Low grade fever , tired ness , headache and swelling and pain at injection site lasting more than 7... Read more
Low grade fever , tired ness , headache and swelling and pain at injection site lasting more than 72 hours
55 2021-01-15 rash, itchy skin Rash on chest and abdomen appeared morning following injection. Appearance of sunburn, blanched when... Read more
Rash on chest and abdomen appeared morning following injection. Appearance of sunburn, blanched when touched, second day it was itchy, resolved totally day 4. Other symptoms included pressure headache which lasted one week. Fatigue and muscle achelasted 2-3 days.
55 2021-01-15 injection site swelling, injection site pain Sever body aches, chills, migraine headache, fever of 100,8, nausea, loss of appetite, extreme fatig... Read more
Sever body aches, chills, migraine headache, fever of 100,8, nausea, loss of appetite, extreme fatigue, pain a swelling a injection site.
55 2021-01-15 injection site pain The adverse events are side effect perhaps but extremely strong. Lightheadedness x 1.5 days, feelin... Read more
The adverse events are side effect perhaps but extremely strong. Lightheadedness x 1.5 days, feeling shaky and short of breath- afternoon of injection Significant headache x 48 hours (note: still having intermittent HA associated with 1st dose.) Significant arm pain (injection site)- 2 days Feeling shaky in legs- evening of injection Low grade fever x 48 hours, ongoing intermittently Waking at night several times- this does not happen to me. Waking overnight last night (AM of 1/16/21) with right hand numbness that lasted for some time. Extreme, extreme fatigue- the worst lasted 48 hours post vaccination. Still continuing but not as severe as the first 48 hours. Body aches, particularly (but not only) right hip and knee that have arthritis- worst sx ~ 36 hours post vaccination. Ongoing intermittently. Heart palpitations but unable to determine if related to vaccination. Chest pain, mid-left sternal, intermittent, ongoing. More of a muscular pain/discomfort. Note: for 1st injection had some similar "side effects" but also some that were different.
55 2021-01-16 rash with redness, rash, rash macular Small, red, itchy blotches on my face, about 3/8? in diameter.
55 2021-01-17 rash 12/27/20 - Presented to urgent care with Nausea, swelling on face and hands, SOB. Was given dose of... Read more
12/27/20 - Presented to urgent care with Nausea, swelling on face and hands, SOB. Was given dose of SoluMedrol 125mg and sent to the emergency room. 12/27/20 Presents feeling sick, body aches, chills, nausea, rash and vomiting. SOB better. Given Zofran and IV fluids in ER. D/C home with prednisone and Zofran. D/C dx: Acute allergic reaction, Nausea and vomiting
55 2021-01-17 skin irritation, hives, rash Day if injection Severe HA- that has not really let up 1 week later Facial numbness of injection sid... Read more
Day if injection Severe HA- that has not really let up 1 week later Facial numbness of injection side that spread to top of head, and down to chest and right arm- sensation of face being scaled on right side Day 2- Brain Fog, Generalized Weakness, Generalized pain Right ear remains numb Day 3 1/13- felt like my entire body received a tetanus vaccine Day 4 unchanged Day5- woke up in head to toe hives- was sent to ED Have been having intermittent rashes ( like dermatitis) pop up all over my body and random numbness typically on head/ neck Continue with headache on day 7
55 2021-01-17 hives, rash Headache, Large welts across back ,right arm , and right leg
55 2021-01-17 injection site pain I had the vaccine on 12/20 and I started feeling cold couple of hours after the vaccine and chills o... Read more
I had the vaccine on 12/20 and I started feeling cold couple of hours after the vaccine and chills on 12/21/20. Mild body aches and soreness at site of injection and just feeling weird. This continued off and on 12/22, 12, 23 and etc. I thought it wasn?t a big deal as I had no respiratory symptoms and no fever. However, I just haven?t been well since then. I have ongoing nausea, head fog, severe weakness, very tired and just feeling unwell
55 2021-01-18 injection site redness, injection site swelling, injection site discomfort 55-year-old female presented to urgent care on 1/13/2021 with headache, body aches, temp up to 100.2... Read more
55-year-old female presented to urgent care on 1/13/2021 with headache, body aches, temp up to 100.2 Fahrenheit, sore throat, and some left axillary lymph node swelling. She also had some erythema and edema to the vaccination site. She received this vaccination on January 11. Her symptoms started January 12. On January 14, 2021, patient returned to urgent care for worsening erythema and discomfort at injection site. Patient was given supportive care and discharged home.
55 2021-01-18 hives, itchy skin 76 hours post-vaccination pt noticed "very itchy hives from the tops of my knees to below my bra. So... Read more
76 hours post-vaccination pt noticed "very itchy hives from the tops of my knees to below my bra. So my torso and thighs, front and back, welty-itchy hives". Pt took oral benadryl (2 tablets, 25 mg). Waited 5 hours, took 2 more oral Benadryl because pt was still itchy. Pt then went to sleep, woke up next morning and hives had disappeared, "it was as if no hives had ever been there". Pt believed this was because of eating "traditional Japanese New Years treats, which were a brand new food for me" on 12/31/2020 at 2300. Pt became itchy on arms about 12 hours after eating new food, and noticed hives on body (in locations noted above) at 1800 on 1/1/2021. Pt did not contact WHS because believed that hives were from new food, and not from vaccine which she had received 76+ hours prior.
55 2021-01-18 injection site redness, injection site hardening, injection site inflammation, injection site bruising, itchy skin Bruising red hard inflammation at injection site. Extremely sleepy within hour of injection lasted ... Read more
Bruising red hard inflammation at injection site. Extremely sleepy within hour of injection lasted 3 days. Itching all over on day 2. Called online Dr for advice. Was told to take Benadryl and use hydrocortisone cream. Was also told it was normal reactions. Missed day of work. Day 4 injection site not as inflamed and itching is gone. Site is still sore and bruised looking with little redness left.
55 2021-01-18 injection site pain Headache Injection site pain Feverish Chills Nausea Dizziness Feelin Unwell Tiredness Stomach Upset ... Read more
Headache Injection site pain Feverish Chills Nausea Dizziness Feelin Unwell Tiredness Stomach Upset Diarrhea
55 2021-01-18 itchy skin I received the vaccine and approx 1min I developed chest pressure, head pressure, Dizzy + lightheade... Read more
I received the vaccine and approx 1min I developed chest pressure, head pressure, Dizzy + lightheaded - Had a hard time waking to gurney due to dizzy. BP +180s Back burning pain traveling mid back to lower back, joint pain, general weakness, throat scratchy, itichess on legs + Think I was monitored for 2 1/2 hrs and sent home after Benadry + Tylenol given. I have continued to have extreme fatigue. general weakness, lightheaded, dizzy and burning back pain lasted 11 days. Today is 12th day and still have lightheaded, dizzy intermittent and general weakness, fatigue, "no energy."
55 2021-01-18 itchy skin Patient developed lightheadedness, shortness of breath, and pruritus about 15 minutes post-vaccine @... Read more
Patient developed lightheadedness, shortness of breath, and pruritus about 15 minutes post-vaccine @ 0835. Patient was treated with Epi-pen x1 dose @ 0840 and Benadryl 25mg po @ 0842 for diffuse pruritus. She then reported continued shortness of breath, with new symptom of subjective throat and lip swelling and pruritus. A second dose of epinephrine via Epi-pen administered at 0850 followed by second dose of Benadryl 25mg po at 0852. Pt was transported to ED for further evaluation and treatment and received a third dose of epinephrine en route to the hospital while in ambulance (time unknown). In the ED, she was treated with Ativan 1mg IV. After observation for several hours in the ED, she was discharged home from ED to home care. Symptoms resolved later that day. She had no residual symptoms the day following vaccination, 14 Jan 2021.
55 2021-01-18 redness, itchy skin Patient experienced wheezing, dizziness, redness, itching, anaphylacyic-type reaction. Patient was ... Read more
Patient experienced wheezing, dizziness, redness, itching, anaphylacyic-type reaction. Patient was given 0.3mg epinephrine and brought to ED. In ED, given acetaminophen, diphenhydramine, famotidine, lorazpeam. Patient stable and released home on 1/17/2021.
55 2021-01-18 itchy skin, redness Patient received first dose of Pfizer vaccine on 12/29/20 and reported minor itching, relieved by Cl... Read more
Patient received first dose of Pfizer vaccine on 12/29/20 and reported minor itching, relieved by Claritin. On 1/17/21, patient received second Pfizer dose and experienced light-headedness, redness, wheezing. Patient given epinephrine 0.3mg IM and taken to Emergency Department. In ED, she received diphenhydramine, famotidine, acetaminophen, and lorazepam and released home on 1/17/21.
55 2021-01-19 injection site pain Injection site soreness
55 2021-01-19 injection site bruising Pfizer vaccine was administered subcutaneously, rather than IM. No local reaction versus bruising a... Read more
Pfizer vaccine was administered subcutaneously, rather than IM. No local reaction versus bruising at site of injection and no post-vaccine systemic symptoms such as fever, HA, myalgias, etc.
55 2021-01-20 itchy skin Body started itching; This is a spontaneous report from a contactable consumer (patient). A 55-year... Read more
Body started itching; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunization. The patient medical history was none. The patient's concomitant medications were not reported. On Jan2021, the patient reported that: "my body started itching but I didn't have any rash or anything like that. I am still itching some but not as much. I have been taking BENADRYL, 50 mg". The patient outcome of the event was not recovered.
55 2021-01-20 injection site pain pt currently has muscle pain at the injection site, chills, and has pain on upper left leg in betwee... Read more
pt currently has muscle pain at the injection site, chills, and has pain on upper left leg in between knee and groin area. Pt had 101.2 fever the night after the injection but it subsided by morning.
55 2021-01-21 injection site pain 1/19/2021 7PM UNTIL 1PM 1/20: HEADACHE, CHILLS, LOW GRADE FEVER (100.9), BODY ACHES, SIGNIFICANT SO... Read more
1/19/2021 7PM UNTIL 1PM 1/20: HEADACHE, CHILLS, LOW GRADE FEVER (100.9), BODY ACHES, SIGNIFICANT SORENESS AT INJECTION SITE. TOOK TYLENOL 7AM 1/20.
55 2021-01-21 itchy rash 4 hours after receiving vaccine pt developed pruritic rash on arms and legs. Treated initially with ... Read more
4 hours after receiving vaccine pt developed pruritic rash on arms and legs. Treated initially with Claritin without relief so then took Benadryl. The following day the rash persisted so took Zyrtec. Also was prescribed triamcinolone cream. The rash resolved after the second day.
55 2021-01-22 injection site redness, injection site pain Severe headache lasting 1.5 days Severe fatigue and body aches lasting 2 days Sore injection site bo... Read more
Severe headache lasting 1.5 days Severe fatigue and body aches lasting 2 days Sore injection site both red (minor) and tissue very sore Self care with Tylenol, Ibuprofen and fluids
55 2021-01-22 injection site pain, injection site swelling Started with sore arm ad raised injection site and two hours later started with headache fever (103.... Read more
Started with sore arm ad raised injection site and two hours later started with headache fever (103.7) and chills as well as achy all over. Continued thru the night and following day have headache and less achy and no fever. Symptoms are starting to get better but not resolved yet. I had known covid in Oct 2020.
55 2021-01-24 injection site pain, injection site redness I had serve tenderness and redness at the site I had dizziness, headache, feeling, tired, I felt lik... Read more
I had serve tenderness and redness at the site I had dizziness, headache, feeling, tired, I felt like I had flu, chills, nausea, stomach cramps, muscle pain, joint pain. I had some insomnia. I had this for about 3-4 days after. I started feeling better on Saturday and got the vaccine on a Tuesday. I spoke to my Dr. about it and we decided to take Tylenol and a lot of baths.
55 2021-01-24 injection site pain Intense throbbing and pain at injection site, severe nausea, got up to vomit in bathroom, fainted an... Read more
Intense throbbing and pain at injection site, severe nausea, got up to vomit in bathroom, fainted and hit my head, was unconscious a couple of minutes.
55 2021-01-24 rash, itchy skin Itching all over my body and scalp. Light rashes here and there. Taking Benadryl. Dr. really didn... Read more
Itching all over my body and scalp. Light rashes here and there. Taking Benadryl. Dr. really didnt want to give me steroid meds because im diabetic but i have an appt with her tomorroe 1/26/21 11:15am
55 2021-01-24 pain of skin, sensitive skin The day after vaccine I started to have a burning, stinging skin reaction on right side of torso. Th... Read more
The day after vaccine I started to have a burning, stinging skin reaction on right side of torso. Thinking it was hives, I applied cortisone cream and took Zyrtec. This continued through following week. I went to my personal physician and was diagnosed with shingles though I never had any outward rash or blisters. Just skin sensitivity . I was prescribed triamcinolone acetonide cream 0.5% which I have been applying twice daily. I have not had an outbreak but have had minimal internal pain that feels like strained or pulled muscle in the same area.
55 2021-01-24 injection site pruritus, itchy skin This was my 2nd. COVID-19 vaccine. First one on Dec 31 caused a headache and itching at injection si... Read more
This was my 2nd. COVID-19 vaccine. First one on Dec 31 caused a headache and itching at injection site. Today, 1/25, about 10 minutes after shot my eyes, face and neck began to itch. Developed small bumps. This continued to spread to armature torso and legs. Took Benadryl which seems to be helping. No difficulty breathing or swelling of any kind.
55 2021-01-25 injection site swelling, injection site pain, injection site redness, injection site warmth Left upper arm redness, at injection site, hot to touch, painful to touch or movement of arm, swolle... Read more
Left upper arm redness, at injection site, hot to touch, painful to touch or movement of arm, swollen.... taken tylenol and motrin and applied ice packs.
55 2021-01-25 injection site pain Muscle - body aches, bad headache, lower back pain, tired arm shot area pain
55 2021-01-25 itchy skin, blister, hives When i first got the shot I didn't think it was bad at all I actually hardly felt the needle. aroun... Read more
When i first got the shot I didn't think it was bad at all I actually hardly felt the needle. around 5 o'clock I started feeling ill and then i started about quarter to 6 I started getting cold and shaking bad but it wasn't like a seizure. So really severe chills. When i got home i got under heated blanket then I started getting itchy and noticed hives all over body. then I started getting blisters on palms of my hands and they were like water blisters. I was uncontrollably itchy. I started looking up online what to do and asked friends and family and started taking Benadryl. I had to take it for 4-4.5 days so then the hives finally went away but I was still itchy. I've just been very very exhausted and been having to push myself to get up. I had anxiety about getting the vaccine but I decided to get it. I still don't feel like myself, I don't have much of an appetite but not losing weight because I've been forcing myself to eat. I'm taking vitamins and praying I feel better but I just don't feel like myself. I don't have as much energy and exhaustion is the big thing. My joints started hurting really bad.
55 2021-01-26 itchy skin Itchiness in left arm (opposite of vaccine site).
55 2021-01-26 vaccination site pain frequent urination; sudden extreme fatigue; headache/headache began receding from the front to back ... Read more
frequent urination; sudden extreme fatigue; headache/headache began receding from the front to back of head and down back of neck; sore injection site; heavy metallic taste; no appetite; This is a spontaneous report from a contactable nurse (patient). A 55-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration on 11Jan2021 08:30 at single dose in right arm for COVID-19 immunization. The patient medical history included obesity and known allergies to sulfa and penicillin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 21Dec2020 11:30 at single dose in left arm for COVID-19 immunization and experienced mild metallic taste and arm soreness (including extreme burning for 10 min following vaccination, the patient believe this was poor administration tech), slight metallic taste 24 hrs post vaccination, lasted a few hours. Concomitant medications in two weeks included metoprolol, colecalciferol (VIT D3), Calcium, ascorbic acid (C) and probiotic. The patient had no covid prior vaccination. It was reported that after the second vaccination, the patient had no burning at site, on 11Jan2021 09:30 the patient had heavy metallic taste approximate 40 mins post vaccine and lasted approximate 12 hrs, at 12 hrs post vaccine (on 11Jan2021 20:30) sudden extreme fatigue, 15 hrs post vaccine (on 11Jan2021 23:30) frequent urination began and lasted approximate 18 hrs. The patient woke up with headache 6/10 that medication would not touch, no appetite but ate and drank anyway hoping would help with headache (it didn't) (reported on 11Jan2021 09:30), approximate 32 hrs post vax headache began receding from the front to back of head and down back of neck. Slept well and woke up 48 hrs post vax feeling normal but with sore injection site (reported as on 11Jan2021 09:30). The patient underwent lab tests and procedures related to covid included nasal swab and PCR with negative result on 04Jan2021. No treatment was received for the events. The outcome of the events was recovered in Jan2021.
55 2021-01-26 injection site hardening, injection site pain had a sudden headache come on about 1 hour after shot, but it went away within about 1 more hour...w... Read more
had a sudden headache come on about 1 hour after shot, but it went away within about 1 more hour...woke up at 5:00 this morning (day after shot) with horrible pain from shoulder all the way to finger tips....fell back asleep, woke again at 7:30 with the same symptoms got up and tried moving the arm (with pain) went ahead and used arm and read reactions and what to do...tried to use arm, after about 1 hour of trying to use arm the pain is just over the injection where there is a grapefruit size hard spot with intense pain. Will continue to try to move the arm and use cold compresses and drink water as the organization site suggested. Pain is not just in upper arm with majority of pain in that grapefruit size area.
55 2021-01-27 itchy skin, hives 1008 - pt c/o itchy spot on right side lower back. one hive noted. bp 150/81, p 99, rr 20, sats 97... Read more
1008 - pt c/o itchy spot on right side lower back. one hive noted. bp 150/81, p 99, rr 20, sats 97. 25 mg of po Benadryl given 1017 - 128/75, p 87, rr 18, sats 98. Pt reports I feel must better, no itching noted.
55 2021-01-27 injection site pain Pain at injection site followed by muscle ache at site with difficulty lifting my arm for 24 hours
55 2021-01-27 redness, itchy skin Redness of cheeks and nose, achy joints, redness, swelling and itching of bilateral hands. Took 2 hy... Read more
Redness of cheeks and nose, achy joints, redness, swelling and itching of bilateral hands. Took 2 hydroxyzine about 6 hours apart. Symptoms resolved and did not return.
55 2021-01-27 injection site pain The injection was unfortunately placed high up on my shoulder. It was much more painful going in th... Read more
The injection was unfortunately placed high up on my shoulder. It was much more painful going in than I have experienced in the past with any other injection. In addition, over the next few hours my shoulder became severely painful and I was no longer able to move my arm. 1/28/21 f/u: "The pain is still there but maybe slightly better. Still can?t take off my shirt without a lot of pain. "
55 2021-01-28 skin burning sensation Approximately 2 minutes after patient received vaccination, she reported dizziness and feeling like ... Read more
Approximately 2 minutes after patient received vaccination, she reported dizziness and feeling like her skin was on fire. She also reported some tingling of her tongue and throat. She was administered Benadryl PO x 1 dose and monitored for approximately 60 minutes. Her symptoms improved and she left in improved condition.
55 2021-01-28 itchy rash, rash, rash maculo-papular Maculopapular pruritc rash on bilateral arms, chest, and back-improving 1/29/21 only with rash on ar... Read more
Maculopapular pruritc rash on bilateral arms, chest, and back-improving 1/29/21 only with rash on arms-prescribed Zyrtec and Clobetasol cream She is recovering but 100% back to noraml
55 2021-01-28 skin spots, injection site rash Patient received vaccine Thursday 1/21/21 and experienced headache and fatigue for two days. By Sat... Read more
Patient received vaccine Thursday 1/21/21 and experienced headache and fatigue for two days. By Saturday, her symptoms began to improve. On Monday 1/25/21, the patient developed a petechial rash around the injection site and noticed sores on her gums and the patient went to OR. Evaluation at outside ED showed a platelet count of 2,000 with a normal H/H. Patient was transferred to our hospital for increased level of care, hematology consult and platelet transfusions. Significant hematology workup with a clinical picture thought to be consistent with ITP. Patient started on dexamethasone 40mg and received IVIG x 3 doses and platelet counts have started to improve
55 2021-01-28 vaccination site pain This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient rec... Read more
This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249, expiry date: unknown), via an unspecified route of administration in right arm, on 16Jan2021 14:45 at a single dose for covid-19 immunization. Medical history included stage 3 breast cancer, tall cell thyroid cancer, chronic lymphocytic leukemia, diabetes, and known allergies: penicillin. The patient's concomitant medications were not reported. The patient is not pregnant. The patient had no other vaccine in four weeks. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 post vaccination. On 17Jan2021 0800, the patient experienced minor pain at injection site and mild headache. Events were not treated. Outcome of the events was recovering.
55 2021-01-28 redness, itchy skin Vaccine was administered at 9:20 AM by public health at the Community Center; patient was observed f... Read more
Vaccine was administered at 9:20 AM by public health at the Community Center; patient was observed for 30 minutes without problems; patient reports she left after 30 minutes of observation and was on her way home when she started to feel itchy and scratched under her chin; around 10:15 AM she had more itching and redness to her skin and was flushed in her cheeks so she took a dose of over the counter Benadryl. by mouth; she continued to have itching throughout the day and reports she took another dose of Benadryl at 4:00 p.m. and again at around 2:00 a.m..
55 2021-01-30 rash Pt starting getting a rash on the arm they received the vaccine. Rash spread to other arm, chest and... Read more
Pt starting getting a rash on the arm they received the vaccine. Rash spread to other arm, chest and back. She is complaining of some small tight chest. Pt was given PO benadryl
55 2021-01-31 redness, skin burning sensation After approx. 10hours of receiving the vaccine in my left arm-shoulder at work , I was sleeping and ... Read more
After approx. 10hours of receiving the vaccine in my left arm-shoulder at work , I was sleeping and was awakened With: SEVERE CHILLS - teeth chattered in my head & legs shook -uncontrollably for over 9 hours FEVER- 103 Degrees -on & off for 8 hours BURNING - STINGING - in both hands and turned red 1-2 days LEFT ARM - sore- swollen 1 week [LEFT ARM - still has aches and stiffness] HEADACHE- -top of head for 2 days JOINT PAIN -all over for 3-4 days WEAKNESS- for over 72 hours
55 2021-01-31 rash Hot rash(almost like a sunburn) on my body. Mainly chest and arms., neck, shoulders. A little on bac... Read more
Hot rash(almost like a sunburn) on my body. Mainly chest and arms., neck, shoulders. A little on back stomach and legs. Started sat jan 30 and is still present. Also had bodyaches, headache and chills. Those are gone now.
55 2021-01-31 injection site pain Immediately after receiving the 2nd dose of the Pfizer vaccine, I had muscle pain at the injection s... Read more
Immediately after receiving the 2nd dose of the Pfizer vaccine, I had muscle pain at the injection site and difficulty lifting that arm the next day (similar reaction as after the 1st dose). I received the vaccine Wednesday evening (6 p.m.) on 1/13/21. Around 2 p.m. the next day, I started having a fever (over 101 degrees); chills; body aches; and fatigue. These symptoms lasted for three days but the fever was slowly going down with Advil. By Saturday evening, my symptoms changed to headaches and diarrhea, which lasted for an additional three days after that. My nose suddenly started running the following afternoon (Wednesday, 1/20/21) for about an hour and then that stopped and did not recur. All symptoms were gone by Thursday, 1/21/21 and I had none of these symptoms prior to taking the second dose of the vaccine (other than the arm pain for 1-2 days following the 1st dose of the vaccine).
55 2021-01-31 injection site pain Pain at injection site followed by muscle ache at site with difficulty lifting my arm for 24 hours
55 2021-01-31 rash Rash inner biceps and inner thighs.
55 2021-01-31 injection site rash, rash maculo-papular, rash Shortly after receiving vaccination -- staff advised me of Macroler papular rash at injection site. ... Read more
Shortly after receiving vaccination -- staff advised me of Macroler papular rash at injection site. This rash continued to spread to entire body surface. Two doses of Benadryl 25mg were given then 911 was called to transport patient to local hospital for further evaluation
55 2021-01-31 shingles Stiff neck/ muscles , daily headache, cough, fatigue and diarrhea Shingles on face resultant after ... Read more
Stiff neck/ muscles , daily headache, cough, fatigue and diarrhea Shingles on face resultant after 4 days. Oral medication/ valacyclovir 1 G tab every 8 hrs. For 7 days.
55 2021-01-31 injection site swelling, injection site redness The day after the vaccination I had redness around my whole shoulder and arm. On the third day I dev... Read more
The day after the vaccination I had redness around my whole shoulder and arm. On the third day I developed swelling of my shoulder and neck with horrible pain when I breathe. I went to urgent care and had an x-ray which was clear and they were treating me for myalgia with Motrin. I refused any narcotic pain medication or a Toradol shot. The pain never stopped on the 19th I went to Work Force Safety and reported it and I was examined by the nurse practitioner who saw all the swelling and the pain that I was in. That nurse practitioner told me if it wasn?t better in a few days to go to the emergency room to be examined. On January 23 , I developed swelling and pain went underneath my armpit it?s a burning pain that?s constant since the third day after my injection. My blood pressure was 153/104 and I was having nausea and not feeling well at all. On January 25 the pain and swelling were still there I went to work for a few hours and I went to the emergency room. They gave me lidocaine patch and Zofran for the nausea my blood pressure was 159/103 and I had an ultrasound to rule out a blood clot there was no blood clot but there was lymphadenopathy under my arm hurt and swelling and inflammation around the shoulder. The chest x-ray showed left pleural effusion / Pneumonia. My oxygen saturation was 93 and they wanted to admit me but I am a single mom with a new diabetic 14-year-old at home so they let me go home with a pulse oximeter and a prescription for doxycycline For 10 days. They called me the next day from the emergency room to follow up with a pulmonologist and cardiologist. On January 28 I saw the pulmonologist who did an ultrasound in his office and saw the fluid on my left lung. He said that most likely because the technique of the injection was so high in my shoulder that they probably had a nerve and I did have the swelling in the lymphadenopathy and all the pain and it hurt when I breathe so I wasn?t breathing correctly and I was splitting my arm against me and that?s how I probably developed plural effusion and pneumonia. I am following up with him on February 4. I still have shortness of breath and my oxygen saturation is 93. I am also on two inhalers that the pulmonologist ordered.
55 2021-02-01 itchy skin 20 minutes after the shot my throat became itchy. I was given pepcid and benadryl. I felt real fogg... Read more
20 minutes after the shot my throat became itchy. I was given pepcid and benadryl. I felt real foggy for the first 30 minutes after the shot. 15 minutes after benadryl I felt better. One week later I started itching especially my head. I did not have anything on my skin but I would just itching for no reason. Also, I started experiencing heart palpations more than usual. I have some palpations at times but this was more than usual. I have experienced these reactions since then. That was Jan. 29 and today is Feb. 2. Today the itching is better but continue to have heart palpation. I am concerned about taking the 2nd dose of the COVID vaccine Feb. 12. I would like for someone to contact me by phone if any way possible.
55 2021-02-01 rash macular, rash with redness, redness, itchy skin APPROXIMATELY 35 MINUTES AFTER INJECTION I BEGAN EXPERIENCING PRURITIS ON MY CHEST AND FOREARMS. WI... Read more
APPROXIMATELY 35 MINUTES AFTER INJECTION I BEGAN EXPERIENCING PRURITIS ON MY CHEST AND FOREARMS. WITHIN 3 HRS I HAD RED, SUNBURN-LIKE SPLOTCHY AREAS ON MY CHEST, JOWLS, EARS, NOSE, INNER & OUTER FOREARMS. THE REDNESS AND ITCHINESS LASTED FOR APPROX 36 HOURS. SELF TREATED WITH BENADRYL WITH ADEQUATE RESULTS.
55 2021-02-01 injection site redness, injection site pain, injection site swelling Employee experienced headache, fever, and body chills that began several hours after administration ... Read more
Employee experienced headache, fever, and body chills that began several hours after administration of the vaccine. She also reported injection site soreness, redness, and swelling. She recovered from the adverse effects by the 3rd day post-vaccination.
55 2021-02-01 vaccination site swelling, vaccination site warmth, vaccination site redness Right arm, where the vaccine was given, swelled up to the soft ball size; It is a reaction, hardness... Read more
Right arm, where the vaccine was given, swelled up to the soft ball size; It is a reaction, hardness, warm at the patch, redness and it kept expanding; Right arm, where the vaccine was given, swelled up to the soft ball size; It is a reaction, hardness, warm at the patch, redness and it kept expanding; Right arm, where the vaccine was given, swelled up to the soft ball size; It is a reaction, hardness, warm at the patch, redness and it kept expanding; Right arm, where the vaccine was given, swelled up to the soft ball size; It is a reaction, hardness, warm at the patch, redness and it kept expanding; This is a spontaneous report from a contactable nurse (patient). A 55 years old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142/expiration date: MAR-2021) on an unspecified date at single dose via an unspecified route of administration on deltoid Right for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient reported that since an unspecified date right arm, where the vaccine was given, swelled up to the soft ball size; It was a reaction, hardness, warm at the patch, redness and it kept expanding. The patient did not receive treatment for the events. At the time of the reporting events outcome was unknown.
55 2021-02-01 itchy skin The first 15 minutes I got hot. 15 minutes after that which would be 30 min I started itching. I wor... Read more
The first 15 minutes I got hot. 15 minutes after that which would be 30 min I started itching. I worked my 12 hour shit. I woke up 300am and my body was hurting so bad, it felt like something was laying on my chest, shoulder arms and legs. I crawled out of the bed and took a Tylenol and that helped a little bit. at 600 am I took another 650 mg Tylenol. And my body has been hurting so bad and I've been itching. I took a bath yesterday about 6:00 and my body is on fire like I'm itching real bad. I don't think I should have took a bath, because that might have made the blood circulate more and my body aches like crazy, worse than before. The last time I took a Tylenol was 6:00.
55 2021-02-02 rash, itchy rash Day 6 after shot broke out in terrible rash on back of hands and wrist, extremely itchy, day 9 after... Read more
Day 6 after shot broke out in terrible rash on back of hands and wrist, extremely itchy, day 9 after vaccine broke out on neck bilaterally and extremely itchy. 75% better now.
55 2021-02-02 hives hives afternoon day of vaccine, next day, stomach ache, fever ( T 100.0) , chills, vomiting, headach... Read more
hives afternoon day of vaccine, next day, stomach ache, fever ( T 100.0) , chills, vomiting, headache, dizziness, hazy feeling and nosebleed. Symptoms slowly improved over 5 days and returned to work.
55 2021-02-03 redness, itchy skin After an hour and a half to two hours after injection, I began to have an allergic reaction but it w... Read more
After an hour and a half to two hours after injection, I began to have an allergic reaction but it was slight. Cheeks turned red and under right eye was slightly swollen and slightly itchy it continued for about 45 min and then my feet and lower legs began to feel the same. The tops of my feet were red for approximately 10 min and then all symptoms subsided. No other problems afterwards
55 2021-02-03 injection site pain I got my first Covid19 shot (Pfizer) at noontime on Wednesday January 27, 2021 12 hours later, abou... Read more
I got my first Covid19 shot (Pfizer) at noontime on Wednesday January 27, 2021 12 hours later, about 12pm I start having side effect: Left Arm sore, hurt to lift (arm that was injected) Farting up a storm in my sleep Wednesday night, waking me up constantly, horrible weird smell, my poor husband, I moved to the couch and stunk up the first floor. Then diarrhea few hours later, about 4am, slight intestinal cramps, not bad. I was able to get ready and go to work for 6am. On Thursday January 28 Farting was over, thank goodness. As the morning went on I felt like I did when I originally had the Covid19 in May. I had to leave work at 10:30am due to: aches every where in body Especially neck hurt My left arm hard to lift or use (injection was in left arm), hard to think and concentrate (brain fog), chills Able to eat some soup Slept several hours at home, felt slightly better, than slept nine hours that night On Friday January 29th felt much better and arm hurt less to lift it. On Saturday January 30th Under my arm, glands are swollen and hurt to touch. All other symptoms have subsided Sunday January 31, glands under arm are better, much less sore Monday February 1st glands under arm, back to normal
55 2021-02-03 vaccination site itchiness, rash macular Massive headache; Severe chills; Couldn't get warm all day even with multiple layers of clothing; Di... Read more
Massive headache; Severe chills; Couldn't get warm all day even with multiple layers of clothing; Dizziness/lightheaded; Feverish; Going from freezing cold to sweating profusely; Right arm is really itchy; Place on right arm started out as a red blotch the size of a nickel, but today is as big around as a grapefruit; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302; Expiration date was not reported) on 16Jan2021 (17:30) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140; Expiration date was not reported) on 30Dec2020 (when the patient was 55 years old) on the left arm for COVID-19 immunization. The patient had no issues with the first dose of vaccination. On 17Jan2021, the morning after the second dose of vaccination, the patient woke up with a massive headache; developed severe chills; could not get warm all day long even with multiple layers of clothing; was dizzy and lightheaded; feverish; was freezing cold one minute, and then sweating profusely the next; right arm was really itchy; and had red blotch that was as big as a nickel, then as big around as a grapefruit at the time of reporting. The outcome of the events was recovered on 19Jan2021 for 'massive headache', 'could not get warm all day long even with multiple layers of clothing' and 'dizziness/lightheaded'; was recovering for 'severe chills', 'feverish' and 'freezing cold one minute, and then sweating profusely the next'; was not recovered for 'right arm was really itchy' and 'red blotch that was as big as a nickel, then as big around as a grapefruit'.
55 2021-02-03 vaccination site pain Pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 55-yea... Read more
Pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Right arm on 20Jan2021 at 02:45 PM as a single dose for COVID-19 immunisation, lot number: unknown. Medical history was not provided. Patient had no allergies to medications, food, or other products. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications in two weeks prior to the vaccination included cetirizine hydrochloride (ZYRTEC ALLERGY), curcuma zanthorrhiza (CURCUMEN TUERMERIC), ubidecarenone (CO-ENZYME Q10) and Beet roo (as reported). Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 21Jan2021 at 06:15 AM patient experienced pain at injection site when she woke up this morning which had lasted through the day. No treatment was received for the event. Since the vaccination patient had not been tested for COVID-19. Patient had not recovered from the event, at the time of the report. Information on the lot/batch number has been requested.
55 2021-02-03 redness, skin warm, itchy rash, rash with redness, itchy skin, injection site warmth, injection site rash, injection site pruritus Patient felt she had warmth at site of injection,89 HR 81. Patient says normal BP 120's/80's. Pati... Read more
Patient felt she had warmth at site of injection,89 HR 81. Patient says normal BP 120's/80's. Patient states she is not anxious. She then started feeling like her throat and chest were getting itchy. Continued monitoring and she felt she needed to be evaluated in ER. Taken to ER. ED notes as follows: 55 y.o. female who arrived by to the emergency department for Throat and chest discomfort associated with voice change and pruritic rash. Past medical history of food and environmental allergies, Addison's disease, thyroid disease, primary immune deficiency disorder. Half an hour ago, the patient received her first injection the Covid vaccine. Seconds later, the patient started having a pruriti rash where the site of the injection was. She then noticed her chest getting red and warm. About 15 minutes later, the patient noticed her voice becoming hoarse her and associated with throat and chest discomfort. Reports that she is unable to take a deep breath. Denies any noisy breathing, nausea, vomiting, abdominal pain, shortness of breath, difficulty swallowing, drooling. She has never been hospitalized for anaphylaxis. She denies any past medical history of asthma or COPD Vital signs demonstrate hypertension with systolic blood pressures into the 180-190s. No oropharyngeal swelling. Hoarse voice. Scleral injection present bilaterally. Chest wall nontender. Mild, blanching, erythematous, pruritic rash on anterior chest. Shallow breathing when asked to take a deep breath. Injection site covered with bandaid with no other obvious rashes or swelling patient arrived to the ED in no acute distress and in stable condition. She was complaining of throat discomfort with voice changes. She has never had an anaphylaxis reaction before. She was given benadryl, famotidine, and methylprednisolone initially for her reaction. With her hypertension and reported chest discomfort, epinephrine was not given initially.   Her symptoms mildly improved with the initial treatment.   Patient complained of chest discomfort and EKG showing T wave inverted in leads V4-5. She was given aspirin. Initial troponin negative and repeat was ordered.   After four hours of observation, the patient reports her voice change has resolved but continued to have pruritis in different, migrating areas of the body such as ears, neck, and arms.   1330: patient complaining of increasing chest and abdominal pain. Described as a cramping chest pain that radiated to her abdominal. Denies nausea, vomiting or diaphoresis. Continues to deny shortness of breath. Given morphine for her pain and aspirin for her nonspecific EKG changes.   Internal Medicine consulted for admission due to allergic reaction. Patient is agreeable to this plan. Patient was transferred under stable condition to the IM service. Initial Vital Signs [02/03/21 1159] Blood Pressure 168/101 Heart Rate 73 Respiratory Rate 15 Temp 36.8 °C (98.3 °F) Temp src Oral SpO2 96 % Following one day admission she was discharged to home with Zio patch monitoring while on new beta-blocker therapy for symptomatic PVCs with plan for PCP follow-up. Regarding adverse drug reaction, she was advised to follow-up with PCP and immunologist for further discussion on benefits:risk of subsequent vaccine in series.
55 2021-02-03 rash, itchy skin within 24 hours of vaccine developed rash on face, neck, chest,sides, arms and back of knees with it... Read more
within 24 hours of vaccine developed rash on face, neck, chest,sides, arms and back of knees with itching. Saw PCP and unsure about receiving 2nd dose of vaccine. Went to work on 1/13. given a prescription for benadryl to premedicate prior to 2nd dose and also prednisolone if benadryl had little or no benefit.
55 2021-02-04 hives, rash ?Pfizer-BioNTech COVID-19 Vaccine EUA" (1st Dose) Muscle aches, severe head ache, hot flashes, rash... Read more
?Pfizer-BioNTech COVID-19 Vaccine EUA" (1st Dose) Muscle aches, severe head ache, hot flashes, rash and hives on scalp, back, stomach, arms, legs, face. Treated with topical prescription cream and allergy pills, ibuprophen
55 2021-02-04 redness Felt crummy; Felt funny and started to get hot and chills at the same time; Felt funny and started t... Read more
Felt crummy; Felt funny and started to get hot and chills at the same time; Felt funny and started to get hot and chills at the same time; Tired; Had increase temperature; Hot and flushed and bright red in face; Hot and flushed and bright red in face; immunocompromised; Slept 14 hours; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3248), intramuscularly in right arm on 15Jan2021 14:27 at single dose for covid-19 immunisation. Medical history included Lupus may make her immunocompromised which diagnosed in 2011, Raynaud's, hypertension which was completely managed, irritable bowel and reflux. All were diagnosed prior to the vaccine. Family medical history was none. There were no additional vaccines administered on same date of the Pfizer suspect. Concomitant medication included hydroxychloroquine for Lupus for many years, tadalafil (CIALIS) took for years for secondary reynauds associated with lupus, amlodipine from Jan2019 for blood pressure abnormal. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient only had the first vaccine and at the time she received it, she got hot and flushed and went bright red in the face. That lasted 2 hours. She was literally bright red on her face. She got it Friday at 2:27 pm on 15Jan2021. Friday night, she slept 14 hours, which was unusual. She only got out of bed to walk her dogs. Saturday (16Jan2021), she felt funny and she started to get hot and chills at the same time. She took her temperature and temperature started in mid 99 degrees Fahrenheit and popped up to 100 degrees Fahrenheit. Then same thing again Saturday night. She slept 14 hours, which was unusual. Sunday (17Jan2021), she felt crummy. Her temperature spikes to 100.3 on Sunday. She contacted her manager who advised her to contact Employee Health the next morning and employee health told her that if her temperature spiked again on Monday to get a COVID test. She said it never went above 99 degrees Fahrenheit. Today (21Jan2021) was the first day she did not feel crummy. The sleepiness improved but only because she had to go to work. She was still tired. Feeling funny lasted 2-3 days. Her temperature on Saturday (16Jan2021) was 100 degrees Fahrenheit and on Sunday (17Jan2021) was 100.3 degrees Fahrenheit. She never took her temperature on 15Jan2021. The temperature had improved, but it was still hanging out around 99.4 and 99.6. Feeling crummy persisted through yesterday (20Jan2021). Today (21Jan2021) was the first day she felt normal again. She felt crappy all week. She took a fair amount of medication and did not know if it was relevant or not. She had other medications and had been on them for a long time. No ER or physician's office required. She contacted with employee health but had not seen a provider. She planned to discuss with her provider because she wanted recommendation if she should receive vaccine 2. She realized it was a judgment call because she was only 50% covered after having the first dose. She was not sure if she will have a worse reaction with the second. Most people she talked to have no reaction but a significant reaction to the second one. She did not have any information on any of those that had a significant reaction. Details and time of onset provided as: Hot and flushed and bright red in face 14:28, Slept 14 hours 21:00-23:00, tired - she felt it the day before and said it started at 10:00 on Saturday morning, Felt funny and started to get hot and chills at the same time: 12:00, had increase temperature shortly after 12:00, because that was when she checked her temperature, felt crummy 10:00. The outcome of event hot and flushed and bright red in face, felt funny and started to get hot and chills at the same time, felt crummy was recovering. The outcome of event slept 14 hours, tired, increase temperature was not recovered.
55 2021-02-04 injection site pain Headache, fatigue, muscle ache, tachycardia, sore throat (mild), severe pain at injection site lim... Read more
Headache, fatigue, muscle ache, tachycardia, sore throat (mild), severe pain at injection site limiting movement, eye pain and blurring. All began approximately 12 hours after vaccination. Did report to the ER at Summit Medical Center 2/3/2021 . Labs were drawn, ekg and cxr done. Md stated all normal. (I had pneumonia and was in a fib upon arrival to Vanderbilt Medical Center when I was admitted there with Covid in March 2020.)
55 2021-02-04 bruising, skin warm Later that night after the vaccination I woke up hot, my body was achy all over, I had a headache an... Read more
Later that night after the vaccination I woke up hot, my body was achy all over, I had a headache and begin to cough. I took another dose of cough meds but it didnt work. That next morning I visited my PCP and my temp was 98.7 when I arrived but the temp elevated to 99.9 while there and another temp was taken shortly after and was 100.8 so I was advised to go back home. Once home I was so tired and weak I could barely make it to the couch. My temp then was 101 so I laid down. The couch was so bad it caused my throat to begin to hurt. I lost my taste and sense smell, my body ached so bad it was unbareable and I developed various bruises all over my body still while continue to cough presistantly. I was off work for about 3 days and those 3 days were the worse days of my life, I was so unconfortable and scared it was almost unbareable I thought I was going to die. And on Thursday the symptoms begin to diminish and by that night it was if nothing had ever happened.
55 2021-02-04 injection site pain, bruising Nausea, lightheadedness, diaphoresis, bruising, and radiating pain from injection site.
55 2021-02-04 injection site rash, injection site reaction, skin spots petechial rash around injection site and mouth; found to have platelet count of 2,000.; patient had ... Read more
petechial rash around injection site and mouth; found to have platelet count of 2,000.; patient had ITP; extreme headaches; fatigue; This is a spontaneous report from a contactable pharmacist. A 55-year-old non-pregnant female patient of received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 21Jan2021 as first single dose for covid-19 immunization. Medical history included hypertension, diabetes, arthritis from unknown dates. Concomitant medication within two weeks included albuterol (salbutamol), dulaglutide (TRULICITY), escitalopram oxalate (LEXAPRO), glimepiride (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), insulin glargine (BASAGLAR), lisinopril (MANUFACTURER UNKNOWN), lorazepam (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN). The patient previously took ibuprofen (MOTRIN) and experienced allergies and drug intolerance. The patient experienced serious events, that involved hospitalization and were life threatening illness (immediate risk of death from the event) as follows: The patient experienced extreme headaches on 21Jan2021 with outcome of recovering; fatigue on 21Jan2021 with outcome of recovering; petechial rash around injection site and mouth on 25Jan2021 with outcome of recovering; patient had immune thrombocytopenia (ITP) on 21Jan2021 with outcome of recovering; found to have platelet count of 2,000 on 25Jan2021 with outcome of recovering. The patient was hospitalized for extreme headaches, fatigue, petechial rash around injection site and mouth, patient had ITP and found to have platelet count of 2,000 for five days. The events were also serious as they were considered life-threatening. The patient underwent lab tests and procedures which included platelet count 2,000 on 25Jan2021; platelet count 1,000 on 25Jan2021. Details were as follows: following the vaccine , which had been 21Jan2021 and had extreme headaches and fatigue for the next two days. On 25Jan2021, the patient developed petechial rash around injection site and mouth. Patient was seen at OSH emergency department and found to have platelet count of 2,000. Patient transferred to the reports facility on 25Jan2021 for hematology consult, and was found to have platelets of 1,000. Extensive hematology workup was completed and it was determined patient had ITP. Therapeutic measures were taken as a result of extreme headaches, fatigue, petechial rash around injection site and mouth (petechiae), patient had ITP and found to have platelet count of 2,000. Therapeutic measures included platelet transfusion, dexamethasone 40mg daily, 3 doses of IVIG. The patient was recovering from the events as aforementioned. The patient has not been COVID tested post vaccination. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event due to temporal association. However patient underlying medical conditions cannot be ruled out as contributing to the reported events
55 2021-02-06 itchy skin, hives About one hour after receiving the vaccine I experienced itching and mild hives. I am still itching ... Read more
About one hour after receiving the vaccine I experienced itching and mild hives. I am still itching 3 days later, but I do have other allergies and am not sure if this itching is from the vaccine or not. The hives are gone. An hour and a half after receiving the vaccine, around 5 p.m., I experienced extreme dizziness for a brief moment, 30 seconds? It took my breath away; it was frightening as I have had 2 strokes in the past.
55 2021-02-06 itchy skin, rash Covid Vaccine given 815am complaining of swollen throat + itchyness. 817 AM Benadryl 25mg po stable ... Read more
Covid Vaccine given 815am complaining of swollen throat + itchyness. 817 AM Benadryl 25mg po stable vital signs. 817AM feels a rash No prior HX of reactions ,denies feeling hot. 820AM NAD Speaking clearly ,throat feeling slightly better., drinking water no dysphagia 828 AM Drinking OJ, throat feels less swollen states feels no better or worse. 831 AM Feeling much better vital signs stable 118/78,73, 98%,speech clear ,D/C with Benadryl 25 mg po, if needed. Recommended to call PCP re: effects 2nd vaccines
55 2021-02-07 injection site mass, injection site redness, injection site rash Lump in Left Arm and Redness and Rash in a Circle of the Shot, at least 3 inches wide.
55 2021-02-08 rash, redness Redness, flushing, rash
55 2021-02-08 redness, injection site pain SWELLING, REDNESS, PAIN AT SITE, VERY TIRED
55 2021-02-10 rash with redness, itchy skin, rash papular ITCHING ON R ARM IN THE MIDDLE OF THE NIGHT. NOTICED RED RAISED BUMPS ON R ARM 4 DAYS LATER. THESE ... Read more
ITCHING ON R ARM IN THE MIDDLE OF THE NIGHT. NOTICED RED RAISED BUMPS ON R ARM 4 DAYS LATER. THESE RED RAISED BUMPS TURNED INTO PUSTULES AND ARE ON BOTH ARMS AND A FEW ON MY BODY LEGS, TORSO. TODAY I PUT LOTION ON AND THEN THEY BECAME MUCH MORE NOTICABLE. THEY FEEL HEAVY AND COULD POSSIBLY BECOME ITCHY IF I STARTED TO ITCH.
55 2021-02-14 rash, rash with redness Small red rash on cheeks and diarrhea for 2 days
55 2021-02-14 injection site swelling Sudden twitching of left foot, feeling idenical to electrical shock/tazer, numbness, tingling sensat... Read more
Sudden twitching of left foot, feeling idenical to electrical shock/tazer, numbness, tingling sensation from my feet going up my legs,lower back, spine, shoulders and neck .NEXT DAY severe aches all over same body parts, headaches,chills,dizziness, difficulty breathing, swollen left arm(injection site(
55 2021-02-15 skin warm First heat in upper arm, nausea, dizziness and jittery
55 2021-02-15 rash Rash all over body, except face and feet for two weeks and continues.
55 2021-02-17 shingles This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient re... Read more
This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3246, via an unspecified route of administration in the left arm, on 14Jan2021 08:30 at SINGLE DOSE for covid-19 immunization. Medical history included penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included loratadine (CLARITINE), ascorbic acid (VIT C), vitamin b complex and ergocalciferol (VIT D). On 21Jan2021 13:00, exactly 7 days after receiving 1st dose, the patient developed shingles. The outcome of event was recovering. The patient received Valacyclovir HCL 1 G as treatment for the event. The event was considered as non-serious by the reporter. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
55 2021-02-18 injection site mass, injection site pain Left arm was very sore at injection site for four days. I had a large lump on the arm at the inject... Read more
Left arm was very sore at injection site for four days. I had a large lump on the arm at the injection site for four days. Mild fatigue for two days.
55 2021-02-21 itchy skin Intense itching throughout my entire body; This is a spontaneous report from a contactable consumer ... Read more
Intense itching throughout my entire body; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9269; Expiration date was not reported) on 05Feb2021 (16:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. Medical history included asthma, high cholesterol and high blood pressure. The patient's concomitant medications were not reported. The patient previously took prochlorperazine maleate (COMPAZINE), and had drug allergy. The patient was not pregnant at the time of vaccination. On 05Feb2021 (18:00), two hours after the vaccination, the patient had intense itching throughout the entire body. There were no hives or rash, just the unbearable itching. The patient had received diphenhydramine (BENADRYL) as treatment for the event. The outcome of the event, intense itching throughout the entire body, was recovered in Feb2021. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.
55 2021-02-22 injection site pain Patient phoned EHS on 2/22 and inquired about her side effects and how long they should be lasting? ... Read more
Patient phoned EHS on 2/22 and inquired about her side effects and how long they should be lasting? Patient experiencing ha, and pain at injection site. Patient states it is getting better, but still voiced her concerns. Education provided of side effects vs illness and side effects lasting 7 days, follow up with PCP Dr. for further advice, and if patient continues to have symptoms after 7 days, phone EHS back for further evaluation. Patient agrees to above plan of care. EHS filled out RL6 for pt.
55 2021-02-23 injection site pain, injection site redness, injection site swelling Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec... Read more
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium
55 2021-02-23 itchy skin, injection site pain Site: Pain at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Me... Read more
Site: Pain at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: She had a horrible taste in her mouth
55 2021-02-24 injection site hives, injection site redness, injection site pain 2/24 tired couldn't stay awake, body ached. It felt like when I had covid. Sstarted at 1:30 by 6:... Read more
2/24 tired couldn't stay awake, body ached. It felt like when I had covid. Sstarted at 1:30 by 6:30 was sound asleep, 9:30 woke up to ok two Alieve, 12 woke up sweating but felt fine. 2/25 feeling better, body ached and still does a little injection site red hive like spot the size of a half dollar and is sore to touch
55 2021-02-24 injection site swelling Large area of swelling around injection site about the size of a softball measuring 14 cm in diamete... Read more
Large area of swelling around injection site about the size of a softball measuring 14 cm in diameter. Treatment- anti-inflammatories- ibuprofen. It has now been 1 week and is down to 4 cm. Also, on 2/23 had a flair-up of the post CoVid syndrome and ended up in the ER with chest pain and severe shortness of breath. All cardiac tests came back within normal limits. Chest X-ray just showed atelectasis in bases remaining from bilat CoVid pneumonia 3 months ago. Diagnosis was post CoVid syndrome. Treatment - nebulizer and anti-inflammatories - more ibuprofen. Returned to baseline shortness of breath that has existed since having CoVid in November in about 8 hours. I'm not sure if this was a reaction to the vaccine, but thought I would include it.
55 2021-02-24 rash, rash papular, itchy skin Raised bumps with a white center, white posture-like bumps on face, neck, upper chest, on eyelids, i... Read more
Raised bumps with a white center, white posture-like bumps on face, neck, upper chest, on eyelids, in eyebrows, inside eyes, on pupils of eyes, on lips, inside mouth, on ear lobes, inside ears, on nose, inside nostrils; tingling in tongue, runny nose, extreme fatigue, wooziness, challenges speaking at times,, itching. It is progressing to a different membrane everyday and I am not receiving any assistance.
55 2021-02-25 rash Both arms, hands and lower legs appear with red dots in the third day I got the second COVID-19 vacc... Read more
Both arms, hands and lower legs appear with red dots in the third day I got the second COVID-19 vaccine. I didn't report before thinking that will disappear in the follow days. I didn't develop any symptoms like fiver or any of the symptoms that are in V-Safe text. Two weeks passed and not get better I have to seek for medical attention and see my primary Dr. 02/25/2021. She send me to get laboratory work and now I'm waiting for the results . Hope in God this vaccine do not affect my health and my life.
55 2021-02-25 hives Broke out in hives around chin and neck. About 30 minutes later hives spread to my entire back. The ... Read more
Broke out in hives around chin and neck. About 30 minutes later hives spread to my entire back. The hives remained, subsiding and then getting worse again. I took Benadryl at about 10:00 pm and went to bed. In the morning the hives were gone. After that I had some of the common and expected symptoms post vaccine (fatigue, body aches and low grade fever).
55 2021-02-25 hives Broke out in hives on my back and blood pressure was very high
55 2021-02-25 skin tightness, injection site pain Reaction to 2nd Dose Pfizer covid19 vaccine I had second dose of the experimental Pfizer vacine Feb... Read more
Reaction to 2nd Dose Pfizer covid19 vaccine I had second dose of the experimental Pfizer vacine February 17, 2021. 1st dose was on January 27, 2021 I had reactions both times. I already reported on this site, on my 1/27/2021 reaction Received through a pharmacy clinic set up at my work. Lot#. EL9263 Received dose #2 about 10:30am on Wednesday 2/17/2021 during my work hours. (7-4pm) Paid closer attention to how I felt during the day, I could feel, I was going to be foggy in my head again. I was getting tried quickly. My left arm was not sore this time. Got home about 4pm (left a little early). Very tired, went to bed by 5:30pm. Slept, woke up to heat soup and eat. 7pm: Back to sleep. Very exhausted, my eyes were hurting (a sign I have a fever) I did not care enough to take my temp. Seemed to hard to try and find the thermometer. 7:30pm: Back to bed. Sleep. I'm very warm in my bed, sweating under arms and chest, I don't care, I can sleep thru that. Smells funny (sweat has a distinct oder) 11pm: wake up. I want to go pee, but I'm too cold to leave my warm covers. as soon as I uncover to get up, I have violent chills. I don't have chills if I stay covered. This was the exact same symtom I had on May 11, 2021 when I had the covid19 and came home sick from work. Violent chills, barely able to stand and walk alone. After midnight: I wait for someone to come upstairs to help me get up, with a blanket ready to throw over me and help me to toilet. I was too weak to call for him or to care, I just slept and waited for him to check on me. someone helped me to to tiolet, chills are under control if I have a blanket on me. The house is not cold, someone has the wood stove cranking that night, it's 70 in my bedroom. I sleep all night Wednesday. 6:30am: Thursday My eyes still hurt, I'm still hot. I don't care what my temp is. No more chills. I'm smelly from sweating all night. I'm motivated to shower, I think maybe I can do stuff today, I try to plan some things for the day. I shower and eat some oatmeal. I'm exhausted from doing those two things. My lower back/hips and neck are and shoulders are tight and sore, aches all over, especially neck. It's hard to think, brain fog, finding the right words. The injection site is not really sore though (last time it was). I have to just go back to bed. I sleep all day Thursday. Get up late afternoon to eat a little bit (soup and crackers) I try to watch TV. I can't focus on the show. I go back to bed by 5:30pm. I look at dumb funny videos on FB. Asleep by 6pm on Thursday evening. Sleep all night and wake up Friday 5am. I'm able to function and do most of my usual activities on Friday, but not very motivated to exercise or go for with dogs like I normally would do. Still stiff muscles. I do play in snow Friday night with dogs. By Saturday most of the stiffness is much better, I'm moving, walking dogs outside, moving furniture, doing my usual activities. I care about things again.
55 2021-02-25 injection site bruising, injection site pruritus, skin hardening, itchy skin, bruising, hives The day after administration, mild itching at the injection site, and on back of the right thigh. Th... Read more
The day after administration, mild itching at the injection site, and on back of the right thigh. The back of the right thigh had an itchy area with hives. The hives were gone by the next day, but the itching continued. The area was scratched and bruised in that area. The bruising has now, grown in size, covering a large area of the back of the thigh. It appears to be growing with induration on the edges. I have never had bruising like this and I think it has something to do with the vaccine, I also got multiple bruises around the first injection site.
55 2021-02-28 rash Developed skin rash on inner thighs, hips, torso, back, neck about 5 hours after injection
55 2021-02-28 hives Hives
55 2021-02-28 itchy skin, hives Patient reports vaccination at about 5-6 PM on Saturday, February 27 developed mild urticarial rash ... Read more
Patient reports vaccination at about 5-6 PM on Saturday, February 27 developed mild urticarial rash isolated complaint later that evening took some Benadryl was able to sleep the following morning increasing rash was noted additional Benadryl was used at home unfortunately this morning March 1 May be 36 or so hours after the vaccination diffuse generalized urticaria and pruritus additional Benadryl and brought to the hospital by her husband. Following consultation with infectious disease MD, determination to go ahead with corticosteroid therapy which would be the standard for any diffuse urticaria such as this even in the setting of the vaccination corticosteroid therapy and H2 blocker will be administered.
55 2021-02-28 injection site redness, injection site rash, injection site warmth Red rash at injection site becoming more red and warm. raised.
55 2021-02-28 vaccination site pain, vaccination site hardening sore arm from shoulder to finger tips barely able to move it; sore arm from shoulder/about an hour l... Read more
sore arm from shoulder to finger tips barely able to move it; sore arm from shoulder/about an hour later the pain was just in the shoulder and site of injection; about an hour later the pain was just in the shoulder and site of injection/a grapefruit size area of paiin where injection was given; hardness where injection was given; slight headache; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El3302, expiry date not reported), via an unspecified route of administration on 26Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included gastric bypass on an unknown date, pseudotumor cerebri (no attacks in over 4 years) from an unknown date to an unspecified date. Concomitant medication included cefprozil (CEFZIL), cetirizine hydrochloride (ZYRTEC), lisinopril. The patient previously took codeine and fluoride [sodium fluoride] and experienced allergies. The patient experienced slight headache on 26Jan2021 14:00, sore arm from shoulder to finger tips barely able to move it on 27Jan2021 05:00, sore arm from shoulder/about an hour later the pain was just in the shoulder and site of injection on 27Jan2021 05:00, about an hour later the pain was just in the shoulder and site of injection/a grapefruit size area of pain where injection was given on 27Jan2021 05:00, hardness where injection was given on 27Jan2021 05:00. The patient reported that hey had slight headache an hour after injection which went away a couple hours later. On morning after injection they work at 5am with sore arm from shoulder to finger tips barely able to move it. At 8:30 they got up and the pain was still pretty intense but read they needed to move it around started to do that and about an hour later the pain was just in the shoulder and site of injection. Hours later it is still a grapefruit size area of pain and hardness where injection was given. The patient recovered from slight headache on 26Jan2021, was recovering from pain in extremity, shoulder pain, vaccination site pain and vaccination site induration.
55 2021-03-01 injection site redness, injection site pain, injection site swelling Pt woke up that night w/ nausea, body aches, chills, fever, fatigue, and swelling/redness/soreness a... Read more
Pt woke up that night w/ nausea, body aches, chills, fever, fatigue, and swelling/redness/soreness at injection site that spread up left neck; s/s continued for 2 days. Pt unable to complete work day and left early on 2nd day of symptoms.
55 2021-03-01 injection site pain Severe Muscle pain throughout my entire left side and severe joint pain left side only. Severe arm p... Read more
Severe Muscle pain throughout my entire left side and severe joint pain left side only. Severe arm pain at the site of injection. This pain was severe visceral pain and lasted for over 6+ weeks. Only on my left side. The pain was present when simply sitting as well as during activity. There are still days when the pain returns for no reason at all. The pain is deep inside my left thigh and lower leg. I need to take ibuprophen to decrease the discomfort.
55 2021-03-02 cellulitis cellulitis in elbow of injected arm; This is a spontaneous report from a contactable healthcare prof... Read more
cellulitis in elbow of injected arm; This is a spontaneous report from a contactable healthcare professional (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at right arm on 15Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included known allergies to penicillin and sulfa. Concomitant medication included acyclovir. The patient was not pregnant at the time of vaccination. The patient experienced cellulitis in elbow of injected arm on 03Feb2021 07:00 with outcome of recovering. Therapeutic measures were taken as a result of cellulitis in elbow of injected arm (cellulitis) with doxycycline as treatment. The event resulted in doctor or other healthcare professional office/clinic visit. The patient already took the second dose of BNT162B2 (lot number: EL9264) on 05Feb2021 08:00 at the right arm.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported cellulitis cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
55 2021-03-03 rash, itchy skin C/o throat feeling tickly or itchy, Denied SOB, felt like her lips were tingling as well. Later had ... Read more
C/o throat feeling tickly or itchy, Denied SOB, felt like her lips were tingling as well. Later had itching in her arm. After second co-vid vaccine had a headache for 2 weeks, now has a rash that comes and goes on her antecubital area.
55 2021-03-05 bruising Extreme pain in right arm, worst in arm pit. Lymph nodes area. Started 25hrs after injection. Inc... Read more
Extreme pain in right arm, worst in arm pit. Lymph nodes area. Started 25hrs after injection. Including fever. Fever gone in 12 hours. Lymph node pain and swelling continues including bruising under right arm. Left arm swelling very minimal but right nodes continue to get worse 3 days in. Today
55 2021-03-06 itchy skin Oralpharynx irritated, mild itchy sensation within 5 mins of injection. Did not resolve or worsen. ... Read more
Oralpharynx irritated, mild itchy sensation within 5 mins of injection. Did not resolve or worsen. Resolved after taking an antihistamine about an hour later. Took 1 Alavert. Next morning started feeling generally unwell with body aches, fatigue, mild chills. Took Tylenol or Advil every 4-6 hours for 36 hours after injection which helped symptoms. Axillary lymph nodes on injection side became tender and sore in about 24 hours after injection and lasted about a week before resolving.
55 2021-03-07 injection site swelling 1st Dose: No problem; just a bit of fatigue 1 day following inoculation. 2nd Dose: My shot was sch... Read more
1st Dose: No problem; just a bit of fatigue 1 day following inoculation. 2nd Dose: My shot was scheduled for 3:40 PM, but probably didn't receive until 4:20 PM. At night, I had insomnia. The next morning, my fever went up to 101.2, I had swelling of the neck, my arm @ injection site, swollen lymph nodes in my left armpit, body aches, occasional stabbing pains in random places (back, arm, leg, etc.), extreme fatigue, it lasted for 1.5 days and then the fever dropped to 99. By the second day the fever was gone, body aches gone & only thing left on day 2 is swollen lymph nodes in arm pit, arm soreness at inoculation site, and fatigue. Day 3 slight fatigue, a bit of soreness in arm and armpit.
55 2021-03-08 injection site pain I had chills, severe headache, muscle ache, injection site pain, nausea, vomiting and fatigue. Afte... Read more
I had chills, severe headache, muscle ache, injection site pain, nausea, vomiting and fatigue. After approximately 12 hours I took a Tylenol PM to sleep. By the next morning all symptoms were gone.
55 2021-03-08 redness, rash Quarter size lump, redness , rash. Inflammation, painful if pressure placed on area.
55 2021-03-08 injection site pain Severe arm injection site pain from shoulder to wrist of left upper extremity.
55 2021-03-09 itchy skin I received the shot in the left arm. Sat for 15 minutes with staff and felt perfectly fine. Started ... Read more
I received the shot in the left arm. Sat for 15 minutes with staff and felt perfectly fine. Started to drive home and in 5 minutes began to feel tingling in mouth, tongue, lips face and itching in throat. Kept checking lips and tongue to see if they were swelling, (which they were not). Event lasted about 15-20 minutes and then subsided after 40 minutes. Itching in throat lasted 24 hours. Whole body felt itchy the next few days.
55 2021-03-09 injection site rash Within 24 hours of the vaccine, I developed body aches, headache, fever of 101..4 degrees, chills, ... Read more
Within 24 hours of the vaccine, I developed body aches, headache, fever of 101..4 degrees, chills, tiredness, and a sore throat. The fever, chills, and sore throat lasted for 1 day. Other symptoms lasted for an additional day, so a total of 2 days. About 3 days after the vaccine I developed a rash below the site of the injection. It didn't itch on my actual skin, but deeper in the muscle. The rash lasted for 4 to 5 days.
55 2021-03-09 vaccination site rash, vaccination site warmth, vaccination site itchiness rash/Rash is about 6 " below injection site; Large hot itchy welts; Large hot itchy welts; Large hot... Read more
rash/Rash is about 6 " below injection site; Large hot itchy welts; Large hot itchy welts; Large hot itchy welts/warmth; injection site has small bruise; arm is very sore; This is a spontaneous report from a contactable consumer (patient). A 55-years-oldnon-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EL9263, via an unspecified route of administration from 06Feb2021 12:00 (at the age of 55 years old) as a SINGLE DOSE in the left arm for COVID-19 immunization. Medical history included migraine from an unknown date and unknown if ongoing, supraventricular tachycardia (SVT) from an unknown date and unknown if ongoing. The patient did not have allergies. Concomitant medication included metoprolol, ibuprofen, acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]). The patient did not receive other vaccine in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 06Feb2021 12:00, the patient experienced large hot itchy welts. Turned into one large spot. Approximately 4 inches around. Rash began appearing about 2 hours after injection (06Feb2021 14:00). Rash is about 6 " below injection site. Actual injection site has small bruise from 06Feb2021 12:00, and arm is very sore from 06Feb2021 12:00. Rash and warmth still present after 24 hours. No treatment was received for the events. Outcome of large hot itchy welts, injection site has small bruise, Large hot itchy welts/warmth, arm is very sore, rash/Rash is about 6 " below injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
55 2021-03-10 hives Acute urticaria. Eyes swelled almost closed. Had trouble keeping them open.
55 2021-03-10 hives, injection site swelling Had swelling at site and lips swelled up from first dose symmetrically but did not affect airway, h... Read more
Had swelling at site and lips swelled up from first dose symmetrically but did not affect airway, had chills , and malaise , 2nd dose had more chills fatigue , GI upset , nausea , swelling at site of injection , arm pain couple of small hives on arm no lip swelling with second dose and migranous headache . Was not as bad as prior reactions to flu vaccine but enough to not feel well enough to go in to work Monday . Was able to go to work Tues though after Sat appt .
55 2021-03-10 injection site redness, injection site rash, injection site warmth Second morning after vaccination I had an 8 cm round, red, warm, rash at the injection site on my r... Read more
Second morning after vaccination I had an 8 cm round, red, warm, rash at the injection site on my right arm with pain which slowly resolved over a period of days. I also had fatigue and chills without fever for approximately 24 hours. Now, two months later, I have significant atrophy of the soft tissues/muscle of my arm at the injection site directly beneath the area of the red rash. I have not seen this atrophy in any discussion of delayed reactions. No other symptoms. I have photos of the arm from January 7 and March 11, 2021.
55 2021-03-10 skin warm Swollen lymph nodes from left breast and under my left arm pit and hot to the touch.
55 2021-03-11 itchy skin Body itching, no rash
55 2021-03-11 injection site reaction Injection site reaction
55 2021-03-11 injection site rash, rash Rash developed on upper body, on arms ,neck, and, around the injection site. I had a tele-heath appo... Read more
Rash developed on upper body, on arms ,neck, and, around the injection site. I had a tele-heath appointment with my doctor unfortunately, the medication did not help the rash it spread so I visited the Urgent Care to receive medical help.
55 2021-03-12 injection site warmth, injection site swelling, injection site pruritus, injection site redness Approximately 3? round, red, slightly raised, warm and very itchy area at injection site that appear... Read more
Approximately 3? round, red, slightly raised, warm and very itchy area at injection site that appeared approx 2 days after 2nd injection and lasted approx 3 days
55 2021-03-12 injection site pain Diarrhea Stomach ache nausea Headache Chills Fever Severe fatigue Unfocused thought process Sore arm... Read more
Diarrhea Stomach ache nausea Headache Chills Fever Severe fatigue Unfocused thought process Sore arm at injection site
55 2021-03-12 injection site swelling, skin warm, rash papular, injection site pain Swelling occurred at the injection site. This has now further progressed to a larger, raised rash. ... Read more
Swelling occurred at the injection site. This has now further progressed to a larger, raised rash. Approx 2x2 inches around. The area is painful, hot and throbbing.
55 2021-03-13 rash Full body hypersensitivity rash with oral involvement, starting 3 days after vaccination.
55 2021-03-13 rash Full body hypersensitivity reaction rash with oral involvement starting three days after vaccination... Read more
Full body hypersensitivity reaction rash with oral involvement starting three days after vaccination.
55 2021-03-13 injection site swelling Swelling at shot site.
55 2021-03-14 rash 3-13-21 1:15PM RASH NOTED ON FACE, NECK AND CHEST, EYES ARE ' ITCHY'. NO SOB / DYSPNEA, NO SWELLIN... Read more
3-13-21 1:15PM RASH NOTED ON FACE, NECK AND CHEST, EYES ARE ' ITCHY'. NO SOB / DYSPNEA, NO SWELLING OF MOUTH, TONGUE OR THROAT. GIVEN BENADRYL 50MG PO. PT STATES SHE 'FEELS OK TO GO HOME WITH HUSBAND'. HUSBAND TO DRIVE PT HOME. PT A/O, PINK, W/D, RESP REG WITH EASE. AMBULATORY BRISK/STEADY. NO ACUTE DISTRESS NOTED. 3-15-21 10AM TC: 'STILL HAS VERY SLIGHT RASH, NO OTHER SYMPTOMS'. CHECK WITH PCP R/T DOSE #2.
55 2021-03-14 rash Hands rash reaction
55 2021-03-14 injection site pain Sore arm at injection site for 2 days after injection. Moderate-Severe headache for 1 day after inj... Read more
Sore arm at injection site for 2 days after injection. Moderate-Severe headache for 1 day after injection.
55 2021-03-14 hives, itchy skin pain , itching, edema, hives on shoulder Recommended patient can use a hydrocortisone cream or Bena... Read more
pain , itching, edema, hives on shoulder Recommended patient can use a hydrocortisone cream or Benadryl cream to help with sx
55 2021-03-15 bruising Day 1 and 2- very tired Day 3- bruised, very tender, slightly painful feeling in left temple. Sore ... Read more
Day 1 and 2- very tired Day 3- bruised, very tender, slightly painful feeling in left temple. Sore when biting down on anything, slightly throbbing otherwise. Day 4- soreness in temple subsiding
55 2021-03-15 injection site pain Right arm is sore about 6" diameter around injection sight.
55 2021-03-15 injection site pain pain muscle soreness at the injection site. Headache
55 2021-03-16 hives 4 days psot vaccine patient developed eye angioedema and hives resulting in ED visit. 6 days post v... Read more
4 days psot vaccine patient developed eye angioedema and hives resulting in ED visit. 6 days post vaccine she devleoped flu like sxs with positive covid 19 test results on day 8 post vaccine as per pateint. 10 days post vaccine patient with dyspnea and hypoxemia-admitted to hospital.
55 2021-03-16 injection site pain After sitting for the required 15 minutes, stood up and felt light headed and fuzzy. Waited for it t... Read more
After sitting for the required 15 minutes, stood up and felt light headed and fuzzy. Waited for it to pass and walked to car. Sat in car for a few minutes, drank some water and had a few bites of a protein bar. Felt hot, flushed, broke out in an all over sweat. Waited about 5 minutes, continued to sip water and nibble on protein bar. It eventually passed. On and off headache for next couple of hours. Only some injection sight tenderness since then.
55 2021-03-16 rash, itchy skin after about 45 minutes, both wrists starting to rash and itch. It spread to my chest, neck, back an... Read more
after about 45 minutes, both wrists starting to rash and itch. It spread to my chest, neck, back and stomach. The itch was kind of a stinging itch and my palms were hot. I called the facility and they asked me to come by so they could look at it. They said it was a reaction but not severe enough for an epi pen. They told me to go to my Dr, which had left for the day so I went to MedExpress. My bp on arrival was 150/98. They gave me a shot of Decadron. My bp went down to 120/80 before leaving and my itch had eased a little. They prescribed 5 days of Prednisone and Zyrtec. The next morning, I had a severe headache and could not concentrate, I felt a little itchy and tired. Today, no rash or itch just nervousness on the inside from the prednisone and my hands are still hot sometimes.
55 2021-03-16 redness redness of the face and numbness of her face for couple of mins
55 2021-03-17 injection site swelling, rash with redness, rash, injection site hardening Allergic reaction; injection site became swollen and indurated, excessive sweating in hands, red ras... Read more
Allergic reaction; injection site became swollen and indurated, excessive sweating in hands, red rash spots on both arms, dizziness, nausea, breathing difficulty. Result: Mild relieve of symptoms.
55 2021-03-17 skin burning sensation, skin tightness Following vaccination in R arm felt tightness in her R hand and back of her neck within 5 min, staye... Read more
Following vaccination in R arm felt tightness in her R hand and back of her neck within 5 min, stayed for observation for about 20min and was feeling better so left - but about halfway home lips started to swell, tongue started to feel thick and throat started hurting - ate a popsicle which seemed to help. Then that evening took her usual dose of lisinopril and about an hour later noticed tightness developing in her neck and new headache, followed by swelling of lips and tongue. Took tylenol arthritis which she usually takes for her neck problems, and went to bed, but a couple of hours later developed burning in her ears and jaw, headache persisted, and swelling seemed to have gone down with ice chips. Lisinopril d/c'd on 3/14, converted 3/17 to losartan which she started at 5pm and within 2 hours had recurrent angioedema for which she was told to call emergency responders, used EpiPen, discharged from ED after 4 hours with another change in BP medication and Medrol dosepak. Allergist recommends no further COVID vaccines.
55 2021-03-17 rash, itchy skin, itchy rash Left arm developed an itchy rash on my wrist and forearm. About 30 minutes later my ears started it... Read more
Left arm developed an itchy rash on my wrist and forearm. About 30 minutes later my ears started itching. About 45 minutes later my right eye was itchy. I took two Benadryl tablets and decided to work from home. I drove home and took a nap. When I woke up the rash and itching were gone.
55 2021-03-17 rash, rash with redness Red rash on breasts and sides of chest, resolved 1 d later. Took cetririzine.
55 2021-03-18 injection site hardening, injection site pain Approx. 1 hr. after getting vaccine, didn't feel well - specifically: * pain and stiffness that slow... Read more
Approx. 1 hr. after getting vaccine, didn't feel well - specifically: * pain and stiffness that slowly spread down left arm (below injection site) * headache * low-grade fever during night, then sweating * waves of nausea the following day * diarrhea also following day Felt OK approx. 32 hrs. after injection
55 2021-03-18 injection site swelling Migraine headaches, fever of 100.8, severe body aches, severe body chills, left upper arm swollen an... Read more
Migraine headaches, fever of 100.8, severe body aches, severe body chills, left upper arm swollen and major pain in whole arm, sneezing and severe running nose and nauseated really bad
55 2021-03-19 rash Swelling of face and neck, eyes itchy, red rash on face and large patches of rash on face, neck and ... Read more
Swelling of face and neck, eyes itchy, red rash on face and large patches of rash on face, neck and chest.
55 2021-03-19 injection site pain With 24 hours pain at site of injection that traveled through shoulders and neck. Severe neck pai... Read more
With 24 hours pain at site of injection that traveled through shoulders and neck. Severe neck pain/swollen glands/- 2 days later pain traveled to mouth and throat- on day 5 in the evening starting run a fever with severe night sweats/Chills/no appetite/fatigue . I have never experienced this feeling before --- the amount of sweat coming out of my body was like a demon was being released. I felt these severe symptoms for about 4 days . One week later from onset of night sweats/c hills/ fatigue I still have these symptoms but not as severe.
55 2021-03-20 skin warm, injection site redness, injection site swelling Injection site swelling, redness expanding in area to approximately four and a half inches in diamet... Read more
Injection site swelling, redness expanding in area to approximately four and a half inches in diameter, still present three weeks after injection. Some swelling still exists and the area is slightly warm to the touch.
55 2021-03-20 rash, itchy skin, itchy rash This weekend I have broken out in a full body itchy rash. I have all these small bumps all over leg... Read more
This weekend I have broken out in a full body itchy rash. I have all these small bumps all over legs, back, arms.. I have not visited Dr yet but will be making an appointment ASAP. I believe this is related to the shot that I took 1 week ago. I am currently taking 4 benadryls every 6 hours to attempt to stop the itching. I've used Aveno Bath to also attempt to sooth the itching.
55 2021-03-21 bruising 48 hrs after vaccination severe stomach cramps/pain after eating spicy food (curry) 4 days after va... Read more
48 hrs after vaccination severe stomach cramps/pain after eating spicy food (curry) 4 days after vaccination severe stomach cramps/pain after eating spciy food 4 days after vaccine armpit of vaccine site arm (left) had dark/purpleish discolored area about 5 cm and moderate swelling . Discoloration has now resolved, slight swelling remains.
55 2021-03-21 injection site pain Pain at injection site, fever, muscle pains
55 2021-03-22 hives, injection site redness 4? red welt near injection site. No pain or itching.
55 2021-03-22 itchy rash, itchy skin, skin warm, injection site reaction 8 days after my first shot I got a large very itchy rash on my upper right arm. Like poison ivy. ... Read more
8 days after my first shot I got a large very itchy rash on my upper right arm. Like poison ivy. Cortisone cream did not work. Nothing has worked. I received my 2nd shot yesterday and the itching is so bad. I am taking 2 benadryl every 4 hours and using the cream but it's not helping. My arm feels very hot this time also.
55 2021-03-22 itchy skin Facial itching eye swelling wheezing- occurrred on two incidences treated with Benadryl and nexium ... Read more
Facial itching eye swelling wheezing- occurrred on two incidences treated with Benadryl and nexium first episode. Second episode was seen by dr - dose pack, famotidine, Benadryl, rescue inhaler were prescribed..
55 2021-03-22 injection site pruritus, injection site swelling, injection site redness, injection site pain First two days very tender at site. 4-5 days later site very itchy. 8-9 days later got itchy again,... Read more
First two days very tender at site. 4-5 days later site very itchy. 8-9 days later got itchy again, when scratching realized there was fairly hard swelling approx. 2" x 1" area; reddish in color
55 2021-03-22 rash Patient received vaccine at CVS. With in 5 min developed flushing. Patient given Benadryl and epi at... Read more
Patient received vaccine at CVS. With in 5 min developed flushing. Patient given Benadryl and epi at CVS, transported to ER. Patient develops difficulty swallowing and a rash, monitored and Evaluated. D/C home with PO prednisone.
55 2021-03-22 rash Rash skin in both sides of my belly under my breast.
55 2021-03-22 rash face swelling, rash on cheeks, eyes,nose, sore arm,
55 2021-03-23 injection site pain, injection site swelling 3/22/21: Pain and swelling at injection site around 4p. Chills, nausea and extreme exhaustion around... Read more
3/22/21: Pain and swelling at injection site around 4p. Chills, nausea and extreme exhaustion around 5p. Just got in the bed to sleep off the symptoms about 6:15p. 3/23/21: Pain and swelling at injection site persisted. Also had pain under left arm that radiated to left breast, down left side, up the neck and upper left back as day progressed. Went to take a shower around 4:30p and noticed the lump/swelling under left arm, beside left breast. Area of the lump was tender to the touch. Went to Patient first to get checked out and was prescribed steroids to reduce the pain, swelling and inflammation.
55 2021-03-23 injection site pain Day of shot developed pain in entire right side(chest area), also acid reflux and nausea. That went ... Read more
Day of shot developed pain in entire right side(chest area), also acid reflux and nausea. That went away about 12 hours after the vaccine. Ten days after I developed a slight pain in right lateral side that progresses to constant pain in 2 places on right side including under right clavicle. I had pain upon taking in a deep breath. Saw MD after 4 days of these SXS. Performed labs, Chest x-ray and EKG. All were essentially normal except elevated WBC count. Have 2 COVID test which were both normal. Md said possibly some sort of inflammation and suggested taking anti-inflammatories which did not help much at all with SXS. After a few more days the SXS changed to constant chest pain(pressure), SOB upon exertion and pain behind knee. F/U with MD again and it was decided to wait a few more days. Upon suggestion from friend asked MD to perform D-Dimer lab test. The result was 4,400. My normal value should have been 550. Sent to ER. CT of chest, EKG and more labs performed. CT revealed large bilateral pulmonary embolisms in pulmonary arteries. Started on blood thinners. Ultrasound of left leg revealed large DVT. Sent home after 2 days on blood thinners. SXS stopped after a few days.
55 2021-03-23 rash with redness Patient brought to the attention of charge nurse @ 1430. Patient returned to the site after receivin... Read more
Patient brought to the attention of charge nurse @ 1430. Patient returned to the site after receiving the vaccine at 1120 at Medical Center. Patient waited in observation after vaccination without incident. Patient stated that she was wearing pants and did not notice redness to her legs and back until about an hour after vaccination. Patient and her husband decided to come back to the site for help. Patient presented with slightly red rash to legs and back and stated she felt a headache, slight dizziness and nausea. Patient guided to chair and vitals assessed. BP 101/84, Pulse 62, SaO2 96%, Resp 18, lung sounds clear. Patient given 25 mg of Benadryl and water, tolerated well. Patient agreed to wait 30 minutes on site. Nurse left to observe patient. Vitals @ 1500, 155/84, Pulse 63, SaO2 98%, T 98.3 F, redness and nausea improving. Patient tolerated medication well. After 30 min patient stated skin redness significantly improved and is no longer nauseous. Vitals before leaving site, BP 135/81, P 62, SaO2 98%, Temp 98.1, Resp 16, lung sounds clear. Patient educated to seek medical attention if side effects continue or worsen. Patient left site with her partner without incident.
55 2021-03-24 redness 2:10 pm arms red bilat from elbows down. No other sign or symptoms blood pressure 136/82 Pso2 99% ... Read more
2:10 pm arms red bilat from elbows down. No other sign or symptoms blood pressure 136/82 Pso2 99% pulse 85 Respirations even and unlabored . remaining skin pink warm and dry. Imformed to seek medical attention if any further problems. sheet given to follow up.
55 2021-03-24 skin discolouration Patient is been complaining of swollen arms, breast, face and neck. she's also having burning sensat... Read more
Patient is been complaining of swollen arms, breast, face and neck. she's also having burning sensation all over body, especially breast area. Patient has also blue spots on upper Thigh. Patient also complaining of weakness, body aches, and abdominal pain sometimes. Patient also today is complaining about head ache and feeling confused.
55 2021-03-24 injection site pruritus, injection site redness, injection site swelling Red, swollen , itchy circle (approx 5?) at injection site.
55 2021-03-24 injection site warmth, injection site swelling, injection site pruritus, hives large 'oval' welt on arm where 2nd shot was given. It is raised, warm and itchy. it appeared.4 days ... Read more
large 'oval' welt on arm where 2nd shot was given. It is raised, warm and itchy. it appeared.4 days after the shot.
55 2021-03-25 injection site pain Fever up to 103. Severe chills that made my teeth chatter. Horrible headache. Severe body aches in a... Read more
Fever up to 103. Severe chills that made my teeth chatter. Horrible headache. Severe body aches in all joints. Cough. Injection site soreness.
55 2021-03-25 injection site pain INCREASE IN BLOOD PRESSURE 50 POINTS, AND INCREASE IN HEARTRATE 30 POINTS IN FIRST 30 MINUTES SORE A... Read more
INCREASE IN BLOOD PRESSURE 50 POINTS, AND INCREASE IN HEARTRATE 30 POINTS IN FIRST 30 MINUTES SORE ARM AT INJECTION SITE DAY 2, FATIGUE DAY 2, NAUSEA AND EASILY DEHYDRATED DAY 2-5 SWOLLEN LYMPH NODES DAY 8-10 ON RIGHT SIDE ONLY
55 2021-03-25 injection site swelling, skin warm, itchy skin, injection site pain, redness Injection sight had muscle pain and then swelling began. Itching and redness occurred the day after... Read more
Injection sight had muscle pain and then swelling began. Itching and redness occurred the day after the shot, and continued to expand the next three days. Swelling also spread. Day three it became warm to the touch. Ice, Tylenol, and Benadryl were used. Had not cleared as of this report.
55 2021-03-25 itchy skin, hives, rash, rash with redness Rash with hives on stomach Both forearms itching in middle of night, mild red rash on left forearm
55 2021-03-25 rash pt stated that she felt a little funny and lightheaded after taking the covid vax. Her skin started... Read more
pt stated that she felt a little funny and lightheaded after taking the covid vax. Her skin started feeling a little prickly and she developed rash on her extremities and upper chest. She started having trouble speaking, her voice got hoarse and she started coughing. She had an intense headache, fatigue and could barely speak. She was taken to the UrgentCare . She was given EPI pen and steroids injections. Paramedics were called and she was taken to a hospital, where she was monitored after getting those injections and given Pepcid and IV fluids. She was diagnosed w/ Anaphylaxis from adverse reaction to vaccine. She discharged and sent home to FU w/PCP. Her appt w/ her PCP on 3/25/2021 she was taken next door by wheelchair to all allergist Dr. She noticed that her respiratory symptoms were improving while she was there as her Pepcid medication was wearing off. Pt is convinced that she is allergic to the ingredient Polyethylene Glycol. She is still taking prednisone medication and continuing to improve.
55 2021-03-30 vaccination site pain Significant pain following the trigeminal (CN5) nerve on right side (injection side); Jaw/tooth/gum/... Read more
Significant pain following the trigeminal (CN5) nerve on right side (injection side); Jaw/tooth/gum/cheek pain; Jaw/tooth/gum/cheek pain; Jaw/tooth/gum/cheek pain; Jaw/tooth/gum/cheek pain; sensitive to pressure/heat/cold both upper and lower jaw; This is a spontaneous report from a 55-Year-Old non- pregnant female contactable Other Health Professional reported for herself that she received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 EUA, Formulation: Solution for injection, Batch/lot number: EL0739), via an unspecified route of administration on 28Jan2021 (age at vaccination: 55 years) at 17:45 at single dose in right arm for covid-19 immunization. The patient's medical history included high cholesterol, Obesity, high blood pressure and known allergies: contrast dye. Concomitant medications included Simvastatin, Lisinopril, Aspirin 81, and Fish oil. On 28Jan2021 at 22:00, the patient experienced significant pain following the trigeminal (CN5) nerve on right side (injection side), Jaw/tooth/gum/cheek pain and sensitive to pressure/heat/cold both upper and lower jaw. The patient did not take any treatment for the events. The outcome of the events was not recovered Information on Lot/Batch number has been requested.
55 2021-03-30 vaccination site pain Temp elevated night 100.9 F; ear pain; ear pressure; lymph node swollen behind right ear; severe nec... Read more
Temp elevated night 100.9 F; ear pain; ear pressure; lymph node swollen behind right ear; severe neck pain; right cheek numb/sometimes left cheek numb feeling in lower cheeks/numbness in chin; hot flash in ears; chest pain; intense shoulder/shoulder pain/elbow pain; feels like it runs up the nerves; Pain in shot site left arm and pain in right arm in the same; severe headache/intense headache/pressure headache/bad headache; body pain at night; Pain in shot site left arm and pain in right arm in the same; This is a spontaneous report from a contactable consumer (patient herself). A 55-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration in left arm at the age of 55-years (non-pregnant at the time of vaccination), on 06Feb2021 at 01:45 PM at a single dose for COVID-19 immunisation. The patient's medical history included diabetes, high blood pressure, lacunar infarct, anemia, and non-rheumatic mitral regurgitation. The patient had no known allergies. Concomitant medications included losartan, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) and acetaminophen. The patient previously took first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient received other vaccine in four weeks was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID. It was reported that Immediately after the shot, severe neck pain that wrapped up my face, right cheek numb, hot flash in ears, chest pain, intense shoulder, elbow pain, feels like it runs up the nerves, severe headache, ear pressure, lymph node swollen behind right ear on 06Feb2021 at 01:45 PM. Headache, body pain at night on 06Feb2021. O7Feb2021, numbness in right cheek, sometimes left cheek numb feeling in lower cheeks and intense headache. On 08Feb2021, ear pain, pressure headache, shoulder pain, cheeks numb left work early not feeling good at all headache very bad with acetaminophen (TYLENOL). Second vaccine shockingly painful side effects day of shot and days after. Pain in shot site left arm and pain in right arm in the same. Temp elevated night 100.9 F. On 09Feb2021, Off work vice grip headache, ear pain. On 10Feb2021, bad headache, numbness in cheeks remain, numbness in chin. The outcome of the events was recovering. It was also reported that post vaccination, the patient had not been tested for COVID.
55 2021-03-30 vaccination site pain diagnosed with Covid on 11Mar2021; Tenderness in area around injection site; This is a spontaneous r... Read more
diagnosed with Covid on 11Mar2021; Tenderness in area around injection site; This is a spontaneous report from a contactable consumer. A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiration date: unknown), via an unspecified route of administration on her right arm on 03Mar2021 as single dose for COVID-19 immunization. The patient's medical history included myelodysplastic syndrome (MDS), bone marrow transplant, low thyroid, hyperparathyroidism, oral and ocular graft versus host disease (GVHD). On 03Mar2021 at 17:00, the patient experienced tenderness in area around injection site. The patient reported with symptoms of COVID (irritated throat, stuffy nose, sneezing) on 11Mar2021. The patient was diagnosed with COVID on 11Mar2021 via PCR nasal swab. The patient went in for testing and was negative on 12Mar2021 via PCR nasal swab. However, the symptoms progressed to include low grade fever and worse fatigue so the patient was rested on 15Mar2021. The patient was tested positive for COVID via PCR nasal swab on 15Mar2021. The outcome of the events was recovering.
55 2021-03-30 hives, rash, itchy skin hands got very swollen and rash and itchy beyond itch; hands got very swollen and rash and itchy bey... Read more
hands got very swollen and rash and itchy beyond itch; hands got very swollen and rash and itchy beyond itch; Anaphylaxis; Double vision; Right eye is going cross eyed/Left eye is dropping; Right wrist pain increased dramatically after the vaccine; Throat starting to close/Throat started tightening; severe rash- latus stranding, purple dots, and hives from face all the way down to toes; severe rash- latus stranding, purple dots, and hives from face all the way down to toes; This is a spontaneous report from a contactable consumer (the patient). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in arm left on 19Feb2021 10:00 (Batch/Lot Number: EN6201), at the age of 55 years, as single dose for covid-19 immunisation. Medical history included ongoing asthma diagnosed 3 years ago, ongoing gastrooesophageal reflux disease diagnosed 4 years ago, ongoing hypertension diagnosed 4 years ago, ongoing food allergy: allergic to eggs, shellfish, dairy/lactose intolerant, ongoing allergies to environmental: standard- hay fever, dust, mold, ongoing allergies to dogs and cats, contrast media reaction (IV contrast CT scan dye- respiratory distress, throat tightens), urticaria, pruritus. She had Covid on 18Dec2020 and "Covid rash it attached her muscular system. She had muscular pain in the wrist and hip on the right side and mild double vision." The patient previously took vitamin k 2 and experienced anaphylactic reaction, Toradol and experienced urticaria, influenza vaccine and experienced rash at the injection site, at the age of 34 years (because she's allergic to eggs). The patient received the first dose of bnt162b2 on 29Jan2021 Lot: EL3247; 9:30 AM; Right arm for covid-19 immunisation and she did not have any symptoms whatsoever with the first shot. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. Vaccination Facility Type: Hospital. Concomitant medications included omeprazole taken for gastrooesophageal reflux disease; lisinopril taken for hypertension; montelukast sodium (SINGULAIR) taken for asthma; salbutamol sulfate (INHALERIN) taken for asthma; start and stop date were not reported for all. The patient experienced anaphylaxis on 26Feb2021 with outcome of unknown, throat starting to close/throat started tightening on 19Feb2021 with outcome of recovered, severe rash- latus stranding, purple dots, and hives from face all the way down to toes on 19Feb2021 with outcome of not recovered, double vision on 20Feb2021 with outcome of not recovered, right eye is going cross eyed/left eye is dropping on 20Feb2021 with outcome of not recovered, right wrist pain increased dramatically after the vaccine on 20Feb2021 with outcome of not recovered, hands got very swollen and rash and itchy beyond itch on an unspecified date with outcome of unknown for Hand swelling and recovered for Localised itching. Therapeutic measures were taken as a result of the events: Benadryl, Zyrtec, Pepcid, New glasses for double vision, Prednisone 7 day ween. The patient underwent lab tests which included Hematology test on unknown date with unknown results; Immune markers on 11Mar2021 with unknown results. Clinical course: The patient received the vaccine on 19Feb2021at 10:00 AM and five minutes after, her throat started tightening and they put her in observation for another hour and then her throat felt fine and they let her go. Caller confirmed she was not referring to this occurrence as anaphylaxis. The anaphylactic reaction occurred days later. She mentioned from 19Feb2021-26Feb2021, her symptoms were progressing and then on 26Feb2021, it was full blown out; the actual anaphylaxis was 26Feb2021. Between this, she had severe double vision, severe rash from face all the way down to toes, one eye going cross eyed (right eye), left eye is still drooping. On 20Feb2021, she started having double vision that started with the sunlight and fluorescent lights and the next day she couldn't see anything without double vision, and her eye started going cross eyed. She still cannot see normally now. She is under eye doctor care for that too. The patient was treated with Epi-Pen into leg and then into the Emergency Room. She received 50 mgs of Benadryl and 125 mg of Solu-Medrol IM injection, but still have to give Epi because her throat was still closing. Her airway was intact and no nebulizer treatment needed. The patient reported also that her hands got very swollen and rash and itchy beyond itch. The patient reported that her weight at that point was 204, the she had been on Prednisone for a week, and her weight has gone up to 210 now. After her throat closed on the 26Feb2021, caller reports she gained 7 pounds while on it for one week. Caller stated she was also put on prednisone when she got diagnosed with asthma, reactive airway. She confirmed her throat stop closing immediately after the Epi. The patient was also treated with 25 mgs of Benadryl, Zyrtec, and Pepcid a day. Outcome for throat closing was improved with medication. Outcome for rash was not improved and she is taking medicine to counteract it; itch went away when she took the Zyrtec. Regarding right wrist pain, it increased dramatically after the vaccine. Caller reports it felt like a spiral fracture down the ulna and it started to ache on 20Feb2021, by the next day it hurt a 5 out of 10. By 22Feb2021, she was wearing a splint, it was 8 out of 10, and she felt like she fractured it and it was swollen on the ulnar side. Regarding eye disorder, she is now under the care of an eye doctor for her severe double vision, eye crossing, and eye drooping. The blurred eyes give bad balance and that kind of stuff. The cross eyedness gives her poor peripheral vision and also her depth perception has now been compromised. They say the glasses will fix it. As of 22Feb2021, a new pair of special lenses with prisms were ordered for her. The patient was not hospitalized.
55 2021-04-04 itchy skin, injection site hives About an hour after receiving the vaccine I developed a large white hive just below the injection si... Read more
About an hour after receiving the vaccine I developed a large white hive just below the injection site. (hive approx 2 inches in diameter) I began to itch on rest of body/ no more hives just itch. I took 50mg of Benadryl. 4 hours later still itching so I took 50mg of Benadryl. Approx, 4.5 hours later, woke up with tightening feeling in throat, itching in throat and roof of mouth, itching tingling of tongue, and tingling sensation of lips. went to the emergency room. Was admitted and monitored, benadryl was administered. Duration of hospital stay 1 day.
55 2021-04-09 itchy skin, rash in respiratory distress; Mild lightheaded; itchy; rash; severe headache; tightening in chest/tightne... Read more
in respiratory distress; Mild lightheaded; itchy; rash; severe headache; tightening in chest/tightness chest; voice increasing hoarse/decreased voice volume and able to say 2 words max; coughing; shortness of breath; very effortful to talk; Eyes droopy; tingling jaw, neck; stressful; Unable to do anything seconda; This is a spontaneous report received from a contactable consumer (patient). A 55-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EP7534), via an unspecified route of administration at Arm Left on 24Mar2021 08:30 (at age of 55 years old) at single dose for COVID-19 immunization. Medical history included Type1 diabetes, allergies, Shellfish allergy. Concomitant medication included insulin lispro (HUMALOG); pravastatin sodium (PRAVASTATIN +PHARMA); cetirizine hydrochloride (ZYRTEC ALLERGY). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 09:30 AM, the patient experienced mild lightheaded first 1/2, by 90mins post skin itchy with rash just under skin, severe headache, tightening in chest, voice increasing hoarse, coughing, shortness of breath, decreased voice volume and able to say 2 words max, no observed swelling but in respiratory distress. Went to AMC Umergent care, epipen + benedryl +steroids administered, transferred to AMC hospital via ambulance. Monitored, IV fluids+ Pepcid, stabilized d/c home on 50mg prednisone + Pepcid. Symptoms (milder)reoccur in Wednesday pm, Thursday AM, Thursday PM following Pepcid. Friday Mild coughing during the day, but overall good energy, activity level, almost back to normal. 1/2 hour prior to prednisone 4:30 pm starting experiencing respiratory symptoms again. Vitals all stable, but very effortful to talk, exhale (coughing). Eyes droopy, tingling jaw, neck, tightness chest. Overall took 1.5 hours post prednisone for symptoms to improve and voice to return to almost normal. Very stressful. Unable to do anything seconda. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment (EPINEPHRINE, BENEDRYL, PEPCID, PREDNISONE) received for AE. The outcome of the events was unknown. Information on the lot/batch number has been provided. Other information has been requested.
55 2021-04-14 injection site pain 2 days of mild soreness at injection site; swollen lymph nodes under jaw/sore throat and fatigue for... Read more
2 days of mild soreness at injection site; swollen lymph nodes under jaw/sore throat and fatigue for 4 days after injection --everything was better after a week.
55 2021-04-14 injection site pain Mild chills one day after with some muscle aches. 2 days of alot of soreness at injection site; swol... Read more
Mild chills one day after with some muscle aches. 2 days of alot of soreness at injection site; swollen lymph nodes under jaw/sore throat and fatigue for 4 days after injection --everything was better after a week.
55 2021-04-15 hives Hives over entire back
55 2021-04-17 itchy rash, blister I broke out in a very itchy rash with blisters on my right forearm then in my left forearm.; I broke... Read more
I broke out in a very itchy rash with blisters on my right forearm then in my left forearm.; I broke out in a very itchy rash with blisters on my right forearm then in my left forearm.; I was very sick for 8 days; This is a spontaneous report received from a contactable consumer (patient). A 55-years-old-female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6205, Expiration date: Not reported) via an unspecified route of administration in right arm on 01Mar2021 at 15:15 at single dose for COVID-19 immunisation. The patient Medical history included allergic to sulfa drugs, chocolate and peanuts. The concomitant medications were not reported. It was reported that she have several medications she take daily. The patient was very sick for 8 days and a few days after that she broke out in a very itchy rash with blisters on her right forearm then in my left forearm. She is still dealing with the rash and itching on her left forearm on 01Mar2021 at 8:00 PM. the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient visited emergency room. It was reported that she was given a shot please medicine. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
55 2021-04-17 injection site rash, injection site pain Injections burn like crazy/ injection is extremely painful; Rash at the injection site; Experiencing... Read more
Injections burn like crazy/ injection is extremely painful; Rash at the injection site; Experiencing flares; Blurry vision / blurriness; This is a solicited report received from a contactable consumer based on information received by Pfizer. This solicited report (USASL2020210290) was reported to Amgen on 23/DEC/2020 by a consumer from a commercial program (PSP00086) and involves a 55 years old, female patient whose injections burn like crazy [PT: injection site pain] and blurry vision/blurriness [PT: vision blurred] while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. No co-suspect medications were reported. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. On an unknown date, the patient's injections burn like crazy. For past three and a half to four weeks in Nov2020, the patient has had blurry vision. The patient saw an Ophthalmologist who stated everything looked fine with her eyes but blurriness persists. No treatment information was received. The outcome of the event vision blurred was reported as not recovered/not resolved. The outcome of the event injection site pain was reported as unknown. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the events injection site pain and vision blurred. The causal relationship between the events injection site pain, vision blurred and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent for follow up. No follow up attempts are possible. No further information is expected. ADDITIONAL INFORMATION RECIEVED ON 02Apr2021: This case is upgraded to serious. In this follow up, the patient was experiencing flares [PT: rheumatoid arthritis], injection is extremely painful [PT: injection site pain], rash at the injection site [PT: injection site rash] while receiving Enbrel, Single Dose Prefilled Autoinjector. The patient's co-suspect medications included covid-19 vaccine. On an unknown date, the patient reported that each injection was extremely painful and she gets a rash at the injection site with almost every dose. On 09Mar2021, she has been experiencing flares since having a COVID vaccine on 09Mar2021. She was not home to provide lot. No treatment information was received. The outcome of the events injection site pain, injection site rash were reported as not recovered/not resolved. The outcome of the event rheumatoid arthritis was reported as unknown. Action taken with Enbrel, Single Dose Prefilled Autoinjector was reported as unknown for the events injection site rash and rheumatoid arthritis. The causal relationship between the events injection site rash, rheumatoid arthritis and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent for follow up. No follow up attempts were possible. No further information was expected. Amgen's causality assessment: events injection site pain and injection site rash were related to etanercept, while events blurry vision and rheumatoid arthritis flare up were unrelated to etanercept. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Amgen Comment: This individual case report does not change the safety profile of the product.; Sender's Comments: Based on information provided, the time association and vaccine's safety profile, the possible contribution of suspect BNT162B2 to the events rheumatoid arthritis flare up ,injection site pain and injection site rash cannot be excluded. The event blurry vision occurred prior to the administration of vaccine BNT162B2, considered unrelated to vaccine injection. The causal relationship of the drug etanercept to the events injection site pain and injection site rash is possible given the implied time association, while the events blurry vision and rheumatoid arthritis flare up were assessed as unrelated to etanercept. The rheumatoid arthritis would involve in eye's disorder when the rheumatoid arthritis is in active status. The clinical course of rheumatoid arthritis would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
55 2021-04-24 vaccination site pain, shingles minor shingles outbreak (left side face nerve pain, headache, itching chin/head and blister on lips)... Read more
minor shingles outbreak (left side face nerve pain, headache, itching chin/head and blister on lips); light headed/dizzy on day 2; exhaustion for four days; intense arm pain at injection site (pain began when shot was being given); slight nausea; This is spontaneous report from consumer (Patient) via (Pfizer/Bio-Tech). A 55-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on 03Mar2021 at 15:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation at hospital. Medical history included restless legs syndrome. The patient was not pregnant at the time of vaccination. Patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included carbidopa, levodopa (SINEMET), levothyroxine sodium (LEVOTHYROXIN). On an unspecified date in Mar2021, patient experienced minor shingles outbreak (left side face nerve pain, headache, itching chin/head and blister on lips), exhaustion for four days, intense arm pain at injection site (pain began when shot was being given), slight nausea, lightheaded/dizzy on day 2. It was unknown whether patient treatment for the adverse events. Outcome for the events were unknown. Information for lot/batch number has been requested
55 2021-04-26 redness this feels like an auto immune thyroid attack; headache/pain in back of head; serious pain heat burn... Read more
this feels like an auto immune thyroid attack; headache/pain in back of head; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area/ The area is also really red and warm to the touch; frontal neck muscles are contracting under chin and on the sides; throat is burning; The area is also really red and warm to the touch; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 03Apr2021 at 14:15 (02:15 PM) (at the age of 55 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunization; and thyroid (ARMOUR THYROID) via unspecified route of administration on unspecified date at 15mg for unspecified indication. Medical history included hypothyroidism and known allergies to sulfa drugs. The patient previously took quinolines and experienced allergies. On 04Apr2021 at 10:00 AM, the patient experienced headache/pain in back of head, but also serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area. This began on day 2 and increased days 3,4,5,6, it became very pronounced after taking Armor Thyroid 15mg medication. It also feels like her frontal neck muscles are contracting under chin and on the sides and throat is burning. The patient called her doctor but no return call yet. She had normal labs several weeks ago for thyroid. She went today again as this feels like an auto immune thyroid attack. The area is also really red and warm to the touch. The patient did not receive other vaccine in four weeks. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not received treatment for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The action taken in response to the events for ARMOUR THYROID was unknown. The patient had not yet recovered from the events. Information on the lot/batch number has been requested.
55 2021-04-28 rash And it most definitely looks like the measles; bad rash developing on her left arm between her elbow... Read more
And it most definitely looks like the measles; bad rash developing on her left arm between her elbow down to her wrist; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 02Apr2021 10:00 (Batch/Lot Number: EWO150) as single dose for COVID-19 immunisation. Medical history included lupus, ovarian cancer, trigeminal neuralgia, interstitial cystitis (IC), and idiopathic anaphylaxis. The patient has many, many prescription and OTC meds (unspecified). No other vaccine in four weeks. It was unknown if the patient had COVID prior to vaccination. The patient has not been tested for COVID post vaccination. The patient first noticed a bad rash developing on her left arm between her elbow down to her wrist on 08Apr2021. She chalked it up to the sun & warmer weather and the fact that she has lupus. A day or so later, she noticed very clearly, the same rash appeared on her left thigh. Just mid thigh to knee cap. And it most definitely looked like the measles. She added that nothing itched. And her thigh has not been exposed to any sun. She consulted her doctor via e-mail who has seen pictures of the rashes. She wanted her to get her blood work checked the next day (unknown results) to make sure her lupus hasn't been compromised by the Covid rash side effect. The event resulted in a doctor clinic visit. The patient has not recovered from the events.
55 2021-04-28 vaccination site pain weakness in her left arm; pain is increasing; Total hysterectomy; pain is up to her shoulder and dow... Read more
weakness in her left arm; pain is increasing; Total hysterectomy; pain is up to her shoulder and down to her elbow; waking her up at night; soreness in her left arm; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot No. EL3246; Expiration Date: unknown) via an unspecified route of administration in left arm on 30-DEC-2020 09:15 at single dose (age at vaccination: 55-year-old) for COVID-19 immunization and patient had second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot No. EL9251; Expiration Date: unknown) via an unspecified route of administration in left arm on 20Jan2021 1:30 PM at single dose for COVID-19 immunization. The patient medical history included high blood pressure (From: Unspecified To: Ongoing). The patient concomitant medications included losartan: (Start: Unspecified Stop: Ongoing), taken for 7 years, amlodipine: (Start: Unspecified Stop: Ongoing) taken for 7 years. It was reported that, she has had both vaccines. First vaccine on 30Dec2020 and the second vaccine on 20Jan2021 and she is having pain. She wasn't having pain, just soreness in her left arm. But that soreness has gotten worse now. She also reports that when she got her first Covid 19 vaccine, the person who gave the injection went straight into her arm with the needle and when she got the second vaccine the person who gave the injection went more towards the back of her arm with the needle. The first injection where the needle went straight on has bothered her since 30Dec2020. She also has weakness in that left arm and it's waking her up at night. She is an administrator and was in the first phase of people who received the Covid 19 vaccine. she did tell the attendant giving her the second Covid 19 vaccine that she was still having soreness in her left arm. That person told her soreness in her arm was normal. She reports she had a total hysterectomy on 18Feb2021 and had preop labs done at that time. Her primary care doctor has not ordered any labs related to her issue with her left arm. On an unknown date in Apr2021, the pain is increasing, and the arm is getting weak. The attendant giving her second vaccine did ask her if she wanted the injection in the right arm, her other arm and she said no. She is right hand dominant, and she needed one working arm. On an unknown date 2021, that soreness, that pain is up to her shoulder and down to her elbow. She reports her doctor did reflex testing and asked the caller to squeeze the doctor's hands and push down on her hands like a strength test to see if there was equal strength. The doctor told her she had less strength in her left arm than her right arm. She had gone to the doctor for a blood pressure check and while she was there, she mentioned to her doctor the problem with her arm. She had gone to the doctor for a blood pressure check and while she was there, she mentioned to her doctor the problem with her arm. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event hysterectomy was unknown, for rest of the events it is not recovered. No follow-up attempts possible. No further information expected.
55 2021-04-30 skin tightness both my doses of vaccine led to facial tightening, twitching, and slightly more paralysis; both my d... Read more
both my doses of vaccine led to facial tightening, twitching, and slightly more paralysis; both my doses of vaccine led to facial tightening, twitching, and slightly more paralysis; both my doses of vaccine led to facial tightening, twitching, and slightly more paralysis; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE)), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 11:30 (Batch/Lot Number: EP7533) as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 11:30 (Batch/Lot Number: ER8729) as single dose for covid-19 immunisation . Medical history included high blood pressure (HBP) from an unknown date and unknown if ongoing , supraventricular tachycardia (PAT) from an unknown date and unknown if ongoing, had Bell's palsy from 2001 to an unknown date. No known allergies. Concomitant medication(s) included amlodipine taken for an unspecified indication, start and stop date were not reported; enalapril taken for an unspecified indication, start and stop date were not reported. The patient did not have any vaccines in four weeks and did not have covid prior to vaccination. In 2001, the patient had Bell s palsy (Medical history). Her left side paralysis never fully went away. Now, both of her doses of vaccine led to facial tightening, twitching, and slightly more paralysis on 23Mar2021 11:30 with outcome of unknown. She did not regret taking the vaccine and would do it again. Her mainly reason for reporting this was that she wanted to know if the vaccine was still effective. No treatment was received. No covid test post vaccination.
55 2021-05-04 itchy skin, hives chills; joint pain/Joint achiness/she fell off of her roof; hives/she broke out in hives; severely i... Read more
chills; joint pain/Joint achiness/she fell off of her roof; hives/she broke out in hives; severely itchy; This is a spontaneous report from a contactable consumer reported that a 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249) intramuscularly in left shoulder as single dose on 04Feb2021 at 12 for COVID-19 vaccination. Medical history reported was ongoing asthma diagnosed at about age 21. Stated that it is under control and she gets her allergy shots. She stated that it was environmental, ongoing bee allergy and severe allergy. She carries an epipen. Concomitant medications were not reported. Caller received the first shot of the Pfizer covid vaccine yesterday at 12 and after staying for 45 mins did not experience any issue. Later on, she started developing hives all over her body (itchy palms, neck, scalp, stomach) which she took 2 Benadryl for. Her hives have gotten 90% better, but she was experiencing some chills and joint pain. Caller was a consumer that was calling about the Covid-19 Vaccine and reported that she went yesterday, 04Feb2021, for her first shot at 12:00 and stayed there for 45 minutes because she was allergic to certain things. She said that she had no issues when she left at 12:45. Caller said that at about 16:45, she started to get severely itchy, and she broke out in hives. Caller said that it was on her scalp, her lips, her neck, her stomach, her arms, the palms of her hands, and the pads of her feet. The caller stated that there was nothing on her legs. She said that she woke up with more symptoms today 05Feb2021, and said that she woke up with chills and like every joint in her body feels like she fell off of her roof. Caller said that she took 2 Benadryl, and the hives are better. She stated that it totally knocked her out and she passed out on the sofa. Caller stated that the hives and the itching are about 90 percent better. Caller estimated her weight at about 160lbs. Caller stated that she took Tylenol for the chills and stated that it did not help the achiness in her joints at all. Caller stated that her chills and her joint achiness are the same. She said that she is allergic to Tetracycline, Penicillin, and sulfa drugs. Caller does not have the NDC, Lot, or expiration date for the medications. She stated that it was a long time ago. She has not followed up with her physician. They told her at the facility that for a reaction she needed to call Pfizer. Caller stated that she has a EpiPen, nebulizer and a rescue inhaler at home with her if needed. There was no previous immunization with the Pfizer vaccine considered as suspect. Prior Vaccinations was reported as non (within 4 weeks). Just takes her allergy shots, but that was 3 weeks prior, and it was cleared with the physician. Outcome of the events hives/she broke out in hives and severely itchy was recovering, chills and joint pain/Joint achiness/she fell off of her roof was not recovered. Follow-up attempts are completed. No further information is expected.
55 2021-05-07 shingles Shingles; bad back pain; felt like something was not right; checked my temperature and it was 102.1/... Read more
Shingles; bad back pain; felt like something was not right; checked my temperature and it was 102.1/fever broke; but I had body aches; My ear my neck my nose my mouth and underneath my chin the lymph node was swollen; Then I had these lesions / sores starting to appear on my face, my nose , my lips and in my mouth all on the left side; my mouth was horrible much difficulty eating and pain was pretty intense; my mouth was horrible much difficulty eating and pain was pretty intense; This is a spontaneous report from a contactable consumer. This patient reported for 2 patients. A 55-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 at 10:30 at the age of 55 years-old(Batch/Lot Number: EN6203) as SINGLE DOSE for covid-19 immunisation. Medical history included High Blood Pressure , Vertigo, Meniere"s Disease, Gallbladder removed, Cluster of Calcifications and Nodules removed in left breast (benign) , Plaque Psoriasis ( had it very bad on hands and feet) Methotrexate (7 tablets I take on Saturdays)Methotrexate ( 7 tablets i take on Saturdays), also lots of enviromental allergies I was tested few years ago, possibly Augmentin and Clindamycin The patient's concomitant medications were not reported. The patient reported that on 13Mar2021, I was awoken up with bad back pain and I felt like something was not right . I checked my temperature and it was 102.1 . The fever broke but I had body aches etc And the left side of my face wasn't feeling right . My ear my neck my nose my mouth and underneath my chin the lymph node was swollen. Then I had these lesions / sores starting to appear on my face, my nose , my lips and in my mouth all on the left side, my mouth was horrible much difficulty eating and pain was pretty intense. Immediately scheduled appointments with my medical doctor and my dermatologist. The dermatologist biopsy and came back as Shingles . He immediately put me anti viral drug and my medical doctor put me on amoxicillin, Acyclovir, Gabapentin. I was out of work for 4 weeks cause I work in a Supermarket ( Deli). The patient did not have COVID prior to vaccination nor tested positive after vaccination. The outcome of the events was recovered with sequelae. No follow-up attempts are needed. No further information is expected.
56 2020-12-31 injection site reaction, injection site pain upset stomach , diarrhea , muscle pain, soreness & stiffness at site of injection in left arm upset... Read more
upset stomach , diarrhea , muscle pain, soreness & stiffness at site of injection in left arm upset stomach started around 11:00am & went away after having bowel movement, it returned again around 2:00pm & again went away after bowel movement, it returned for a third time around 3:00pm & that is when the diarrhea occurred. That was the last time of any signs or symptoms. I drank 2 cups of ginger tea afterwards which seem to help settle my stomach. The muscle pain, soreness & stiffness in left arm at injection site started at bedtime around 9:00pm on the day of receiving vaccine & still continues today but is improving
56 2021-01-01 injection site pruritus advised to wait 30 min post shot for monitoring d/t latex allergy. completed without s/s. returned a... Read more
advised to wait 30 min post shot for monitoring d/t latex allergy. completed without s/s. returned approx 20 min c/o itching to arm at injection site, stated, throat had been internally itchy for about 10 min after leaving vaccination area but that passed on its own. advised to use cold compress on arm and monitor self. let vaccination center without questions, concerns.
56 2021-01-02 hives SEVERE HIVES FROM HEAD TO TOE LASTING APPROXIMATELY 21 HOURS I TOOK BENADRYL MULTIPLE DOSES
56 2021-01-03 injection site swelling, injection site pain 12/31/20 - Pain and swelling at injection site, as well as pain and swelling in left arm pit that is... Read more
12/31/20 - Pain and swelling at injection site, as well as pain and swelling in left arm pit that is not relieved with Tylenol. This has continued beyond 72 hours.
56 2021-01-03 injection site redness, injection site warmth Extreme left arm pain. Site is redden and warm to touch. Low grade fever. Head ache. Loss of appe... Read more
Extreme left arm pain. Site is redden and warm to touch. Low grade fever. Head ache. Loss of appetite I had a hard time sleeping. I just took Tylenol.
56 2021-01-03 pain of skin, injection site pain Headache Chills Temp (101.6) Body aches Skin hurts to touch Soreness in arm (injection site)
56 2021-01-03 injection site swelling, injection site pain Initial reaction day of vaccine: tenderness to injection site and swelling the size of half dollar. ... Read more
Initial reaction day of vaccine: tenderness to injection site and swelling the size of half dollar. On day 2, patient experienced shills, diarrhea, headache, weakness that lasted 3.5 days. Reports follow-up with primary physician.
56 2021-01-03 redness, itchy skin MASS VACCINATION CLINIC BEING HELD BY PUBLIC HEALTH AT PATIENTS WORK LOCATION. PATIENT HAD BEEN OBSE... Read more
MASS VACCINATION CLINIC BEING HELD BY PUBLIC HEALTH AT PATIENTS WORK LOCATION. PATIENT HAD BEEN OBSERVED AND RELEASE BUT RETURNED AT 15:21 WITH C/O ITCHING TO LOWER LEFT ARM. REDNESS NOTED IN THE SIZE OF ABOUT A HALF DOLLAR ON LOWER LEFT ARM.THIS NURSE ADMINISTERED 25MG OF PO DIPHENHYDRAMINE. PATIENTS VITIALS TAKE AND ADDITIIONAL OBSERVATION. PATIENT DID REPORT A HISTORY OF ALLERGIES TO COCONUT AND ASA ON CONSENT FOR (HIVES). PATIENT WAS LET WITH SUPERVISING NURSE FROM WORK. I CALLED TO CHECK ON PATIENT THE NEXT DAY AND PATIENT REPORTED THAT SHE WAS DOING FINE. PFIZERBIONTECH COVID-10 VACCINE EUA
56 2021-01-03 rash Morbilliform rash started am of 1/2/2021 on abdomen and then lower chest to back over 3 days Mild a... Read more
Morbilliform rash started am of 1/2/2021 on abdomen and then lower chest to back over 3 days Mild and improving in some areas as progressed to new areas by 1/4/2021 No fever, sore throat, cough, loss of taste or smell
56 2021-01-03 injection site pain Patient stated to this nurse @ 1100. Stated she had pain @ injection site to L arm. States that, "... Read more
Patient stated to this nurse @ 1100. Stated she had pain @ injection site to L arm. States that, "the needle went in to deep and touched her bone".
56 2021-01-04 itchy skin About 15 minutes after vaccination I started itching all over, became flushed, my throat and sore. I... Read more
About 15 minutes after vaccination I started itching all over, became flushed, my throat and sore. I was taken to the ED where I was given non drowsy antihistamine and observed. At home I experienced severe fatigue, muscle aches and chills. At about 30 hours the symptoms went away
56 2021-01-04 shingles Aching all over; headaches; shingles; This is a spontaneous report from a contactable Nurse (Patient... Read more
Aching all over; headaches; shingles; This is a spontaneous report from a contactable Nurse (Patient). A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) via an unspecified route of administration at right arm on 17Dec2020 13:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Relevant medical history and concurrent conditions was reported as "Structured information (Patient episode name): Fibromyalgia, tachycardia, shingles, breast cancer". Patient was diagnosed with COVID prior to vaccination. Patient known allergies included Codeine, morphine sulfate (Duramorph) and Sulfa. Concomitant medication included metoprolol succinate (TOPROL), alprazolam (XANAX) and desvenlafaxine succinate (PRISTIQ) received within 2 weeks of vaccination. No other vaccine in four weeks. Adverse events were reported as "Started day after shot. Aching all over headaches. Broke out in shingles 7 days later". Adverse event start date was reported on 24Dec2020. No treatment received for the events. since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.
56 2021-01-04 rash Developed a rash in the evening after dose #1...in the wrist area, circular around entire wrist...lo... Read more
Developed a rash in the evening after dose #1...in the wrist area, circular around entire wrist...looks like a contact dermatitis. Left wrist Topicals not helping. Wears a watch on that wrist, but not that day.
56 2021-01-04 vaccination site pain Nausea; Dizziness; vomited once; Chills/her left hand, where she got the shot, it does not feel righ... Read more
Nausea; Dizziness; vomited once; Chills/her left hand, where she got the shot, it does not feel right. It feels chilled.; soreness and pain at the vaccine site; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via intramuscular on left top upper arm where the muscles are below shoulder on 24Dec2020 at single dose for prevention because she works in hospital (COVID-19 immunisation). The patient medical history included high blood pressure. Concomitant medication included Hydrochlorothiazide started a year ago in 2019 at 12.5mg, once daily for High blood pressure. A later response of symptoms including nausea, dizziness, and vomited once. The patient got the COVID vaccine last Thursday, 24Dec2020. That day she had chills on 25Dec2020 06:00. (PENDING CLARIFICATION) She did not have any more problems with that. The second day, 25Dec2020 00:00 she had soreness and pain at the vaccine site. Then, it was ok but sore that day and then this morning. She is having dizziness, nausea and vomited one time at 07:30 on 29Dec2020. Started on 10:00 25Dec2020, her left hand, where she got the shot, it does not feel right. It feels chilled. On Monday, she was completely fine. She did not leave. At work on Sunday. No discomfort. Today morning, she has chills and started getting all the symptoms. Her left hand is not normal. She cannot say it is weak though. The left hand is chilled. She would like to know if Pfizer has reports of others with similar issues. She also would like to know if she should get the second dose and if she should see a physician about any of these. She works at the hospital and they were giving out to employees. There was no prescriber. It was not mandatory. Her daughter got it on 20Dec2020. She is a doctor and did not have any issues. Lots of people in her family got the vaccine. No further details provided. Regarding the first day she got chills, it was like an all over body chill. The chill described on her left hand went away on 25Dec2020, and today is feeling it again. Left hand is not bad cold, just chilly. She was still tired. She is not dizzy but didn't feel all that good. Outcome was provided as persisting but improved. She was tired the day she got the vaccine at night time on 24Dec2020, she went to bed early, slept all night and Friday morning she was also tired. By Friday afternoon, she felt better and was doing better until this morning and it started again. She did not feel this bad when she got the vaccine. Today, it is worse. She is nauseated, dizzy and tired. She never had a flu vaccine. This is the first time in her life getting a vaccine. The outcome of the events chills and left arm sore and painful was recovering and the outcome of the other events was unknown.
56 2021-01-04 rash, rash papular, rash with redness Red raised flat and raised bumps/rash on thighs front and back, knees, shins, ankles, and feet. Very... Read more
Red raised flat and raised bumps/rash on thighs front and back, knees, shins, ankles, and feet. Very small amount on back maybe 3-4 bumps
56 2021-01-05 rash Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade ... Read more
Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; This is a spontaneous report from a contactable nurse. A 56-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EKS730), intramuscularly on 20Dec2020 08:45AM at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. Patient was diagnosed with COVID-19 prior to vaccination. Known allergies included Penicillin. Concomitant medication included levothyroxine, pravastatin, buspirone, zinc, ascorbic acid (VITAMIN C), tocopherol (VITAMIN E), vitamin d3, vitamin b complex (B COMPLEX), calcium citrate, chondroitin sulfate, glucosamine sulfate, methylsulfonylmethane (GLUCOSAMINE CHONDROITIN & MSM). The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash on 20Dec2020. Patient didn't receive treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. The patient underwent Covid test type post vaccination - Nasal Swab: Negative on 23Dec2020.
56 2021-01-05 rash, skin spots Petechial rash which developed 3 days post vaccination on bilateral lower extremities. No respirator... Read more
Petechial rash which developed 3 days post vaccination on bilateral lower extremities. No respiratory distress. No changes in medications or diet habits. Feels weel
56 2021-01-05 vaccination site pain Severe left side knee and shoulder pain; Could barely walk; could not lift left arm above 90 degrees... Read more
Severe left side knee and shoulder pain; Could barely walk; could not lift left arm above 90 degrees; The arm pain was not your typical injection site pain from a flu shot; This is a spontaneous report from contactable healthcare professional, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1685), intramuscular in the left arm on 25Dec2020 at 09:00 as a single dose for COVID-19 immunization. Medical history included asthma, hypertension, arthritis, and sulfa allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included colecalciferol (VITAMIN D) and losartan (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Dec2020 at 21:00, the patient experienced severe left side knee and shoulder pain, could barely walk, and could not lift left arm above 90 degrees. The patient stated that the arm pain was not your typical injection site pain from a flu shot. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any treatment for the events. The clinical outcomes of severe left side knee and shoulder pain, could barely walk, could not lift left arm above 90 degrees, and arm pain was not your typical injection site pain of flu shot, were recovering. The events were all reported as non-serious. However, it was also reported that the duration of hospitalization was 1 (not further specified).
56 2021-01-06 rash macular "Hot, Blotchy" given Benadryl 25mg liquid, po x1 dose. Resolved
56 2021-01-06 rash Fever, body aches, and body rash on Day 2
56 2021-01-06 itchy skin Fever, chills, fatigue, itching
56 2021-01-06 rash Headache, chills, hot flashes, rash on face, feeling like "mosquito bites" all over the body
56 2021-01-06 rash Headache, feeling chills and hot flashes, shortness of breath, rash on face, feeling "mosquito bites... Read more
Headache, feeling chills and hot flashes, shortness of breath, rash on face, feeling "mosquito bites" all over body
56 2021-01-06 injection site hardening, injection site redness, injection site pain Pain on injection site, turned red, swollen & hard.
56 2021-01-06 redness, itchy skin Patient received COVID-19 vaccine and waited 15 mins prior to leaving clinic. Patient begin to walk ... Read more
Patient received COVID-19 vaccine and waited 15 mins prior to leaving clinic. Patient begin to walk back to work area and started to feel numbness and tingling in tongue and throat, face as itching and cheeks red. Patient taking in observation room and emergency response team called for precaution. Patient remained alert. Team arrived taking taking blood pressure which was 185/108, Benadryl given, patient monitored. Team and patient agreed no emergency department care needed. Patient monitored for another 30 mins, blood pressure rechecked 158/95 . Patient allowed to return to unit. Had no signs of distress, denies shortness of breath or any throat discomfort. Patient was stable when leaving unit.
56 2021-01-06 injection site numbness, vaccination site pain Pfizer-BioNTech COVID- 19 Vaccine EUA. Vaccine recipient received Pfizer-BioNTech vaccine on 12/19/... Read more
Pfizer-BioNTech COVID- 19 Vaccine EUA. Vaccine recipient received Pfizer-BioNTech vaccine on 12/19/2020. On 12/26/2020, the area on the left arm where the vaccine was administered started to get sore again, numb to the touch, and was throbbing sometimes. She reported that when she raises her arm up, it feels like something is tearing and sometimes feels weak. On 12/27/2020, she woke up with vertigo which subsided but has been lightheaded ever since and feeling off-balance. She also reported to have loud noises coming from her ears described as hissing sounds. This has been constant. She noted that years back, on two separate times she received chemotherapy treatment which really affected her ears. It felt like there was pressure and same kind of noises. She is pending occupational health follow-up.
56 2021-01-06 itchy skin, rash, redness Rash, itching, facial flushing/redness
56 2021-01-06 rash SkinRash, CoughWheeze & Syncope
56 2021-01-06 itchy skin, rash with redness Started with muscle aches and weakness in the right arm on Jan 7th, this afternoon I have a red la... Read more
Started with muscle aches and weakness in the right arm on Jan 7th, this afternoon I have a red lacy rash all down my arm a little itchy. Headache and lips tingle .
56 2021-01-06 rash headaches, hot flashes, chills, rash on face, feeling like "mosquito bites" all over body
56 2021-01-06 itchy skin, rash rash on my upper thighs; left more inflamed than the right. Eventually went away. Ittchy.
56 2021-01-07 skin infection at injection site Fatigue, body aches, cellulitis at injection site
56 2021-01-07 injection site pain Fever 102.9, chills, body aches, pain at injection site, nausea, cough
56 2021-01-07 itchy skin, redness HEAD ACHE, MUSCULAR ACHES, FEVER, CHEST PAIN AND IRREGULAR HEART RATE, EDEMA, ITCH, ERYTHEMA, ENLARG... Read more
HEAD ACHE, MUSCULAR ACHES, FEVER, CHEST PAIN AND IRREGULAR HEART RATE, EDEMA, ITCH, ERYTHEMA, ENLARGEMENT OF LYMPH NODE
56 2021-01-07 injection site pain Sore arm at injection site
56 2021-01-07 itchy skin, redness itching to lower left arm; redness noted in the size of about a half dollar on lower left arm; This ... Read more
itching to lower left arm; redness noted in the size of about a half dollar on lower left arm; This is a spontaneous report from a contactable nurse. A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899) intramuscular in the left arm on 29Dec2020 at single dose for COVID-19 immunisation. Relevant medical history included hives and allergy to coconut and acetylsalicylic acid (ASA). Concomitant medications were not reported. The patient had been observed and released but she returned at 15:21 on 29Dec2020 with itching to lower left arm and redness was noted in the size of about a half dollar on lower left arm. Corrective treatment taken as a result of the events included 25mg of diphenhydramine orally. Patients vitals were taken (results unknown) and additional observation was done. The patient was left with supervising nurse. The patient was called the following day, 30Dec2020, and she reported that she was doing fine; she recovered from the events on 30Dec2020.
56 2021-01-08 itchy skin Had COVID vaccine and was being monitored. at 11:25a she developed dizziness, nausea, chest pain, l... Read more
Had COVID vaccine and was being monitored. at 11:25a she developed dizziness, nausea, chest pain, left arm weakness/numbness, skin itching. BP checked and was 190/110, then 180/110. Hx HTN and BP meds taken today. Hx of allergies -- took loratadine and hydroxyzine this AM. Due to the dizziness and skin itching, feeling unwell/woozy with history of anaphylaxis, given epipen and called 911. EMS arrived and taken to ER.
56 2021-01-08 injection site pain Headache, Myalgia, Arthralgia, fatigue, injection site pain Narrative:
56 2021-01-08 injection site pain Metallic taste, palpitations, nausea, dizziness, flush Subsided after 30 min headache 4 hours later ... Read more
Metallic taste, palpitations, nausea, dizziness, flush Subsided after 30 min headache 4 hours later Tylenol taken Next day painful injection site, body aches chills fatigue Tylenol Advil taken with some relief
56 2021-01-09 skin warm, injection site pain 1.) immediate pain in injection site that lasted until the next day. Pain relieved after taking Tyle... Read more
1.) immediate pain in injection site that lasted until the next day. Pain relieved after taking Tylenol the morning after 2.) elevated skin temperature at night documented as 3 degrees above baseline by Fitbit Sense 3.) headache felt 26 hours after vaccine administration; 101.7 degree temperature documented 26 hours after vaccine administration since Tylenol 500 mg taken in the morning 4.) symptoms resolved the next day
56 2021-01-09 injection site pain Mild pain/soreness at injection site starting later the day of injection and next day. Approximately... Read more
Mild pain/soreness at injection site starting later the day of injection and next day. Approximately 2 pm the day after injection, began feeling overly hot and nauseated. That was followed by pressure type headache, muscle/bodyaches, and overall feeling of no energy progressing as the afternoon and evening continued. Spent that evening sleeping on/off. The following day spent in bed with continued headache, body/muscle aches, feeling overall drained/ no energy. Nausea improved some; was able to stomach some soup later in the day. So far today, feeling some improvement with bodyaches, but overall drained of energy. Headache has lightened some as well.
56 2021-01-09 injection site pain, injection site swelling, injection site reaction, injection site hardening Raised, painful, erythematous and indurated injection site area with local increase in temperatur... Read more
Raised, painful, erythematous and indurated injection site area with local increase in temperature, compatible with Arthus Reaction at injection site.
56 2021-01-10 itchy skin, injection site mass, injection site redness 01/05/2021 Warmth inside the body and cold outside the body. Rigid jaw I could not open it completel... Read more
01/05/2021 Warmth inside the body and cold outside the body. Rigid jaw I could not open it completely and in the vaccination area it turned red and with a protuberance. 01/06/2021 when ingest food the chewing made difficult the chewing process I bit my cheek on the inside throughout the day. Itching in the right arm throughout the day. 01/07/2021 the tongue felt enlarged and I had to keep my mouth half open so it did not stick to the palate. 01/08/2021. On this day the arm had already improved the body warmth had decrease I was not tired and the tongue had decreased in size and heaviness. At no time was medications ingest other than propranolol which I must take daily under doctor's order.
56 2021-01-10 redness 10 days post vaccination presented to ED with LUE swelling redness and pain. Treated with antibiotic... Read more
10 days post vaccination presented to ED with LUE swelling redness and pain. Treated with antibiotics and f/u w Allergy to determine whether to have second dose
56 2021-01-10 rash Fever, chills, arm ache, mouth ache, body aches, sore throat, dry cough, rash and exhaustion
56 2021-01-10 injection site redness, injection site warmth Fever, chills, body aches, injection area red and warm to touch started the next day
56 2021-01-10 injection site redness, injection site pain Fever, headache, chest wall soreness, muscle and joint pains, and site of injection redness and pain
56 2021-01-10 rash My face broke out in a mild rash in the morning and progressed to my mid back and a few on my arm.
56 2021-01-10 injection site redness fever, body aches, chills, and red halo around injection site. Had vaccine on 01/07 and adverse symp... Read more
fever, body aches, chills, and red halo around injection site. Had vaccine on 01/07 and adverse symptoms began on 01/09 have continued through 01/11 but have gotten better.
56 2021-01-11 itchy skin, rash I got extremely hot with sweating, I got a massive headache that started at the base of my neck tha... Read more
I got extremely hot with sweating, I got a massive headache that started at the base of my neck that effected my vision. I was dizzy, BP was high over 140, temperature increased. I had some tingling in my upper extremeties. I had really bad GI pains, I had itching and a light rash. I had to go to the ED where I received a cocktail.
56 2021-01-11 injection site pain Patient was given first dose of Pfizer COVID vaccine and had no immediate pain on injection. She sta... Read more
Patient was given first dose of Pfizer COVID vaccine and had no immediate pain on injection. She stated she developed increased pain in her right shoulder joint and was unable to sleep the night of the injection on 12/22/20. She stated the pain continued to increase and was unable to sleep on that shoulder. She was seen by her primary care provider on 1/8/21 for continued pain and decreased range of motion in her R shoulder, she is unable to raise it above shoulder height. She continues to have pain and decreased range of motion despite rest and ibuprofen.
56 2021-01-11 rash Within 90 minutes of receiving the 2nd vaccine dose patient reported developing a full body fine dif... Read more
Within 90 minutes of receiving the 2nd vaccine dose patient reported developing a full body fine diffuse rash with mild lip swelling. The following morning she reported that the rash was gone but still had an itching sensation in her mouth and throat, no swelling just irritating itch.
56 2021-01-11 vaccination site redness injection site was really red. It was the size of a 50 cent piece if not bigger; This is a spontaneo... Read more
injection site was really red. It was the size of a 50 cent piece if not bigger; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# 037K20A, expiration date: Jul2021), via an unspecified route of administration in left arm on 05Jan2021 at single dose for Covid-19 immunisation. Medical history was none. Concomitant medication included escitalopram oxalate (LEXAPRO), warfarin and another medication. The patient worked in health care. She received the Covid-19 injection. The injection site was really red on 06Jan2021. It was the size of a 50 cent piece if not bigger. She wasn't sure if she should be worried. The outcome of event was not recovered.
56 2021-01-12 sensitive skin 1/11/21 woke up feeling tired, muscle aches, took migraine medicine, and ibuprofen. Back pain towar... Read more
1/11/21 woke up feeling tired, muscle aches, took migraine medicine, and ibuprofen. Back pain toward the kidney, stomach area. Felt like she would pass out. Dizzy, nausea. Seeing a patient she had to leave the room and go sit on the floor. Blood pressure was very low, couldn't stand up. Painful to have clothes touching the skin all over. Felt like she need more air, panting. Didn't sleep 8-10 hours. Started with sever H/A and muscle pain. Sensitive to light and sound. Fatigue. Out of work 1/12-1/13. Skin sensitivity is gone. Talk big dose of ibuprofen. Still fatigue. H/A is better.
56 2021-01-12 rash, rash vesicular Evening after second dose of Pfizer sars-cov2 vaccine she developed a painful vesicular rash on her ... Read more
Evening after second dose of Pfizer sars-cov2 vaccine she developed a painful vesicular rash on her face consistent with shingles. She does have a fair amount of stress in her life and it could have been unrelated but figured I should report anyway.
56 2021-01-12 injection site pain, injection site swelling Experienced pain and swelling at the injection site. Developed mild fever, headache, body aches and... Read more
Experienced pain and swelling at the injection site. Developed mild fever, headache, body aches and sinus congestion.
56 2021-01-12 injection site pain Received the vaccine at 330p. Began to have mild upper eyelid itching around 11:59p. Eyes felt sw... Read more
Received the vaccine at 330p. Began to have mild upper eyelid itching around 11:59p. Eyes felt swollen then began to feel nauseous (tried to vomit, but no food came up) and then a runny nose (clear fluid). I took another Claritin 10mg and also Zofran 8mg ODT which resolved the nausea. Had to blow my nose 2 times. Went to sleep with my Epipen at bedside but didnt have to use it. Woke up at 815am and only symptom remaining was arm soreness. Felt like my normal self and played 3 hrs of tennis. Arm soreness at injection site worsened during the day. By 72 hrs post-injection, arm soreness resolved.
56 2021-01-12 injection site swelling, injection site warmth, injection site redness, injection site pain Took advil starting on the 9th. 18 HOURS LATER - next day (10th) took tylenol for fever - woke up v... Read more
Took advil starting on the 9th. 18 HOURS LATER - next day (10th) took tylenol for fever - woke up very lethargic ; as day went on had severe fatigue. About six pm strike fever; headache and fatigue (fatigue was the worst). Muscle aches started on the 10th and through the 11th. Next day (11th) no more fever; still fatigue but not as bad (moderate). By 11th in evening was feeling better that night. But still did not feeling well at all. On 12th - joint pain on 12th; and swelling and redness and it had heat and some pain on injection site (maybe had before but I didn't notice before). Took advil through all of this. Still have a mild headache off and on and today as well. And feeling fatigue now, too. No longer taking Advil.
56 2021-01-12 injection site pain significant body aches at night, 24 hours later headache,chills, fatigue, temp of 99.5, 48 hours lat... Read more
significant body aches at night, 24 hours later headache,chills, fatigue, temp of 99.5, 48 hours later fatigued in general not well-being, chills, fatigue, injection site pain, malaise new or worsened join and muscle pain
56 2021-01-13 injection site numbness, injection site tingling "Pfizer-BioNTech COVID-19 Vaccine " I, the client sitting 5 minutes after receiving vaccine began t... Read more
"Pfizer-BioNTech COVID-19 Vaccine " I, the client sitting 5 minutes after receiving vaccine began to feel dizzy and drank the provided bottled water. The dizziness lasted for 2 hours. Within 10 minutues I also started having numbness and tingling from my right elbow to my hand, anterior and posterior. This continued throughout the day. After being observed by staff, after 30 minutes I was given Benadryl tablet25 mg by mouth. The adverse event has also been reported to my manager and employee health.
56 2021-01-13 vaccination site pain ENTIRE body hurts. Joints, muscles; ENTIRE body hurts. Joints, muscles; ENTIRE body hurts. Joints, m... Read more
ENTIRE body hurts. Joints, muscles; ENTIRE body hurts. Joints, muscles; ENTIRE body hurts. Joints, muscles; headache; Minimal pain at injection site; This is a spontaneous report from a contactable nurse (patient herself). A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248; expiry date: unknown) intramuscular (left arm) on 07Jan2021 at 15:30, at a single dose, for COVID-19 immunization. Relevant medical history included hypertension (HTN), hypothyroid, and early pulmonary HTN. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899) intramuscular (left arm) on 17Dec2020 at 15:15 for COVID-19 immunization. The patient previously received bactroban ointment and experienced allergies. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 08Jan2021, at 5:00 a.m. the patient's entire body hurts, including joints and muscles and also had severe headache and minimal pain injection site (less sore than first shot). Patient confirmed that she did not have any of these symptoms with the first dose. Patient took ibuprofen but did not seem to help. Patient is a registered nurse working in a small, rural hospital. Outcome of the events headache and minimal pain at injection site was unknown, while for the remaining events was not recovered. The patient has not been tested for COVID-19 since vaccination.
56 2021-01-13 skin warm Had flushing and warm BP elevated to 158/98 pulse 68 for 30 min and resolved on own
56 2021-01-13 injection site pruritus, injection site swelling, injection site pain PAIN INJECION AREA, SWELLING INJECTION AREA,INCHING.
56 2021-01-13 redness PATIENT HAS SWOLLEN, RED FACE, HEADACHE, INCREASE BLOOD PRESSURE, INCREASE HEART RATE, TROUBLE BREAT... Read more
PATIENT HAS SWOLLEN, RED FACE, HEADACHE, INCREASE BLOOD PRESSURE, INCREASE HEART RATE, TROUBLE BREATHING AFTER 2 HOURS OF ADMINISTRATION OF VACCINE. PATIENT WENT TO THE ER AND GOT EPIPEN AND ORAL BENADRYL AND ORAL ATIVAN. PATIENT IS RECOVERING NOW.
56 2021-01-13 injection site pain Temp 99.6, headache, body & muscle aches, nausea, eye pain, injection site pain radiating into neck ... Read more
Temp 99.6, headache, body & muscle aches, nausea, eye pain, injection site pain radiating into neck and arm
56 2021-01-13 vaccination site itchiness, rash, itchy skin itching/itching at the site and on her chest going all the way to her groin; rashes/She does have th... Read more
itching/itching at the site and on her chest going all the way to her groin; rashes/She does have the rash some already but she expects it to get worse. The rash starts at the armpits and goes down to the groin; itching at the site; soreness on her arm; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for herself that the 56-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), by injection via an unspecified route of administration on Arm Left on 06Jan2021 12:00 noon at single dose for covid-19 immunisation (front line health care worker). Medical history included Hot flashes, Hashimoto's disease, Osteoporosis and Allergy. Concomitant medications included ongoing estrogens conjugated/medroxyprogesterone acetate (PREMPRO) at 0.45mg; take once daily by mouth for Hot flashes from 2017, ongoing Levothyroxine at 50mcg; take once daily by mouth for Hashimoto's disease from 2014, ongoing alendronate sodium (FOSAMAX) at 70mg; take once weekly by mouth for Osteoporosis from 2017, montelukast sodium (SINGULAIR) at 10mg; take once daily by mouth for allergy from 2018, ongoing Azelastine at one spray per nostril daily for Allergy from 2019, ongoing Fluticasone at 50mg; one spray each nostril daily for Allergy from 2019, ongoing Hydroxyzine at 10mg; once daily by mouth for Allergy from 2019. The patient had the COVID-19 vaccine yesterday (06Jan2021) and today (07Jan2021) 16:00 experienced itching and rashes. She also had soreness on her arm. She is concerned whether this is expected of the COVID-19 vaccine and will it happen again because she has heard that the side effects may worsen on the second dose of the vaccine. What would happen if I don't get the second dose of the vaccine? Itching was reported as worsened. Rash was reported as worsened. Occupational Therapist calling regarding the Pfizer COVID 19 vaccine. States she had the vaccine yesterday and just started itching and can't get up with her primary care provider. Asking if this is a normal side effect? Will it happen again? Reports she received the first dose of the COIVID 19 vaccine 06Jan2021 at 12:00 noon in the left arm. Today 07Jan2021 within the last the hour, 16:00, she started itching at the site and on her chest going all the way to her groin. Adds she has a lot of allergies and that is how it always starts. She knows she will wake up with a red bathing suit rash. She does have the rash some already but she expects it to get worse. The rash starts at the armpits and goes down to the groin. Reporter is Occupational Therapist reporting on herself She is unsure if she will take the second dose of the vaccine. Vaccination Facility Type was nursing home. No vaccine Administered at Military Facility. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No AE(s) require a visit to Physician Office or ER.Prior Vaccinations (within 4 weeks) was none. Patient's Medical History (including any illness at time of vaccination) was none. Family Medical History Relevant to AE(s) was none. Relevant Tests was none. The outcome of the events Itching and rash was not recovered. The outcome of the other events was unknown.
56 2021-01-13 vaccination site pain soreness at injection site by the end of day; This is a spontaneous report from a non-contactable ot... Read more
soreness at injection site by the end of day; This is a spontaneous report from a non-contactable other HCP (patient). This 56 year-old female reported for herself and received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231 and Expiration date were not reported) on 05Jan2021 15:00 (at the age of 56-years) as single dose, unspecified route, left arm for COVID-19 immunisation. Medical history included known allergy to latex, wheat intolerance, and seasonal allergies, and hypothyroidism. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications include levothyroxine (LEVOTHYROXINE), colecalciferol (VIT D3), ascorbic acid, copper, tocopheryl acetate, xantofyl, zinc (OCUVIT) and zinc (ZINC). Since the vaccination, the patient has not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 05Jan2021 at 21:00 AM the patient experienced soreness at injection site by the end of day. The patient did not received treatment as a result of the event. The outcome of soreness at injection site by the end of day was recovered with sequele. No follow-up attempts are possible. No further information is expected.
56 2021-01-14 vaccination site pain Chills; Insomnia; soreness at injection site; This is a spontaneous report from a contactable health... Read more
Chills; Insomnia; soreness at injection site; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 09Jan2021 12:15 in left arm at single dose for COVID-19 immunization. Medical history included chronic sinusitis from an unknown date and unknown if ongoing. There were no concomitant medications. On 09Jan2021 12:45, the patient experienced chills, insomnia and soreness at injection site. No treatment was given to the patient for the events. The outcome of the events was recovering. The facility where the most recent COVID-19 vaccine was administered was in the Public Health Clinic/Veterans Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events was considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
56 2021-01-14 vaccination site pain, vaccination site hardening, vaccination site itchiness, vaccination site redness Large erythematous area over site of injection 7cm x 5cm; Large erythematous area over site of injec... Read more
Large erythematous area over site of injection 7cm x 5cm; Large erythematous area over site of injection 7cm x 5cm, blanching; Large erythematous area over site of injection 7cm x 5cm, Pruritic; Large erythematous area over site of injection 7cm x 5cm, Tenderness (mild)/Area painful for first 24 hours after injection; Large erythematous area over site of injection 7cm x 5cm, Induration (mild); Generalized fatigue; Joint pain; Slight increased temperature 99.3F for about 12 hours; This is a spontaneous report from a contactable physician (patient). A 56-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via intramuscular on 05Jan2021 08:45 at single dose in left arm for covid-19 immunisation. Medical history included asthma, diabetes. Concomitant medication included metformin, rosuvastatin, empagliflozin (JARDIANCE), omeprazole, vitamin c (ascorbic acid), ergocalciferol (VITAMIN D), paracetamol (TYLENOL), ibuprofen (MOTRIN), naproxen (NAPROSYN) and Multivitamin. The patient had known allergies to sulfamethoxazole, trimethoprim (BACTRIM) and experienced rash; raltegravir potassium (ISENTRESS) and experienced rash; emtricitabine, tenofovir disoproxil fumarate (TRUVADA) and experienced rash. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via intramuscular on 15Dec2020 13:30 at single dose in right arm for covid-19 immunisation. It was reported that on 07Jan2021 the patient experienced large erythematous area over site of injection 7cm x 5cm, blanching, pruritic, + tenderness (mild), + induration (mild). Area painful for first 24 hours after injection, that has gotten better, area of erythema is slowly getting larger, pruritus started 1 day ago and is slightly worsening (also starting to have slight generalized pruritus). After injection on 05Jan2021, the next morning (on 06Jan2021) had slight increased temperature 99.3F for about 12 hours with generalized fatigue and joint pain for about 24 hours on 07Jan2021. The area in question started to get red and indurated after that time period. The fatigue and joint pain have resolved completely. The patient received treatment for events included topical 1% hydrocortisone ointment, diphenhydramine. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had been tested for COVID-19, included nasal swab and SARS-COV-2 RNA PCR on 22Dec2020 with negative result. The outcome of the events area painful for first 24 hours after injection was recovering, the outcome of the events fatigue and joint pain were recovered on 08Jan2021, the outcome of the event slight increased temperature 99.3F was unknown, the outcome of the rest events was not recovered.
56 2021-01-14 vaccination site pain This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient rec... Read more
This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), via an unspecified route of administration from 19Dec2020 11:00 AM at single dose on left arm for COVID-19 immunization. Age at vaccination was reported as 56 years. Patient was not pregnant at the time of vaccination. Medical history included cancer and penicillin allergies. Concomitant medications (received within 2 weeks of vaccination) included Irbesartan, Pantoprazole, Levothyroxine and Calcium. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination. COVID-19 vaccine was administered in the hospital. On 26Dec2020 13:00 (reported as 01:00 PM), patient experienced vertigo, then dizzy-lighted since. Patient also experienced loud hissing sounds in her ears. Patient's arm (site of injection) became sore again, numb to the touch and she felt like she had a sunburn when her clothes touch the skin. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment was received for "vertigo-dizziness". The events were assessed as non-serious. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since the vaccination.
56 2021-01-14 hives Vaccine received on 1/7/21. Joint pain, nausea, gastric reflux started on 1/9/21. Generalized hives ... Read more
Vaccine received on 1/7/21. Joint pain, nausea, gastric reflux started on 1/9/21. Generalized hives started on 1/11/21. Symptoms improved with Zofran, Pepcid and Benadryl. Symptoms resolved on 1/15/21. Patient had a history of COVID 19 virus infection in October 2020.
56 2021-01-14 vaccination site pain sore/pain injection site; This is a spontaneous report from a contactable nurse (patient herself). A... Read more
sore/pain injection site; This is a spontaneous report from a contactable nurse (patient herself). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) intramuscular (left arm) on 17Dec2020 at 15:15, at a single dose, for COVID-19 immunization. Relevant medical history included hypertension (HTN), hypothyroid, and early pulmonary HTN. Concomitant medications were not reported. The patient previously received bactroban ointment and experienced allergies. Patient is a registered nurse working in a small, rural hospital. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On an unspecified date, the patient experienced sore/pain injection site. Outcome of the event was unknown. The patient has not been tested for COVID-19 since vaccination.
56 2021-01-15 itchy skin tingling in jaw and neck, under ear. BP 130/68
56 2021-01-16 rash 12/16/2020 First vaccination. 12/17/2020 rash began. Nausea. 12/18/2020 rash over all extremities.... Read more
12/16/2020 First vaccination. 12/17/2020 rash began. Nausea. 12/18/2020 rash over all extremities. Lasted until 12/22/2020. Nausea. called clinic on 12/21/2020 to report the rash. I tend to get rashes with different aspirin, cough medication, etc. PCP advised to take benadryl if happens again to control rash if occurs. I did take as the rash came back, took for one day, and the rash was gone the next day. 2nd vaccine EL3246
56 2021-01-16 rash 12/16/2020 vaccine 12/17/2020 rash began, Nausea 12/18/2020 Rash covered all extremities; called cli... Read more
12/16/2020 vaccine 12/17/2020 rash began, Nausea 12/18/2020 Rash covered all extremities; called clinic that tuesday to report. Advised to take benadryl 2nd shot for rash. EL3246. Rash did occur. Went away after one day.
56 2021-01-16 rash papular, skin spots, itchy rash, rash About 10 days following the vaccine, developed an itchy, slightly painful, papular and petechial ra... Read more
About 10 days following the vaccine, developed an itchy, slightly painful, papular and petechial rash, primarily in underarms, arms, and legs. Antihistamine helped reduce symptoms. Rash has persisted, but improving.
56 2021-01-16 bruising I got the vaccine at 5:45 Friday night was having symptoms of arm pain headache dizziness lighthead... Read more
I got the vaccine at 5:45 Friday night was having symptoms of arm pain headache dizziness lightheadedness and nausea upon awakening Saturday morning. Saturday night was having increased nausea and lightheadedness. Got up to use the bathroom at 1 AM Sunday morning was very dizzy and nauseous and passed out on my hallway floor. I woke choking on vomit, crawled to the bathroom, continued to vomit. Sustained bruised lump to forehead, bruised nose, split lips. Went back to bed. Later Sunday felt better.
56 2021-01-17 injection site pain Symptoms began approximately 7 hours after receiving the vaccine and continued throughout the follow... Read more
Symptoms began approximately 7 hours after receiving the vaccine and continued throughout the following day. The first symptoms were ear and sinus pressure. Then malaise/fatigue, headache, mild stomach upset. Fever occurred in the middle of the night and got up to 101.1. Also developed shakes/tremors and severe back and body aches. My arm was sore at site of injection.
56 2021-01-18 injection site warmth, skin warm, injection site pruritus 10 minutes after the time of the injection I developed metal taste in mouth this lasted about 1 hour... Read more
10 minutes after the time of the injection I developed metal taste in mouth this lasted about 1 hour went away and came back later in the day. 13 hours after the vaccine injection I developed extreme rigors lasting atleast 60 minutes followed by very hot body temperature to touch unable to sleep body not comfortable cold then hot and very bad headache. Next day rested all day terrible headache, body aches and chills on and off. The next night did sleep for 5 hours then woke up soaked hair night garments had to change still had headache and just felt achy and tired all day mild headache arm was sore warm at inj site and very itchy. Third day headache was gone just felt extreme fatigue and today tired but feel more like myself.
56 2021-01-18 vaccination site warmth, vaccination site redness Dose1 start time 28Dec2020, dose 2 start time 11Jan2021; Red, inflamed, hot to touch injection site;... Read more
Dose1 start time 28Dec2020, dose 2 start time 11Jan2021; Red, inflamed, hot to touch injection site; Red, inflamed, hot to touch injection site; Red, inflamed, hot to touch injection site; Chills; fever- 99.8; severe headache (migraine); This is a spontaneous report from a contactable nurse (patient) reported for herself. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand=Pfizer, lot number=Ek9231) intramuscularly at left arm on 11Jan2021 at 01:30 PM at a single dose (dose number:2) for COVID-19 immunization. Medical history included type 2 diabetes mellitus (DM) and known allergies to latex. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included metformin, atorvastatin, lisinopril, exenatide (BYDUREON) and bimatoprost (LUMIGAN). Historical vaccination included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand=Pfizer, lot number= Ek5730) intramuscularly at left arm on 28Dec2020 at 02:30 PM at a single dose (dose number:1) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced adverse events included "red, inflamed, hot to touch injection site", chills, fever- 99.8, and severe headache (migraine); all with start dates on 11Jan2021 at 08:00 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
56 2021-01-18 hives Hives
56 2021-01-18 vaccination site redness, vaccination site itchiness Left arm injection site mild itching and redness; Left arm injection site mild itching and redness; ... Read more
Left arm injection site mild itching and redness; Left arm injection site mild itching and redness; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ELD142; Expiration date was not reported) on 06Jan2021 (14:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the nursing home. Medical history included atrial fibrillation (AF). Concomitant medications included metoprolol and paracetamol (TYLENOL). On 08Jan2021 (13:00), the patient had mild itching and redness on the left arm injection site. The patient did not receive any treatment for the reported events. The outcome of the events, mild itching and redness on the left arm injection site, was not recovered. The patient had no COVID-19 prior to vaccination, and had been tested post-vaccination. The patient's nasal swab COVID-19 test was negative on 07Jan2021.
56 2021-01-18 itchy skin, hives itching, hives, short of breath, numbness and tingling to lips with hives to bottom. headache.
56 2021-01-19 injection site pain At first nothing but muscle soreness at the site, but I woke up soon after going to bed feeling naus... Read more
At first nothing but muscle soreness at the site, but I woke up soon after going to bed feeling nauseated almost threw up, also felt drunk (balance, lack of clear thinking, a little weak, etc). That lasted from about 8 hours after the shot (when it started) to 20 hours after the shot was administered.
56 2021-01-19 itchy skin Bitter taste and itching (General) Received Benadryl 50 mg and improved
56 2021-01-19 injection site pain From the evening of the day I have received the vaccination, my left arm started to feel dull contin... Read more
From the evening of the day I have received the vaccination, my left arm started to feel dull continuous pressure pain, progressed stronger and stronger as the time goes. No treatment given. Following day, the pain was worse and stayed same. The IM insertion site was also painful to touch or pressure. Then afternoon of the same day, I started nausea, light headache, dizziness, and occasionally chills as well as occasional dry cough accompanied by itchy throat or without itchy throat. At this point, I took Advil 200mg 1 tab around 3pm. The muscle pain on my left arm and headache is eased but other symptoms stayed same at this time, 4:30pm.
56 2021-01-19 itchy skin, redness Itchy sensation to arms, redness to chest. Rapid response called, patient monitored. No additional i... Read more
Itchy sensation to arms, redness to chest. Rapid response called, patient monitored. No additional intervention
56 2021-01-19 redness, itchy skin My arm is got really red but it's itchy; like skin allergy; I have a trouble hearing today as I am l... Read more
My arm is got really red but it's itchy; like skin allergy; I have a trouble hearing today as I am little congested; I have a trouble hearing today as I am little congested; My arm is got really red but it's itchy; like skin allergy; My arm is got really red but it's itchy; like skin allergy/ small red spot; This is a spontaneous report from a contactable Nurse. This 56-year-old female Nurse (patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284, Expiry Date: 30Apr2021) at single dose for COVID-19 immunization on 07Jan2021. Relevant history included blood pressure (abnormal). Relevant concomitant drug included Lisinopril 5 mg for blood pressure. The patient had the first BNT162B2 and she had no problems with this one. She had some side effects for this one, it's been 48 hours since she had the vaccine. On 08Jan2021, the patient had a very small red spot but its probably 6 inches long and probably 2 inches wide on 09Jan2021. Her arm was got really red, but it's itching almost like an skin allergy. Itching was much in the night. The patient want to know if it is okay to take Benadryl? The patient also had a trouble hearing on 09Jan2021 as she was little congested. The patient was taking Tylenol (not appropriately paraphrased and clarified). Outcome of events was unknown.
56 2021-01-19 injection site vesicles, injection site redness Patient reports that the day after receiving the vaccine, she had a reddened area around the site. T... Read more
Patient reports that the day after receiving the vaccine, she had a reddened area around the site. The following day, she began having blisters and redness, near where the vaccine had been given. She reports she had taken Benadryl and Aleve, and the next day the the redness was half the size. Today, that area is intact, but shows white scaring.
56 2021-01-19 injection site pain Reaction site pain and muscle aches
56 2021-01-19 injection site pain fever extensive muscle and bone pains headache soreness at injection site lack of appetite chills
56 2021-01-19 itchy skin, hives had itching and tingling the next day. with in 2 days hives all over chest and arms.
56 2021-01-19 itchy skin, redness itchy sensation to arms, redness to chest. Rapid response called, patient monitored. No additional i... Read more
itchy sensation to arms, redness to chest. Rapid response called, patient monitored. No additional intervention
56 2021-01-20 redness, rash with redness, itchy skin 3 hours post innoculation, sore throat with swollen glands, chills, shaking and a mild headache. S... Read more
3 hours post innoculation, sore throat with swollen glands, chills, shaking and a mild headache. Shortly thereafter, started experiencing uncontrolled itching and my skin was bright red (flushed) from above pubic bone and up to top of my head. (nothing on lower extremities). No fever (98.1) and no visible rash. The itching became so uncontrollable, I took 25mg Benadryl and remained taking it every 4 hours until 1/21/21. A very fine, red rash appeared on 1/20/21 in the early morning. The rash was, mainly at my fatty areas, breasts, abdomen and hips, but the Benadryl helped to control the itching. The Benadryl did not take away the itching entirely. As of this morning, the rash has faded, but i'm still itching, mildly, in my abdomen and out edges of my breasts. I am going to try to stop the Benadryl this morning and see how I do. If not better, will go see my PCP.
56 2021-01-20 hives Hives Charlie horse in right leg, front calf
56 2021-01-20 itchy skin, hives Hives and itching all over - took a Benadryl
56 2021-01-20 itchy skin Right side neck stiffness; small area on lower left arm itching (no rash); tenderness right side ste... Read more
Right side neck stiffness; small area on lower left arm itching (no rash); tenderness right side sternum and pec muscle; tenderness right side sternum and pec muscle; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1686), via an unspecified route of administration in left arm on 11Jan2021 07:15 in a hospital at a single dose for COVID-19 immunization. Medical history included known allergies with CT contrasting agent, walnuts, pecans, patient also has high blood pressure, pre-diabetes, and depressive disorder. Concomitant medications included hydrochlorothiazide and lisinopril. The patient previously took (promethazine hydrochloride) REGAN and carbomer and experienced allergies. The patient experienced right side neck stiffness, small area on lower left arm itching (no rash), tenderness right side sternum and pec muscle on 11Jan2021 19:30. The patient was not pregnant. The patient does not have COVID prior vaccination. Patient was not tested for COVID post vaccination. No treatment was received for the adverse event. The outcome of the events was recovering.
56 2021-01-20 injection site redness Site: Redness at Injection Site-Mild, Systemic: Generalized Body Aches -Mild, Systemic: Fainting-Mil... Read more
Site: Redness at Injection Site-Mild, Systemic: Generalized Body Aches -Mild, Systemic: Fainting-Mild, Systemic: Patient felt faint then had an overall body flushing sensation, quickly went away shortly after vaccination-Mild
56 2021-01-21 hives EVENING THAT VACCINE WAS GIVEN HIVES BROKE OUT ON BACK AND NECK , RESOLVED WITH BENADRLY.
56 2021-01-21 injection site swelling, injection site warmth, injection site reaction Fever, joint and muscle pain, swelling and redness at injection site began 24 hours after injection.... Read more
Fever, joint and muscle pain, swelling and redness at injection site began 24 hours after injection. Arm increasingly red, inflamed and hot to touch at 72 hours post injection.
56 2021-01-21 itchy skin Swelling to upper ridge of top lip, irritation to outer upper gum, and numbness to tip of tongue and... Read more
Swelling to upper ridge of top lip, irritation to outer upper gum, and numbness to tip of tongue and itching. I took Benadryl to help control symptoms.
56 2021-01-21 injection site pain Very cold, headache, fatigue for 24hrs Pain at injection site for 36hrs
56 2021-01-22 redness At the clinic today had who suffered an adverse reaction. When she came in for the vaccine she was e... Read more
At the clinic today had who suffered an adverse reaction. When she came in for the vaccine she was extremely nervous due to a hatred for needles. She got the vaccine and within 5 minutes she turned red and her blood pressure sky rocketed to 203/104. She had no difficulty breathing, no rash, just flushed skin and high blood pressure. Her pulse was also elevated to 103. Due to, the ambulance was called. She expressed her wish to not go to the hospital multiple times due to being afraid of missing work and hating the hospitals. By the time the ambulance came her blood pressure was 203/104 with a pulse of 104. Her pulse ox remained at 98 on room air. From the minute she felt ill to the minute they left made sure she was breathing ok and showed no signs of anaphylactic shock. She had a history of panic attacks and GERD, with no blood pressure problems. She did also report an allergy to latex and penicillin prior to the vaccination. All products again were double checked to show her they were latex free. Patients blood pressure decreased at the hospital and was discharged with directions to follow up with her primary. They stated they aren't sure why her blood pressure increased so high.
56 2021-01-22 rash with redness, rash papular, rash Prickly red rash developed about 4-6 hours after the inection. mild rash on neck, chest and back
56 2021-01-22 blister, cellulitis swelling and blistering of skin around nose, right eye and right cheek. started 4 days after inject... Read more
swelling and blistering of skin around nose, right eye and right cheek. started 4 days after injection and worsened over 4 additional days before seeking medical treatment
56 2021-01-23 skin discolouration fell down on Thursday and got vaccine on Friday, Had swelling and resolved now with purple area larg... Read more
fell down on Thursday and got vaccine on Friday, Had swelling and resolved now with purple area large where swelling was and migrating to feet and experiencing dizziness, heart is racing; gasping for air over phone but able to speak a complete sentences
56 2021-01-24 redness, skin warm, skin swelling, bruising, itchy skin Sudden intense itching on back of left leg, right at/below back of knee. It felt hot and it swelled.... Read more
Sudden intense itching on back of left leg, right at/below back of knee. It felt hot and it swelled. Next morning it was pink and still itched but not as bad. I took pictures. The following evening I also took pictures. By then it was a dark red, looked like a bruise and followed the shape of my vein.
56 2021-01-24 rash papular, rash Systemic rash all over the back, chest, stomach and thighs; Some spots on arms and legs; This is a s... Read more
Systemic rash all over the back, chest, stomach and thighs; Some spots on arms and legs; This is a spontaneous report from a contactable Nurse (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL3248), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient stated, "I got my first dose yesterday at 4:30 and then everything was fine and then at about 10:30 that night, I got a systemic rash all over my back, my chest, my stomach and my thighs and there were some spots on my arms and my legs. So, I went ahead and had took some Benadryl and I just monitored the rash and made sure it wasn't going to my face, or my eyes or my throat. I never had any difficulty in breathing or anything but it definitely was a reaction to something that was in the vaccine." Treatment: Consumer stated, "I took Benadryl last night. It was a capsule, 25 mg. Indication: Consumer stated, "I work at a hospital and right now the hospital that I work at is not requiring that we get it but they just advised that we should. But they left it to us if we want to get it or not and they said that they just have the first doses available." The outcome of the events was unknown.
56 2021-01-24 bruising face swelling and pain where I had dermal fillers put in in August 2020. Started with upper lip on ... Read more
face swelling and pain where I had dermal fillers put in in August 2020. Started with upper lip on 1/22/21 and then my eyes were swollen, bruised and painful upon waking 1/23/21 and lasted until early morning of 1/25/21. My whole face was sore to touch during this time. I also had fatigue and headache starting 1/21/21 which lasted a few days along with fever, chills, body aches and sore left armpit which started early morning 1/22/21. I had expected these last symptoms so was not alarmed. I was not warned about the facial swelling and that was a bit scary.
56 2021-01-24 vaccination site itchiness, vaccination site swelling, vaccination site redness had a knot on her arm where the shot was administered; where the shot was administered that was itch... Read more
had a knot on her arm where the shot was administered; where the shot was administered that was itching; where the shot was administered that was redness; where the shot was administered that was swelling; This is a spontaneous report from a contactable consumer (patient herself). A 56-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on left arm, via unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunization. Medical history included she was exposed to Covid from a patient she was working with that came back positive on 05Jan2021 which exposed to Covid was prior to taking the shot. Concomitant medications were reported as none. Reporter stated that she came in last week and took Pfizer shot. Stated before the shot that she was exposed to Covid from a patient she was working with that came back positive. Wanted to know if she took Covid test would it come back positive automatically. Wanted to know if she was allowed to take the Covid test. She had on all of her PPE gear and N95 mask. She screened the patient but the patient had a mask on, she worked in dental, for a time period he that the patient had his mask off for a short time period. Stated that this was for the Pfizer Covid 19 shot, it was her first shot and she would take the second shot on 26Jan. Reporter was a dental assistant and calling on behalf of herself. Stated that she had a knot on her arm where the shot was administered that was swelling, red and itching on 06Jan2021. Stated that the knot was almost not there. Later stated that the knot was gone Saturday 09Jan. The outcome of event "where the shot was administered that was itching" was resolving while outcome of other events were resolved on 09Jan2021. Information about lot/batch number has been requested.
56 2021-01-25 injection site pain, injection site warmth I felt warm feeling in left arm at injection site. minor pain in arm just after injection. pain in a... Read more
I felt warm feeling in left arm at injection site. minor pain in arm just after injection. pain in arm increased later in the evening. The following morning no pain felt in arm . Moderate pain felt at top of left shoulder to neck. Decreased ability to fully raise left arm and decreased range of motion in left shoulder.
56 2021-01-25 vaccination site pain little nauseous, queasy; low grade temperature; chills and shakes; scratchy throat; decreased sense ... Read more
little nauseous, queasy; low grade temperature; chills and shakes; scratchy throat; decreased sense of smell; decreased sense of taste; everything she eat or drinks has a metallic taste to it; muscle stiffness; Fatigue; arm soreness/right arm was still tender to touch/The first shot hurt way more and hurt all over the whole arm, it was throbbing; sinus pressure and congestion; sinus pressure and congestion; felt really lightheaded; low grade headache; chest feeling tight/chest tightness; she is not feeling good; wheeze; cough; This is a spontaneous report from a contactable nurse (patient). A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular (IM) in right deltoid on 07Jan2021 15:30 at second single dose for preventative. The patient medical history was not reported. There were no concomitant medications. The patient previously took H1N1 flut shot in 2015 or 2016 for immunisation and experienced muscle stiffness and fatigue, first dose bnt162b2, via IM in left deltoid for preventative on 18Dec2020 at 18:00 and patient was tender in her left arm, the first shot hurt way more and hurt all over the whole arm, it was throbbing. No additional vaccines administered on same date of the pfizer suspect. No prior other vaccinations administered within 4 weeks. The patient took the second dose of the Pfizer Covid vaccine on Thursday 07Jan2021 at 15:30. She called employee health and was advised to call Pfizer to report side effects since she is not feeling good. She had never had the covid diagnosis. On Friday (08Jan2021) she worked all day and felt arm soreness and sinus congestion but nothing out of the ordinary. The patient reported her right arm was still tender to touch, if she rotated her arm she can feel that she had the shot and she was still tender in her left arm from the first shot. The first shot hurt way more and hurt all over the whole arm, it was throbbing. On 08Jan2021 evening she felt really lightheaded, she thought maybe it was her sinuses since it is dry due to winter. She felt like a truck hit her. She had a low grade headache. On 09Jan2021, she felt a little nauseous, queasy, no vomiting. On Saturday (09Jan2021) she had a low grade temp of 100.3 degrees F. She had the chills and shakes on Saturday and most of yesterday. She got up today (reported on 12Jan2020) at 5:30 am, she checked her temperature and it was 97.2 after the shower, an hour later it was 98 degrees F. She felt like she had to keep clearing her throat, her chest felt a bit tight which started Friday evening, the chest tightness was not terrible but it was there. She was not wheezing but when she took a deep breath she felt a little like a wheeze and she had to cough, she had a scratchy throat on 09Jan2020. She stayed home from work yesterday. The patient did not feel lightheaded today, felt it yesterday and did not notice it at all this morning, reported it has resolved. The sinus pressure and congestion started Friday night, she felt stuffy. She had a decreased sense of smell and taste on 09Jan2021. Unless something is right in front of her, she could not smell anything. She felt quite nauseous this morning but at the moment her nausea is under control. She had a decreased sense of taste, everything she ate or drunk had a metallic taste to it, on 09Jan2021. She felt that all the side effects mentioned were related to getting the vaccine. On 08Jan2021, she also experienced muscle stiffness and fatigue which had improved after a hot shower, that helped. She felt like she had a bad flu shot. The only time she ever felt similar to this was when she received the H1N1 flut shot in 2015 or 2016. She did not have lot number, NDC, or expiration date to provide. Treatment included: took Tylenol on Saturday. The events did not require a visit to emergency room and physician office (she is trying to get an appointment to see the doctor). Outcome of the event lightheaded was recovered on 12Jan2021, of events low grade headache, chest tightness, scratchy throat, sinus pressure and congestion, decreased sense of smell, decreased sense of taste, everything she eat or drinks has a metallic taste to it, arm soreness was not recovered, of events chills and shakes, muscle stiffness, fatigue was recovering, of other events was unknown. Information about Lot/Batch has been requested.
56 2021-01-26 redness High fever, malaise, sore throat, went from independent to help with assistance in feeding, red sor... Read more
High fever, malaise, sore throat, went from independent to help with assistance in feeding, red sore arm, ROM affected.
56 2021-01-26 skin spots, rash Outbreak started on upper extremities and some on abdomen; Petechial rash; This is a spontaneous rep... Read more
Outbreak started on upper extremities and some on abdomen; Petechial rash; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) intramuscular in right arm on 29Dec2020 10:30 at single dose for COVID-19 immunisation. The patient was not pregnant. The patient received vaccine in hospital. Medical history included rheumatoid arthritis (RA), hypertension. The patient didn't have known allergies. Concomitant medication included infliximab (INFLECTRA), leflunomide (ARAVA), meloxicam, acetylsalicylic acid (ASA), hydrochlorothiazide/losartan potassium (LOSARTAN/HCTZ), amlodipine besilate (NORVASC), cetirizine hydrochloride (WAL ZYR), multivitamin, biotin, collagen, cyanocobalamin (B12), echinacea. No other vaccine was received in four weeks. The patient had no COVID prior vaccination. Nasal swab was tested post vaccination on 05Jan2021 and result was negative. The patient experienced petechial rash on 01Jan2021 05:45 PM. On 05Jan2021 it started pinpoint barely noticeable. It rapidly spread till 05Jan2021, the patient took high dose steroids till Saturday 09Jan2021. On 09Jan2021 outbreak started on upper extremities and some on abdomen. The treatment for events included prednisone, diphenhydramine (BENADRYL) and acetaminophen (TYLENOL). The events resulted in emergency room visit and physician office visit. The outcome of events was recovering.
56 2021-01-26 injection site pain headache; fever; L Arm (injection site) pain/severe left arm pain; dizziness; blurred double vision ... Read more
headache; fever; L Arm (injection site) pain/severe left arm pain; dizziness; blurred double vision and couldn't function; eyes wouldn't focus, Couldn't function; blurred double vision and couldn't function; eyes wouldn't focus, Couldn't function; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 11Jan2021 15:00 at a single dose in the left arm for COVID-19 immunization. The patient received the vaccine in a skilled nursing facility or long term care facility. The patient received no other vaccinations recently. Medical history included attention deficit disorder diagnosed at least 5 years ago for which the patient was taking Ritalin; hypothyroidism diagnosed a long time ago, probably 10 years and depression diagnosed a long time ago, probably at least 25 year, she takes a cocktail of anti-depressants for this (no further details provided about her anti-depressants). The patient also had a similar reaction of blurred double vision and couldn't function/eyes could not focus before when her doctor put her on an antibiotic (unspecified). The patient was also very overweight. Concomitant medications included methylphenidate hydrochloride (RITALIN; lot: unknown, expiry: 28Jul2021) for attention deficit disorder and the patient takes a cocktail of anti-depressants (unspecified) for her depression. The patient received the first dose of the covid vaccine on 11Jan2021 at 3 PM and by 5PM she was experiencing bad headache, fever, L arm (injection site) pain that was severe. Later that evening she had blurred double vision and couldn't function. She also got a fever of about 100 degrees Fahrenheit, was dizzy and her eyes could not focus and were almost like double vision but not quite, it was hard to explain. She just remembered that she had a similar reaction with her eyes before, when her doctor put her on an antibiotic. She cannot recall what antibiotic that was. The patient also experienced dizziness on 11Jan2021. The patient treated her side effects with ibuprofen and most of these improved. The injection was given in her left arm, her non-dominate one. She says that the pain was so bad it woke her up, and she doesn't take any pain meds, but that was really bad. She says that she took some Ibuprofen (lot: P113671, exp: Jan2022), about a total of 800mg over a few hours. Her fever had started pretty fast, by 05:00PM on the 11th, and it was better after taking the Ibuprofen, as was her arm pain, and headache. She says that the dizziness went away probably around 02:00AM the following day (12Jan2021). She says her eyes can focus again as well. The patient thinks that these effects are medically significant, mostly that her eyes were not able to focus, it was very scary. The patient stated that the purpose of this call is to have this documented, and possibly find out if there are recommendations that she should not get the second dose, since she had to call out of work because she couldn't function. The outcome of the event "blurred double vision and couldn't function; eyes wouldn't focus, couldn't function" was recovered on an unspecified date and dizziness recovered on 12Jan2021 at 02:00. The outcome of the event "she had to call out of work because she couldn't function" was unknown while the other events were recovering. Information on the lot/batch number has been requested.; Sender's Comments: The 56-year-old female patient had medical history included attention deficit disorder; hypothyroidism and depression and she takes a cocktail of anti-depressants for this. The patient also had a similar reaction of blurred double vision and couldn't function/eyes could not focus. Based on information reported, the reported double vision and difficulty focusing eyes were more likely due to pre-existing condition (s); and less likely causally related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The rest events fever, headache, vaccination site pain and dizziness were likely causally related to the use of vaccine due to plausible temporal relationship and known safety profile of this product. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
56 2021-01-27 redness Face, neck, arms turned bright red; Face extremely swollen; Nausea; This is a spontaneous report fro... Read more
Face, neck, arms turned bright red; Face extremely swollen; Nausea; This is a spontaneous report from a contactable healthcare professional. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), intramuscular (left arm) on 12Jan2021 10:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included lamotrigine. The patient experienced Face, neck, arms turned bright red, Face extremely swollen, Nausea; all on 12Jan2021 10:45 AM. The outcome of the events was recovering.
56 2021-01-27 rash, skin peeling, redness On Sunday, 1/17/21, patient was nauseous and vomiting and could not keep anything down at one point ... Read more
On Sunday, 1/17/21, patient was nauseous and vomiting and could not keep anything down at one point vomit was dark in appearance. Patient receives home dialysis when nurse came to home on Monday, 1/18, saw condition of patient and sent them to the hospital. At the hospital it was noted she had redness throughout body, no hives or blisters. Patient was lethargic, received antiemetic and medication for rash, does not know what medications were. On Tuesday, 1/19, she received 2 liter transfusion, discharged on Thursday, 1/21. Today, Thursday 1/28 patient still feels lethargic and states rash is peeling.
56 2021-01-27 injection site swelling, injection site pain PAIN ON INJECTION SITE,SWELLING ON INJECTION SITE,INFLAMATION ON UNDERARM PIT WITH GANGLIOS.
56 2021-01-27 hives, injection site swelling, injection site pruritus, injection site redness, injection site warmth Sore arm after dose 1 (mild, ,resolved); Mild-Moderate side effects after dose 2 (headache, fatigue,... Read more
Sore arm after dose 1 (mild, ,resolved); Mild-Moderate side effects after dose 2 (headache, fatigue, muscle aches, dizziness, chills, sleeplessness) persisting past 48 hours and ongoing but fluctuating; At 72 hours: Injection site is red, with raised welt around 2 inches in diameter, with itching and warm to touch; ongoing.
56 2021-01-27 skin mass, hives, hardening, itchy skin, redness Swollen, Large Red whelp with hard knot inside arm. Burning and itching sensation. Ibuprofen and i... Read more
Swollen, Large Red whelp with hard knot inside arm. Burning and itching sensation. Ibuprofen and ice packs did not improve area.
56 2021-01-27 injection site swelling Tenderness under arm, - lymph node association, mid to lower back, site swelling Ibuprofen 400 mg ... Read more
Tenderness under arm, - lymph node association, mid to lower back, site swelling Ibuprofen 400 mg relieved symptoms
56 2021-01-27 rash Warm feeling in back of throat that started about 10 minutes after the shot, then immediate dizzines... Read more
Warm feeling in back of throat that started about 10 minutes after the shot, then immediate dizziness and I went out for help from a physician in hallway. Next thing I remember I was on an exam table and I had not strength in my limbs and core. I had a rash on neck and chest. They monitored my vitals and decided I needed to go to urgent care or ER. Since the urgent care was on the way to the ER they took me there. They moved me from wheel chair to ecam table. Gave me epi and Benadryl injections, prednisone by mouth and started an IV. They monitored my vitals and said if I worsened are didn't respond then they would send me to ER. They gave me some Pepcid and eventually over the 3 hours I was able to stand on my own and they decided to discharge me around 14:00, making sure that I had someone who could stay with me at home.
56 2021-01-27 injection site pain, injection site swelling, injection site pruritus, injection site redness, rash with redness, injection site mass felt feverish and very tired. I am still tired. but the worst reaction is the large swollen red lump... Read more
felt feverish and very tired. I am still tired. but the worst reaction is the large swollen red lump on my arm where the vaccine was injected. It is painful and itchy in this area. I have a red rash around the site that seems to be spreading more every day. I keep hoping it will subside, but as of yet it has not.
56 2021-01-27 redness, rash, itchy skin started yawning 5 minutes, yawning multiple times a minute, could not even speak without yawning. S... Read more
started yawning 5 minutes, yawning multiple times a minute, could not even speak without yawning. Stopped yawning at 2pm then broke out in rash on trunk, neck, arms, face, flushed. Took 2 benadrdyl, monitored x 1 hr, rash subsiding, then started itching at 5pm all over, at 8pm left arm got blood red, throbbed x 30 min, took more benadryl. She has itched all over since day of vaccination and cannot get a deep breath.
56 2021-01-28 skin warm, redness 10 minutes into 30 minute observation post vaccination client reported feeling warm with erythema de... Read more
10 minutes into 30 minute observation post vaccination client reported feeling warm with erythema developing on her chest.
56 2021-01-28 rash, itchy rash Pruritic Rash every night all over Relieved by combination of Benadryl 50 mg, Claritin and pepcid
56 2021-01-28 itchy skin, hives, redness redness on her arm that extended to her elbow and up to her ear; She stated that she has a lot aller... Read more
redness on her arm that extended to her elbow and up to her ear; She stated that she has a lot allergies; stated that they were like hives and it was a little raised/bumps below her ear and below her jaw line now; said that her arm was itching by the time she got to her car; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot number: EL3246; expiry date: unknown) intramuscular injection in the left arm, on 15Jan2021 at 10:20, for COVID-19 prophylaxis. Medical history included diabetic (type 2, insulin controlled, sugars are controlled, diagnosed about 1.5 years ago), allergies to Bee stings (needs EpiPen (hornets, yellow jackets) and a trip to the hospital) and anaphylactic allergy to tomatoes. Patient has no concomitant medications. The patient previously received flu vaccine that is allergen free. She said that she had a reaction to the regular flu vaccine about 10 years ago. She went to The ER and had severe hives, but no breathing issues, just a localized hive reaction. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. Patient has no previous immunization with the Pfizer vaccine. The patient stated that she had her first dose of the Covid-19 vaccine today 15Jan2021. She said that about a half hour to 45 minutes after receiving the injection she had real redness on her arm that went down to her elbow and up to her ear and stated that they were like hives and it was a little raised. She said that she has bumps below her ear and below her jaw line now. She stated that she has a lot of allergies. She treated her symptoms with Benadryl. She also took Benadryl as a premed prior to getting the vaccination. She said that she called her allergist and sent her pictures of what was happening, and her allergist told her to take another Benadryl and to lay down and relax. She was a little worked up. The redness is not as red, but it is still warm, and it is still "raise" a tiny bit. The area on her arm is now about the size of a CD and doesn't extend to the elbow anymore. She said that she got the injection at 1020 and had to wait until 40minutes. Her arm was itching by the time she got to her car and she put an ice pack on it that she keeps for emergencies in her car. She took her second dose of Benadryl at 1300. She said that she probably slept until 1530 and noticed it was looking a little bit better. She was told that people have reactions like these, and it was not a big deal and she notified her doctor and occupational health. Outcome of the event redness was recovering, while for the other events was unknown.
56 2021-01-29 injection site pain Came home my shift at work 1/28/21 at 8:30pm and all of the sudden I had the chills and within 1/2 h... Read more
Came home my shift at work 1/28/21 at 8:30pm and all of the sudden I had the chills and within 1/2 hour a fever of 101, muscle aches, very tired. I went to bed and in morning fever was gone but still fatigued and soreness at injection sight
56 2021-01-29 itchy skin Headache fatigue chill fever nausea diarrhea lymph node swelling. Pain itchiness
56 2021-01-30 injection site redness Uncontrollable shivering for 3 hours, headache, numbness and tingling in hands and feet, swelling an... Read more
Uncontrollable shivering for 3 hours, headache, numbness and tingling in hands and feet, swelling and redness at injection site, swollen armpit, chest pain, extreme tiredness and slept for 22 hours, weakness.
56 2021-01-31 vaccination site pain minor muscle aches at the sight of the injection; minor aches/super minor aches; minor muscle pain; ... Read more
minor muscle aches at the sight of the injection; minor aches/super minor aches; minor muscle pain; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot# EL3248), via an unspecified route of administration in left arm on 17Jan2021 10:30 at single dose for COVID-19 immunization. Medical history included the patient had a spit of asthma since a child and she didn't have any trouble after the vaccine. Concomitant medication included ongoing montelukast sodium (SINGULAIR) for asthma taking for 3 or 4 years. Vaccination Facility Type: hospital. Vaccine Administered at Military Facility? No. History of all previous immunization with the Pfizer vaccine considered as suspect: none. Additional Vaccines Administered on Same Date of the Pfizer Suspect: none. Prior Vaccinations (within 4 weeks): none. Family Medical History: none. The patient experienced minor muscle aches at the sight of the injection, minor aches/super minor aches, minor muscle pain, all on 17Jan2021 with outcome of recovering. Relevant test none. Investigation Assessment: No. She had some minor muscle pain and maybe some minor aches. Today was the day that you felt like you always do when you go back to work after being sick. She had minor muscle pain that was low grade right away, minor, started right away and consistent through today but not like it kept you up. She also had super minor aches, not feeling herself, but not bad in any way. The minor muscle aches started later on the 17Jan2021 at the sight of the injection, like a bruise. She is planning to receive the second dose on 07Feb2021. No event required a visit to physician or emergency room.
56 2021-01-31 skin spots petechiae bilateral lower legs
56 2021-02-01 rash, shingles Shingles left sacrum along S4 with pain radiating to left medial thigh down to left medial knee; Shi... Read more
Shingles left sacrum along S4 with pain radiating to left medial thigh down to left medial knee; Shingles left sacrum along S4 with pain radiating to left medial thigh down to left medial knee; rash; right inguinal large tender lymphadenopathy appeared same time; fatigue; muscle aches; This is a spontaneous report from a contactable nurse reporting for herself. A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685) via an unspecified route of administration on 12Jan2021 14:00 at single dose in left arm for COVID19 immunisation. Patient age at time of vaccination was 56 Years. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685) administered on 22Dec2020 at 14:00 in left arm. The patient has allergies to Duricef, milk, almonds. Prior to vaccination, the patient was diagnosed with COVID-19. The patient received unspecified concomitant medications. On 13Jan2021 the patient experienced Shingles left sacrum along S4 with pain radiating to left medial thigh down to left medial knee; rash appeared 18 hours after 2nd Covid vaccine; right inguinal large tender lymphadenopathy appeared same time; also had normal fatigue, muscle aches from vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. As treatment for the events the patient received Acyclovir 800 mg QID x 7 days and terrasil ointment. The events were reported as non serious. Since the vaccination, the patient has not been tested for COVID-19. The events had not resolved.
56 2021-02-01 rash, shingles Shingles rash; did have lethargy and was dragging; did have lethargy and was dragging; This is a spo... Read more
Shingles rash; did have lethargy and was dragging; did have lethargy and was dragging; This is a spontaneous report from a contactable healthcare professional reporting for self. This 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via intramuscular on 11Jan2021 at left deltoid at single dose for COVID Prevention. Medical history and concomitant medications were none. Her health had improved over the last six months and she was on no medications, and her labs had been good. The patient previously received first dose of BNT162B2 (lot number: EJ1685) via IM injection into the left deltoid on 23Dec2020 at single dose for COVID Prevention. She stated that she may have had some dragging after the first dose, but it was after the holidays and she was laying around anyway, so if she did, it was not of note to her at the time. She confirmed that she received no other vaccines on the same day as either her first dose, nor her second dose of the vaccine. The patient experienced shingles rash starting on 14Jan2021. It was reported that the patient received her second dose of vaccine last Monday (11Jan2021). The Thursday following that (14Jan2021), she noticed a small patch of a rash on her right side, and she did not think much of it at first, because she had been gardening. But she stated that by Friday, it was clear that she had the initial onslaught of Shingles. She stated that over the weekend, the rash had taken a very predicable course, where it is now in circles around her body. She had had no other sentinel events, she had not been sick, she was not stressed, the only thing was that four days prior to the rash, she got the last COVID shot. She just wanted there to be accuracy in known side effects because she was 56 years old, but she was not immunosuppressed at all, and she knew that it would be given to people 65 and older soon. Patient stated that she was no sick as a dog, but two days after receiving the second dose, she did have lethargy and was dragging on 14Jan2021. She thought after the second dose, the vaccine may have hit her immune system. The outcome of shingles rash was not recovered and reported as worsened, outcome of other events was unknown. The reporter considered the event shingles rash was serious as medically significant and was related to the vaccine.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in triggering the onset of shingles rash cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021092332 same patient/drug, different event separated with time
56 2021-02-01 redness, itchy skin extreme itching and 11/2 inches big redspot on arm. The itching is so severe and cannot relieved by ... Read more
extreme itching and 11/2 inches big redspot on arm. The itching is so severe and cannot relieved by over counter hrdrocortisone, it make me feel my heart starting beat irregularly
56 2021-02-01 itchy skin severe itching; had some different allergies; This is a spontaneous report from a contactable nurse ... Read more
severe itching; had some different allergies; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got the first dose of BNT162B2 for COVID-19 immunisation on 28Dec2020, and the patient had no side effects. The patient got the second COVID shot (vaccine) and she had a reaction to it, she had some different allergies and she got severe itching on 16Jan2021, admitted into emergency room from 16Jan2021 to 16Jan2021. Seriousness of the events was hospitalization. The patient stayed at the site for a while because the itching didn't end they wanted the patient to go into an Emergency Room (ER) but they were able to get it under control and the patient was fine today. The patient received diphenhydramine hydrochloride (BENADRYL) and steroids for the events. The outcome of the events was unknown. The reporter considered that the events were related to BNT162B2. Information on the lot/ batch number has been requested.; Sender's Comments: Based on a compatible temporal association and known product safety profile, a causal relationship between events "reaction to it, she had some different allergies and she got severe itching" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
56 2021-02-01 injection site pain sleeping a lot; she sweated overnight; Fever; Headache; Fatigue; Feeling of total lack of energy; se... Read more
sleeping a lot; she sweated overnight; Fever; Headache; Fatigue; Feeling of total lack of energy; severe abdominal pain; Nausea; Injection site pain; This is a spontaneous report from contactable other hcps (including patient herself). A 56-year-old female patient received second dose of bnt162b2 (Pfizer-Biontech Covid19, lot number EL3248) , via an unspecified route of administration 08Jan2021 17:30 at single dose on left deltoid for covid-19 immunisation. Medical history included covid-19 the first time in Oct2020 to an unknown date , then from 16Nov2020 to an unknown date and experienced "every symptom except for vomiting". The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 18Dec2020 for covid-19 immunisation and experienced neck hurting, Shingrix Vaccine on 04Dec2020 for immunization and experienced no adverse effect. The patient experienced severe abdominal pain, nausea, Injection site pain on 12Jan2021, headache, fatigue, feeling of total lack of energy on 13Jan2021, fever on 16Jan2021. She had severe abdominal pain and nausea for three days (as reported). The caller stated she took Zofran for her nausea. The caller stated she had a rapid COVID-19 Virus test that was negative, but continued to feel queasy. She stated she had 100.5-101.8 degree fevers over the weekend, and has been sleeping a lot. Reported she woke at 4:00AM on Tuesday, 12Jan2021, with severe abdominal pain. She said the abdominal pain is better but not completely gone. Abdominal Pain Treatment: Declined any. Reported she hasn't discussed with her doctor the adverse events she has been experiencing since receiving the second COVID-19 Vaccine dose. She stated she had injection site pain for 2-3 days after receiving the second COVID-19 Vaccine dose. She said she didn't have any injection site soreness with the first COVID-19 Vaccine dose. She said she thought she was good after receiving the second COVID-19 Vaccine dose, but then on Tuesday, 12Jan2021, she woke at 4:00AM with severe abdominal pain. She said the abdominal pain came in waves. She described the abdominal pain as an 8 out of 10, clarifying the abdominal pain would be sharp and then fade away, and then the abdominal pain would cycle back around. She said she found herself standing over her toilet a few times because the abdominal pain was so severe, she thought she was going to throw-up. She clarified she had nausea and took and old prescription of Zofran she had received for vertigo years ago. She stated she did not have the Zofran NDC, Lot, and Expiration Date. Reported her abdominal pain and nausea went away by Thursday, 14Jan2021, saying the abdominal pain and nausea was less and less each day. She clarified the abdominal pain and nausea were intermittent, saying all of a sudden she would not feel good. She said her nausea has been better for the past 2-3 days. She clarified she called off work on Tuesday, 12Jan2021, and on Wednesday, 13Jan2021, she had a Rapid COVID-19 Virus Test before she started work that day (13Jan2021) to make sure that she wasn't positive for the COVID-19 Virus. She said she had a headache, no energy, and felt fatigued at work on Wednesday (13Jan2021), and Thursday (14Jan2021), but didn't take her temperature during that time. She said she didn't work on Friday (15Jan2021), but continued to have the headache, fatigue, and feeling like she had no energy. She said she didn't check her temperature until Saturday, 16Jan2021. She said she woke up Saturday (16Jan2021) at 9:40AM and went back to sleep until 11:30AM. She said she woke back up at 1:42PM and her husband told her she felt hot to the touch. She said she checked her temperature and it was 101.8 degrees. She said she checked her temperature first thing this morning (18Jan2021) because she could tell she sweated overnight, and her temperature was 100.3. She said she just checked her temperature again, and her temperature was now 99.3 degrees. She said by this afternoon, her temperature will be in the 101 range. Headache & Fever Treatment: Reported she took Naproxen (clarified as a prescription Naproxen 500mg tablet), and Tylenol (clarified as Equate brand Acetaminophen 500mg tablet) for her headache and fever on Saturday (16Jan2021). She said she took the Naproxen and Acetaminophen 500mg once in the morning, and again at night, before bed. She stated she did not take any Naproxen or Acetaminophen on Sunday, 17Jan2021. Acetaminophen 500mg tablet (Equate Brand): UPC Number: Unknown, Lot Number: 0HV1335, Expiration Date: May2022 Naproxen 500mg tablet (Prescription dispensed in round, pharmacy bottle): No NDC, Lot, or Expiration Date Reported she had another COVID-19 Virus test performed on Sunday, 17Jan2021, at 11:40AM at a drive-thru test site at Pharmacy. She clarified it was a "send-out" PCR COVID-19 Virus test, and she had not received her test results yet. She said her belly doesn't hurt anymore. She said she doesn't have a gallbladder and appendix. She said if she had the flu, the flu lasts for 3-5 days, and she is not coughing. She said she feels like now, what she felt like when she had the COVID-19 Virus the first time in Oct2020. She said she had a 12 days of severe fatigue when she had COVID-19 in Oct2020. She said her COVID-19 Virus symptoms started on 14Oct2020 with nasal congestion, and by 16Oct2020 she couldn't taste her yogurt. She said she got tested later in the day on 16Oct2020 for the COVID-19 Virus. She clarified she definitely had no sense of smell or taste on Friday, 16Oct2020. She said on Thursday, 15Oct2020, she kept falling asleep in the evening, saying that never happens. She said on Friday, 16Oct2020, she had a fever of 100.3, as well. The outcome of the events severe abdominal pain, nausea was resolved on 14Jan2021, of Injection site pain was resolved on an unspecified date, of sleeping a lot and she sweated overnight was unknown, of other events was not resolved.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of abdominal pain, nausea and other events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
56 2021-02-02 redness Anaphylaxis: abrupt throat swelling, shortness of breath, facial redness, GI distress
56 2021-02-02 injection site pain I had dizzy spells one day after the 2nd vaccine, aches in my knees (which I had recovered from an ... Read more
I had dizzy spells one day after the 2nd vaccine, aches in my knees (which I had recovered from an injury 2 months prior and had stopped hurting), a sore arm at site of injection, and tiredness. After receiving my 1st vaccine I did not have any side effects other than a sore arm at site of injection.
56 2021-02-03 itchy skin, rash, hives 2nd dose of pfizer covid vaccination today with a prior h/o scalp itchiness but no rash , angioedema... Read more
2nd dose of pfizer covid vaccination today with a prior h/o scalp itchiness but no rash , angioedema or anaphylaxis with the first dose of covid vaccination 3 weeks ago. pt today with itchy palmar rash but no generalized itchiness no angioedema no anaphylaxis . exam remarkable for palmar urticarial rash with sparing of the dorsum no urticaria elsewhere no angioedema no anaphylactic signs. pt noted improvment of pruritis and rash after 25mg of oral benadryl.. pt called for family member to provide home due to mild sedation from the benadryl. pt observed for a full hour without any other sequelae
56 2021-02-04 vaccination site swelling, rash, vaccination site pain Rash; tenderness at the site of the injection that progressed and got more painful and swollen until... Read more
Rash; tenderness at the site of the injection that progressed and got more painful and swollen until she could hardly raise her shoulder; tenderness at the site of the injection that progressed and got more painful and swollen until she could hardly raise her shoulder; tenderness at the site of the injection that progressed and got more painful and swollen until she could hardly raise her shoulder; This is a spontaneous report from a contactable other healthcare professional (patient). A 56-year-old female patient receive bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration in the left arm from 12Jan2021 12:30 to 12Jan2021 12:30 as SINGLE DOSE (first dose of the vaccine by injection) for COVID-19 immunisation. The patient medical history was not reported. Ongoing concomitant medication included propranolol 80mg once daily by mouth, apixaban (ELIQUIS) 5mg one twice daily by mouth, omeprazole 40mg once daily by mouth, hydrochlorothiazide 12.5mg once daily by mouth, and atorvastatin 80mg once daily by mouth. The patient stated she got the Pfizer COVID 19 vaccine and she experienced tenderness at the site of the injection that progressed and got more painful and swollen until she could hardly raise her shoulder but she could use her arm and her hand. She got the shot on Tuesday and still had some symptoms the next Monday. On an unspecified date, the patient experienced rash. The patient also asked, can you take Tylenol or Ibuprofen before or after vaccination? I have heard it can it lessen the immune response. With the first dose of the vaccine my arm hurt from Tuesday and the last day of it hurting was the following Monday, so about a week. Someone told me with the second vaccine the pain is higher. I am fine and still getting the second dose. The outcome of the event rash was unknown; while the rest of the events was recovered on 18Jan2021. Information on the lot/batch number has been requested.
56 2021-02-04 injection site pain chest soreness/pain; pain with breathing/hurt to breathe; severe fatigue; soreness at injection site... Read more
chest soreness/pain; pain with breathing/hurt to breathe; severe fatigue; soreness at injection site; This is a spontaneous report from a contactable other healthcare professional (hcp), reporting for herself. A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot ELO142) , on 18Jan2021 at 09:00 intramuscular in Right arm at single dose for COVID-19 immunization.Medical history included allergy to Shellfish. Patient was not pregnant. Concomitant medication included ibuprofen (ADVIL) prophylactically, at 2DF daily on 18Jan2021 and at 2 DF each day through on 19Jan2021; vitamin D3; fish oil; ascorbic acid (VITAMIN C) and cyanocobalamin (VITAMIN B12). The patient experienced chest soreness/pain, pain with breathing/hurt to breathe, severe fatigue, soreness at injection site, on 14Jan2021 (as reported). Events were also described as follows: patient prophylactically took 2 ibuprofen 30 minutes before vaccine on 18Jan2021 at 08:30 am and got the vaccine on 18Jan2021 at 9am. She just had soreness at injection site that evening. She kept up with the ibuprofen (only 2 doses each day) through on 19Jan2021. On 21Jan2021 she felt severe fatigue and later in the evening she started to feel chest soreness/pain and pain with breathing. It felt muscular but she went to emergency department (ED) because it hurt to breathe. They did a cardiac and PE work up which was negative. The pain was relieved by Toradol IV. She was discharged from emergency department (ED) . She took more ibuprofen on 22Jan2021 when she started to feel the same, but lesser, symptoms and the pain went away. On 23Jan2021, so far patient felt okay. The final outcome of the events was reported as recovering.; Sender's Comments: Based on the temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the events "chest soreness/pain, pain with breathing/hurt to breathe". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
56 2021-02-05 itchy skin 56 y.o. female with a history of a latex allergy, cancer and childhood asthma who received her secon... Read more
56 y.o. female with a history of a latex allergy, cancer and childhood asthma who received her second dose of the Pfizer COVID-19 mRNA vaccine and subsequently developed generalized pruritis five minutes after. She developed similar symptoms 6 hours after receiving the first dose, but this time was more severe. She arrived to the emergency department and after 15 minutes began to develop a cough, increased work of breathing, and voice changes. She received 0.3 mg epinephrine subcutaneously and albuterol nebulizers. Over her three hours in the department she received famotidine, 125mg methylprednisolone, diphenhydramine, an additional dose of epinephrine and 4x albuterol nebs. However, he dyspnea continued to return, and she was admitted. Improved overnight and was discharged HD2. widespread pruritis initially 5min post-Pfizer vaccination (2nd dose). Progressed to severe coughing, dyspnea requiring repeated doses of epinephrine and albuterol. Admitted to intermediate unit for further cares. Noted to have had mild delayed pruritis prior to first dose of pfizer vaccine.
56 2021-02-06 injection site swelling, injection site redness, injection site hardening, injection site warmth Approx 1 1/2" Localized red, raised, firm, warm area @ injection site-morning after injection and st... Read more
Approx 1 1/2" Localized red, raised, firm, warm area @ injection site-morning after injection and still present @ report time.
56 2021-02-06 itchy skin, hives Awoke at 414am with itching scalp, palms, eyelids, skin folds (neck, elbows, knees, hips), welts, sw... Read more
Awoke at 414am with itching scalp, palms, eyelids, skin folds (neck, elbows, knees, hips), welts, swelling in eyes, hands, face, neck.
56 2021-02-06 rash with redness, rash, itchy rash Rash on lower back - wide spread, red bumps, itch
56 2021-02-07 hives, rash, redness After receiving the injection, my face and neck turned bright red. It took about an hour for the red... Read more
After receiving the injection, my face and neck turned bright red. It took about an hour for the redness to go down. The next morning, I noticed a few small pimples on my cheeks and a slight red /dry patch on my forehead.
56 2021-02-07 injection site hardening, injection site pain, injection site redness complaint of increased swelling, pain and redness at injection site and circumference of left are 3 ... Read more
complaint of increased swelling, pain and redness at injection site and circumference of left are 3 days after second COVID injection right deltoid are measure 18.5inches Left deltoid measured 20 inches with hardness and redness
56 2021-02-07 redness, itchy skin itchy sensation to arms; redness to chest; This is a spontaneous report from a contactable pharmacis... Read more
itchy sensation to arms; redness to chest; This is a spontaneous report from a contactable pharmacist. A 56-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number EL1284, intramuscular in left arm, on 21Dec2020 at12:30 ( at the age of 56 years old) as a single dose for COVID-19 immunization. Medical history included asthma, hyperlipidemia, PTSD, and seasonal allergies. Concomitant medications were not reported. The patient previously took acetylsalicylic acid (ASPIRIN) (rash), ciprofloxacin, codeine (vomiting, rash), escitalopram (dizziness, rapid heart rate). Prior to the vaccination the patient was not diagnosed with COVID-19. The COVID-19 vaccine was administered at a hospital. There were no other vaccines within four weeks prior to the vaccination. On 21Dec2020 at 12:30, the patient experienced itchy sensation to arms, redness to chest. Rapid response was called, patient monitored. No additional intervention, no treatment provided. The outcome of the events was recovered. The patient was not tested for COVID-19 post vaccination.
56 2021-02-07 itchy skin, hives my lips and tongue started itching and got swollen; my lips and tongue started itching and got swoll... Read more
my lips and tongue started itching and got swollen; my lips and tongue started itching and got swollen; my lips and tongue started itching and got swollen; my lips and tongue started itching and got swollen; itching and got hives; itching and got hives; This is a spontaneous report from a contactable Nurse reported for herself. A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jan2021 16:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient was not pregnant. Medical history included Asthma, food and environmental allergies, allergy to PCN and Sulfa. Concomitant medications included montelukast sodium (SINGULAIR), bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (LEXAPRO), loratadine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first dose of BNT162B2 on an unknown date for covid-19 immunization. The patient previously took acetylsalicylic acid (ASA), levofloxacin (LEVAQUIN), codeine and azithromycin (ZITHROMAX) and experienced allergy. 8 minutes after the vaccine was given on 22Jan2021 16:08, patient started itching and got hives. She was given Benadryl. About 5 minutes after that on 22Jan2021 16:13, her lips and tongue started itching and got swollen. At that time she was given an injection of Epinephrine and transferred to the Emergency Department. The outcome of the events was recovered on an unknown date in Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: Pfizer comment: Based on the information currently available, a possible contributory role of the BNT162B2 in the reported events lip and tongue itching and got swollen cannot be excluded in this 56 years old female patient, who with medical history of allergy to food, environment and multiple medications. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
56 2021-02-07 injection site reaction, injection site numbness within 5 minutes of receiving the vaccine, my left arm became numb & weak & resolved by the next da... Read more
within 5 minutes of receiving the vaccine, my left arm became numb & weak & resolved by the next day; 1-2 hours later my legs/feet from the knees down became numb/tingling with tightening muscles; 2 hours later left side entire face became numb with puffy left eye lid which lasted for 8 days; by the 8th day my symptoms began to resolve only to return with 4 days with left face/throat numbness & left side numbness/tingling with tightening forearm muscles both hands/fingers/arms from elbows down & numbness/tingling/muscle tightening in both legs/feet/toes from the knees down along with pain in both knees which lasted another 2 days; I continue to have some residual symptoms of numbness on the left side of my face that comes and goes as well as the same symptoms of numbness/muscle tightening and tingling in both legs/feet that comes & goes.
56 2021-02-08 injection site pruritus at 8:45 patient reported that the "site itches" and reported it was "hard to breath". Patient instur... Read more
at 8:45 patient reported that the "site itches" and reported it was "hard to breath". Patient insturected to "take a deep breath". She had her own benadryl and took it. Given epinephrine at 8:50 AM. BP was 140/84 and pulse was 64. At 8:55 patient reported relief from hard to breathe. Ambulance arrived at 9:00 AM.
56 2021-02-08 injection site pain fatigue arm hurt at site fever
56 2021-02-09 itchy skin Face and scalp itching, headache, fever, pain to soles of feet, extreme fatigue, body and joint pain... Read more
Face and scalp itching, headache, fever, pain to soles of feet, extreme fatigue, body and joint pain. Started approx 3 hours after injection and is continuing on day 3, but symptoms are lessening some. Tylenol and Motrin and rest treatment. Contacted my physician for further advice or treatment needed.
56 2021-02-09 hives, rash with redness Hot painful red rash on abdominal area; Hot painful red rash on abdominal area; welts; swelling; Thi... Read more
Hot painful red rash on abdominal area; Hot painful red rash on abdominal area; welts; swelling; This is a spontaneous report from a contactable other hcp. A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration at single dose left arm on 23Jan2021 11:15 for covid-19 immunisation. Medical history included thyroid disorder, breast cancer female, migraine, allergy to sulfonamide and topamax, food allergy. Concomitant medications included levothyroxine, liothyronine (NP THYROID), multivitamin, plant based calci. The patient experienced hot painful red rash on abdominal area on 23Jan2021 18:00, welts on 23Jan2021 18:00, swelling on 23Jan2021 18:00. No treatment received. The outcome was not recovered. Information on the lot/batch number has been requested
56 2021-02-09 itchy skin Pt Feels itchy with past history of anaphylaxis to peanuts. Pt Monitored no treatment or transport.
56 2021-02-09 vaccination site pain only mild muscle soreness at injection site; This is a spontaneous report received from a contactabl... Read more
only mild muscle soreness at injection site; This is a spontaneous report received from a contactable nurse. A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EC324U, expiry date: unknown), via an unspecified route of administration in the left arm, on 11Jan2021 (also reported as 21Jan2021, pending clarification), at single dose, for covid-19 immunization, at the hospital. Medical history included penicillin allergy. The patient was not pregnant at the time of vaccination. Concomitant medication included daily vitamins (other medications in two weeks). The patient did not receive other vaccines in four weeks. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. On 11Jan2021, first dose, the patient only experienced mild muscle soreness at injection site. Treatment was not given for the event. The patient recovered from the event in Jan2021.
56 2021-02-09 rash rash on my elbow; loss of appetite; tired; dizzy; This is a spontaneous report from a contactable co... Read more
rash on my elbow; loss of appetite; tired; dizzy; This is a spontaneous report from a contactable consumer (patient). This 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Jan2021 10:00 on Arm left at single dose (Lot # EL3246) for covid-19 immunisation. No medical history and concomitant therapy. She woke feeling dizzy on 24Jan2021, went to bed feeling dizzy and woke up feeling dizzy and the feeling isn't going away and she has a rash on her elbow on 25Jan2021. She took an antihistamine for it. She took the (Pharmacy name) off brand antihistamine. She does not know the name of it. She doesn't have an appetite on 25Jan2021. She doesn't feel sick but she usually loves her breakfast. She also maybe is a little tired on 25Jan2021. She also reports that her second vaccine dose is due today and feeling like this she doesn't know if she should get it. Outcome of the event dizzy was not recovered. Outcome of other events was unknown.
56 2021-02-10 vaccination site redness, vaccination site itchiness, vaccination site pain pain, redness, itching at site; pain, redness, itching at site; pain, redness, itching at site; Musc... Read more
pain, redness, itching at site; pain, redness, itching at site; pain, redness, itching at site; Muscle ache; heaviness to arm; overall malaise; This is a spontaneous report from a contactable Nurse (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number Ek9231), via an unspecified route of administration, on 13Jan2021 10:30 AM, in right arm as single dose for COVID-19 immunisation. The patient was vaccinated at workplace clinic. Patient age at vaccination was 56 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history includes seasonal allergies. Concomitant medications were not reported. On 13Jan2021 at 10:30 AM the patient experienced pain, redness, itching at site, muscle ache and heaviness to arm plus overall malaise as well lasting 2 weeks (clarification requested). No treatment was received for the events. The events were resolving. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has been tested for COVID-19 (Nasal Swabs, on 14Jan2021; 19Jan2021; 21Jan2021; 25Jan2021, all with negative result).
56 2021-02-11 itchy skin Anaphylaxis, itching, tightness of the throat, shortness of breath, low oxygen levels Treatment: 1... Read more
Anaphylaxis, itching, tightness of the throat, shortness of breath, low oxygen levels Treatment: 1 Benadryl 1130am, 1 Epipen 1155am, 1 Epipen 1225, steroids intravenously 1pm Outcome: Released home
56 2021-02-14 injection site pain 1/21/2021- First Dose- Following day mild muscle soreness at site, ongoing fatigue, never feels res... Read more
1/21/2021- First Dose- Following day mild muscle soreness at site, ongoing fatigue, never feels rested or wants/needs to sleep, a lot. Noticed abdominal pain, but did not connect the two. 2/11/2021- 2nd dose- Two hours later (approx) moderate pain at site, my head/mind felt "off", out of sync like one side of brain slower, affected balance. It was strange, and unpleasant. 2/12/2021- Groggy, face/eyes swollen, did not feel well, but not so bad I could not go to work. It was a 50 mile drive, and as I drove the same feeling of not thinking straight did not want to drive. The feeling of being unwell escalated quickly. Congestion, muscle aches throughout, sore throat, chills, and a need to catch my breath caused dizziness. I pulled over, called work, and made my way home where I went directly to bed. My head ached, abdominal (sharp) pains, especially after ingesting fluids. or food similar to gall bladder pain, but not close to its worse intensity still, continues. 2/15/2021- Update- Nearly 96 hrs. passed: What remains is: Feeling exhausted, need to sleep, more frequent and intensifying abdominal pains, headaches, pain in left lung/easily winded, and site pain expansion. Injection arm (left) pins & needles, and fingers ice cold, neck pain (stiffness).
56 2021-02-14 injection site pruritus 24 hours Chills/body aches fever 102.5 Next 24 hours chills/body aches fever 101.5 Headache/ injecti... Read more
24 hours Chills/body aches fever 102.5 Next 24 hours chills/body aches fever 101.5 Headache/ injection site itchiness for 3 days lethargic and shaky Total recovery time 36 hours
56 2021-02-14 rash macular Generalized macular rash after 15 minutes. No SOB, wheezing. Noted partial improvement of rash afte... Read more
Generalized macular rash after 15 minutes. No SOB, wheezing. Noted partial improvement of rash after dose of Benadryl 50 mg
56 2021-02-14 injection site warmth My arm is hard and feels like I have a knot in my arm. The area where I got the injection is warm
56 2021-02-14 redness, itchy skin Patient developed diffuse redness of the skin and itchiness less than 15 minutes after receiving the... Read more
Patient developed diffuse redness of the skin and itchiness less than 15 minutes after receiving the vaccine. Vital signs initiall BP 178/92, HR 98, spo2 98%. Denied shortness of breath or other symptoms at that time. Patient took benadryl 25 mg PO, after about 10 minutes verbalized tingling of her tongue. No further progression of symptoms. 911 called & patient sent to ED for evaluation in stable condition. Medical staff
56 2021-02-15 skin discolouration 1/7/21 arm soreness overnight, 10 AM 1/8/21 next morning pt noticed pulse was about 135 resting, pt... Read more
1/7/21 arm soreness overnight, 10 AM 1/8/21 next morning pt noticed pulse was about 135 resting, pt went to work and felt out of it, overall unwell feeling, went to walk in clinic, blood pressure was high even after meds, EKG showed tachycardia but normal rhythm, pt went home went to bed at 2 PM slept until next morning, 1/9/21 fatigue, swollen lymph node under left arm, small lymph node in neck also swollen, headaches, flushed/grey looking, as of 2/16/21 pt is feeling much better
56 2021-02-15 rash macular, injection site reaction, injection site warmth, skin swelling, injection site rash, injection site pruritus, injection site inflammation, injection site redness 8 days after the injection, my left arm where the needle went in because itchy. I looked at it, and ... Read more
8 days after the injection, my left arm where the needle went in because itchy. I looked at it, and it was red, inflamed and hot to the touch. The affected area grew to a circular 3" in diameter, puffy, blotchy, itchy, hot rash surrounding the injection site. I panicked at first because I never heard of such a delayed reaction. I did read of this sometimes happens with the COVID vaccine, so I thought I should report it. As of today, 2 days later the rash is fading, but it is still there.
56 2021-02-15 skin swelling I noticed on the 14th that I had a large bump or growth on my left calf. It just suddenly appreared ... Read more
I noticed on the 14th that I had a large bump or growth on my left calf. It just suddenly appreared that day.
56 2021-02-15 itchy skin patient reported to observers feelings of anxiety, jitteriness, shaky hands, and chest itchiness. As... Read more
patient reported to observers feelings of anxiety, jitteriness, shaky hands, and chest itchiness. Assessment performed respirations counted and were within normal limits, clear respiratory sounds. had patient sit near the door for cooler air, symptoms continued and Benadryl was given. Paramedics arrived and further assessment was completed and she refused to received further treatment in the ambulance and was allowed to go home. LVN and RN assessed further and patient stated symptoms no longer present 20 minutes after Benadryl was given.
56 2021-02-19 itchy skin, redness The area is swollen with redness, soreness and itches sometime. It Underarm area sore. Yesterday I b... Read more
The area is swollen with redness, soreness and itches sometime. It Underarm area sore. Yesterday I began rubbing alcohol on the area. I hope this is common and will disappear soon.
56 2021-02-19 rash rash, whole body
56 2021-02-22 blister "Blister"
56 2021-02-22 itchy skin Reaction happened 20 minutes after. Itching. A little headache. Lasted a few hours. Followed up at... Read more
Reaction happened 20 minutes after. Itching. A little headache. Lasted a few hours. Followed up at ER and was discharged after an hours observation.
56 2021-02-23 hives 01/14/2021 102 fever, myalgias, exhaustion. Lasted about a day. 01/17/2021 hives on face, right ear... Read more
01/14/2021 102 fever, myalgias, exhaustion. Lasted about a day. 01/17/2021 hives on face, right ear, neck, chest, bilateral hands and bilateral feet for 5 days. Washed gently with clear water, patted dry, used Benedryl, Benedryl cream and bag balm. None helped. No new laundry soap, bath soaps, foods etc. Started Chantix 01/23/2021, stopped smoking. 02/20/2021 Discontinued Chantix, still no smoking. 01/31/2021 occasional (5-10 times daily) dyspnea, frequent need to clear throat, constant sinus congestion with clear thin mucus.
56 2021-02-23 itchy skin Approx 10 minutes after the immunization the patient started showing s/s of difficulty breathing and... Read more
Approx 10 minutes after the immunization the patient started showing s/s of difficulty breathing and c/o itching. The patient was very flushed. Mouthed "I can't breathe". Wasn't able to speak a full sentence. Staff at the clinic first administered IM Benadryl out of the emergency bag, with Epinephrine on stand-by. About 2 minutes after the Benadryl was given, she started showing signs of breathing easier, and was starting to speak to staff. She said her doctor's office was across the street and he told her to go to his office if there was any reaction. She was able to walk out on her own, accompanied by her friend who was able to take her to her doctor's office.
56 2021-02-23 hives, itchy rash, rash papular Itchy raised rash over large area of body 12 hours after vaccine. Large area of welt left arm and le... Read more
Itchy raised rash over large area of body 12 hours after vaccine. Large area of welt left arm and left chest. Took 3-4 days to resolve.
56 2021-02-23 redness, itchy skin, skin burning sensation, rash They were kind of itched; I was scratching and it was starts to bleed; They were kind of itched; I w... Read more
They were kind of itched; I was scratching and it was starts to bleed; They were kind of itched; I was scratching and it was starts to bleed; They were kind of itched; I was scratching and it was starts to bleed; They are scabbed like almost like scars; that scars on my arm; They were burning kind of and they scabbed over; I had a type of rash; little red dots on my arm, on my forearm and also my trapezius of on the same site of the injection; I had a type of rash; little red dots on my arm, on my forearm and also my trapezius of on the same site of the injection; I had a type of rash; little red dots on my arm, on my forearm and also my trapezius of on the same site of the injection; This is a spontaneous report from a contactable consumer reported for herself. A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), lot number# EL0142 via unspecified route at the arm on 26Jan2021 (at 56 year old) at single dose for COVID-19 immunization. Medical history was not reported, and concomitant medications included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patient reported as follows: "I was scratching and it was starts to bleed ,I had a type of rash; little red dots on my arm, on my forearm and also my trapezius of on the same site of the injection , they were kind of itched; they are scabbed like almost like scars; that scars on my arm , they were burning kind of and they scabbed over .Then the consumer added: I would say probably came on about I have to guess may be 3 to 5 days after I had the shot and they were kind of the itched and I was scratching and it was starts to bleed that want to I don't know about a week and a few days after I noticed on my arm, also noticed on my back of right trapezius muscle. So on top like on my in my back and behind my neck and it started all of my right side and I was awaken one night because they were burning kind of and they scabbed over so it was just look like scabbed kind of and when I scratch it scab kind of come off and it would bleeding kind of burn. "they are still there but they are having healed like on my arm have like you can see them, but they are scabbed like almost like scars. That scars on my arm, I can see they are still there, but they are not bleeding anymore." Regarding treatment she stated, "I only took Benadryl on one night because night before they woke me up because it was burning. They were hurting when I scratched them." The patient was recovered from wound bleeding while the outcome of the other events was unknown.
56 2021-02-23 vaccination site pain severe soreness at the injection site; soreness at the injection site was so severe that she was una... Read more
severe soreness at the injection site; soreness at the injection site was so severe that she was unable to sleep or lift her arm; soreness at the injection site was so severe that she was unable to sleep or lift her arm; Chills; mild headache; Nausea; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EC324U), via an unspecified route of administration on 11Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient's medical history included penicillin allergy. Concomitant medications included unspecified daily vitamins. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), via intramuscular on an unspecified date at 12:00 pm at 56- years of age on the left arm for COVID-19 immunization and had only mild muscle soreness at injection site. The patient was not diagnosed with COVID-19 prior to vaccination. On 11Jan2021, at eight hours post injection, the patient experienced severe soreness at the injection site. The patient stated that the soreness at the injection site was so severe that she was unable to sleep or lift her arm. On the same day, the patient also had chills, mild headache and nausea. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the event mild headache was not recovered while the other events was recovered on an unspecified date in Jan2021.
56 2021-02-23 vaccination site pain sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes; Swollen soft pala... Read more
sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes; Swollen soft palate, nose, eyes; Swollen soft palate, nose, eyes; scratchy throat on eating red meat, milk, or cheese; muscle and joint pain; earache; pain was all over; muscle and joint pain; headache; exhaustion; pain at injection site; slight fever; mild nausea; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL9264), on right arm via an unknown route of administration on 03Feb2021 13:45 for COVID-19 immunization. Medical history included VonWillebrand's and history of lyme disease. The patient had allergy to peanut and allergy to latex. Concomitant medications included unspecified vitamin supplements. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3302) on Left arm, on 13Jan2021 13:30 for COVID-19 immunization. Patient stated, "After first shot in left arm, only on her left side she had: Muscle and joint pain, earache, goopy eye, headache, exhaustion, and pain at injection site from 12 hours to 36 hours after shot administered. Second shot in right arm: Same as above (muscle and joint pain, earache, headache, exhaustion, and pain at injection site), although no eye drainage and pain was all over with slight fever, mild nausea in Feb2021. Lasted from 12 hours to 36 hours after the test. Arm remained sore longer, but not problematic. Bizarre possible response: 6 days after second shot on 09Feb2021 17:30, the patient experienced sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes, scratchy throat on eating red meat, milk, or cheese. Patient did not need epi-pen but needed double dose of benadryl. Events resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Benadryl and epi-pen on hand was received as treatment for events. The events were assessed as non-serious by the reporter. Outcome of events muscle and joint pain, earache, headache, exhaustion, pain at injection site, pain was all over, slight fever, mild nausea was recovered in Feb2021, whereas outcome for other events was reported as unknown. No follow-up attempts are possible. No further information is expected.
56 2021-02-24 rash with redness, skin discolouration, redness Covid fingers - left ring finger swollen and black and blue (with a bump) - from base of the finger ... Read more
Covid fingers - left ring finger swollen and black and blue (with a bump) - from base of the finger to the joint as of 4pm on 2/24. On 2/25 in the morning the black and blue has extended beyond the knuckle toward the end of the finger but only about 1/4" beyond the knuckle. Right hand, middle finger, black and blue between the knuckle nearest the hand and the knuckle nearest the finger tip. No swelling. This was noticed about 9pm on 2/24. Covid Toes - possibly - red bumps on toes same toe, both feet, red. Toes next to pinky toe.
56 2021-02-24 injection site pain Informed would like to discuss her reaction to the Covid vaccine. States received the vaccine 12/21... Read more
Informed would like to discuss her reaction to the Covid vaccine. States received the vaccine 12/21 at 10:15 a.m. Approx 1500 - 1600 , the same day the injection site had "normal soreness, like a flu shot". On 12/22 woke up around 7 a.m. and couldn't move the affected arm due to pain. Reports it hurt to move her fingers. Temp was 99.5, maximum. The upper arm was swollen. On 12/23, temp is 97.6. Feels "normal soreness, like a flu shot
56 2021-02-24 vaccination site swelling, vaccination site itchiness, vaccination site redness Itchy; Runny nose; swelling on site; Very little redness when I got the vaccine/ very red; This is a... Read more
Itchy; Runny nose; swelling on site; Very little redness when I got the vaccine/ very red; This is a spontaneous report from a contactable consumer (patient). A 56-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date: unknown), via an unspecified route of administration on the left arm on 05Feb2021 at 09:30 at a single dose for COVID-19 immunization. Medical history included palpitations controlled by medicine. The patient has no allergies to medications, food, or other products. Concomitant medication included metoprolol (METOPROLOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had a little swelling on the site and very little redness when she got the vaccine. However, on the 8th day it was a bigger area, itchy and very red. No pain or other symptoms. The patient did start with a runny nose the day after the vaccine and still have, but not sure it's related. No treatment administered for the events. The events had not resolved. Information on the batch/lot number has been requested.
56 2021-02-25 itchy skin, rash papular, redness A 56 year old female: within 5 minutes of receiving Pfizer vaccine lot # 6200 Patient had red raised... Read more
A 56 year old female: within 5 minutes of receiving Pfizer vaccine lot # 6200 Patient had red raised area on right arm and it was itching, Patient had no other complaints of shortness of breathe or difficulty breathing, Dr and RN assessed patient and she was given 50mg of benadryl. Initial vital signs HR 74, RR 24, bP 155/50, SpO2 98%. RN observed patient for 30 minutes and the welt appeared less than before and the patient stated that it wasn't bothering her as much. Exiting vital signs, HR 70, RR 16, BP 140/42, SpO2 97%. Patient driven home by friend/significant other.
56 2021-02-25 itchy skin Itching; fever; chills; This is a spontaneous report from a contactable nurse (patient). A 56-year-o... Read more
Itching; fever; chills; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female nurse received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date unknown), via unknown route of administration, on 25Jan2021 at 08:15 AM (at the age of 56 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included hypothyroid and had BNT162B2 vaccine dose 1 on unknown date, lot unknown, administered at 10:45 AM on right arm. The patient had known allergies: Ibuprofen. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), sertraline hydrochloride (ZOLOFT), liothyronine sodium (CYTOMEL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received levothyroxine, sertraline hydrochloride, liothyronine sodium within 2 weeks of vaccination. On 25Jan2021, at 12:00 PM, the patient experienced Itching, Fever, Chills. No treatment was received for the events Itching, Fever, Chills. The outcome of the events Itching, Fever, Chills was not recovered. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
56 2021-02-25 rash, redness Rash on upper thighs, abdomen/stomach and crease of arms. Noticed the morning after injection light ... Read more
Rash on upper thighs, abdomen/stomach and crease of arms. Noticed the morning after injection light red, slightly raised. Doesn't really bother me. No itching, burning or problems breathing. Took a Claritin and worked on 2/25. When I got home from work on2/25 showered and took a Benadryl. Rash is still here this morning. On my arms it is much lighter but still the same everywhere else.
56 2021-02-25 injection site pain Vaccine received at approximately 1010 on 1/11/21. I felt fine...just some soreness at the injectio... Read more
Vaccine received at approximately 1010 on 1/11/21. I felt fine...just some soreness at the injection site. Overnite, intense HA noted that slightly subsided after 400mg ibuprofen, completely subsided by end of day 1/12/21. Body aches, malaise and a feeling that my left axillary lymph nodes were enlarged. All of these symptoms were at the worst in the middle of the night but all pretty much subsided by eve of 1/12/21.
56 2021-02-25 vaccination site pain Woke up the next morning and she felt numbness in her ear. She could hear, but it felt muffled. As... Read more
Woke up the next morning and she felt numbness in her ear. She could hear, but it felt muffled. As the day went on she realized that her ear was ringing. It started as a buzzing and now a high pitched ringing that she still has in her left ear. She also had a nose bleed that occurred twice on her right nostril. She has had nose bleeds in the past, but none recently. She was sitting working and her nose just started bleeding. The vaccine site itself was sore, minor and not unbearable. It's just the humming and buzzing in her ear that will not go away.
56 2021-02-25 itchy skin all over itching, given po benadryl
56 2021-02-27 skin warm, itchy skin Almost immediate left shoulder tingle. Tingle progressed up to shoulder, collarbone area, left side... Read more
Almost immediate left shoulder tingle. Tingle progressed up to shoulder, collarbone area, left side of neck, underside of chin. Some numbness accompanied the tingling. Left cheek and left ear felt hot (internally). These symptoms never worsened. Subsided approximately 2-3 hours after vaccination. About 6 hours later, my left calf was incredibly itchy. I took a Benadryl and went to bed. Felt normal the next day.
56 2021-02-28 injection site rash, rash Did have the quarter sized red ring and rash around the injection site about 3 days after vaccine. A... Read more
Did have the quarter sized red ring and rash around the injection site about 3 days after vaccine. About 8 days after vaccine pt has a fine rash on both forearms, top of hands, tricep area, later sides of torso, lower back, lateral sides of thighs and quads
56 2021-02-28 skin infection at injection site From the employee: Received 2nd vaccination on 24th, developed cellulitis in the injection site on ... Read more
From the employee: Received 2nd vaccination on 24th, developed cellulitis in the injection site on the 26th, went to quick care, they sent me to the ER due to concerns over cellulitis moving up arm. Placed on oral antibiotics. From the QuickCare note: Concern for left arm vaccine site cellulitis versus COVID vaccine reaction or both . She wishes to go to ER for medical attention to have her left upper arm COVID vaccine injection site evaluated. She left per ambulatory in stable condition in no acute distress. Report called to ER. She is aware and agreeable to notify Employee Health of above findings per protocol and policy From the employee: I did fill out a FROI. A quick question, I did go to the Quick Care initially and she saw me and then wanted me to go to the ER due to concerns that there was a streak going up my arm. I did elect to go to the ER, so as to not have a long wait and elevate some of the congestion in our ER.
56 2021-02-28 injection site pain I feel achy, bad headache, slight cough, chills, feverish, and soreness on right arm where vaccine w... Read more
I feel achy, bad headache, slight cough, chills, feverish, and soreness on right arm where vaccine was administered.
56 2021-02-28 bruising I noticed on my forearm red spot(bruise under the skin),swelling right arm and into hand. The swelli... Read more
I noticed on my forearm red spot(bruise under the skin),swelling right arm and into hand. The swelling lasted for about a week and the spot faded after time.
56 2021-02-28 cellulitis The patient was diagnosed with cellulitis at urgent care on day 2 of 2nd vaccine and was started on ... Read more
The patient was diagnosed with cellulitis at urgent care on day 2 of 2nd vaccine and was started on an antibiotic. She also had a fever from day 2 through day 4 after vaccine.
56 2021-03-01 itchy skin, hives On Tuesday morning after receiving 2nd vaccination the previous Friday afternoon, I suddenly broke o... Read more
On Tuesday morning after receiving 2nd vaccination the previous Friday afternoon, I suddenly broke out in hives on both arms and across upper torso that alternated between itching and burning like fire. It quickly spread over entire body. I called my PCP to speak to a nurse and while on the phone, I begin experiencing tingling around nose and mouth, nose stuffed up making breathing difficult, and tongue became numb. PCP office told me to hang up and go to the nearest emergency room.
56 2021-03-01 injection site nodule Pt reports with left deltoid nodule s/p vaccination
56 2021-03-01 redness Within 12 hours I had extreme fatigue, extreme muscle/body ache, chills, brain fog. This lasted for ... Read more
Within 12 hours I had extreme fatigue, extreme muscle/body ache, chills, brain fog. This lasted for about 48 hours. After 48 hours the rash started on top on both ankles. That lasted probably 8 days and didn't get better with cream. The muscle aches started in my neck and upper body and about 11days ago decided to settle in my knee (right). I though I maybe slipped or fell but didn't because of the pain. The pain is cross between a cramping muscle and shin pain. I've been walking with a limp. I got in yesterday with my PCP and sending me for an ultrasound to rule out a blood cot. He doesn't believe it is because it moves, I don't have any swelling or redness. I have just been really fatigue. I had BP done to make sure my Thyroid is ok and it is. The past 3 nights it has stopped waking me up at night. I've been doing epsilon salt baths, I can't put weight on it and still walk with a limp. I go for ultrasound tomorrow.
56 2021-03-02 bruising Bleeding upon injection; large bruise; extreme nausea; chills; fatigue; headache; This is a spontane... Read more
Bleeding upon injection; large bruise; extreme nausea; chills; fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261) solution for injection, via an unspecified route of administration at right arm on 11Feb2021 at 4:15 PM at single dose for COVID-19 immunization. Medical history included allergies to penicillin, glaucoma (reported as glaucomo) and high blood pressure. Concomitant medication included metroprolol. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at right arm on 20Jan2021 at single dose for COVID-19 immunization. The patient was not pregnant. The vaccine was administered at a hospital. There was no other vaccine in four weeks. The patient was no COVID prior to vaccination and she was not tested for COVID post vaccination. The patient experienced bleeding upon injection, large bruise, extreme nausea, chills, fatigue, and headache, all on 12Feb2021 at 04:00 AM. She did not receive any treatment in response to the events. The outcome of the events was recovering.
56 2021-03-02 redness, itchy skin Bodyache for 3 days, soreness of arm for 5 days, redness, ichy,
56 2021-03-02 vaccination site pain Injection site pain; Fever of 101.3; Tired; Headache; This is a spontaneous report from a contactabl... Read more
Injection site pain; Fever of 101.3; Tired; Headache; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248, expiry date: unknown), via an unspecified route of administration on 18Jan2021 20:00 (at the age of 56 years old), at a single dose in the left arm for covid-19 immunisation. Medical history included allergies: dust, mold, trees & grass; and diagnosed with covid-19 on unspecified date. Concomitant medications included escitalopram oxalate (LEXAPRO) and fexofenadine hydrochloride (ALLEGRA 24 HOUR). The patient previously took augmentin and experienced allergies. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient has not been tested for covid-19 since the vaccination. On 19Jan2021 20:00, the patient experienced injection site pain for seven days and fever of 101.3 which lasted for 12 hours; tired and had a headache for two days. The patient did not receive any treatment for all the events. Outcome of all the events was recovered on unspecified date. The events were reported as non-serious.
56 2021-03-03 injection site pain pain at injection site, fatigue, headache
56 2021-03-04 itchy skin itching on right side of abdomen near liver and gallbladder followed by pale/light colored stools on... Read more
itching on right side of abdomen near liver and gallbladder followed by pale/light colored stools on day 2 and 3 so far
56 2021-03-06 rash Patient received her covid vaccination at 1950, right deltoid. She was escorted to the 30 minute wa... Read more
Patient received her covid vaccination at 1950, right deltoid. She was escorted to the 30 minute waiting zone as she has had anaphylactic reactions in the past. At 2008 patient stated she felt hot. She had a rash developing on her neck, noted a dry mouth and thickening tongue. EMS brought in for evaluation. Blood pressure 204/102, pulse 65, oxygen 100% on 2L nasal cannula. 50 mg benadryl administered IM left deltoid 2011. 20g PIV started left antecubital, 125 mg administered. Ambulance on site. Patient able to speak clearly, verbalized the need to void her bladder. Patient accompanied by 2 RNs to the restroom. She was stable on her feet, escorted back to EMS stretcher. She was taken to hospital. VAERS submitted.
56 2021-03-06 skin burning sensation, rash with redness, redness Vaccine at 6:00 PM Thursday, 3/4/21, symptoms started Friday afternoon 3/5/21 (About 20 hours after... Read more
Vaccine at 6:00 PM Thursday, 3/4/21, symptoms started Friday afternoon 3/5/21 (About 20 hours after vaccine) my cheeks and eyelids became slightly red and felt irritated and felt like a bad sunburn.. Woke up on Saturday 3/6/21 at 8:00AM and the left side of my face and eye was swollen and red rash covered most of cheeks on both sides and well an the entire eyelids on both eyes as well as my far head. Was very painful and felt like a bad burn. Went to Urgent Care and was prescribed over the counter products and said rash is most likely a related to Covid Vaccine and to report it to VAERS. As of 6:45 PM on 3/7/21 as I am filling this out my face is still the same as it was Saturday still red in the same places and still sore.
56 2021-03-07 hives 1ST DAY PATIENT HAD HIVES AND WAS TIRED TOOK BENADRYL 2ND DAY WENT TO WALK IN CLINIC AND GOT A CORTI... Read more
1ST DAY PATIENT HAD HIVES AND WAS TIRED TOOK BENADRYL 2ND DAY WENT TO WALK IN CLINIC AND GOT A CORTISONE SHOT 3RD DAY HIVES IN MOUTH AND DOWN THROAT TAKING PREDNISONE, A STEROID OINT, BENADRYL EVERY 4 HOURS AND PEPCID AC
56 2021-03-07 rash with redness, itchy rash, rash Extreme hot, sweating, rash and itching all over chest, neck, back, red and horrible itch on face a... Read more
Extreme hot, sweating, rash and itching all over chest, neck, back, red and horrible itch on face and head, out of breath, fast heartbeat, dizzy
56 2021-03-07 injection site warmth, injection site pain, injection site redness, injection site mass Seven days after receiving my 2nd dose, I developed a painful lump near the injection site. The ski... Read more
Seven days after receiving my 2nd dose, I developed a painful lump near the injection site. The skin was red and very warm to the touch. It continued to grow and get darker red, but I believe it has stopped growing now and I think that the color is lighter. the lump seems smaller, also. It still hurts (much like the original vaccine) and it is still warm. It has been two days since I first noticed it.
56 2021-03-08 injection site pain, injection site warmth Covid-type headache, severe neck muscle pain, fatigue, injection site pain, injection site fever, ch... Read more
Covid-type headache, severe neck muscle pain, fatigue, injection site pain, injection site fever, chills
56 2021-03-08 injection site pain Nausea, fatigue, sore muscles, injection site pain
56 2021-03-08 injection site swelling, injection site pain Pain and swelling at injection site. Nausea Muscle aches Earaches Joint pain Chills Tiredness Fatigu... Read more
Pain and swelling at injection site. Nausea Muscle aches Earaches Joint pain Chills Tiredness Fatigue
56 2021-03-08 vaccination site redness, vaccination site pain, vaccination site swelling injection site swelling, redness, pain; injection site swelling, redness, pain; injection site swell... Read more
injection site swelling, redness, pain; injection site swelling, redness, pain; injection site swelling, redness, pain; This is a spontaneous report from a contactable other health professional. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, intramuscular, in the right arm, on 05Feb2021 10:00 at SINGLE DOSE for covid-19 immunization. Medical history included allergies (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient's concomitant medications were not reported. The patient experienced injection site swelling, redness, pain on 05Feb2021 10:00. The outcome of event was unknown. Patient did not receive any treatment for the events. No follow-up attempts possible. No further information expected.
56 2021-03-09 rash 4 days later developed entire body rash, seen at care spot and treated for itching
56 2021-03-09 injection site pain 5 hours after first shot I began to feel the pain at the injection site but I also began to feel pai... Read more
5 hours after first shot I began to feel the pain at the injection site but I also began to feel pain in my lower back at the trunk of my spine. By the next day, March 4th I was in agony and could barely move. But Saturday morning the pain had not dissipated even with rounds of ADVIL and TYLENOL heat and ice packs. I went to the ER as given Tramadol, Naxoproxin, Cyclobenazprine and Lidocaine patches. I use these all weekend but I discontinued everything but the Lidocaine patches because I need to drive and function at work. The pain is still there as a constant ache but travels up my spine in the forms of spasms. I feel it is definitely at the trunk but more pain to the right side. I have an appoint with a Spinal Pain doctor for next week.
56 2021-03-09 injection site pain, hives Headaches, Hives, muscles and joint aches, pain on injection site.
56 2021-03-09 hives One week after the vaccine, I developed hives in the arm where the shot occured. Then, it has now sp... Read more
One week after the vaccine, I developed hives in the arm where the shot occured. Then, it has now spread and I have hives on my arms and legs.
56 2021-03-09 rash, rash papular, itchy rash Pfizer BioNTech COVID-19 Vaccine EUA Rashes appeared on both legs one day after first dose of vaccin... Read more
Pfizer BioNTech COVID-19 Vaccine EUA Rashes appeared on both legs one day after first dose of vaccine. Rashes are slightly raised and slightly itchy.
56 2021-03-09 injection site reaction, hives, rash, injection site redness, injection site swelling, injection site warmth, itchy skin Rash on arm with main large red hot welt at injection site on day 1-6, no rash on day 7-8 and welt w... Read more
Rash on arm with main large red hot welt at injection site on day 1-6, no rash on day 7-8 and welt was no longer red raised or hot, rash returned on day 9. Large raised red hot itchy welt on day 9.
56 2021-03-09 injection site swelling, injection site pruritus, injection site pain soreness at injection site, pain and itching with swelling, no use of bandages, unable to wear long... Read more
soreness at injection site, pain and itching with swelling, no use of bandages, unable to wear long sleeve shirt, no fever.
56 2021-03-10 injection site pain, skin warm, itchy rash, rash with redness, rash I broke out in red, hot, itchy patches, headache , chills and sweats 8 hours later. I called my do... Read more
I broke out in red, hot, itchy patches, headache , chills and sweats 8 hours later. I called my doctors office and took two benedryl ultratabs each. The next day, the red skin was gone, bno more itching. The next day injection site pain, muscle aches and headache. Still had headache and backache Monday, which was two days later.
56 2021-03-10 injection site redness, redness Severe facial burning , neck redness, 2 red spots around injection site that happened 30 minutes aft... Read more
Severe facial burning , neck redness, 2 red spots around injection site that happened 30 minutes after she left facility
56 2021-03-10 rash Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild
56 2021-03-10 injection site pain initial normal soreness in arm at injection site, followed by fatigue and flulike symptoms going on ... Read more
initial normal soreness in arm at injection site, followed by fatigue and flulike symptoms going on 14 days now. Some improvement but continue to feel somewhat breathless at times, extreme fatigue (abnormal for me), decreased appetite, muscle aches (severe at times), tightness in my jaw on left side with noticeable jaw clicking that I have never had, and on day 3 woke with severe, noticeable swelling in my left axilla (egg shaped and protruding) and my left neck/jaw -- also seems to be in the lymph node area. Underarm swelling improved but still have a sense of tightness in my neck and jaw.
56 2021-03-10 rash, hives rash / hives about size of a quarter on left arm (not arm of injection)
56 2021-03-11 hardening 45 minutes after receiving the vaccine I felt like I was helping by getting my vaccine. After 45 min... Read more
45 minutes after receiving the vaccine I felt like I was helping by getting my vaccine. After 45 minutes I started to get weird symptoms. I started to have a hot flushing sensation in my left chest and became mentally dissociated from the situation. I felt separated from the conversation and tried to touch my hands together and couldn't feel them it was like a part of me. I was still trying to function for days and the feeling of being unable to think continued. I remember muscle weakness and dizziness. It was hard to focus. I had body tremors and some nausea and fatigue, headaches, body aches. The dissociation came and went and I felt really wobbly. I tried driving on day four and was unable to function in traffic. I started having abdominal pain which has lasted for five weeks. The flushing was still there in my chest and started to move up into my neck. Extreme dizziness on day 6 and I slept for much of the day, brain fog. I reached out to many doctors for help but no one had advice. I felt really scared and overwhelmed. Day 8 I had severe nausea and abdominal pain muscle pain in legs and dizziness. I thought I wasn't going to wake up after sleeping on many days. My muscles hurt so bad that I thought it wouldn't end. I had many days of day long headaches and the flushing sensation with shortness of breath. All of my symptoms continued with different levels of severity for five weeks. On the fifth week I had a few days that I thought I was not going to live. I had a band of pain and abdominal fluid that felt hard to touch. I had no appetite and I still had severe muscle pain. I was still disoriented and dizzy. Over this time I reached out through telehealth and several medical professional that had no advice. My symptoms seemed to lessen from the five week point with more periods of feeling more normal. I have only felt a little normal for three weeks.
56 2021-03-11 injection site swelling, injection site warmth Day 2 after the shot I began to feel chills and fatigue. My temperature was 102.2 when I checked it.... Read more
Day 2 after the shot I began to feel chills and fatigue. My temperature was 102.2 when I checked it. Later that same day it had gone up to 102.4. I had no appetite and extreme fatigue. Took Tylenol which lowered the fever. Day 3 my temperature stayed at 102.4 and I had painful, swollen glands along my left clavicle, as well as fatigue. Also, the injection site became hot and swollen. Day 4, my temperature has gone down but I have a terrible headache, swollen clavicle glands and a chain of swollen nodes (?) from the base of my skull down the back of my neck on the right side. My left arm is still hot and swollen at the injection site. I've had to miss two days of work.
56 2021-03-11 rash, itchy skin, redness Within seconds tingling and chills surged through my body. As I sat, lips started to tingle, and I h... Read more
Within seconds tingling and chills surged through my body. As I sat, lips started to tingle, and I had chills. Moved to the clinic area. While under observation, symptoms increased. Tongue was reported to be swelling on right side. In retrospect, believe this was lymph nodes.Administered 2 doses together of Benadryl. Oxygen level and blood pressure remained strong. Hands turned bright red and itched. Left at 2:30. Took Benadryl and Tylenol at 3:00. Rashes and itchy throat continued for 48 hours as well as chills and aches. Overall outcome, positive health returned. Lack of energy. Bit of brain fog still remain.
56 2021-03-12 redness At my OMT (Oestopathic Manipulative Therapy) Dr. appt on Wednesday, 3/10/21, my BP was 134/80. On 3/... Read more
At my OMT (Oestopathic Manipulative Therapy) Dr. appt on Wednesday, 3/10/21, my BP was 134/80. On 3/12/21, Friday afternoon around 2:30pm, I noticed my left eye didn't feel right. I looked in the mirror and my left eye was slightly red in the corner of my eye towards my nose. When I woke up this morning on 3/13/21, my eye was completely red in that same corner of my left eye. I went to the a walk-in clinic this morning to have it checked out. The doctor indicated that it was a burst blood vessel in my eye and that the redness should go away in about a week. My BP was 148/100. The doctor asked if I had a history of high blood pressure and I told him no and showed him 3 of my previous BP card records that I keep in my purse. He said I should monitor my blood pressure and follow up with my primary care doctor. I have had a blood vessel burst in my eye before a few years back. I do not remember which eye. I have had fibromyalgia for over 20 years. I was diagnosed with Occular Myesthenia Gravis in January 2017 which affects my left eye only.
56 2021-03-12 injection site pain Nausea, weakness, severe body aches, very painful injection site
56 2021-03-12 rash, injection site pain Pain at injection site, rash on chest and face, severe body aches and pains, nausea, dry heaves, dia... Read more
Pain at injection site, rash on chest and face, severe body aches and pains, nausea, dry heaves, diarrhea.
56 2021-03-12 injection site pain Site: Pain at Injection Site-Medium, Additional Details: pins and needles numbness/ tingling that is... Read more
Site: Pain at Injection Site-Medium, Additional Details: pins and needles numbness/ tingling that is spreading up her arm
56 2021-03-13 itchy skin Light-headed and tired immediately following vaccination that lasted a few minutes; mild labored br... Read more
Light-headed and tired immediately following vaccination that lasted a few minutes; mild labored breathing around 30 minutes post-dose but fine after using inhaler (may have been due to wearing multiple masks vs. vaccine; tension, dull headaches starting 1hr post-dose lasting several hrs; high-pitching ringing in ears starting approx 7-8 hrs post-dose and still have as of March 14 at 5:00pm; systemic itching starting 8-9 hrs post-dose and still have as March 14 at 5:00pm and managing with Benadryl/zyrtec. Alerted Dr. to ringing in ears and following up with Dr tomorrow on ringing in ears and itching.
56 2021-03-14 injection site pain Injection site sore, tiredness, muscle pain all over body (especially my back), chills, sweats, join... Read more
Injection site sore, tiredness, muscle pain all over body (especially my back), chills, sweats, joint pain all over (even my fingers), nausea and just not feeling well. All symptoms was really bad the day after the vaccine. The second day there was some relief and on the third day I was still having most of the symptoms but feeling better than I did the first and second day.
56 2021-03-14 itchy skin PATIENT RECEIVED FIRST DOSE OF PFIZER COVID 19 VACCINE. AT APPROXIMATELY MINUTE 15 POST VACCINATION ... Read more
PATIENT RECEIVED FIRST DOSE OF PFIZER COVID 19 VACCINE. AT APPROXIMATELY MINUTE 15 POST VACCINATION PATIENT STATED THAT SHE WAS HOT AND FELT JITTERY. PATIENT WAS GIVEN WATER AND A BANANA AND HAD SEVERAL COUGHING SPELLS, SAID THAT SHE FELT A LOT OF MUCUS IN HER THROAT AND THAT SHE WAS ASTHMATIC. PATIENT HAD RESCUE INHALER WITH HER BUT NEVER USED IT. PATIENT REPORTED FEELINGS OF ITCHINESS AND WAS OFFERED BENADRYL BY RPH. PATIENT TOOK BENADRYL FROM EMERGENCY SUPPLY KIT. AFTER MINUTE 45 PATIENT WAS FEELING BETTER AND WAS RELEASED FROM OUR CARE.
56 2021-03-14 injection site pain, injection site swelling, injection site redness Patient started developing redness at injection site within 24 hours. The site continued to swell an... Read more
Patient started developing redness at injection site within 24 hours. The site continued to swell and get painful over the next 2 days. Pharmacy contacted on Monday 11/15/21. Patient says the swelling about the size of a "half-dollar". Pharmacy informed patient to use cold compresses and pain reliever (has allergies to NSAID's). Patient will contact MD later if no improvement.
56 2021-03-14 rash papular, itchy rash, rash with redness Rash to anterior neck, 10x10 cm, raised, red, itching.; Rash to anterior neck, 10x10 cm, raised, red... Read more
Rash to anterior neck, 10x10 cm, raised, red, itching.; Rash to anterior neck, 10x10 cm, raised, red, itching.; Rash to anterior neck, 10x10 cm, raised, red, itching.; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration in the left arm on 30Jan2021 14:00 at a single dose for COVID-19 immunization. Medical history included ovarian cancer and chemotherapy; both from 2018 to an unknown date. The patient's concomitant medications were not reported. The patient has not received other vaccine in four weeks. On 01Feb2021 10:00, patient experienced rash to anterior neck, 10x10 cm, raised, red, itching. Outcome of events was recovering. Therapeutic measures were taken as a result of events includes Claritin, steroid and antihistamine. Events resulted in doctor or other healthcare professional office/clinic visit. The patient was not diagnosed of covid prior vaccination and has not tested for covid post vaccination.
56 2021-03-14 redness, dry skin Swollen lymph nodes under arm, small red, dry area on arm, pimple style sores
56 2021-03-14 itchy skin, hives annoying feeling in her chest; allergic reaction; Her pressure was low then normal then high.; nonre... Read more
annoying feeling in her chest; allergic reaction; Her pressure was low then normal then high.; nonresponsive for a few moments/was asked a question and did not respond; sweats; high blood pressure; annoying pain; itching; hives on the arms and chest; Hot flashes; This is a spontaneous report from a contactable consumer (patient) A 56-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# EN5318 at left arm on 16Feb2021 at SINGLE DOSE for covid-19 immunisation . Age at vacciantion 56 years.Vaccination Facility Type: Workplace Clinic. Medical history included ongoing allergies (5-10 years). She had a flu shot in Oct2020. There were no concomitant medications.Immediately after the vaccine she became nonresponsive for a few moments, broke out in sweats, had high blood pressure, annoying pain, and has been having itching and hives on the arms and chest.Clincal course was reported as follows: On 16Feb she had hot flashes,pruritus and blood pressure has not been right .On17Feb she developed annoying feeling in her chest.Then , it was added as follows: she received the first dose of the Covid-19 vaccine on 16Feb2021. She had an allergic reaction. The second dose was due 09Mar2020. She was under the impression that she has to take the vaccine she was told she needed a cocktail to get the shot.She had hot flashes and was itching. Her blood pressure has not been right. Her pressure was low then normal then high. She has an annoying feeling in her chest. The itching has stopped after she was medicated. She can't take Benadryl and she was given something else. She applied hydrocortisone cream and it helped. She had a flu shot in Oct2020. She went to the ER on 20Feb2021 because her blood pressure was spiking too high. She had an EKG which was normal. When she went to the ER her blood pressure was 167/100. Yesterday her blood pressure was 167/102. She was nervous about taking the second dose. Her blood pressure usually ranges from 119-120. It was off the charts at 130/80 and 150/99. Pateint was treated for pruritus.She was wondered if she can get the second dose .Events reported as non serious.Lab data included:EKG on20Feb2021:normal.Blood pressure measurement (16Feb2021): has not been right. Her pressure was low then normal then high , blood pressure measurement: 167/100 on 20Feb2021 , blood pressure measurement: 167/102 on 24Feb2021.Patient's recovered from pruritus while the outcome of the other events was unknown.
56 2021-03-15 itchy skin Itching started in feet immediately after shot. Weird pain in lower middle back. Itching progresse... Read more
Itching started in feet immediately after shot. Weird pain in lower middle back. Itching progressed to entire body after about an hour. Took 12.5 mg Benadryl, then took 12.5 mg two hours later. Next day arm was swollen and aching, itching continued. Took 625 mg Tylenol Arthritis, 25 mg. Hydroxyzine every 8 hours for two days.
56 2021-03-15 hives Patient self-reported to the clinic that she experienced intermittent hives over a 3 week period aft... Read more
Patient self-reported to the clinic that she experienced intermittent hives over a 3 week period after receiving the Pfizer vaccine.
56 2021-03-15 itchy rash, rash with redness, rash Received Pfizer vaccine @ 10:00 am in my left arm. Heart palpitations and headache started about 2 ... Read more
Received Pfizer vaccine @ 10:00 am in my left arm. Heart palpitations and headache started about 2 hours after vaccine. Took Tylenol around 3:00 pm because headache worsened. Around 7:00 pm, I broke out in a red bumpy and very itchy rash around both ankles, with the worst being on my left ankle. I took Benadryl and rubbed Cortizone 10 on the rash. Rash did not spread any further overnight, but heart racing continued throughout the night. By 03/12/2021, I was no longer itching, but still had the rash. Heart palpitations/racing was gone.
56 2021-03-15 hives flushing on upper torso and face, hives on lips, tingling of tongue, throat itching , bloating and g... Read more
flushing on upper torso and face, hives on lips, tingling of tongue, throat itching , bloating and gas approximately 35 to 40 minutes after injection. Self dosed with Benadryl, alerted my physician
56 2021-03-15 redness pain in R arm/bicep swollen lymph nodes over right clavicle, with redness and pain on palpation
56 2021-03-16 rash papular, rash Diffuse pruritic papular rash that spread over back, arms, legs, neck, etc
56 2021-03-16 rash, redness I experienced a redness and heat coming from my chest on the third day (Sunday) and a few bumps -ras... Read more
I experienced a redness and heat coming from my chest on the third day (Sunday) and a few bumps -rash. I contacted my Dr and he prescribed steroids and I took one week course. It calmed it down a little. My chest wasn't red any more after that. I got another bump last week (on my finger) but it disappeared and then it went away. I started having dizziness about two weeks ago. I still am a little dizzy. I feel a little dizzy when I go to bed at night - the bed spins. I wake up and I'm okay but during the day, I get a little dizzy and lose my step and get it back but at night when I lie down I notice it the most.
56 2021-03-17 injection site pain About 3 days after the vaccine I started feeling arm pain (right below the shoulder, not exactly at ... Read more
About 3 days after the vaccine I started feeling arm pain (right below the shoulder, not exactly at the injection site, a little back), in the evening, around suppertime. In the morning it got much worse. I had a little trip the next morning (3 hours each way) and when I returned home the pain was really severe. Used Ibuprofen at home and it solved the problem at first (for the weekend), it would take off that edge. But by Tuesday, I noticed that it was not getting any better just would ease off while taking Tylenol and Ibuprofen. Decided to go see my PCP. Initially PCP thought it was a case of tendinitis and was treated with Voltaren and Tramadol for night time in case it was too hard to sleep. Took Voltaren for a couple of days but did not see any real improvement so decided to go back to the Ibuprofen. The next Monday or Tuesday (about a week later) it was really really bad, and PCP gave me a shot of cortisone into that shoulder because at that time I was feelings numbness on my fingers and horrible pain in the shoulder. About 48/72hrs after the shot the pain subsided but the numbness and the tingling on my pointer finger and thumb were still present. The pain went away in about a week. Then PCP decided to refer me to see a neurologist. By the time I had my appt the numbness and tingling were much better and I had some tests done and they came back normal. Never lost strength in my arm. Neurologist said the numbness and tingling should go away on its own. Now, 2 months later he numbness and tingling are really mild, I am a stomach sleeper and I can't because if I do it will make my arm tingling again. Nowadays I feel it maybe once or twice a day an not extreme.
56 2021-03-17 injection site pain Chills and tiredness on 3/14/2021. Injection site pain from 3/14-3/17. Sore breasts from 3/15-3/17. ... Read more
Chills and tiredness on 3/14/2021. Injection site pain from 3/14-3/17. Sore breasts from 3/15-3/17. No treatment. Outcome - resolved.
56 2021-03-17 itchy skin generalized pruritus, resolved after PO Benadryl administration
56 2021-03-18 hives, itchy skin, redness "PFIZER COVID 19 VACCINE EUA". Patient received first dose Pfizer vaccine (right deltoid) today at v... Read more
"PFIZER COVID 19 VACCINE EUA". Patient received first dose Pfizer vaccine (right deltoid) today at vaccination site. Due to Pt's hx of moderate allergice reaction to IV iodine during a medical procedure "years ago", pt placed on 30-minute ovservation period. Approx 10 minutes into observation, pt notified staff that she felt some itching on her right arm in crease of elbow. Pt. also saw what she described as bumps or hives the size of a half dollar. Pt moved to private restroom and redness and swelling found progressing behind pt's right knee 5 minutes later. IM Benedryl administered to patient and transport medic unit called. Full report given to transport crew. Pt transported to ED.
56 2021-03-18 injection site pain Fever, chills, headache, N/V, injection site pain beginning 3/13/2021, reports that she "passed out"... Read more
Fever, chills, headache, N/V, injection site pain beginning 3/13/2021, reports that she "passed out" on 3/13/2021. Spoke with PCP who advised her to go to hospital but she did not go. Taking tylenol as needed. Started feeling better yesterday, eating and drinking. Advised to follow PCP recs and we will follow up with her tomorrow.
56 2021-03-18 rash Full arm rash on left arm. Rash on both hands also.
56 2021-03-18 rash, skin warm Within 5 minutes, burning and swelling in throat, cramps and diarrhea, flushing and hot neck and fac... Read more
Within 5 minutes, burning and swelling in throat, cramps and diarrhea, flushing and hot neck and face, rash on chin and face. Responded to Benadryl and Ventolin.
56 2021-03-19 itchy skin 5 minutes after the shot my heart began to beat very hard and very fast. It lasted about 5 minutes. ... Read more
5 minutes after the shot my heart began to beat very hard and very fast. It lasted about 5 minutes. For the remainder of the day into the evening I had heart palpitations. The following day I felt tired and nauseous until around 11am. My arm is sore and itchy.
56 2021-03-20 itchy skin 56 year old F with hx/ of multiple autoimmune conditions and hx/anaphylaxis to multiple agents prese... Read more
56 year old F with hx/ of multiple autoimmune conditions and hx/anaphylaxis to multiple agents presented with generalized pruritis 10 minutes after receiving first dose of Pfizer COVID-19 vaccine. Denied lip swelling, tongue swelling, or throat swelling, and had absence of urticaria. Received 50 mg of PO Benadryl with some improvement in her symptoms prior to leaving facility. Advised of CDC Recommendation to avoid second shot with any allergic reaction to the first dose. Counseled to discuss with her allergy/immunology physician prior to making a decision about whether to return for a second dose.
56 2021-03-20 hives, itchy skin, rash Three days after injection, there was a sudden onset of hives over much of my body, accompanied by a... Read more
Three days after injection, there was a sudden onset of hives over much of my body, accompanied by an intense feeling of heat. Affected areas were face, neck, arms, hands, and knees. I took one Benadryl and went to bed. The next morning, most visible signs of the rash are gone, with a slight itchiness remaining.
56 2021-03-21 hives Hives on face beginning approximately 6 hours post vaccine and dissipating approximately 36 hours po... Read more
Hives on face beginning approximately 6 hours post vaccine and dissipating approximately 36 hours post vaccine. Hives on face again beginning 18 days post vaccine. Patient has never had hives before. Wondering if it is related to vaccine and whether to proceed with second vaccine.
56 2021-03-21 injection site rash Large rash at injection site
56 2021-03-21 bruising RECTAL BLEEDING AND EASILY BRUISING NOTED IN THE LAST 2 DAYS
56 2021-03-22 injection site rash, rash After the expected reaction of fever, chills and aches subsided. I developed a rash at injection sit... Read more
After the expected reaction of fever, chills and aches subsided. I developed a rash at injection site that spread to my right arm and right side of my back
56 2021-03-22 injection site pain Injection site soreness shortly after administration. Fever started by 7:30 a.m. on 3/21/21, Fever r... Read more
Injection site soreness shortly after administration. Fever started by 7:30 a.m. on 3/21/21, Fever reduced after taking Advil. By 7:00 p.m. 3/21/21, fever returned and achiness and respiratory distress started. Asthma medication administered, but only helped for a couple minutes at a time. An additional dose of Mucinex also administered. Respiratory distress increased if lying down. Respiratory distress eased by 8:00 a.m.. on 3/22/21.
56 2021-03-22 injection site pain, injection site pruritus Just a very sore arm, and itchiness at the injection site on March 23. I hope within a few days it ... Read more
Just a very sore arm, and itchiness at the injection site on March 23. I hope within a few days it will go away.
56 2021-03-22 hives, itchy rash Two days after vaccine - I break out in a rash on my arms, legs, back, neck. It is a allergic react... Read more
Two days after vaccine - I break out in a rash on my arms, legs, back, neck. It is a allergic reaction rash. It has lasted four days and still going. Very itchy and burning. Red welts. Have been taking Bendryl and Zytrtec
56 2021-03-23 injection site pain 3/22/2021 at 12:00 p.m. Intense headache relieved somewhat with Tylenol. Ended around midnight on 3... Read more
3/22/2021 at 12:00 p.m. Intense headache relieved somewhat with Tylenol. Ended around midnight on 3/23/2021. 3/22/2021 at 1:00 p.m. mild diarrhea which lasted until 3/23/2021 7:00 a.m. 3/23/2021 1:00 p.m. overall weakness and fatigue. Resolved 3/24/201 at 7:00 a.m. 3/22/20221 7:00 p.m. left arm pain at injection site. Almost completely resolved 3/24/2021 at 7:00 a.m.
56 2021-03-23 itchy skin Itching at various areas from waist to head. Used benadryl. To relieve itching.
56 2021-03-23 rash with redness Red rash on chest and on the back; This is a spontaneous report from a contactable other health care... Read more
Red rash on chest and on the back; This is a spontaneous report from a contactable other health care professional (patient). A 56-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: El9262) in left arm on 19Feb2021 11:00 AM at single dose for Covid-19 Immunisation. Medical history included osteoporosis. Concomitant medications included teriparatide (FORTEO). Patient was not pregnant, no known allergies. No other vaccine in four weeks. Historical Vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL3247) in left arm on 01Feb2021 12:00 PM for Covid-19 Immunisation. Patient experienced red rash on chest and on the back on 21Feb2021 09:00 AM with outcome of not recovered. No treatment was received. If COVID prior vaccination was No. If COVID tested post vaccination was No.
56 2021-03-23 hives, itchy rash, rash Uticaria rash to left arm and face which occurred 9 days after vaccine. Itching and picking discomf... Read more
Uticaria rash to left arm and face which occurred 9 days after vaccine. Itching and picking discomfort to rash . On antihistamine twice a day, hydrocortisone cream to face and triamcinolone cream to arm. Hydroxyzine for itching. At this time the rash continues . Note my father (different home) had the same reaction with biopsy of rash to confirm and 2 months later is still battling the rash.
56 2021-03-24 itchy skin 1. Mild headache 2. Moderate itchiness all over (I am on my 4th round of antihistamine) 3. On the l... Read more
1. Mild headache 2. Moderate itchiness all over (I am on my 4th round of antihistamine) 3. On the location of the shot (left upper arm) muscles are very tender. It hurts when I put pressure. Unable to sleeping on my left side. 4. Mild stomach pain - typical feeling when I am having an allergic reaction.
56 2021-03-24 injection site pruritus, injection site rash, injection site redness At time of the shot, just a sore arm for about a day. Then fine for a week. One week later the inj... Read more
At time of the shot, just a sore arm for about a day. Then fine for a week. One week later the injection site started to itch. By the 8th day, there was a red itchy rash at injection site.
56 2021-03-24 itchy skin Experienced swelling of eyelids (both L/R), intense itching primarily in eyes, some itching on hand... Read more
Experienced swelling of eyelids (both L/R), intense itching primarily in eyes, some itching on hands and feet, sneezing, runny nose Took 1 25mg Benadryl tablet within 5 minutes of start of symptoms, had to take another 25mg Benadryl tablet approximately 30 minutes later because eyes were continuing to swell and itch Also experienced onset of severe headache about 45 minutes after shot Went to bed and slept for 3 hours after taking the second Benadryl. Felt better after waking, still had slight swelling in eyelids. Experienced minor itching at 10:30 pm, took 2 more Benadryl tablets at 11 pm. Minor eyelid swelling next morning, minimal itching.
56 2021-03-24 itchy skin Flushing/itching. BP 147/104 (pulse 85), 97% O2 sat. Final BP 133/96 (pulse 78), 96% O2 sat. Benadry... Read more
Flushing/itching. BP 147/104 (pulse 85), 97% O2 sat. Final BP 133/96 (pulse 78), 96% O2 sat. Benadryl 25 mg PO given.
56 2021-03-24 vaccination site itchiness Itching to vaccination site, extending to left lower arm at 12:08, Benadryl PO 25mg administered 12... Read more
Itching to vaccination site, extending to left lower arm at 12:08, Benadryl PO 25mg administered 12:10 by nurse practitioner. Symptoms resolved at 12:15, patient discharged to home.
56 2021-03-24 injection site pain severe arm pain on arm of injection - limited movement and difficulty sleeping due to pain. Sever fo... Read more
severe arm pain on arm of injection - limited movement and difficulty sleeping due to pain. Sever for 2 days, then just sore. After 9 days severe pain returned for 2 days. Now at 14 days am still sore but most range of motion is returning. Have treated with ice and advil but concerned that I won't be healed before vaccine #2.
56 2021-03-25 redness, rash, itchy rash About 10 days after first Pfizer shot I developed red, itchy rash on left side of neck (same side as... Read more
About 10 days after first Pfizer shot I developed red, itchy rash on left side of neck (same side as shot). It was improving then 2 weeks after second shot in other (right) arm it flared back up and worsened significantly. Bright red, itchy painful rash all over neck, red swollen eyes, rash patches on face, down arms and hands. Treated with antihistamines and cortisone ointment. Overall rash symptoms lasted about 6 weeks, while worst symptoms lasted several days. While not formally diagnosed with covid, I believe I had it Jan-March 2020 and the final symptom was a very similar rash on my neck. These are the only 2 times I have ever had such a rash. I have photos to share of you want to see them.
56 2021-03-25 blister, cellulitis Cellullitis with large blisters & orange draining watery fluid
56 2021-03-25 injection site pain I experienced mild fatigue and headache about 24 hours after shot. It actually got a bit worse the ... Read more
I experienced mild fatigue and headache about 24 hours after shot. It actually got a bit worse the 2nd day after the vaccine. It is now the 3rd day after the vaccine and I am feeling better. I also had significant pain at the sight of the injection, enough pain that it woke me up the night right after I received the shot when I rolled over in bed and pressed on the painful area.
56 2021-03-25 redness, itchy skin Patient made online appointment for Covid Vaccine. On immunization consent form, she noted that she ... Read more
Patient made online appointment for Covid Vaccine. On immunization consent form, she noted that she didn't have any allergic reaction to another vaccine or to an injectable medication but she has allergy to sunflower, flaxseed, and latex. So she received Pfizer vaccine. 9 minutes after the vaccine, patient started to feel itchiness on her face especially around the nose and mouth, then she felt it going down to her chest. Vaccinating pharmacist noticed that the patient was getting redness around patient's neck, she called other pharmacist and they both went to talk to the patient. When patient was asked about symptoms that she was feeling, patient mentioned that it was the itching that bothered her the most. She denied that she has difficulty breathing or dizziness. So I drew up 1 mL of diphenhydramine and injected it IM to the other arm. Pharmacist watched her for another 20 minutes in the room. Patient kept complaining about the itchness but no other symptoms. Patient called her husband to come and pick her up. Patient was instructed to take benadryl at home if symptoms persist. And patient was also instructed to see medical help if symptoms were getting worse. Husband came and picked up the patient and patient went home
56 2021-03-26 itchy rash, redness, skin warm, injection site swelling No reaction after first shot on February 28, 2021. Second shot on March 19, 2021 a Large red, itchy... Read more
No reaction after first shot on February 28, 2021. Second shot on March 19, 2021 a Large red, itchy rash started two days after injection with arm being warm to touch, swollen and a large bump at the injection site for 7 days and then on the 8th day redness disappeared somewhat but then hive-like bumps appeared and itch worsened. The Pharmacy called and we had to come in two days early as the vaccine was going to expire on Saturday at 3:00 p.m. so we went on Friday at 6:00 p.m.
56 2021-03-27 itchy skin, rash macular, injection site bruising, injection site reaction Red, itchy splotch on skin directly below injection site. Also bruising at injection site.
56 2021-03-27 redness Sarcoidosis was in remission. I am now in full blown flare with severe joint pain and stiffness, swe... Read more
Sarcoidosis was in remission. I am now in full blown flare with severe joint pain and stiffness, swelling, redness. Extremity swelling. Coughing and chest pain. Extreme fatigue. Today, the pain is so bad I am on the couch. Doctors visit tomorrow
56 2021-03-28 redness, itchy skin 3-24-21 7:25PM PT 'ITCHING TO BOTH ARMS, BACK AND LT LEG'. SLIGHT REDNESS NOTED. NO SOB/DYSPNEA, NO... Read more
3-24-21 7:25PM PT 'ITCHING TO BOTH ARMS, BACK AND LT LEG'. SLIGHT REDNESS NOTED. NO SOB/DYSPNEA, NO DIFFICULTY SWALLOWING. A/O, PINK, W/D, RESP WITH EASE.NO ACUTE DISTRESS NOTED. BENADRYL 50MG PO GIVEN. 7:31PM PT STATES SHE IS 'FEELING BETTER AND OK TO GO HOME'. AMBULATORY TO EXIT - GAIT BRISL AND STEADY.
56 2021-03-28 injection site pain Extreme tiredness two hours post vaccine. Eleven hours post vaccine, extreme nausea, headache, body ... Read more
Extreme tiredness two hours post vaccine. Eleven hours post vaccine, extreme nausea, headache, body aches, chills, fever, pain at vaccination site. 24 hours post vaccine: Extreme nausea and vomiting, diarrhea, fever, body pain, difficulty remaining awake, extreme aversion to light and sound, headache. Currently 96 hours post second dose of Pfizer vaccine and still have leg aches, cramps, severe tiredness and diarrhea.
56 2021-03-28 rash within 4 hours and 20 minutes of receiving the Pfizer vaccine I had a rash on my Right forearm that ... Read more
within 4 hours and 20 minutes of receiving the Pfizer vaccine I had a rash on my Right forearm that last approximately 3 hours and then disappeared. My throat was itchy for six days (I have No other allergies other than the medication Levaquin which was disclosed at the time of the vaccine. I was assured ingredients from Levaquin are not in the vaccine). That evening at approximately 9:30 my tongue swelled slightly and stayed that way for four days
56 2021-03-29 rash, itchy skin A rash developed; Within three hours of receiving the Pfizer vaccine my right thigh became painful; ... Read more
A rash developed; Within three hours of receiving the Pfizer vaccine my right thigh became painful; started itching; area of the rash is tender when pressure is applied; This is a spontaneous report from a contactable consumer (Patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration, administered in Left arm on 16Feb2021 16:00 as SINGLE DOSE for covid-19 immunisation. Medical history and concomitant medications were not reported. If Other vaccine in four weeks: No. Facility type Vaccine: Doctor's office/urgent care. if Covid prior vaccination: No, if covid tested post vaccination: No. known allergies: n/a. The patient experienced a rash developed (non-serious) on 16Feb2021 18:30, within three hours of receiving the pfizer vaccine my right thigh became painful (non-serious) on 16Feb2021 18:30, started itching (non-serious) on 16Feb2021 18:30, area of the rash is tender when pressure is applied (non-serious) on 16Feb2021 18:30. if treatment AE: No. Within three hours of receiving the Pfizer vaccine my right thigh became painful and started itching. A rash developed, about 5" wide and 6" long. The itching lasted about two to three hours. Twenty-four hours after the vaccine, the rash remains and the area of the rash is tender when pressure is applied. For event rash developed, area of the rash is tender when pressure is applied, outcome was not recovered and for started itching, outcome was recovered on unspecified date in 2021, for other remaining, outcome was recovering.
56 2021-03-30 bruising, vaccination site pain Pain at injection site; Bruising; This is a spontaneous report from a contactable consumer (patient)... Read more
Pain at injection site; Bruising; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3247) via an unspecified route of administration in left arm on 27Jan2021 14:00 as SINGLE DOSE for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medications included letrozole 2.5mg, aspirin 81 mg, multivitamins (within 2 weeks of vaccination). The patient had allergies to Amoxicillin. On 27Jan2021 14:00 the patient experienced pain at injection site, bruising. The most recent COVID-19 vaccine was administered at the workplace clinic. No other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. No covid prior to vaccination, Since the vaccination, the patient has been tested for COVID-19. The reporter reported seriousness criteria as non-serious. The outcome of event was recovering. No further follow-up is possible. No information is required.
56 2021-03-30 hair loss severe hair loss/On the left side of my head I had the bald spot 4 cm in diameter bald no hair; phys... Read more
severe hair loss/On the left side of my head I had the bald spot 4 cm in diameter bald no hair; physiological traumatic; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6199), via an unspecified route of administration, administered in the left arm on 07Mar2021 14:15 (at the age of 56 years old) at a single dose for COVID-19 immunization. Vaccination was done in a hospital. Medical history included type 1 diabetes, psoriasis and sensitive immune system, all from an unknown date and unknown if ongoing. The patient was not pregnant. There was no other vaccine in four weeks. There were no known allergies. Concomitant medications included insulin taken for type 1 diabetes mellitus, start and stop date were not reported. The patient experienced severe hair loss/on the left side of my head i had the bald spot 4 cm in diameter bald no hair and physiological traumatic, both on 08Mar2021 07:30. It was reported that after the vaccination, on 08Mar2021, the patient had severe hair loss and now she has a bald spot of 4 centimeters. The patient's hair started falling out but she didn't think much of it, from time you brush your hair it just happens but as the day progressed they just kept falling out and she had very thick bulky hair and she didn't even look the same and on the left side of her head which was weird because that was the side where she got the shot, on the left side of her head , she had the bald spot 4 cm in diameter bald no hair. Her hair still continues to fall and she can't brush it or touch it because it becomes more severe. As the day progressed, they just kept falling out. This was emotionally, it's horrible, it's like losing part of her body. No treatment was received. She doesn't even know what to do, she went to the doctor today to talk to them about that and then she was going to the dermatologist on Thursday, She never had that in her life. Today is 16Mar2021, and her hair was still falling. It was also reported that she is looking for justice since this is physiologically traumatic. She was scared to wash her hair. It was reported that the events resulted in disability/permanent damage. No treatment was received. There was no COVID prior vaccination and not COVID tested post vaccination. The patient underwent lab tests and procedures which included Hemoglobin A1-C: 6.2 (average blood sugar is 6.2) on an unspecified date. The outcome of the events was not recovered.
56 2021-04-08 itchy skin 57 y/o with Past Medical History of Rheumatoid Arthritis on Methotrexate and a biologic medication ... Read more
57 y/o with Past Medical History of Rheumatoid Arthritis on Methotrexate and a biologic medication completed her 15 minute observation period post administration of her 2nd Pfizer COVID vaccination. As she walked out and she began listing to the right side. She sat down, confused, and complaining of chest pain. She also noted pruritus over her face and scalp. No c/o Shortness of Breath, wheezing or nausea. She was immediately evaluated by me and EMT's . Vital signs demonstrated a HR of 74 in sinus rhythm, O2 Sat of 98% and BP was 192/104. She did not have a rash but was scratching at pruritic areas on scalp and face. See continuation page...
56 2021-04-11 itchy skin, hives generalized itching, intermittent hives over torso and arms
56 2021-04-12 vaccination site pain elevated resting heart rate; dizziness; nausea; Injected arm went numb; bad stomach cramps; fever; s... Read more
elevated resting heart rate; dizziness; nausea; Injected arm went numb; bad stomach cramps; fever; smell altered on and off; taste altered on and off; muscle pain; headache; all over pain first 36 hours preventing sleep; a little bleeding from bowel at 24 hrs and nose at 36 hrs; Burning like fire at injection site; Hair follicle pain; a little bleeding from bowel at 24 hrs and nose at 36 hrs; extreme armpit pain like torn muscles; no use of arm first two days; fatigue; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number ER 8733) via an unspecified route of administration at left arm on 27Mar2021 15:15 at a single dose for Covid-19 immunization. Medical history of patient was not reported. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included multivitamin, calcium and fish oil (other medications the patient received within 2 weeks of vaccination). Patient stated as injected arm went numb within 15 minutes and stayed that way 48 hrs, extreme armpit pain like torn muscles began at 48hrs, bad stomach cramps first 24 hours, a little bleeding from bowel at 24 hrs and nose at 36 hrs, no use of arm first two days could not even put a robe on, fever that climbed to 101.7 until breaking first 48 hrs, smell and taste altered on and off. Burning like fire at injection site 12 hours later that came and went in waves for another 36 hrs. Hair follicle paint at 12 hrs when headache started, headache lasting 72 hours, all over pain first 36 hours preventing sleep, nausea began within first hour lasting about 40 hours, muscle pain first 48 hrs, fatigue begins at 36 hrs and continues, elevated resting heart rate since first night, dizziness and light headedness from 1st hour. The patient underwent lab tests and procedures which included body temperature was 101.7 and heart rate was elevated (elevated resting heart rate since first night) on 27Mar2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and also not been tested for COVID-19 after vaccination. The outcome of event was recovering.
56 2021-04-13 rash Received 2nd dose of vaccine on Wednesday. About 5 hours after 2nd dose, chills and fever. Part-way ... Read more
Received 2nd dose of vaccine on Wednesday. About 5 hours after 2nd dose, chills and fever. Part-way through night (about 12 hours after) started with violent diarrhea and intense abdominal pain. Fever continued for about 65 hours. 2 X 3 inch rash appeared on thigh on Friday, 2 days after receiving vaccine. Liquid diarrhea continued despite fever breaking, as did intense abdominal and back pain. Pain medication helped temporarily with pain. Immodium tried on Saturday but only made things worse. Became dehydrated. Visited emergency department on Sunday morning, 4 days after receiving vaccine. Was diagnosed with infectious colitis and possibly Lyme disease. Treated with doxycycline and metronidazole. Received 2 liters of IV fluid for dehydration.
56 2021-04-17 injection site redness, vaccination site pain, vaccination site swelling, injection site warmth Received 2nd shot of Pfizer-BioNTech COVID-19 vax on 04/14 @ Church (vax card not on hand). 04/15 - ... Read more
Received 2nd shot of Pfizer-BioNTech COVID-19 vax on 04/14 @ Church (vax card not on hand). 04/15 - felt fine, able to mow lawn + ride her Harley. 04/16 - started to have some localized pain on R arm at vax site - tolerable. 04/17 PM - started to have worsenign pain, swelling in R arm at vax site, radiating down. 04/18 - presented to hospital for evaluation, R arm swelling, warmth, redness noted, most prominent in upper arm surrounding deltoid. On DVT US - found to have partially occlusive thrombus in subclavian, axillary, and basillc veins. Plt = 201K, within baseline of 170s-210 within the past 10 years.
56 2021-04-19 injection site pain Woke up at 2am (approx 14 hrs after vaccine) with bad chills/shaking/sweating, fell asleep for a few... Read more
Woke up at 2am (approx 14 hrs after vaccine) with bad chills/shaking/sweating, fell asleep for a few hours then woke up feverish, bad headache, major bodyaches, nauseous with throwing up throughout the day, fatigue, weakness and sore arm at injection site so I slept most of the day in general, in between sickness. 2nd day after vaccine, April 15th I woke up with still a bad headache, bodyaches, nauseous, and sore arm. Headache subsided that night. April 16th I still was nauseous most of day and sore arm. Took extra strength tylenol a couple times on April 13th, 14th and 15th.
56 2021-04-20 rash Fever; chills; severe abdominal and back pain; severe abdominal and back pain; severe cramping; unre... Read more
Fever; chills; severe abdominal and back pain; severe abdominal and back pain; severe cramping; unremitting liquid diarrhea; infectious colitis; rash on leg; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received second dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 56-years-old via an unspecified route of administration, administered in Arm Left on 31Mar2021 08:45 AM (Lot Number: EW0150) as single dose for covid-19 immunisation. Medical history included Coronary artery disease; Acid reflux; possibly Lyme disease (1-4 days prior to vaccine), known allergies was Paradoxical reaction to Benzodiazepines. Concomitant medications included clopidogrel; ezetimibe; evolocumab (REPATHA); rosuvastatin and Ome. No other vaccine in four weeks. The patient received first dose of BNT162b2, at the age of 56-years-old via an unspecified route of administration, administered in Right arm on 10Mar2021 12:00 PM (Lot Number: EN6207) as single dose for covid-19 immunisation. Patient experienced Fever, chills, severe abdominal and back pain, severe cramping and unremitting liquid diarrhea, infectious colitis, rash on leg all on 31Mar2021 with outcome as Recovering. The events resulted in Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Treatment received was IV fluid, antibiotics. No covid-19 prior vaccination. Covid-19 test post vaccination was PCR, covid test type post vaccination was Nasal Swab on 04Apr2021, result was Negative.
56 2021-04-24 redness tightening sensation in throat air way restricting; tightening sensation in throat air way restricti... Read more
tightening sensation in throat air way restricting; tightening sensation in throat air way restricting; Taste in mouth followed by burning sensation throughout my body; Taste in mouth followed by burning sensation throughout my body; Turned red skin hot to touch; Turned red skin hot to touch; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received BNT162B2 (Brand: Pfizer), dose 2 via an unspecified route of administration, administered in arm right on 13Apr2021 (Lot Number: EW0158) as single dose for COVID-19 immunisation. Medical history included asthma and high blood pressure. Known allergies: Sulfa drugs. If Covid prior vaccination: No. If Covid tested post vaccination: No. The patient was not pregnant. The patient's concomitant medications were not reported. If other vaccine in four weeks: No. The patient previously received first dose of BNT162B2 on 23Mar2021 01:15 PM (Lot number: ER5732), in left arm, at the age of 56-year-old for COVID-19 immunization. 1st shot hot spot red swelling at injection area. 2nd shot severe instant adverse reaction. The patient experienced taste in mouth followed by burning sensation throughout her body. Turned red skin hot to touch. Immediately followed by tightening sensation in throat air way restricting on 13Apr2021 at 01:45 AM. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Treatment was received for the events which included Medics treated oxygen Dr administered Benadryl. The patient was recovering from the events.
56 2021-04-26 vaccination site pain Injection site soreness; This is a spontaneous report received from a contactable consumer. A 56-yea... Read more
Injection site soreness; This is a spontaneous report received from a contactable consumer. A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL 3247) via an unspecified route of administration in left arm on 22Feb2021 12:00 at single dose for COVID-19 immunization. Patient medical history included ADHD and Depression. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), multivitamin, fish oil and ademetionine (SAM-E). On 23Feb2021 05:30 patient experienced with Injection site soreness. Patient did not receive any treatment. Outcome of event was recovering.
56 2021-04-27 hair loss it started falling out into my hands/ My hair is very thin now; This is a spontaneous report from a ... Read more
it started falling out into my hands/ My hair is very thin now; This is a spontaneous report from a contactable Nurse (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Right on 19Mar2021 07:15 (Batch/Lot Number: Ep7534) as SINGLE DOSE for covid-19 immunisation. The patient is not pregnant at time of vaccination. Medical history included HBP and Pre-Diab both from an unknown date and unknown if ongoing (reported as Other medical history: HBP, pre-Diab). The patient had no Covid prior vaccination and not tested for Covid post vaccination. No other vaccine in four weeks. The patient was vaccinated at a clinic. Concomitant medication (reported as other medications in two weeks) included sitagliptin phosphate (JANUVIA [SITAGLIPTIN PHOSPHATE]), metformin (METFORMIN), asa (reported as 325), colecalciferol (VIT D3), metoprolol (METOPROLOL), famotidine (FAMACE); all taken for an unspecified indication, start and stop date were not reported. The patient previously took bnt162b2 for COVID-19 immunization first dose (lot: EL8982) on 27Feb2021 at 08:00 am administered in left Arm. It was reported that "Within a few days of my 2nd shot, I was in the shower washing my hair and it started falling out into my hands. I haven't changed any hair products. I've always had nice thick hair. I told my Dr during a visit 06Apr2021, he didn't note any bald patches. My hair is very thin now, Im hoping this is temporary." It was reported that the event occurred on 21Mar2021 at 08:00 am. The outcome of the event was not recovered. The events resulted in Disability or permanent damage.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event alopecia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
56 2021-04-28 vaccination site itchiness, rash, vaccination site rash raised rash on LEFT forearm & upper arm with itching & burning sensation; raised rash on LEFT forear... Read more
raised rash on LEFT forearm & upper arm with itching & burning sensation; raised rash on LEFT forearm & upper arm with itching & burning sensation; raised rash on LEFT forearm & upper arm with itching & burning sensation; raised rash on RIGHT forearm; This is a spontaneous report from a non-contactable consumer (patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 26Mar2021 at 10:15 at single dose for COVID-19 immunization. Medical history included allergic to penicillin, tetracycline, keflex, all sulfa drugs, Diflucan. Concomitant medication was not reported. Patient was not pregnant at time of vaccination. On 18Mar2021, patient tested nasal swab and resulted negative. Since the vaccination, the patient had been tested for COVID-19. On 26Mar2021 at 11:00, the patient experienced raised rash on left forearm & upper arm with itching & burning sensation. The patient visited doctor or other healthcare professional office/clinic and emergency room/department or urgent care. Patient received treatment with steroids & Benedryl. The outcome of the events was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
56 2021-04-30 vaccination site pain only on my left side I had: muscle and joint pain; only on my left side I had: muscle and joint pain... Read more
only on my left side I had: muscle and joint pain; only on my left side I had: muscle and joint pain; earache; goopy eye; headache; exhaustion; pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 56-years-old non-pregnant female patient received bnt162b2 (Pfizer, Solution for injection, Lot Number: EL3302), dose 1 via an unspecified route of administration, administered in arm left on 13Jan2021 13:30 (at the time of 56-years-old) as single dose for covid-19 immunisation. Medical history included Von Willebrand's and history of lyme disease, allergies: Peanut and latex. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received vitamin supplements within 2 weeks of vaccination. Concomitant medication included vitamin supplements. After first shot in left arm, only on my left side I had: muscle and joint pain, earache, goopy eye, headache, exhaustion, and pain at injection site from 12 hours to 36 hours after shot administered on Jan2021. The patient received treatment as epipen on hand. Therapeutic measures were taken as a result of events. The outcome of events was unknown.
56 2021-05-04 injection site swelling, injection site redness, skin warm, rash macular Red, hot, itchy swelling directly under site of injection. Blotchy redness down arm to below elbow.
56 2021-05-05 hives, rash Approx 24 hours after shot 1 I started developed a rash and hives. It was mild at first but was get... Read more
Approx 24 hours after shot 1 I started developed a rash and hives. It was mild at first but was getting worse when I got my second shot. The hives are very uncomfortable but benedryl alleviates them for 12 to 24 hours.1.5 weeks after shot 2 it is remaining the same or getting worse.
56 2021-05-05 hives HIVES ON FEET
56 2021-05-10 vaccination site itchiness, vaccination site redness, vaccination site swelling, vaccination site warmth she thinks may be blood clot or a muscle but not really sure; passed out; very anxious and nervous; ... Read more
she thinks may be blood clot or a muscle but not really sure; passed out; very anxious and nervous; her heart is beating fast and she is nervous.; burning sensation in her ear; tiredness; headache; heaviness on her back and chest on the left side; heaviness on her back and chest on the left side; no appetite; nauseous; diarrhea; throbbing is almost like a band-aid is too tight. If she rubbed her hand across her thigh she could feel crushing and throbbing; her heart is beating fast and she is nervous.; sharp pain in her thigh/pinching sensation on inner thigh; sick; throbbing; muscle pain; weird sensation; throbbing sensation to the left side of her belly button/It was like at her stomach; fever of 100.3F; had a feeling of heat on her neck, face, and ears; redness and itchiness at the injection site; redness and itchiness at the injection site; the injection was large, red, hot, and itchy; the injection was large/ the swelling went down; dizzy; This is a spontaneous report from a contactable consumer reported herself. A 56-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included disability, obese, covid-19 when she was sick with COVID last year, she has never been that sick. she thinks she made it through because she owns a nebulizer and can say her lungs have never felt like they were full of fluid. If anything, they felt heavy. It was heavy in her back and chest. She also had a fever. She guesses she would be considered obese. Concomitant medications included paracetamol (TYLENOL). The patient received the first dose of the Pfizer COVID vaccine last week and she has experienced several side effects and is very anxious and nervous. She experienced redness and itchiness at the injection site, pinching sensation on inner thigh that she thinks may be blood clot or a muscle but not really sure, fever of 100.3F from 24Apr2021, burning sensation in her ear, tiredness, headache, heaviness on her back and chest on the left side, no appetite, nauseous, diarrhea, had a feeling of heat on her neck, face, and ears, throbbing sensation to the left side of her belly button from 26Apr2021 and she felt dizzy from 22Apr2021. The patient stated there was a bad connection and she was having difficulty hearing. The patient was a little nervous. Maybe this was a psychosomatic issue and she was thinking of things too much. She was sick for 5 weeks. She was never in the hospital or intubated. The site where she had the injection was large, red, hot, and itchy. It was from 22Apr2021 (Thursday) for the next maybe 3 days. Now the color is diminishing, the color is going down more like to pink and smaller and it not itching anymore. Once in a while she got a pinching sensation on her inner thigh ever since she had the injection. In the last couple days, she has been feeling a that a little more. She wanted to make sure it was not a symptom of a blood clot. She doesn't feel short of breath. She was nervous talking the call handler so that is why she is talking fast. She doesn't want to feel so sick like she did last year when she had it in March or April. She wanted to know that it's not a symptom of a blood clot. It was a throbbing pinching pain that goes and doesn't come back for a little bit, but it might come back a little bit later. It happened when she woke up. She has no swelling in her legs or thighs or anything else. She says she would not be talking this fast, but her heart was beating fast and she was nervous. She tended to be an anxious and nervous person. The patient never had blood clot issues. She wanted to make sure with everything that she has heard about Pfizer she hasn't heard of anyone having blood clot issues. She had to read to calm herself down a bit. It is a sharp pain with throbbing that comes and goes. She didn't read where it could be a blot clot, she just wanted to know. She is horrible at running to the hospital when she feels something because she gets so nervous and she thinks knowing is better because she's a realist. It takes her a minute to go to the hospital to figure it out. If she continues to feel like this she and her daughter will go to the emergency room. It is 5 blocks away. It is a small little hospital and they will be able to ease her mind. It could be her nerves getting to her too. Her fever got up to 100.3 and that was only on Saturday, 48 hours after the vaccine. Once she took Tylenol it was gone and didn't return again. She took her temperature; it was a beeping one. She always says she would take like 2 out of 3, and every time she took it went up. She felt a weird sensation of burning in her ears, the same as when she first had Covid, feeling like a fever. It brought her back to a bad place and it freaked her out. She is on disability and has people go to the store for her. She did that for 3 to 4 months. She is not agoraphobic, but she hadn't gone out until she got the vaccine. It took her all day to get back home because she loves the outdoors. It is kind of sad, and she knows she is not the only one who experienced that. She was able to actually stay at home, and when she went out, she wanted to stay. She still has her second dose to take, not everyone in has this and she doesn't want to feel that sick again. Eventually she will perish away one day, from God knows what but a slow death of not being able to breathe she cannot picture for herself or anybody else. She tries not to watch the news, it was depressing, because it is all over the news, she tries to stay in the loop. She was tired and had a headache. She took Tylenol and slept for an hour or hour and half. When she woke up she felt heaviness on her back and chest on the left side, and as she moved around more it was on her back and less on her chest. It was the same as she felt when she had Covid. She didn't have any aches or pains. The other thing was she had no appetite for the next 3 days. Every time she woke up, she felt extremely nauseous but had nothing to vomit. For the next 3 days or 72 hours, she had diarrhea. If she ate anything, she was in the bathroom. On 24Apr2021 (Saturday) after 48 hours she started to feel the heat in her neck and face and ears like right on her ears. She was talking to her daughter and her daughter said these are normal. Where she got the injection was itchy and a little more red. She told herself not to scratch it in her sleep, she is one of those people if something itches, she scratches. What she would do is rub her arm up and down on the site. It was almost the size of an 8 ounce tomato sauce can or maybe the size of a baseball. Then the third day it got redder. In her sleep she was rubbing her arm because it got itchy. Today the swelling went down, the color is like a light pink, and the size is also minimized. The fever lasted that night. She took her temperature again the next day and it was 97.9. That is usually what it is when she wakes up. She is not just tired; she is exhausted and feels like she has to go to sleep. Her daughter came with her granddaughter who is a baby, and she didn't know how to tell them. She was happy to see them but so exhausted. She worries about the sharp pain in her thigh. The other thing is she started getting pain in the middle of her thigh, her inner thigh. A sharp pain with like a throbbing is almost like a band-aid is too tight. If she rubbed her hand across her thigh, she could feel crushing and throbbing. She can feel it from touching the area. She had this before like when she is stretching. It started maybe 3 months ago and went away but then after she took the injection and heard about thing, she worried about a blood clot with Johnson & Johnson, not that she would know because she has never had a blood clot. It could be psychosomatic and all working in her head. It started the last 2 days when she woke up, she felt fine and as she was lying in bed, she started feeling a sharp throbbing pain that eventually goes away. She has no swelling of her legs or thighs, and her daughter said it looks fine. She is semi-terrified of hearing bad news. It takes her longer to go to the hospital. If she starts feeling worse, she will be there in no time. She does not want to wait until it is worse, but she does not want to spook herself into going. She suffers from anxiety. She definitely had the fever not like she was just tired it was like she was exhausted. She got up early and would take a little nap because she was doing a bunch of stuff. That hasn't happened, but that's her. It will be 2300 when she goes to sleep. She was doing a bunch of stuff and felt like she just needed to take a nap. Maybe it is part of that too, but usually she doesn't feel tired like this. After her daughter left, she read something on her phone and passed out. When she woke up, she saw she actually dropped her phone. Her thigh is now not a pinch but more a little bit of a muscle pain. Now it is not like the inner thigh, it is more behind the thigh now, but not below the knee, right behind the thigh, closest to the knee but not on the knee. It is the same thing as if the middle had gone behind her thigh a bit. The little pillow on her chair is not helping anything either. It feels like it maybe muscular, its deep feeling. It feels like it could be muscle, if she rubs it, she can feel it. When asked has it improved persisted or worsened, caller states it is there, but it is dull. She can say there is pain, but it is a little duller just because it is more in the muscle. It is hard to explain, it was not the same throbbing pain but there is a dull pain, it goes around the chunkier part of her thigh, like the inner thigh. When she rubs it there is pain but a dull pain. When she rubs it, it feels better but she can still feel the site where it hurts. When she rubs it, it is still located right in the lower middle going toward her knee but not at the knee, maybe 3 to 4 inches away from the fold of her knee, almost at the center of her thigh almost. Almost like a dull muscle ache, there is a bit of throbbing with it. She will go to the doctor if something weird happens and will call back when they have an idea of what happened to her. This will sound crazy. The next thing she felt was a light throbbing where her belly button is but more to the left side, but not at the belly button. It was like at her stomach, not right at the belly button but right on the same line as her belly button but more at her waist. It was a small throbbing started today about an hour ago. She is hoping it is gas. Her fever went away pretty fast. She was on the phone and took her temperature to tell what it was. The woman said to take some Tylenol. It went from 99.9 to 100 to 100.3. She thought oh no. That was the highest she saw. Then eventually it started going down to 99.4, and then by morning it was back to normal. She only took Tylenol the one time. She is thinking maybe it is from being nervous and causing her body to heat up. She doesn't know she is just thinking. She thinks the fever went away the same day within an hour to 2 hours. She also wasn't drinking enough water. When asked if her fever has recovered completely or with last effects, caller states that is fine now, her temperature today was 99.4 without the fan on, she says she thinks that was pretty normal. When she first wakes up it is 97.9 usually. There was also a 98.4. The redness and itching at the injection site started 3 hours after the injection. She took her 2 sons with her. She took it and then her son took it. They said to wait 15 minutes. As soon as she stepped out, she looked up and felt so dizzy. It looks like when in summer and it seems to be boiling hot, that is how it got for her. Things got blurry. It was not like she was going to black out, but she had to close her eyes because the room was going to spin. She knocked back on the door and took a seat, so she sat down because she was not feeling right. When she gets nervous, she chews gum as a coping mechanism. Her son got some gum for her. She felt better but kind of nervous waiting for 15 minutes to go by, what if she felt dizzy again. She let 20 minutes go by and she got up and was fine. She wanted to be out of there and in the cool air outside. That is the first reaction that she had. She is one of those people that feel so nervous she is sure that happens that they feel like, oh they are so nervous, and they read so much, and it is in our faces everyday no matter what. Maybe it had nothing to do with the injection, maybe more that she was so nervous, but it was a weird sensation after. She knows when people first started getting the COVID vaccine, people were just like falling to the ground, she was like that would be terrible. She went with high expectations and was also nervous. Her heart was beating, and she could hear her own heartbeat. She still feels tired and like she can go take a nap now. She asks if that is normal. She would rather talk to Medical Information now. She is over this statistics part of it. She doesn't feel a release, she is just giving her information and she doesn't feel any better. Outcome of the event throbbing sensation to the left side of her belly button/It was like at her stomach was not recovered; of the event dizzy was recovered; of the events the injection was large, red, hot, and itchy/ the swelling went down, tiredness was recovering; of the other events was unknown. Information about lot/batch number has been requested.
56 2021-05-11 vaccination site itchiness, vaccination site warmth, vaccination site redness headache; Fever was reported as worsened.; low grade fever; allergic reaction redness, warmth and it... Read more
headache; Fever was reported as worsened.; low grade fever; allergic reaction redness, warmth and itching at the injection site; allergic reaction redness, warmth and itching at the injection site; nodule/ bump; allergic reaction redness, warmth and itching at the injection site; nausea; This is a spontaneous report received from a contactable Nurse (patient) via medical information team. A 56-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8727), via an unspecified route of administration, administered in Arm Right on 22Apr2021 at 10:00 (at the age of 56-year-old) as single dose for covid-19 immunization. Medical history included hair dye, allergy vaccines. The patient's concomitant medications were not reported. The patient previously took polyethylene glycol 3350. The patient experienced allergic reaction redness, warmth and itching at the injection site on 24Apr2021, nodule/ bump on 24Apr2021, low grade fever on 26Apr2021, headache on an unspecified date, nausea on 23Apr2021, fever was reported as worsened on an unspecified date. The events were reported non-serious. Patient stated she had delayed reactions, 3 days after the vaccine. She experienced "allergic reaction redness, warmth and itching at the injection site, a nodule/ bump, low grade fever, headache, nausea". She said she is allergic to the hair dye and she feels similar to after taking the vaccine. It could be due to the PEG in it. Patient stated that she was having symptoms that began on day 4 after the vaccine, a red circle around the vaccine site, it's warm and there is a hard knot under the skin. She still has a fever this morning and nausea, bad headache. She stated my concern was the amount of itching right at the site which reminded me of a true allergy not just a side effect. She experienced the same as when she was young. She had allergy vaccines and would react the same. The reaction she had is the same as with this vaccine reaction. She had a bad reaction to hair dye, and I started reading about the ingredient PEG that is sometimes found in that. The ingredient Polyethylene glycol, she had a question asked about the ingredient before the vaccine, she stated I guess that's in the diluent, and she never thought about the bad reaction she had to hair dye. When she put it together, and she understands it is in the vaccine. She was screened before the vaccine and she did have a pretty good reaction to hair dye at the end of last year. Her reaction started 2-3 days ago. Today, the redness is pretty much gone and the itching is gone, but it is still itching slightly. Confirmed that red circles, itching, and warm hard not started on 24th. Her fever was a little bit higher today, but still low grade. She stated when looking at her vaccine card that she may be wrong when it started after. She stated it would have been about 3 days ago so the 25th when the symptoms started. History of all previous immunization with the Pfizer vaccine considered as suspect was none. No additional vaccines administered on same date of the Pfizer Suspect. The adverse events required to go to Emergency Room and Physician Office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events allergic reaction redness at the injection site was recovered on 27Apr2021, events allergic reaction warmth and itching at the injection site, nodule/ bump was recovering, events low grade fever and Nausea was not recovered while for the events headache and Fever was reported as worsened was unknown. No follow-up attempts are needed. No further information is expected.
57 2020-12-31 hives I am a support healthcare worked at a physician's off ice. Therefore, I qualified for the Covid vacc... Read more
I am a support healthcare worked at a physician's off ice. Therefore, I qualified for the Covid vaccine. At 10:15 am on Thursday 12/31/2020 I received the Pfizer Covid 19 vaccine in my left arm at Hospital. After receiving the vaccine, I went to a 15 minute observation area. At approximately 10:20-10:25, I started to get hives on the left side of my neck below the jaw line. When the nurse circulated by to ask how I was feeling, I reported the start of hives and showed her the location. She asked if I frequently get hives and I said yes. She asked if I had any Benedryl with me. I said I did. She directed me to take 1 - 25 mg tablet and advised would call a physician, who arrived soon after. She observed the hives, asked several questions and then I was taken to ER by wheelchair. I was evaluated by PA, given an IV of steriod, prednisone, and montitored for until 12:20 PM, then was discharged.
57 2020-12-31 injection site swelling, injection site pruritus, injection site redness REDNESS AT INJECTION SITE (WHICH IS COMMON) BUT BECAME MORE RED AND ITCHY AFTER 9 DAYS. STILL VERY S... Read more
REDNESS AT INJECTION SITE (WHICH IS COMMON) BUT BECAME MORE RED AND ITCHY AFTER 9 DAYS. STILL VERY SWOLLEN, RED AT SITE, AND PT REPORTS VERY ITCHY
57 2021-01-01 injection site bruising, injection site pain Very sore arm, weakness and dizziness after an hour. Next day, feverish, body aches, overall tired.... Read more
Very sore arm, weakness and dizziness after an hour. Next day, feverish, body aches, overall tired. Arm bruised and more sore than regular I'M injection. Feeling "off".
57 2021-01-03 itchy skin Itchiness in scalp, face and both arms that feels like bugs crawling on my skin, since 1/3. Nausea... Read more
Itchiness in scalp, face and both arms that feels like bugs crawling on my skin, since 1/3. Nausea and diarrhea on 1/4 in the morning, and still have the itching.
57 2021-01-04 injection site pain 48hr Headache which evolved into a migraine with vomiting,lethargy and pain at injection site 1... Read more
48hr Headache which evolved into a migraine with vomiting,lethargy and pain at injection site 12 hour after the injection, fever 99.1
57 2021-01-04 itchy skin, rash allergic reactions; rash on all my chest and in abdomen; Itchiness; Eyes got red; eyes got red and i... Read more
allergic reactions; rash on all my chest and in abdomen; Itchiness; Eyes got red; eyes got red and itch; Chills; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received BNT162B2 (Lot: EH9899), via an unspecified route of administration on deltoid right on 22Dec2020 at single dose for COVID-19 immunization. Medical history included blood pressure high, hypothyroidism, and environmental allergies. Concomitant medications included amlodipine besilate (NORVASC) at 10 mg, daily for blood pressure high, and levothyroxine sodium (TIROSINT) at 112 mcg (ug) for hypothyroidism. Patient got Covid Vaccine on Tuesday (22Dec2020) night and was fine on Wednesday (23Dec2020). She expected the normal side effects like maybe a little fever like that but she believed she was having allergic reactions. It started from 24Dec2020 and she got a rash on all her chest and in abdomen and also just like itchiness feeling all over. So she took some diphenhydramine hydrochloride (BENADRYL) and a PPI 'a cup of' them on 24Dec2020 and she thought that she only had to do that one's today (25Dec2020) and the only thing she noticed when she got the shot (Covid Vaccine) they kept her there for like 15 minutes and her eyes got red and itch. She didn't scratch them but they felt like itchy and she never had that before. She never had a problem with the vaccine before. She didn't know if that was the true allergic reaction to the vaccines or if it just something she had internal allergies and she just didn't know what it was. But she was okay at the time of the report. She took some diphenhydramine hydrochloride a little while before and a PPI (unspecified medication). She was still itchy but it was not that bad and she seemed to be doing fine. Her arm was fine. She was not having any (unspecified), except sometimes. 24Dec2020 she had chills which she expected and she was all good but the side effects whatever happened that way was not the allergic portion. She tried to contact the doctor. The doctor just switched his clinic only for geriatric patients. She had to find another doctor. She knew a Doctor whom she could try and call and she actually went to the infectious disease physician and he said she should go to get the vaccine, now she was trying with that too. She got allergic to anything. Covid Shot was the only thing new that she had in her life but like she was not sure if it was triggered by something out like (unspecified) because she had always environmental allergies too. She didn't know because she was going to consult the Physician on Monday. She was just going to see the regular doctor. She was just seeing that first that anything because she knew it didn't happen very often but the Covid vaccine she just wanted to make report. She was going to the Physician on Monday because right now she thought she didn't know how long it lasted like. Outcome of the events was unknown.
57 2021-01-04 vaccination site pain cough; change in taste and smell; change in taste and smell; injection site pain; feverish but afebr... Read more
cough; change in taste and smell; change in taste and smell; injection site pain; feverish but afebrile; chills; intense headache; nasal congestion; malaise; This is a spontaneous report from a contactable nurse (patient herself). A 57-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; lot number: EKS730, expiration date: unknown), via an unspecified route of administration on the left arm on 18Dec2020 at 13:00 at a single dose for COVID-19 immunization administered at the workplace clinic. Relevant medical history included hypertension (HTN), hypothyroidism, high cholesterol, and COVID-19 prior to vaccination. The patient had no known allergies. Concomitant medications included levothyroxine, amlodipine, and pravastatin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. The patient experienced feverish but afebrile, chills, intense headache, nasal congestion, malaise, cough, change in taste and smell, and injection site pain on 19Dec2020 at 12:00. The events were assessed as non-serious. The patient did not receive any treatment for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient recovered with sequelae/lasting effects from the events "feverish but afebrile, chills, intense headache, nasal congestion, malaise, cough, change in taste and smell, and injection site pain" on an unspecified date.
57 2021-01-04 vaccination site swelling, vaccination site pain, vaccination site redness injection site pain, swelling, and redness; injection site pain, swelling, and redness; injection si... Read more
injection site pain, swelling, and redness; injection site pain, swelling, and redness; injection site pain, swelling, and redness; This is a spontaneous report from a contactable consumer (patient). A 57 year old female consumer (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Lot Number/Expiration date: not provided), via an unspecified route of administration, on 28Dec2020 (at the age of 57 years old), at the hospital she works out of, as a single dose in the left arm for COVID-19 immunization. Relevant medical history included penicillin allergy. Concomitant medication was not provided. The consumer reported that she has taken no new medications, and did not receive any other vaccines when she got this one. On the same day, on 28Dec2020, the consumer experienced injection site pain, swelling, and redness. The consumer described the injection site swelling, and redness as a big bullseye, it is a raised knot, and the whole area is red. The consumer reported that she used a tape measure to measure it, and it was only 2 inches by 2.5 inches. The consumer reported that the redness, swelling, and pain she has does not interfere with her day other than she is sore and it is big. Treatment received for the events included icing it off and on. The outcome of the events injection site pain, swelling, and redness was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
57 2021-01-04 itchy skin, redness metallic taste; developed mild headache; about 30 minutes developed itching and redness of both legs... Read more
metallic taste; developed mild headache; about 30 minutes developed itching and redness of both legs; about 30 minutes developed itching and redness of both legs; Started immediately having dizziness; Right upper facial muscles started twitching around eye area; This is a spontaneous report from a contactable physician (patient). A 57-year-old female patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), intramuscularly on 16Dec2020 14:00 at left arm, at single dose for covid-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. After vaccination injection, the patient started immediately having dizziness from 16Dec2020 14:00 and then about 30 minutes developed itching and redness of both legs on 16Dec2020 14:30. About 2 hours after vaccine on 16Dec2020 16:00 went home still itching with redness, dizziness, developed mild headache and metallic taste. Right upper facial muscles started twitching around eye area. Took Benadryl and Tylenol went to sleep. Woke up 5 hours later, all symptoms gone accept still a little dizzy. By the next morning felt weird then by 24 hours everything resolved. The outcome of the events was recovered in Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
57 2021-01-05 rash, itchy skin Described started "itching 30 minutes after shot administered. That night she noticed a "rash all ov... Read more
Described started "itching 30 minutes after shot administered. That night she noticed a "rash all over her body, no problems breathing". The next day she experienced "swollen lips and tingling and itching from head to toe". She reports she is taking Pepcid and Benadryl. She also reports " no problems with breathing".
57 2021-01-05 redness Patient had redness and flushing around the neck and sweaty palms. Patient reported pain in left ey... Read more
Patient had redness and flushing around the neck and sweaty palms. Patient reported pain in left eye and left forehead above the eye. The patient reported feeling ?out of sorts? with a tingling or numbness from her shoulder to her neck and tingling in the left side of her face. She felt light headed when standing and her feet hurt. She was given diphenhydramine 25 mg and observed for an hour and a half at which time she reported feeling better . Her temperature was 97.5 F at 13:23 and 97.9 at 13:45. She left work early and went to the walk-in clinic later that evening. She reported that the clinic said all of he vital signs were normal and they did not note any specific problems. She took second diphenhydramine 25 mg. She was contacted at around 8:30 AM on 1/6/2021 and reported that she was feeling better.
57 2021-01-05 itchy skin Pfizer-BioNTech COVID-19 Vaccine EUA Approximately, 1 hr after receiving COVID-19 vaccine, noted ge... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Approximately, 1 hr after receiving COVID-19 vaccine, noted general pruritus without rash, mild scleral injection. No other systemic symptoms. Pt treated with Benadryl 25mg x1. Symptoms resolved within 30-45 minutes.
57 2021-01-05 rash Rapid heart rate, shakiness, headache, rash, scratchy throat, raspy voice, dizziness, extreme weakn... Read more
Rapid heart rate, shakiness, headache, rash, scratchy throat, raspy voice, dizziness, extreme weakness
57 2021-01-06 redness, itchy skin 57 yo F, healthcare worker, with history of asthma and penicillin allergy who presented to emergency... Read more
57 yo F, healthcare worker, with history of asthma and penicillin allergy who presented to emergency department for reaction to COVID-19 vaccine. Patient received first dose of COVID-19 vaccine (Pfizer) and immediately became flushed, erythema to trunk and face, and intensely pruritic. No signs of airway involvement or wheezing. Vitals were stable. Patient was treated with benadryl which improved symptoms. Anaphylactoid reaction.
57 2021-01-06 injection site pain Pfizer BioNTech COVID 19 vaccine EUA 0530 on 01/06/21 took naproxen for injection site pain. 0600 on... Read more
Pfizer BioNTech COVID 19 vaccine EUA 0530 on 01/06/21 took naproxen for injection site pain. 0600 on 01/06/21 reports extreme fatigue and continued sore arm at injection site. 1000 started having chills and generalized muscle aches. Temperature elevated to 101.2 at 1545, took Tylenol and temp went down to normal range with 1-2 hours back to 100.0 at 1815. Reports dizziness during that time as well.
57 2021-01-06 redness WARM NAUSEOUS, RAPID HEART BEATS , OBSERVED IN CLINIC IMPROVE AND RELEASED. RETURNED 1 HOUR LATER WI... Read more
WARM NAUSEOUS, RAPID HEART BEATS , OBSERVED IN CLINIC IMPROVE AND RELEASED. RETURNED 1 HOUR LATER WIT SCRATCHY THROAT AND RED NCK AND CHIN. THEATED WITH BENADRYL AND DECADRON FROM THE ED.
57 2021-01-06 rash at 4:08 pm, 10 minutes after receiving vaccine pt reports feeling dizzy and has bilateral rash on ar... Read more
at 4:08 pm, 10 minutes after receiving vaccine pt reports feeling dizzy and has bilateral rash on arms. pt was evaluated by EMS. BP 124/80, P 82, O2 Sat 100%. pt reports feeling better and declined EMS transport to hospital and left AMA 4:26
57 2021-01-07 itchy skin Approx 20 mins after vaccination, just after leaving observation, pt began to complain of itching at... Read more
Approx 20 mins after vaccination, just after leaving observation, pt began to complain of itching at scalp. She mentioned this to one of the vaccination nursing staff. This author arrived as discussion was taking place. Itching increasing to torso, began coughing. Denies dyspnea. Placed in wheelchair and taken to ACC without delay. ACC notifed of arrival and was taken directly to Triage. Arrival vitals: 131/85 81 98.5 R- 20 SPO2= 99 RA At ACC - treated with: - Benadryl 25mg IV - Famotidine 20mg IV - Solumedrol 125mg IV - Albuterol Inhaler Improved after meds.
57 2021-01-07 injection site pain Dizziness, Headache, NauseaVomiting, arm sore at injection site,fatigue Narrative:
57 2021-01-07 injection site pain Fever 101.5, Chils, Rigors, Headache, body ache, much pain at site of injection Treated with tylenol... Read more
Fever 101.5, Chils, Rigors, Headache, body ache, much pain at site of injection Treated with tylenol, benadryl Next day at time of report, symptoms had not resolved.
57 2021-01-07 vaccination site pain Getting sick; I am so upset; typical body aches; headaches; cough; nasal congestion; Pain injection ... Read more
Getting sick; I am so upset; typical body aches; headaches; cough; nasal congestion; Pain injection site; This is a spontaneous report from a nurse (patient herself). A 57-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer Covid-19 Vaccine, lot E"JI"1685 but not clarified), via an unspecified route of administration on 21Dec2020 at single dose, for Covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included levothyroxine. The patient got her first Covid Vaccine on 21Dec202 and got the minimal pain at the injection site which was no big deal but about 10 days later (31Dec2020), she started getting sick. She was getting sick with Covid type symptoms, so she was off of the work and get swabbed yesterday and waiting her result to come out. She had typical body aches, headaches, cough and nasal congestion everything was along with that. She does not think these were side effects of the vaccination but just "quite" (not clarified) wondering how you she felt. She was so upset. She took Ibuprofen and Alcazar. The outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: There is a reasonable possibility that the events vaccination site pain and headache were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other reported events with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
57 2021-01-07 itchy skin Patient complained of generalized itching at 0900. Denied shortness of breath, sweating, hives. 25 ... Read more
Patient complained of generalized itching at 0900. Denied shortness of breath, sweating, hives. 25 MG of IM Benadryl given at 0936. Patient observed observed after. Patient stated denied itching following Benadryl administration.
57 2021-01-07 redness Pt. started feeling tingling in lips and facial flushing within 2 minutes after administration. Dr. ... Read more
Pt. started feeling tingling in lips and facial flushing within 2 minutes after administration. Dr. in clinic for pt. assessment. Pt. uneasy/anxious with increased facial flushing to face and some mild swelling to lips. Pt. with tingling sensation to right side of body. Benadryl 100mg IM administered immediatly per Dr.'s order. Epi-Pen also available if needed. Pt. with improved redness to face and lips after administration.
57 2021-01-07 rash, itchy skin Rash on trunk, Itchiness
57 2021-01-07 vaccination site itchiness, vaccination site redness, vaccination site swelling Return of redness, itching, swelling at injection site one week after injection.; Return of redness,... Read more
Return of redness, itching, swelling at injection site one week after injection.; Return of redness, itching, swelling at injection site one week after injection; Return of redness, itching, swelling at injection site one week after injection; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Dec2020 at 07:30 (at the age of 57-years-old) as a single dose for Covid-19 vaccination. Medical history included Multiple Chemical Sensitivity (affecting my respiratory tract) from an unknown date. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Dec2020 at 20:30, the patient experienced a return of redness, itching, swelling at injection site one week after injection. Therapeutic measures were not taken for the redness, itching, swelling at injection site. The clinical outcome of the events redness, itching, swelling at injection site was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
57 2021-01-07 injection site pruritus, injection site redness Soreness, redness, itching to injection site Severe headache Nausea, vomiting and diarrhea Sym... Read more
Soreness, redness, itching to injection site Severe headache Nausea, vomiting and diarrhea Symptom last about 24 hours.
57 2021-01-08 itchy skin, hives, rash Myalgia, SkinRash, Rash & UrticariaPruritus Narrative:
57 2021-01-08 itchy skin Patient reported feeling itchy during 15 min observation, nothing noted on skin. Resolved at end of ... Read more
Patient reported feeling itchy during 15 min observation, nothing noted on skin. Resolved at end of obs period.
57 2021-01-08 hives, itchy skin Within 15 minutes of vaccine being administered I developed itching then hives on my head which pro... Read more
Within 15 minutes of vaccine being administered I developed itching then hives on my head which progressed to my upper lip. Took 25 mg benedryl capsule at approximately 25 minutes after vaccine administered. Waited 1 hour at vaccine site to ensure benedryl had been effective at slowing progression of reaction. Hives remained for several hours but no rash or other reaction noted. Also had a large broad hive Penny size at the injection site that still remains 19 hours after vaccine injection.
57 2021-01-09 itchy skin Mild General whole body Itchiness ; tachycardia; body tingling sensation Administered 50mg Benadr... Read more
Mild General whole body Itchiness ; tachycardia; body tingling sensation Administered 50mg Benadryl 4mg Dexamethasone 1-10-21 @ 11:28am monitored and resolved by 12pm
57 2021-01-10 itchy skin, hives 5 days after vaccine developed hives. Day 6 and 7 was really really bad hives. Did a tele appt. List... Read more
5 days after vaccine developed hives. Day 6 and 7 was really really bad hives. Did a tele appt. List of meds: Pepcid - 20 mg 2 x/day; Satirazine - 10 mg 1 day per day; benydryl 25 mg - several times a day - took over the weekend (over the counter). On 28th they prescribed Prednisone: 20 mg two times/day for five days. There was a fever with the hives so I wasn't allowed to work; off work for six days (three scheduled and three were scheduled off). Resolved after prednisone. Still a bit itchy but no hives.
57 2021-01-10 injection site mass Dizziness, body ache, lethargic, lump at site of injection for about 5-7 days
57 2021-01-10 itchy skin, hardening HEALTH CARE WORKER ARMS WAS SWOLLEN , ITCHY, HARD AND PAINFUL AFTER SECOND DOSE OF GETTING PFIZER C... Read more
HEALTH CARE WORKER ARMS WAS SWOLLEN , ITCHY, HARD AND PAINFUL AFTER SECOND DOSE OF GETTING PFIZER COVID-19 VACCINE
57 2021-01-10 redness, rash Redness and pain Rash
57 2021-01-10 injection site pain, injection site warmth Second Dose: Felt nasal congestion after receiving the shot, then 24 hours later, I started feeling ... Read more
Second Dose: Felt nasal congestion after receiving the shot, then 24 hours later, I started feeling aching all over. Then the next day, I awoke with a warm area around injection site. Warm to touch, and is very tender.
57 2021-01-10 injection site warmth, injection site pain, injection site redness, redness Second dose; received on Friday 01. .21. On that evening, I had nasal congestion, which is no bi... Read more
Second dose; received on Friday 01. .21. On that evening, I had nasal congestion, which is no big deal. I had some redness, then on the next day, Saturday I started having body aches everywhere, I took two tylenol, and then I was fine. Then when I awoke the next morning, my arm was really sore. The injection site is red and warm and is tender, but not bad bad. The warmth of it is the worst part.
57 2021-01-10 injection site pain Site Pain, HA, Fever, Joint pain, Body Aches
57 2021-01-10 injection site pain headache swollen glands in throat injection site soreness
57 2021-01-10 injection site pain injection site pain, tiredness, headache, muscle pain, chills, joint pain, nausea, feeling unwell, l... Read more
injection site pain, tiredness, headache, muscle pain, chills, joint pain, nausea, feeling unwell, lymphadenopathy, blurry vision, dizziness; Tylenol 1 tab X 3 times per day during 3 days
57 2021-01-10 injection site swelling, rash, injection site pain nausea, dizziness, feeling uneasy after 20 min. Feeling elated as if am drank lasted the whole day ... Read more
nausea, dizziness, feeling uneasy after 20 min. Feeling elated as if am drank lasted the whole day the vaccine was given. injection site pain swelling, severe headache, developed chills at night joint pains, rashes on my face, feeling weak as if I dont have energy. At night time i went to the restroom 5 times with an interval of 5-10 minutes and i cannot even control my bladder it comes out continuously. Slow to comphrend or response. I stayed fully awake the whole night on the night when the vaccine was given to me and was able to sleep only the following day (sat) at 5 pm.
57 2021-01-11 injection site pain Pain at injection site (two days) Joint pain, predominantly in shoulders and knees (three days) Head... Read more
Pain at injection site (two days) Joint pain, predominantly in shoulders and knees (three days) Headache (three days) Diarrhea (three days) Extreme fatigue (three days)
57 2021-01-11 itchy skin itching in hands and feet which progressed to back, neck and head/ later stated her head as well; Th... Read more
itching in hands and feet which progressed to back, neck and head/ later stated her head as well; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: 5K5730) via an unspecified route of administration in the upper right arm on 19Dec2020 11:00 at a single dose for covid-19 immunisation. Medical history included asthma in 1996, allergies to penicillin, high blood pressure, reflux, allergies, and broke her leg 17 years ago in 2003. The patient has no prior vaccinations within 4 weeks. Concomitant medications included unspecified medications for high blood pressure, reflux, and allergies. The patient previously had allergies with morphine (manifestation: holding hands over ears and felt everyone was screaming at her) and vancomycin. The patient got first dose on 19Dec2020 and is supposed to go back Saturday (09Jan2021) for follow up dose. She wanted to verify if she should get it. After the first injection, it was uneventful the day she got it, and then 4-5 days later, she got itching in hands and feet. It was not so alarming. She still has it and then it started progressing to her back and neck and later stated her head as well. It is not all the time just intermittent. She needed to take Benadryl to keep from scratching so much. Yesterday seemed to be worse. She did not have any hives. Around the end of last week is when it spread to other places besides hands and feet. She doesn't have itching today on back, but she does on her hands and feet. The outcome of the event was not recovered. No ER or physician's office required. She does take daily maintenance medications and she does not know if they are relevant. She also takes medication for high blood pressure, reflux and allergies. She was taking all of them before she took this.
57 2021-01-12 itchy skin, redness 1:45 pm she received the vaccine. 2:10 pm she started to have the following signs and symptoms; red ... Read more
1:45 pm she received the vaccine. 2:10 pm she started to have the following signs and symptoms; red swollen arms, dizziness, blurred vision, gastrointestinal symptoms, blood sugar 143, blood pressure 86/40, pulse 87, oxygen 88. We gave diphenhydramine 50mg at 2:16 pm. Then at 2:35 pm her symptoms were not improved her blood pressure was 80/40 so we gave one dose of 0.3mg epinephrine by auto-injector and called an ambulance. Post epinephrine her vision improved but her skin was still red and starting to itch. She was talking and said she was feeling a little better. She was taken by ambulance to the hospital for additional treatment. There was not reaction visible at the injection site it appeared to be all systemic.
57 2021-01-12 injection site redness, injection site swelling, injection site pain Minor reaction, still came to work. General muscle/join soreness and fatigue. injection site pait, ... Read more
Minor reaction, still came to work. General muscle/join soreness and fatigue. injection site pait, site redness, swelling and new or worsened joint and muscle pain
57 2021-01-12 injection site swelling, injection site redness, injection site pain Minor reaction, still came to work. General muscle/join soreness and fatigue. Injection site pain, r... Read more
Minor reaction, still came to work. General muscle/join soreness and fatigue. Injection site pain, redness and swelling and new or worsened joint and muscle pain.
57 2021-01-12 rash Systemic: Rash (other than injection site), Systemic: Hyperventilation without airway block from nec... Read more
Systemic: Rash (other than injection site), Systemic: Hyperventilation without airway block from neck
57 2021-01-13 injection site pain Fever, chills, body aches, headache, sinus drainage, soreness at vaccine sight. All symptoms start... Read more
Fever, chills, body aches, headache, sinus drainage, soreness at vaccine sight. All symptoms started 10 hours after receiving the vaccination.
57 2021-01-13 vaccination site pain Fever; weakness; horrific headache; body aches; pain at administration site; This is a spontaneous r... Read more
Fever; weakness; horrific headache; body aches; pain at administration site; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient (no pregnancy) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly at site of left arm at 15:00 on 05Jan2021 at single dose for COVID-19 immunization. Medical history included hon, asthma and allergies: metronidazole (FLAGYL). Prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient experienced fever, weakness, horrific headache, body aches, and pain at administration site at 08:30 on 06Jan2021. The patient underwent Nasal Swab for COVID test with negative on 04Jan2021. Facility where the most recent COVID-19 vaccine was administered in Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications that the patient received within 2 weeks of vaccination. No treatment received for the adverse event. Since the vaccination, the patient has been tested for COVID-19. This case was identified as non-serious by reporter. The outcome of events was recovering. Information on the lot/batch number has been requested.
57 2021-01-13 injection site pain Injection pain/tenderness at site, tiredness, HEADACHE, muscle pain, chills, joint pain, fever, nau... Read more
Injection pain/tenderness at site, tiredness, HEADACHE, muscle pain, chills, joint pain, fever, nausea, feeling body aches
57 2021-01-13 injection site swelling Swollen injection site, muscle aches, fever (104), fatigue, mild nausea, swollen taste buds
57 2021-01-13 injection site pruritus, injection site swelling THE PATIENT RECEIVED THEIR 2ND DOSE AND WAS OBSERVED FOR THE REQUIRED 15 MINS WITHOUT INCIDENT. IT W... Read more
THE PATIENT RECEIVED THEIR 2ND DOSE AND WAS OBSERVED FOR THE REQUIRED 15 MINS WITHOUT INCIDENT. IT WASN'T UNTIL THE PATIENT WAS HOME, ABOUT 11 HOURS POST VACCINATION, THAT THEY REPORTED SWELLING & ITCHINESS AT THE INJECTION SITE, SWOLLEN, TINGLY LIPS AND SWELLING UNDER THE EYES. THE PATIENT REPORTED TAKING BENADRYL, WHICH EFFECTIVELY RESOLVED THE REPORTED SIGNS & SYMPTOMS.
57 2021-01-13 shingles shingles to lower back after 2nd dose
57 2021-01-13 redness throat tightening/Throat tightened up; metallic taste in her mouth; Turned red; Nausea; Diarrhea; Wa... Read more
throat tightening/Throat tightened up; metallic taste in her mouth; Turned red; Nausea; Diarrhea; Was pretty weak; This is a spontaneous report from a contactable nurse(patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EH9899), via an unspecified route of administration in the right arm on 17Dec2020 at single dose for covid-19 immunization; diphenhydramine hydrochloride (BENADRYL) and paracetamol (TYLENOL), both via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. Medical history included high blood pressure from 2008 and ongoing. Concomitant medication included amlodipine from 2017 and ongoing at 5 mg at night for high blood pressure, losartan from 2017 and ongoing at 12mg once in the morning for high blood pressure. Following her 1st dose of the COVID vaccine on 17Dec2020, the patient had throat tightening, metallic taste in her mouth. She was scheduled to have her 2nd dose today (07Jan2021) and would like to know what to do and if she was still covered 80% from the 1st dose of her COVID vaccine shot. When she got her first COVID shot 3 weeks ago she got a metallic taste in her mouth and her throat tightened up a little. Throat tightening happened right after she got the shot and lasted about less than 2 minutes. She also turned red when she got it. Then about 14 hours later, on the same day she got nausea, diarrhea, and was pretty weak. This lasted until about 20Dec2020 as well. She was supposed to get 2nd dose today (07Jan2021). Before her first shot she had taken paracetamol and hydrochloride prior. She also took both of those today (07Jan2021). But then she was reading through the paperwork and it says that a severe reaction includes tightening of the throat. She was not sure if what she had was truly a reaction or not. She did not have other allergies. She had many flu shots and never had any difficulty with those. She was a nurse, she wanted the second dose, but she was concerned about the throat tightening, and it getting worse with the second dose. She was unsure of seriousness. She figured that she would get aches and pains. Everyone else who got it said their arm hurt, but nothing else. She thought it was weird. She was just wired differently she guesses. The action taken in response to the events for paracetamol and hydrochloride was unknown. The outcome of events throat tightening, turned red was recovered on 17Dec2020. The outcome of event metallic taste in her mouth, nausea, diarrhea, and was pretty weak was recovered on 20Dec2020.
57 2021-01-13 itchy skin tingling to face, tongue and lips; lightheaded; no swelling; hr normal; observed extra 30 minutes; g... Read more
tingling to face, tongue and lips; lightheaded; no swelling; hr normal; observed extra 30 minutes; given water& crackers - lightheadedness subsided but states is itching all over; offered to call 911 - refused. stated is going to primary care physician. total observation 45 min
57 2021-01-14 injection site pain Approximately 4-6 hours post vaccine I experienced site soreness and felt my hands were stiff, felt ... Read more
Approximately 4-6 hours post vaccine I experienced site soreness and felt my hands were stiff, felt swollen, especially the right. Within a few more hours my arm became heavy and I had some general muscular achiness. By approximately 11pm I had intense muscular pain on the back of my legs making it difficult to stand. It felt like I had been hit repeatedly with 2x4s. About that time my posterior ribcage hurt also. I couldn't sleep, turning frequently as my hips hurt. This is what I felt like when I had COVID. Intense pain. At 0630 (1/14) I got out of bed and felt I was going to faint, was extremely nauseous (I did not vomit) and had a very bad, global headache. I had to lay down again. My temp was 100.1 orally. I could not go to work. I was able to take Tylenol. It helped the pain but two hours later my temp was 100.8. I could not get out of bed until 6pm, I felt delirious when I tried. I was able to go to work on 1/15. Of note, following my first dose of COVID vaccine (Pfizer BioNtech Lot #EH9899 on 12/23/20) I had site soreness, heaviness of my left arm, T of 99.5 same day (about 10-12 hours post vaccination), and mild body aches for about a day.
57 2021-01-14 injection site pain Body Aches (mostly low back and leg), chills, fever (100.7), headache. (A given..Injection site sore... Read more
Body Aches (mostly low back and leg), chills, fever (100.7), headache. (A given..Injection site soreness) Symptoms resolved by the next day with ibuprofen.
57 2021-01-14 rash, itchy skin Headache, slight dizziness and stomach cramping started later that day of vaccination. Stomach cramp... Read more
Headache, slight dizziness and stomach cramping started later that day of vaccination. Stomach cramping and Headaches continued intermittently. I took Excedrin as needed for symptoms. Itchiness started after a week and rash developed on 1/14/2021. I am waiting for return call from my Primary Doctor. I started taking Benadryl 25mg for rash/itchiness as needed.
57 2021-01-14 injection site swelling Local swelling without redness at injection site; rest and told to contact provider if elevates.
57 2021-01-14 itchy skin, rash Rash on upper body, extreme itching on face, chin & neck; Rash on upper body, extreme itching on fac... Read more
Rash on upper body, extreme itching on face, chin & neck; Rash on upper body, extreme itching on face, chin & neck; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 08Jan2021 14:30 at SINGLE DOSE at left arm for COVID-19 immunization. Medical history included Sarcoma Gist (removed on 12Oct2020), seasonal allergies, known allergies: peanut, sesame. The patient's concomitant medications were not reported. On 08Jan2021 20:00, the patient experienced Rash on upper body, extreme itching on face, chin & neck. The events were assessed as non-serious. The patient did not receive treatment for the events. The outcome of the events was recovering. Information on the lot/batch number has been requested.
57 2021-01-14 injection site warmth, injection site redness Red circle appeared on the site where shot was given three days after very warm to touch
57 2021-01-15 injection site redness, injection site rash Myalgia, weakness, fatigue, rash at injection site Left deltoid red area moving outside of circled a... Read more
Myalgia, weakness, fatigue, rash at injection site Left deltoid red area moving outside of circled area
57 2021-01-15 injection site discomfort Pulsing injection site blood pressure was fine at 138/93
57 2021-01-15 shingles Shingles
57 2021-01-15 injection site pain Very painful injection site. Cold, chills, fatigue, overall unwell feeling, exhaustion
57 2021-01-16 skin warm Developed severe bilateral leg pains from pelvis to feet, sharp,cramping,burning, pain made difficul... Read more
Developed severe bilateral leg pains from pelvis to feet, sharp,cramping,burning, pain made difficulty walking , skin self like bad sunburn when touched. lasted approximately 36 hrs. For approx 12 more hrs moderate symptoms, then 24hrs minor symptoms. Started on Tuesday night resolved by Saturday morning.
57 2021-01-16 itchy rash, rash, rash with redness I noticed pruritic erythematous papules on my right little finger as I woke up the next morning (6:0... Read more
I noticed pruritic erythematous papules on my right little finger as I woke up the next morning (6:00 am) after the vaccine. The affected area has increased in size (about 2.5 x 1 cm now), and the finger is slightly swollen, with pain in the proximal interphalangeal joint when pressure is applied. Two days ago (1/15/2021; 8 days after vaccination), a small pruritic purple papule (2-3 mm) appeared on my ring finger over the distal interphalangeal joint, same hand, and the area is slightly painful when pressure is applied; today, the papule measures 3 x 5 mm. Skin lesions in both fingers are on the dorsal surface. I will seek medical attention.
57 2021-01-18 hives 30 minutes after injection developed urticarial reaction to upper arms, chest, neck, ears, and legs.... Read more
30 minutes after injection developed urticarial reaction to upper arms, chest, neck, ears, and legs. No angioedema or respiratory involvement. Treated in vaccine clinic with 50mg oral diphenhydramine and 40 minutes of additional observation. Symptoms began improving 20 minutes after diphenhydramine administration .
57 2021-01-18 vaccination site pain Extremely tired, sore at the injection site, a headache, chills; Extremely tired, sore at the inject... Read more
Extremely tired, sore at the injection site, a headache, chills; Extremely tired, sore at the injection site, a headache, chills; Extremely tired, sore at the injection site, a headache, chills; Extremely tired, sore at the injection site, a headache, chills; This is a spontaneous report from a contactable healthcare professional. A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EK9381, intramuscularly on 08Jan2021 07:30 as a single dose, right arm (age at vaccination: 57 years old) for COVID-19 immunization. Medical history included breast cancer survivor and diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included gabapentine (GABAPENTINE). On 08Jan2021 17:00, the patient experienced being extremely tired, sore at the injection site, a headache, and chills. Therapeutic measures were taken as a result of the events and included "Tylenol sleep." The events did not require hospitalization and were reported as non-serious. The clinical outcome of the events extremely tired, sore at the injection site, a headache, and chills was not recovered. The patient was not COVID tested post-vaccination.
57 2021-01-18 injection site swelling, injection site bruising Site: Bruising at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Nausea-Mild
57 2021-01-18 itchy skin, rash vesicular, shingles, skin irritation sharp pain R side of neck along dermatome; vesicles break out R anterior chest with mild burning and... Read more
sharp pain R side of neck along dermatome; vesicles break out R anterior chest with mild burning and itching; vesicles break out R anterior chest with mild burning and itching; vesicles break out R anterior chest with mild burning and itching; minor shingles outbreak; skin irritation; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), intramuscularly on 17Dec2020 at 10:15 at a single dose on the left arm for COVID-19 immunization. Medical history included Afib/ flutter, ablation, and total hysterectomy. Patient had allergies to food: grapes. Concomitant medications included fish oil, zinc, and estradiol (1 mg, 2x/week) transdermal patch. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. On 20Dec2020 at 09:00, the patient experienced sharp pain R side of neck along dermatome, vesicles break out R anterior chest with mild burning and itching consistent with a minor shingles outbreak. MD had examined it and his opinion was that the minor shingles outbreak was most likely triggered by the vaccine. Very mild but skin irritation was also present. No treatment was given for the events. Since the vaccination, the patient has not tested for COVID-19. The outcome of the events was recovering at the time of the report.
57 2021-01-19 injection site pain Fever, lethargy, pain in arm around injection site, headache
57 2021-01-19 injection site pain I received my vaccine at noon and after a couple of hours I had severe muscle pain in both legs. I w... Read more
I received my vaccine at noon and after a couple of hours I had severe muscle pain in both legs. I was very fatigued the rest of the day and had a headache. During the night I had chills and was dizzy. My temp was only 99.1 but I felt awful. I still had a temp this morning (day 2) No dizziness but I do have an awful headache and my arm is very sore where I received the injection.
57 2021-01-20 itchy skin 1150AM: 10 minutes post vaccine, patient with "itching" to "hairline, feet, and neck & back" without... Read more
1150AM: 10 minutes post vaccine, patient with "itching" to "hairline, feet, and neck & back" without urticaria, erythema, SOB, pain, weakness, or other complaint. Temp 98.1F non-contact, BP 140/90, Pulse 86, Resp 16 1201PM: Increase in sensation of itching to neck and back to 3/10 without change in other signs and symptoms, BP 138/86. Per RN provide 25 mg PO Benadryl. Benadryl provided to patient. 1211PM: Some reduction in itching sensation 3/10. 1215PM: Continued itching sensations with expansion to upper arms at 5/10 1220PM: RN with orders from Dr. for up to a total of 75 mg Benadryl starting with additional 25 mg PO now. 1230PM: Itching reduced to right ear and right leg at 3/10. Much improved. 1233PM RN with orders from Dr. for patient to take 2 Claritin (loratadine) a day, one in the morning and one at night for the next three days. Benadryl as needed according to package instructions if needed for symptoms. 1242PM BP120/42 P 68, Temp 98.2 Resp 18. Patient reports feeling much better, slight itching to right ear at 2/10. No SOB, pain, or other discomfort 1245PM Awaiting patient?s husband to meet her in the vaccine clinic. RN to with patient to her work area in the hospital CT area of the ED to wait for her husband to pick her up. 1252PM Patient?s husband arrived. Patient escorted to vehicle reporting comfort in managing further signs and symptoms with the orders from Dr. She will seek emergency care from EMS if shortness of breath occurs or weakness.
57 2021-01-20 redness, vaccination site redness, hives At 10am feel hot, took temp was 102.7; At 10am feel hot, took temp was 102.7/ Temp at 12am was 101; ... Read more
At 10am feel hot, took temp was 102.7; At 10am feel hot, took temp was 102.7/ Temp at 12am was 101; Red all over; Face swelling; Shot site was red; Allergic reaction; Hives; Around 8pm start to feel chill; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: el1284), via an unspecified route of administration on 09Jan2021 09:30 at SINGLE DOSE at right arm for COVID-19 immunization. Medical history included HTN, GERD, IBS, known allergies: PCN, IV contrast. Concomitant medications included lisinopril (LISINOPRIL), atorvastatin (ATORVASTATIN), linaclotide (LINZESS). The patient previously took morphine and percocet [oxycodone hydrochloride;paracetamol]; and experienced known allergies. The patient received first dose of bnt162b2 on 19Dec2020 09:30 at right arm. Lot number: el1284. The patient got the 2nd shot at 09:30, went back to work was fine, got home at 07:15pm, around 8pm on 09Jan2021 start to feel chill. On 09Jan2021 20:45, the patient was reported to be red all over, took 650 of Tylenol. Face swelling, the shot site was red. Went to bed at 9pm. Temp at 12am was 101. Went to the ER 12:50am. They stated the patient was having allergic reaction and hives (reported as 09Jan2021 20:45). The ER gave the patient Benadryl IV, Prednisone IV, Pepcid. They discharge the patient with Prednisone and Pepcid. On 10Jan2021 at 10am feel hot, on the same day took temp was 102.7. The patient had to miss work 1 day of work sunday 10Jan2021. The patient received treatment for the events. The patient visited the ER for the events. The outcome of the events was recovering.
57 2021-01-20 injection site redness, injection site pain Chills, fever, headache, nausea, sweats. Arm sore and red at injection site.
57 2021-01-20 injection site pain Heaviness in legs with muscle tightness/soreness, slight temporal headache, sore L UE at injection s... Read more
Heaviness in legs with muscle tightness/soreness, slight temporal headache, sore L UE at injection site, some nausea later in the day.
57 2021-01-20 rash I developed the rash on the inside of my elbow about an inch and half in circular; This is a spontan... Read more
I developed the rash on the inside of my elbow about an inch and half in circular; This is a spontaneous report from a contactable consumer (patient). This 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL1284), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient's medical history included high blood pressure. The patient's concomitant medications included lisinopril for blood pressure high. Patient stated she was keeping that under control with lisinopril. Patient stated she took bnt162b2 because she didn't want to die. Patient stated she got the vaccine shot on and 08Jan2021 and just this evening she developed the rash on the inside of my elbow about an inch and half in circular. Patient was fine, she meant it's just a skin rash nothing itchy. No treatment received in response to event. Outcome of the event was unknown.
57 2021-01-20 injection site pruritus Itchy at the site of injection
57 2021-01-20 injection site mass, injection site pain Reporter describes low grade fever (99.1-100F) and lower extremity body and joint aches starting app... Read more
Reporter describes low grade fever (99.1-100F) and lower extremity body and joint aches starting approx 14.5 hours after receiving the vaccine and lasting 36 hours. Treated with acetaminophen and ibuprofen. Injection site was sore x1 week - "felt like there was a baseball" in arm.
57 2021-01-20 rash presented to vaccine clinic - received vaccination and while waiting - observer noted person was swa... Read more
presented to vaccine clinic - received vaccination and while waiting - observer noted person was swallowing frequently and asked if she was doing okay - she stated she felt a pressure in her chest "like my asthma" - relayed she thought she needed some Benadryl. Person was masked - observing staff asked for her to remove her mask and they noted where her mask was a pink to red outline of a fine rash. Person was subsequently taken to the ED for further evaluation and any needed treatment. ED notations: Patient is a pleasant 57 year old female with a history of asthma, eczema, obesity, LE edema presenting for vaccine reaction. Patient states she was upstairs at SCB getting her first COVID shot. She was sitting in the waiting area after receiving injection and noted to have sensation of chest tightness "similar to my asthma" within 10 minutes of receiving the vaccine. She was noted by nursing staff to also have redness to her face. Patient denied any difficulty breathing or swallowing, no raised rash/bumps to her face or body, no palpitations or fast heart rate, no swelling more than her usual baseline LE edema. She denies headache, feeling light headed, nauseous, or any symptoms of abdominal discomfort. Patient has a history of allergies to sulfa drugs and seasonal allergies, no food allergies/intolerances, or previous reactions to vaccines. Patient was determined to not be in anaphylactic shock but did have immediate symptoms after injection suggesting an allergic Type I hypersensitivity, redness and sensation in her chest improved with 50 mg of benadryl. The patient was reassured after an observational period of about 1 hour and no additional symptoms. She was notified that CDC guidelines are that even with a mild allergic reaction to the vaccine, that she should avoid getting the 2nd in series, continuing to practice other preventative measures against COVID, maintaining social distance and wearing a mask.
57 2021-01-20 vaccination site pain soreness in her left arm; headache; tired; This is a spontaneous report received from a contactable ... Read more
soreness in her left arm; headache; tired; This is a spontaneous report received from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EZ0140, expiry date: unknown), intramuscular in upper left arm, on 20Dec2020 at 14:45-15:00 (as reported), at single dose, for preventive/COVID-19 immunization, in an education center that was turned into a hub for vaccine. Medical history included thyroid, cholesterol and blood pressure. Concomitant medications include medications (unspecified) for thyroid, cholesterol and blood pressure. The patient did not receive prior vaccinations within 4 weeks. The patient experienced a little headache and was tired on 20Dec2020. The patient took Advil and on 21Dec2020, her headache was gone, and she was tired. On 22Dec2020, the second day after receiving the first dose, she recovered completely. It was also reported that the patient experienced soreness in her left arm on an unspecified date. The patient recovered from headache on 21Dec2020 and from fatigue on 22Dec2020. The outcome of vaccination site pain was unknown.
57 2021-01-20 vaccination site pain tenderness at injection site; This is a spontaneous report from a contactable other hcp (patient). T... Read more
tenderness at injection site; This is a spontaneous report from a contactable other hcp (patient). The 57-years-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2, lot number: EK4176), on left arm unknown on 09Jan2021 13:30 at SINGLE DOSE for covid-19 immunisation. Medical history was none. The patient did nor receive other vaccine in four weeks. The patient did not experience COVID prior the vaccination. The patient did not test covid post vaccination. No known allergies. Concomitant medication included alprazolam (XANAX), cetirizine hydrochloride (ZYRTEC DAIICHI), omeprazole (PRILOSEC), zolpidem tartrate (AMBIEN). The patient experienced tenderness at injection site on 10Jan2021 05:00, described as Woke up the next morning with tenderness at injection site. No swelling or redness. No treatment received for the event. The outcome of the event was recovering. No follow-up attempts possible. No further information expected.
57 2021-01-21 injection site warmth, injection site redness, injection site hardening, injection site mass, injection site pruritus, rash 2 days after receiving the 2nd dose of COVID vaccine I developed itchiness on upper arm below the in... Read more
2 days after receiving the 2nd dose of COVID vaccine I developed itchiness on upper arm below the injection site. Symptoms progressed to a patch of redness,diffuse and bumpy induration, and warmth measuring approximately 8x10 cm. Skin is intact with no pustules or vesicles. Indistinct margins. No symptoms or involvement of the inner aspect of the arm or axilla. No adenopathy. Have used topical Hydrocortisone and oral Benadryl with some relief, but symptoms persist now 6 days post vaccine. Symptoms are enough to wake me at night due to arm itchiness and discomfort.
57 2021-01-21 injection site pain Headache, dizziness and severe pain at injection site
57 2021-01-21 rash Pfizer-BioNTech COVID-19 Vaccine EUA Rash patch on both sides of neck, rash on both sides of upper c... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Rash patch on both sides of neck, rash on both sides of upper chest (size of an orange), rash on inside of upper arms. Started 1/9/2021 Rash patch on inside and top of right forearm. Started 1/13/2021. Rash patch on left side of lower back. Started 1/15/2021. Treatment tried without relief - Zyrtec, Benadryl, Hydrocortisone Cream, Atarax, Triamcinolone Cream.
57 2021-01-21 rash Pfizer-BioNTech Covid-19 vaccine EUA Rash patch on both sides of neck, both sides of upper chest (si... Read more
Pfizer-BioNTech Covid-19 vaccine EUA Rash patch on both sides of neck, both sides of upper chest (size of orange), inside of upper arms. Started 1/9/2021. Rash patch on inside and top of right forearm. Started 1/13/2021. Rash patch on lower left side of back. Started 1/15/2021. Treatments tried-no relief - Zyrtec, Benadryl, Hydrocortisone Cream, Atarax, Triamcinolone Cream.
57 2021-01-21 injection site swelling, injection site pain chills, headache, body aches, pain and swelling at the injection site
57 2021-01-23 hives Around 3 am on 1/18/2021 I woke up with a very sore lymph node on my lower head left side. Within a... Read more
Around 3 am on 1/18/2021 I woke up with a very sore lymph node on my lower head left side. Within a few hours lympnodes in my neck, behind my ear and on my collar bone were all swollen and painful. On Wednesday 01/20/2021 I developed hives on my scalp, in my left ear, and on and around all swollen lymph nodes. I left work on 1/20, still couldn't go to work 1/21 on 1/22 I saw Dr. Who have me a shot of Kenalog and some triamcinolone cream for hives. I tried to work, but only lasted 4 hrs and went home. It is now one week since vaccine number two and on top of still raw spreading hives, and swollen glands , I now have a sharp pain constantly shooting through my left temple which is relentless. I am miserable.
57 2021-01-23 skin warm By 830 pm I was aching, had a headache, by 9 bad chills, the fever, skin was very hot. Lasted all ni... Read more
By 830 pm I was aching, had a headache, by 9 bad chills, the fever, skin was very hot. Lasted all night. By am I was dizzy once, Achey all day, no energy. Slept all day. Today, dizzy again for a moment. Headache when I woke up. No energy, abit Achey. Not as bad.
57 2021-01-23 injection site pain Dose 1 - no adverse reaction Dose 2 - excruciating headache, severe body aches, joint pain, left arm... Read more
Dose 1 - no adverse reaction Dose 2 - excruciating headache, severe body aches, joint pain, left arm felt weighted down and tender at injection side lasting 30 hours
57 2021-01-24 redness, shingles, blister 1/9/21 Fever 100.4, fatigue, and mild body aches lasting 1 day. 1/17/21 Began developing red areas o... Read more
1/9/21 Fever 100.4, fatigue, and mild body aches lasting 1 day. 1/17/21 Began developing red areas on left arm, which eventually blistered and extended from upper arm to thumb tip. Also associated with pain in the arm and hand. Physician diagnosed shingles on 1/20/21. Treated with valacyclovir.
57 2021-01-25 redness, rash macular Pt states her hands were turning red at which time RN was called to assess. Bilateral hands were red... Read more
Pt states her hands were turning red at which time RN was called to assess. Bilateral hands were red and blotchy. She states she feels the need to frequently clear throat but is not short of breath. She states her lips feel tingly. No angioedema noted, redness is not spreading from palms of hands. No redness or rashes noted at injection site. Pt was given 50mg of diphenhydramine prior to leaving. She waited in lobby with staff observation for another 15 minutes, Redness in hands was resolved. Educated pt to call emergency services should symptoms persist or worsen. Pt verbalizes understanding. This RN will call later today and tomorrow to follow up with pt.
57 2021-01-25 redness, dry skin Sat. 1/23 knuckles very red, Sun. 1/24 Knuckles red and dry, Mon 1/25 Knuckles red and swollen, no ... Read more
Sat. 1/23 knuckles very red, Sun. 1/24 Knuckles red and dry, Mon 1/25 Knuckles red and swollen, no pain. Tues. 1/26 had 30 seconds where it was hard to breathe, "like gasping for air".
57 2021-01-25 vaccination site pain Soreness at injection site; joint pain; muscle pain; chills; Loss of appetite; Low-grade fever; This... Read more
Soreness at injection site; joint pain; muscle pain; chills; Loss of appetite; Low-grade fever; This is a spontaneous report from a contactable other hcp. A 56 year old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number:EH9899), intramuscular on the left arm on 21Dec2020 09:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing known_allergies: Sulfa drugs. Concomitant medication included progesterone (PROGESTERONE), estradiol (ESTRADIOL), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient experienced soreness at injection site, joint pain, muscle pain, chills, low-grade fever and loss of appetite on 21Dec2020. The outcome of the events was recovered.
57 2021-01-25 itchy skin Starting itching, then face and lips started tingling. Took Benadryl and Pepcid. Next morning starte... Read more
Starting itching, then face and lips started tingling. Took Benadryl and Pepcid. Next morning started having difficultly swallowing, went to ER-1-6-21 On 1-7-21 started itching from all over, blood pressure was 262/106, went back to ER
57 2021-01-25 vaccination site pain she is still tender in her left arm from the first shot/The first shot hurt way more and hurt all ov... Read more
she is still tender in her left arm from the first shot/The first shot hurt way more and hurt all over the whole arm, it was throbbing; she is still tender in her left arm from the first shot/The first shot hurt way more and hurt all over the whole arm, it was throbbing; This is a spontaneous report received from a contactable nurse (who is also the patient). A 57-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via intramuscular route in the left deltoid, on 18Dec2020 18:00, at single dose, for preventive/COVID-19 immunization, in the hospital. The patient's medical history was not reported. There were no concomitant medications. Historical vaccine included H1N1 flu shot (INFLUENZA VACCINE), in 2015 or 2016 (as reported), for immunization and experienced muscle stiffness and fatigue. The patient reported she is she is still tender in her left arm (unspecified date) from the first shot. The first shot hurt way more and hurt all over the whole arm, it was throbbing (unspecified date). The outcome of the events was not recovered. Information about lot/batch has been requested.
57 2021-01-26 hives, redness, itchy skin About 3 minutes after receiving the vaccine, patient started to experience itching at neck area. Vis... Read more
About 3 minutes after receiving the vaccine, patient started to experience itching at neck area. Visible redness and a few hives present.
57 2021-01-26 itchy skin, hives, redness About 3 minutes after receiving the vaccine, patient started to experience itching at neck area. Vis... Read more
About 3 minutes after receiving the vaccine, patient started to experience itching at neck area. Visible redness and a few hives present. Benadryl administered.
57 2021-01-26 rash, itchy skin Itching and rash over whole body starting the day after injection and continuing now for 5 days from... Read more
Itching and rash over whole body starting the day after injection and continuing now for 5 days from head to toe.
57 2021-01-26 injection site pain Nausea, body aches, headache, exhaustion, pain in left armpit/axillary area started 2 days post inje... Read more
Nausea, body aches, headache, exhaustion, pain in left armpit/axillary area started 2 days post injection, pain and tenderness around injection area.
57 2021-01-26 skin infection at injection site cellulitis at injection site, treated with oral antibiotics, gradually improving
57 2021-01-27 vaccination site pain, vaccination site swelling generally weak; Pale; Headache; migraines; feels foggy; Hard time concentrating; pain in her shoulde... Read more
generally weak; Pale; Headache; migraines; feels foggy; Hard time concentrating; pain in her shoulder, she thought it was cause of the injection site/muscle pain from the injection; pain in shoulder immediately after getting the injection and it was really swollen; body is in pain/lot of pain all of her body; achy like she is having flu like symptoms; injection was administered higher in her left shoulder; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 12Jan2021 (16:00) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK9231) injection in left deltoid/shoulder on 22Dec2020 at single dose for Covid-19 immunization. The patient's medical history was reported as "none". There were no concomitant medications. It was reported that the patient received the first dose on 22Dec2020 and the second dose on 12Jan2021. After she received the second dose of the vaccine, she immediately had pain in her shoulder, she thought it was cause of the injection site (12Jan2021 16:00). She had the pain in shoulder immediately after getting the injection and she got it at 4pm, and it was really swollen now. She mentioned this injection was administered higher in her left shoulder (pending clarification) and it feels like they may have gotten the injection in more of the arm muscle and she was thinking that is why she had muscle pain from the injection. She added that it was like her body is in pain, achy like she is having flu like symptoms that started the evening she got the vaccine, like 6PM or 7PM. The next day, yesterday (13Jan2021), she had a lot of pain all of her body. She also started to have a headache yesterday at noon (13Jan2021 12:00PM). The headache started at noon on 13Jan2021 and it continued for at least 8 hours and it was constant. It started to subside over the next 12 hours. She mentioned she also suffers from migraines (pending clarification). It feels like she is having residual migraine, like she is coming off of having a migraine. It is presenting, but she is not in severe pain. It is a feeling like she is coming off her migraine medication even though she did not take her migraine medication. She went to work yesterday (13Jan2021) even though she did not feel like it. She went home a few minutes early. She let her supervisor know she was in severe pain and had a headache. She was advised to stay home today and has not gotten better. However, the headache subsided. She feels foggy, like she could not just quite wake up. It is like she is in a daze or haze. She is having a hard time functioning. She continued to reiterate she was having a hard time concentrating. Now (14Jan2021) she is generally weak and is pale. In addition, the pain has not gone away. She stated she is weak, very weak. She felt it most of the day and it is worse today. She feels like she can hardly stand. She is trying to get fluids in her and trying to make coffee, however, it is a struggle. She stated, she has not gone yet, but she will call her doctor's office next and the health nurse as well to advise them she has been having symptoms. She stated she did not have a fever last night. Her temperature during the call was normal for her, 97.3. The outcome of events vaccinations site pain, vaccination site swelling, general body pain, flu like symptoms, weak, and pale was not recovered; while the outcome of other events was unknown. Information on lot/batch has been requested.
57 2021-01-28 vaccination site pain This is a spontaneous report from a contactable physician (patient). A 57-year-old female patient re... Read more
This is a spontaneous report from a contactable physician (patient). A 57-year-old female patient received the second dose of BNT162B2 (lot number: EL1283), via an unspecified route of administration in left arm on 06Jan2021 14:00 at single dose for covid-19 immunization. The patient's known allergies: latex (rash, occ. mild bronchospasm); dysphoria c valium; innumerable food reactions - dairy & eggs, nuts/seeds/grains, fish, latex associated foods, nightshades, meat -but none anaphylactic (occ. debilitating headache, very occ. mild bronchospasm; mostly cholinergic urticaria / joint pain / diarrhea). Other medical history included atopic incl. Raynauds; parox. atrial tach (after ablation for PA-fib.); almost-asx'tic asthma; endometriosis c small bowel resection (terminal ileum). Concomitant medication included metoprolol and a very long list of supplements. The patient previously received the first dose of BNT162B2 (lot number: EH9899), at the age of 57-year-old, via an unspecified route of administration in left arm on 18Dec2020 10:00 at single dose for covid-19 immunization and experienced deltoid soreness. The patient experienced trivial deltoid soreness for maybe 36 h after injection, starting about 4-6h later (06Jan2021) (same as after 1st injection, tho maybe lasted a bit longer); not sore enough to limit her use of the arm even a little bit. However, post injection day #4 (10Jan2021) after mod. intense workout for 2nd day in a row (swimming 1mi, including butterfly & synchro; usu. She wait 1-2 days between workouts) She developed a mod./severe headache, joint aches and malaise. She neglected to take a temp; and interestingly the injection site got sore again. This lasted about 48h; fortunately she was not scheduled to work. No sx since then, 1week. No treatment received. No pregnant. The outcome of the events was recovered on Jan2021.
57 2021-01-30 injection site pain 5pm 1/28/2021 developed headache, low grade fever, chills and severe pain at the injection site
57 2021-01-30 redness First day, H/A, nausea, diarrhea, later that day got very red like a sunburn, took Benadryl. Could... Read more
First day, H/A, nausea, diarrhea, later that day got very red like a sunburn, took Benadryl. Could not raise the arm. Fever of 99.5. H/A for 9 days. Got joint pains then pain in the back shooting pain. The pain kept going from joint to joint. It has been 28 days and she is taking Advil and Tylenol for the joint pain every day. Her doctor recommended that she not get the 2nd shot.
57 2021-01-30 injection site pruritus, injection site redness, injection site hardening, injection site mass, injection site pain, injection site swelling, injection site warmth Injection site was red and began itching on the morning of the 8th day after vaccination. By end of... Read more
Injection site was red and began itching on the morning of the 8th day after vaccination. By end of day it was red, swollen, hot, sore, and a large hard lump 3.5 " in diameter. Went to urgent care clinic the following morning (today, Day 9 after injection). I was told it was a local hypersensitivity reaction, no cellulitis. I was told to take histamine blockers both Allegra and Pepcid, use hydrocortisone cream for the itching, apply ice, and use ibuprofen or acetaminophen as needed for soreness.
57 2021-01-31 hives Driving home 40 minutes after vaccination ears and throat started to feel tight and felt like a lum... Read more
Driving home 40 minutes after vaccination ears and throat started to feel tight and felt like a lump in my throat , almost 2 hours after vaccination ears ringing and lump in throat. I took 2 Benadryl and in about hour the lump feeling was not as bad, lump feeling subsided. I had muscle joint pain the next 4 days and stayed on Benadryl those days until throat and ears felt better. On day 5 my left arm started stinging and broke out in hives , some on torso but mainly vaccinated left arm. I went to primary care to talk to her about my reactions on day -7 . She documented in my records but told me to report through Vsafe app. I did. I do not want to take 2nd dose after having this happened and no one able to tell me the 2nd wont be worse,
57 2021-01-31 injection site pain I had extreme pain in my shoulder at the vaccine site; then I had extreme pain - my whole upper back... Read more
I had extreme pain in my shoulder at the vaccine site; then I had extreme pain - my whole upper back (especially my right side) - like someone had taken a hammer and beaten my back. I exercise a lot and I'd exercised cross country skiing and downhill skiing the day of the vaccine and the next day I worked. I could barely use my right arm to treat my patients. I was sore and as the days went on I was really fatigued. I felt like I had a low grade fever. I usually have lower than normal temperature and it was 99.4-99.7 range. So on Monday I called the Occupational Health Dept of the Hospital - and they told me stay off work. And they had me test for COVID - negative. It took about a week until I started to feel better. To treat during the course of it I just took Advil. Recovered before my second dose on January 20th, 2021. I did not exercise before that second dose vaccine or work the next day and I stayed very hydrated and went into it rested.
57 2021-01-31 redness, injection site warmth, injection site redness I had the vaccine 3 days ago, and this morning my arm got really red snd hot around the injection si... Read more
I had the vaccine 3 days ago, and this morning my arm got really red snd hot around the injection site. About an hour later, my lips and throat starting itching a little bit,
57 2021-01-31 injection site pain Soreness on the arm/ soreness at the site; felt a little achy/ achiness like you have on flu; I am C... Read more
Soreness on the arm/ soreness at the site; felt a little achy/ achiness like you have on flu; I am COVID positive/ woke up with every COVID symptoms/ got real sick with positive COVID; I am COVID positive/ woke up with every COVID symptoms/ got real sick with positive COVID; This is a spontaneous report from a contactable nurse (patient herself). A 57-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELO140, reporter stated "could be ELO or ERO"), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. Medical history included bronchitis from Oct2020 and ongoing and occasional cough. Concomitant medications were not reported. The patient reported that "I am a nurse I work with COVID patients. I got my vaccination on 28Dec2020. After the vaccination I had soreness on the arm and I felt a little achy. I felt like that with the flu shot (no further clarification) for couple of few days maybe. Then my whole family developed COVID and I am COVID positive. On 06Jan2021, I woke up with every COVID symptoms. I tested positive on the 7th. So, I have been in isolation for 10 days from work. The reason I called you guys is that I am getting 10 different answers. I am due to get my vaccination on 18th. I still have some symptoms and I did not know I am hearing where symptoms go away. I am concerned, my shot is not going to work. If I have mild symptoms can I get it? I am getting tensive for answers, she gave a little bit of information. Do you want me to tell you all my symptoms the time I contracted the COVID? What I told you about the shot was from 28th. Yes, the vaccination on the 28th was soreness at the site like achiness like you have on flu. I had bronchitis (Intent: History) back in at the month of Oct. I have an occasional cough. So, I do not even count that because that is being going on but then I got real sick with positive COVID on the 6th. I am concerned about getting my second shot. That is the reason of my call. The symptoms from the 28th is just what I told you. I have COVID so I am on a lot of medication right now. I am taking medications for the COVID. I am on budesonide (SYMBICORT) inhaler, albuterol (VENTOLIN) inhaler, I am taking acetaminophen (TYLENOL), guaifenesin (MUCINEX). As of Thursday I am taking ranitidine (ZANTAC) and some Steroids, pepper too and cough medicine as needed. When asked about causality, the patient stated "No because my whole family got COVID. Like my daughter, in-laws. It just went through our whole family. I do not think anything is related to the vaccine." Nurse added, "I do not really know what to do about this. If I feel better, I am just wondering if I should go ahead and get it because she told me there is no studies beyond that day. That was my main reason for the call." She was referring to the 'TCP'. "When I am going to get it if I am having mild symptoms because I do not want to lose my immunity. I am kind of troubling with myself what to do." The outcome of the event "I am COVID positive/ woke up with every COVID symptoms/ got real sick with positive COVID" was not recovered and of the remaining events was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive for corona virus infection based on the known safety profile. However the short duration of 10 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity. It worth to note that the patient's whole family developed COVID.
57 2021-01-31 rash had rash on left hand after shot in 10 minutes (same arm having vaccine) then was given one tablet ... Read more
had rash on left hand after shot in 10 minutes (same arm having vaccine) then was given one tablet of zyrtac after ~15 to 20 minutes, having swelling tongue after ~10 to 15 minutes, took one dose of benadryl ~1 to 2 hour, all symptoms go away
57 2021-01-31 vaccination site pain trivial deltoid soreness starting about 4-6h later (maybe lasted a bit longer then 36 hours); not so... Read more
trivial deltoid soreness starting about 4-6h later (maybe lasted a bit longer then 36 hours); not sore enough to limit use of the arm even a little bit.; This is a spontaneous report from a contactable physician (patient). This 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, EH9899), via an unspecified route of administration in left arm, on 18Dec2020 at 10:00 AM at single dose for COVID-19 immunisation. The patient was vaccinated at hospital, age at vaccination was 57-years-old. No other vaccine was received in four weeks. Patient's known allergies: latex (rash, occ. mild bronchospasm); dysphoria c valium; innumerable food reactions - dairy & eggs, nuts/seeds/grains, fish, latex associated foods, nightshades, meat -but none anaphylactic (occ. debilitating headache, very occ. mild bronchospasm; mostly cholinergic urticaria / joint pain / diarrhea). Other medical history included atopic incl. Raynauds; parox. atrial tach (after ablation for PA-fib.); almost-asx'tic asthma; endometriosis c small bowel resection (terminal ileum). Concomitant medication included metoprolol and a very long list of supplements. On an unknown date, the patient experienced trivial deltoid soreness starting about 4-6h later (maybe lasted a bit longer then 36 hours); not sore enough to limit use of the arm even a little bit. No treatment was received for the event. Outcome was recovered on an unknown date.
57 2021-02-01 vaccination site pain Pain injection site; short term memory problems/short term memory loss; reduction in mental clarity/... Read more
Pain injection site; short term memory problems/short term memory loss; reduction in mental clarity/feels like she has not been clear headed; scary feeling; worried; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0140), via an unspecified route of administration on 12Jan2021 at 13:30 at single dose to prevent Covid. The patient's medical history included ongoing blood pressure high, ongoing cholesterol, ongoing anxiety, ongoing sleep disorder, fatigue from 10Jan2021 to 10Jan2021, and spacey from 10Jan2021 to 10Jan2021. Concomitant medication included pravastatin for cholesterol, amlodipine besylate for blood pressure high, lisinopril for blood pressure high, zolpidem tartrate (AMBIEN CR) for sleep, olanzapine for anxiety, all ongoing; and naproxen sodium (ALEVE). The patient previously received the first dose of BNT162B2 (Batch/lot number: EJ1685) by injection in left arm on 22Dec2020 for COVID-19 immunization and experienced fatigue and spacey on 10Jan2021, and pain at injection site on an unspecified date. The patient experienced short term memory problems and reduction in mental clarity from 14Jan2021. The patient called and wanted to know if there were reported cases in the clinical trials that experienced "brain fog" and "memory loss" after taking the COVID 19 vaccine. The patient asked if anyone else reported spaciness, brain fog and short term memory problems after receiving the Pfizer COVID 19 vaccine. The patient reported that she received the second dose of vaccine on 12Jan2021. She reported reduction in mental clarity and short term memory loss. On 10Jan2021, the patient experienced fatigue and "spacy". The patient stated that that she has had both doses of the vaccine, she got the second dose last Tuesday. She was wondering if there were any known side effects of the product including mental clarity, or foggy brain, or memory loss, because the patient felt like she has not been clear headed. She received her 2nd dose on 12Jan2021, and has been experiencing short term memory problems and reduction in mental clarity. She stated that on 10Jan2021, she noticed feeling fatigue and spacey. The patient stated that seriousness criteria for short term memory problems and reduction in mental clarity was not serious, but stated that it was a scary feeling. She laughed and stated that she was worried, is she getting dementia or is it just the shot. She received her 2nd dose of the vaccine on 12Jan2021 at 13:30PM. Lot: EL0140, No Expiry/NDC written on card. She stated that she did get some pain at the injection site; did not clarify after which injection. She stated that she took Aleve 2 capsules as needed. The patient asked if there have been any reports of patients experiencing this after having the vaccine. It was reported that the patient works in the lab. The outcome of the events short term memory problems/short term memory loss and reduction in mental clarity/feels like she has not been clear headed was not recovered, while the outcome of the other events was unknown.
57 2021-02-01 injection site pain Staff described having the chills, headache, and body aches throughout the day, 1 day after receivin... Read more
Staff described having the chills, headache, and body aches throughout the day, 1 day after receiving the vaccination. She also had injection site pain in her arm that made it difficult to perform lifting movements. Adverse event was severe enough the staff felt she could not attend work the day after vaccination.
57 2021-02-01 vaccination site pain pain at the injection site; fatigue; spacey; This is a spontaneous report from a contactable consume... Read more
pain at the injection site; fatigue; spacey; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), via an unspecified route of administration on 22Dec2020 at 15:00 at a single dose in the left arm to prevent Covid. The patient's medical history included ongoing blood pressure high, ongoing cholesterol, ongoing anxiety, and ongoing sleep disorder. Concomitant medications included pravastatin for cholesterol, amlodipine besylate for blood pressure high, lisinopril for blood pressure high, zolpidem tartrate (AMBIEN CR) for sleep, olanzapine for anxiety, all ongoing. On 10Jan2021, the patient noticed feeling fatigue and spacey. On an unspecified date, the patient stated that she did get some pain at the injection site and took Aleve 2 capsules as needed. The patient considered the events fatigue and spacey as non-serious. The outcome of the events fatigue and spacey was recovered on 10Jan2021, while unknown for the other event.
57 2021-02-02 injection site hardening, injection site redness, injection site pruritus, itchy skin, injection site pain I noticed the itchiness and heat about an hour after I received the vaccination. By the time I went... Read more
I noticed the itchiness and heat about an hour after I received the vaccination. By the time I went to bed at approximately 10 PM, the site was beginning to get very hard. By the next day, the site of the vaccination was the size of a baseball and very hard in addition to very red and itchy and painful. Benedryl eliminated the itchiness. However, it is five days later and there is still a very hard and a little less than half the size of a baseball. Most of the pain, heat and redness is gone, but the site is still very hard and itchy.
57 2021-02-02 injection site pain Jan 28 4:30am - woke up to excruciating muscle pain in left leg. As the day progressed, I had the f... Read more
Jan 28 4:30am - woke up to excruciating muscle pain in left leg. As the day progressed, I had the following symptoms: injection site pain, fatigue, headache, muscle pain, chills, fever (ranging from 100.3 to 101.7) nausea, swollen lymph nodes Jan 29 achy, chills, headache, injection site pain, swollen lymph nodes, trouble falling asleep Jan 30 - headache, throat hurt, achy, slight sniffles, got a cold sore, ear pain, trouble falling asleep Jan 31 - ear pain, headache, slight aches, trouble falling asleep Feb 1 - feeling better, some ear pain, trouble falling asleep
57 2021-02-03 itchy skin Received my 1st Pfizer vaccine 1/10/2021. Did great! Received my 2nd Pfizer vaccine 1/31/2021 1130... Read more
Received my 1st Pfizer vaccine 1/10/2021. Did great! Received my 2nd Pfizer vaccine 1/31/2021 1130 am 6 hours later at 6:30 pm ate packaged veggie dumplings and 15 min later my tongue swelled and my face felt swollen and itchy. Took Benadryl 25mg, Allegra 180mg and Pepcid 20mg with relief. 6 hours later, awoke with itchy throat and face and took Benadryl 25mg with relief. Next morning, 2/1/2021: 8 am ate my regular breakfast of peanut butter on toast and 15 minutes later my face started itching. Took Allegra 180mg with relief. 11:30 ate pretzels and face started itching `15 minutes later. Everything I ate that day caused me to itch 15 min afterwards just like when I would have food reactions when first diagnosed with Alpha Gal and my IGE histamine levels with 3x normal. I increased my Allegra 180mg to 3x a day for 24 hours and Pepcid 20mg to 2x a day for 24 hours. 48hours after vaccine I was able to decrease Allegra 180mg to 2x a day with Pepcid 20mg to 2x a day and was able to eat bland food without itching afterwards. My allergist felt the 2nd vaccine may have caused an inflammatory response and flared up my alpha gal symptoms.
57 2021-02-03 injection site pain, injection site redness Report of body aches, fever, swelling, dry throat, redness and pain at the injection site day 1 pos... Read more
Report of body aches, fever, swelling, dry throat, redness and pain at the injection site day 1 post vaccination. Treatment: Tylenol, Outcome: no improvement does not interfere with ADLs.
57 2021-02-04 itchy skin Patient developed chest tightness, palpitations, and SOB approximately 8 min after vaccination. At 1... Read more
Patient developed chest tightness, palpitations, and SOB approximately 8 min after vaccination. At 12min post-vaccination patient developed throat tightness/itching. 0.3mL epinephrine auto-injector was administered at the vaccination site and the patient was transported to the emergency department for further treatment. Patient reported epinephrine made her symptoms worse. Emergency Department provider diagnoses symptoms as anxiety and gave a dose of lorazepam which improved the patient's condition. The patient was discharged from the ED after being monitored for 4 hours with improvement in symptoms. No further treatment was given.
57 2021-02-05 injection site pain Fever of 100, nausea, injection site pain, lympnoid pain right side into right breast, stiff neck, ... Read more
Fever of 100, nausea, injection site pain, lympnoid pain right side into right breast, stiff neck, all over pain ,achness, headache, fatigue and all over chills. Took tylonal and went to bed for 14 hours. Still experiencing pain, slight headache and achness all over. Fever and nausea gone.
57 2021-02-05 rash, rash papular, itchy rash ITCH RASED BLANCHABLE RASH 1-2 DAYS AFTER VACINATION. OVER EXTREAMITIYS . STILL PERSIST 9 DAYS POST... Read more
ITCH RASED BLANCHABLE RASH 1-2 DAYS AFTER VACINATION. OVER EXTREAMITIYS . STILL PERSIST 9 DAYS POST VACINATION
57 2021-02-07 itchy skin, redness At midnight the same day after the vaccine she awakened feeling cold, sweating, and had a temp of 10... Read more
At midnight the same day after the vaccine she awakened feeling cold, sweating, and had a temp of 101.6 F. Pt had fever for 24 hours. She took Tylenol at that time. Her face was also red after the second vaccine and has remained red around the lower half of her face. Her face tingles at times. She feels like bugs are walking on her face and body at times, get itchy at times, gets hot, then gets cold. Pt felt a zap like electricity in her bosom for on 1 day in her left breast/ chest fleetingly. She feels it, zaps, sometimes in other places in her body since then rarely, not daily.
57 2021-02-07 injection site pain, injection site bruising Fever of 101 starting 14 hours after injection and fever 99-101 lasting 26 hours. Bruise and pain at... Read more
Fever of 101 starting 14 hours after injection and fever 99-101 lasting 26 hours. Bruise and pain at site of injection
57 2021-02-07 injection site redness, injection site warmth, injection site swelling, injection site pruritus, injection site pain First Vaccination on 01/13/21 right arm - pain at injection site for several days following. Brai... Read more
First Vaccination on 01/13/21 right arm - pain at injection site for several days following. Brain fog and some fatigue. Second vaccination on 02/3/21 left arm - approx. 3 hours later felt a little woosie and spacey. Pain at injection site. At approx. 3am the following morning experiencing chills and body jerks along with long deep breathing. Temperature 100.1. Also had a painful headache and full body aches along with some nausea and very fatigued and pain at injection site was growing in size and was also hot and red and swollen. Contacted primary care doctor about these side effects. On 2/5/21 the temperature reached 100.7 and the previous days aliments continued and fever came down to 99.6. Lots on pain in left side of neck and left arm. Let arm continues to be swollen, red and hot and is itchy. Fever finally broke on the night on Feb. 6th.
57 2021-02-07 injection site reaction My arm and shoulder were sore throughout the day and that evening it was really sore. I woke up at 3... Read more
My arm and shoulder were sore throughout the day and that evening it was really sore. I woke up at 3:00 in the morning and my head hurt very bad, and I woke up and I took two Tylenol and waited 20 minutes and then took alleve, drank four cups of coffee and half floreset and that helped a little bit and this morning I woke up with a terrible a headache and stiff neck and shoulder, and its only my left shoulder where I got the shot.
57 2021-02-07 rash My throat became dry and irritated, white or nude colored bumps appeared on back of throat and palat... Read more
My throat became dry and irritated, white or nude colored bumps appeared on back of throat and palate. Eventually became sore after the 2nd vaccine Lot # EL1284 on 1/23/21 worsened and throat became red under the bumps. To date bumps and redness remain. Soreness comes on and off, lasts hours improves then returns. Also headaches daily since initial vaccine. I saw PMD am currently on Amoxicillin 875 and it is not helping at all.
57 2021-02-07 rash hard time breathing; Rash all over body; This is a spontaneous report from a contactable pharmacist.... Read more
hard time breathing; Rash all over body; This is a spontaneous report from a contactable pharmacist. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El3249), intramuscular at arm left on 24Jan2021 at 13:30 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 24Jan2021 at 13:30, the patient experienced rash all over body and hard time breathing. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with BENADRYL and EPIPEN. The patient outcome of the events was recovering.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events dyspnea and rash cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
57 2021-02-08 rash 20 minutes post injection started to feel clammy, increased heart rate and rash appearance on both a... Read more
20 minutes post injection started to feel clammy, increased heart rate and rash appearance on both arms and hands. Reported to doctor at site and EMS was called. Heart rate was 98, BP 218/110 taken three times by EMS. Administered Benadryl liquid by EMS and monitored for thirty minutes. Rash stopped spreading and improved heat rate and B/P. Was released to go home by EMT. While traveling home had to stop by roadside because of vomiting and nausea. Next morning rash still present on arms and fingers.
57 2021-02-08 itchy skin Patient received her vaccine about 11:50 AM and waited in the parking lot (because she is under quar... Read more
Patient received her vaccine about 11:50 AM and waited in the parking lot (because she is under quarantine and not allowed to enter the facility) for the appropriate 15 minutes. Within about 10 minutes she began experiencing shortness of breath, throat felt restricted and severe nausea. Myself, another pharmacist, and several members of the staff met them in the parking lot and assessed her condition. Because of her symptoms, we determined it was appropriate to go ahead and administer the EpiPen 0.3mg and call 911 at that time. About 10 minutes later we gave her a 25mg oral dose of Benadryl while we waited on the ambulance to arrive. The ambulance arrived within the next 10 minutes and by then the patient stated she was feeling much better. The EMT examined her and declined any further medical assistance. I called the patient at her home 2 hours later and she said she had some light itching and dizziness. I told her the dizziness could be due to the after-effects of the EpiPen but if it worsened or there were any other signs of an allergic reaction to report to the ER immediately or call 911. This may have been more of an anxiety related reaction due to there being no signs of swelling around the lips or mouth, but we decided it would be best to be overly cautious in this situation.
57 2021-02-09 skin warm 103.5 fever; severe back pain; body aches; Nausea; felt horrible; a girl touched her arm, said it wa... Read more
103.5 fever; severe back pain; body aches; Nausea; felt horrible; a girl touched her arm, said it was burning; This is a spontaneous report from a contactable nurse reported for herself. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) by injection once to right deltoid on 25Jan2021 at single dose for COVID-19 immunization. Medical history included she had COVID, she was diagnosed, was positive on 29Dec2020, and spent 9 days in the hospital. concomitant mediation was none. Patient calling about the COVID vaccine; her boss texted, she had to leave work, she had a 103.5 fever (26Jan2021), she felt horrible, she got her first COVID vaccine yesterday, and woke up this morning and felt horrible. a girl touched her arm, said it was burning, and she was very nauseous, and was trying to pass meds, and took her temperature and it was 103.5, and the thing is when you come into the facility, they took her temperature and it was 97.2, but those thermometers suck and she has an oral thermometer, and it was 103.5. It's improving. Also has severe back pain and body aches, she was scared with the fever. Felt nauseous this morning (26Jan2021), had chicken noodle soup and crackers, but it was pretty bad to point she had to pull the trash can behind her. she was on a ventilator in March for a week, not with COVID, she doesn't want to die, she thought she was going to die with COVID, she had every symptom. No Investigation Assessment. The last outcome of 103.5 fever, nausea and severe back pain was recovering, body aches was not recovered, outcome of other events was unknown. Reporter seriousness for 103.5 fever was Medically significant. For severe back pain, body aches and Nausea was Not serious. Relatedness of drug to reactions/events 103.5 fever, severe back pain, body aches and Nausea per source of assessment of Primary Source Reporter and Method of assessment of Global Introspection with drug result of Related.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product BNT162B2 to reported event pyrexia and remaining events cannot totally be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
57 2021-02-09 injection site pain fatigue body aches low ferver chills injection site pain
57 2021-02-09 vaccination site pain her upper chest, the medial aspect of her left arm and down her upper arm initially pain; her upper ... Read more
her upper chest, the medial aspect of her left arm and down her upper arm initially pain; her upper chest, the medial aspect of her left arm and down her upper arm initially pain/fingers ached; down her upper arm initially pain; About 15 minutes later her wrist and fingers ached/joint pain; a gradual increase of body aches; nausea; feeling 'hot'; Big time tired, fatigue the patient would go to bed early; This is a spontaneous report from a contactable Nurse (patient). A 57-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration at Arm Left on 25Jan2021 14:15 at the 57 years old at single dose for COVID-19 immunization. The medical history included FAP (Familial adenomatous polyposis), hernia repair, ankylosing spondylitis, bipolar disorder II, chronic depression, PTSD(Post-traumatic stress disorder), anxiety, GERD, Penicillin allergy, Adhesive tape allergy, Antiemetics allergy. The concomitant medications were amlodipine, ASA, HCTZ, lamotrigine (LAMICTAL), losartan, naproxen. The patient previously took Ciprofloxacin and experienced allergy, Ativan and experienced allergy. Right after the patient received the shot on 25Jan2021 14:30, her left side of her upper chest, the medial aspect of her left arm and down her upper arm initially pain. About 15 minutes later her wrist and fingers ached. From then on 25Jan2021 14:30, a gradual increase of body aches and joint pain, some nausea feeling 'hot' but not 'hot flashes' no sweats, Big time tired, fatigue the patient would go to bed early. She was keeping very hydrated. There was no other vaccine in four weeks. There was no treatment for the adverse events. There was no covid prior vaccination. There was no covid tested post vaccination. The outcome of the events was recovering. Information about lot/batch number has been requested.
57 2021-02-10 injection site pain 1/15/21-#1, soreness left upper arm, radiating to left upper back. Started morning 1/16/21 & lasted ... Read more
1/15/21-#1, soreness left upper arm, radiating to left upper back. Started morning 1/16/21 & lasted 3 days 2/9/21-#2, soreness left upper arm & left wrist, 30mins after injection. 2/10/21 Left shoulder very sore with limited mobility continual with increased soreness into evening & nighttime. 2/10/21 @ 6pm oral temp 100.3F & body "achiness" , took Ibuprofen 400mg with relief. 2/11/21- only slight discomfort L upper arm with movement, all other resolved.
57 2021-02-10 shingles 12/22 vaccination 12/27 8AM started feeling going on with TMJ. Had appt with audiologist. Wondering ... Read more
12/22 vaccination 12/27 8AM started feeling going on with TMJ. Had appt with audiologist. Wondering if it was in ear. Ran along facial nerve. 12/30 pain increased tremendously, exploded. Weird, yucky lesions on face and mouth. My husband asked if could be shingles; positive. 1/12 Neurology. 2/7/2021 Major pain has subsided. Still recovering from Shingles. *2nd vaccination 1/12/2021 7:30 R arm
57 2021-02-10 itchy skin bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid ca... Read more
bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands; bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands; bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands; This is a spontaneous report from a contactable physician. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3284), intramuscular into the left arm on 11Jan2021, at 16:00 as second single dose for covid-19 immunization. Medical history included Obstructive sleep apnea from an unknown date, oligodendroglioma from 1996 (noted as history of oligodendroglioma status post resection 25 years ago with stable follow up and no residual deficits). The patient had no known allergies to medications, food, supplements or herbal remedies. There were no concomitant medications; Patient was not taking any OTC medications, prescribed medications, supplements or herbal remedies at the time as well as in the period prior to her vaccinations. The patient previously received BNT162B2 (lot number EH9899 ) on 22Dec2020. On 18Jan2021, at 08:00, the patient experienced bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands, which was medically significant and had not recovered, as it was persisting. This was elaborated as follows: patient experienced one week following 2nd Pfizer covid-19 vaccine patient developed bilateral feet, left worse than right, burning, itching sensation. the symptoms progressed up to her mid calves and to a slight extent. The events were considered medically significant. Details were as follows: The symptoms were quite intense and interfered with her life, requiring gabapentin prescription for control of neuropathic complaints. Patient denied any significant weakness, low back pain, neck pain, balance problems, dizziness, bowel or bladder involvement. Patient saw physician who performed workup for common associated etiologies of polyneuropathy, which were negative. Patient underwent EMG/NCS which were normal, and subsequently skin bx (skin biopsy) to rule out small fiber neuropathy (results pending). The patient further described the incident as a week after receiving the second dose of the covid vaccine, the patient experienced new onset bilateral feet burning that went into her upper legs, mid calves and to a slight extent in both hands. The burning was experienced more in the left foot than the right foot. Reports it was severe enough for the patient to reach out to her primary care provider. (PCP) to start Gabapentin for neuropathic pain. PCP ordered labs to rule out infection and other causes for neuropathy which all came back negative. Patient has no known underlying risk factors that would predispose her to neuropathy. Neurologist did an EMG which showed no evidence of neuropathy. The patient went into to the office, and she had a skin biopsy to rule out small fiber neuropathy. She does not have results to provide for the skin biopsy at this time, however, the neurologist feels if the skin biopsy is positive, there may be an association with the vaccine in regards to the burning pain the patient is experiencing. She is calling to ask if this is a reported side effect. Treatment was confirmed as gabapentin was prescribed by PCP, and the patient started on it a few days after the onset of the burning pain. Outcome was noted as it has not improved, and has not resolved. No COVID tested post vaccination was noted. The outcome of the events was not recovered; the condition was persisting. Causality for the events was noted as related.; Sender's Comments: Based on a compatible temporal association contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) to the onset of events pruritus, burning sensation, condition aggravated cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
57 2021-02-10 hives lip tingling, dizziness, heart racing had hives 24-48 hours after 1st dose
57 2021-02-10 injection site pain rectal bleeding; Severe chills; hot flashes with temp remaining at 95 degrees; hot flashes with temp... Read more
rectal bleeding; Severe chills; hot flashes with temp remaining at 95 degrees; hot flashes with temp remaining at 95 degrees; stomach pain; dizziness; weakness; severe fatigue; severe headache; nausea; injection site pain; lack of appetite or thirst; lack of appetite or thirst; This is a spontaneous report from a contactable other healthcare professional. A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date was not reported), intramuscular on 07Jan2021 15:30 at single dose on the left arm for covid-19 immunization. Medical history included PTSD, CRPS, anxiety, and chronic pain. The patient has no allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) and clonazepam. On 21Jan2021 at 16:00, the patient experienced severe chills and hot flashes with temp remaining at 95 degrees, stomach pain, dizziness, weakness, severe fatigue, severe headache, nausea, injection site pain, lack of appetite or thirst. On 26Jan2021, the patient experienced rectal bleeding (medically significant). It was reported that the patient received Zofran and she missed her work days. The patient had a clinic visit to her doctor. It was reported the patient was not diagnosed with COVID-19 prior to vaccination. The patient had Nasal Swab on 25Jan2021 with negative results. The patient has not recovered from all of the events at the time of the report.
57 2021-02-11 hardening Expanding hematoma and blood accumulation at elbow, now spreading to left pectoral area to elbow wit... Read more
Expanding hematoma and blood accumulation at elbow, now spreading to left pectoral area to elbow with increasing induration and edema. She was sent to ER for evaluation.
57 2021-02-14 injection site pain, injection site swelling After first shot no significant adverse effects until Day 8 my right upper arm started to exhibit se... Read more
After first shot no significant adverse effects until Day 8 my right upper arm started to exhibit severe pain and decreased mobility. Did NOT have redness, only minor swelling at injection area. Initially treated with Tylenol and ice with no relief. Day 9 increased pain, difficult to lift or move arm. Seen in clinic- Rx Motrin 600mg 3x daily, ice/heat. Day 10- returned to urgent care with severe right arm pain- could hardly move arm, unrelieved with Motrin. unable to sleep last 2 nights. RX with Medrol pack (6 days). Now day 3 have most arm function back and only mild pain in right arm.
57 2021-02-14 injection site pain, injection site bruising Delayed adverse effects occurred about 8 hours after 2nd dose administered. Injection site tenderne... Read more
Delayed adverse effects occurred about 8 hours after 2nd dose administered. Injection site tenderness and bruising. Headache, chills, fatigue, achy joints, runny nose but no fever. Symptoms continued for 2 days after vaccine although not as severe by the 2nd day. Experienced nausea, dizziness or fogginess for 3-4 days after.
57 2021-02-14 bruising, rash macular, rash, skin warm On 1/11/21, the next day the arm was swollen, hot, bruised, and so swollen that she had to use an XL... Read more
On 1/11/21, the next day the arm was swollen, hot, bruised, and so swollen that she had to use an XL shirt, wears M. Had red splotches on it, pain and swelling for 7 days after the vaccine. There was red splotches on the arm, but now 2/15/21 there are now white dots where the red lines used to be. Did not take anything for it, as she did not know what to do. She called her doctor, but they did not address the problem. When she went to work on 1/12/21 had another lady that is a corporate nurse and told her that it was bad. Arm is still hurting, and is in the process of recovering. If she pushes on the location of the vaccine it does hurt. She has not and will not take the 2nd vaccine.
57 2021-02-15 rash, itchy rash, rash papular, rash with redness Developed erythematous papular rash on torso (98%) few lesion on upper arm and into groin area. Rash... Read more
Developed erythematous papular rash on torso (98%) few lesion on upper arm and into groin area. Rash remains in same place daily, can be pruritic. Consulted with Dermatologist, sent photos, felt to be consistent with Pityriasis Rosea. (NOT urticaria) Difficult to control with topical corticosteroid and oral anti-histamines. Currently taking 6 day taper of oral prednisone with some rash improvement.
57 2021-02-16 injection site numbness numbness around vaccine site. nausea. typical reaction she has with vaccines. feels better after... Read more
numbness around vaccine site. nausea. typical reaction she has with vaccines. feels better after 10 mins
57 2021-02-18 itchy skin, rash * ~10 pm on day vaccine given (Friday, 1/8/21), developed mild headache * Progressed to severe mig... Read more
* ~10 pm on day vaccine given (Friday, 1/8/21), developed mild headache * Progressed to severe migraine with some nausea during night, and lasted all day Saturday (~20 hrs.) I took Children's Tylenol dye free liquid late in day which took slight edge off headache. * Developed severe central chest pain in night, which felt like pain I experienced with esophagitis/gastritis in past. This lasted for about 20-30 minutes, then resolved. * Awoke next morning (Saturday, 1/9/21) with low grade fever (~99.3 degrees F), and had fever for 2 days (never exceeded 100.3 degrees F that I detected)--no appetite all day * Developed central low back pain/ache on Saturday ~ mid-day, which lasted through at least Sunday * Awoke Sunday morning with rash on torso (same rash familiar to me when I have infections--biopsied in past and determined to be interface dermatitis). Rash progressed throughout day to portion of arms, neck, groin (as always does with illness), and faded until resolving Monday am/mid-day. Itching then occurred over next couple of days (as it always does with illness). Appetite still limited. * Sunday evening experienced acute abdominal pain and urgent diarrhea x 3 or 4 episodes * Monday I felt better, but was fatigued and trying to get back on my feet
57 2021-02-18 injection site pain After the first dose the next day strong pain in my left arm from the elbow to the wrist, Ceased the... Read more
After the first dose the next day strong pain in my left arm from the elbow to the wrist, Ceased the next day. After the second dose strong pain in the left side of my neck and back, mild pain in the injection site, malaise and muscular ache, all these symptoms improve the next day.
57 2021-02-19 itchy skin Severe body aches, headache, left earache pain, unable to sleep entire night, diarrhea, itching, sto... Read more
Severe body aches, headache, left earache pain, unable to sleep entire night, diarrhea, itching, stomachache.
57 2021-02-19 injection site pain Sore at injection site, used rubbing alcohol. Felt better after a few rubs. Nausea, a few days after... Read more
Sore at injection site, used rubbing alcohol. Felt better after a few rubs. Nausea, a few days after, drank tea and honey. Came and left for a couple days Slight headache the next day, did not take anything. Meditation, Cramps in pelvic area, did stretches and yoga.
57 2021-02-21 shingles Developed Shingles, approx 7 days after 2nd dose after 2nd dose
57 2021-02-21 injection site pain Extreme Abdominal Pain-8 hours, Extreme Arm pain (in the arm that didn't receive the shot)-24 hours,... Read more
Extreme Abdominal Pain-8 hours, Extreme Arm pain (in the arm that didn't receive the shot)-24 hours, Extreme fatigue-5 days, Chills-8 hours, Fever-3 days (reducing in severity each day), arm pain in shot area- mild and continuous for 6 days.
57 2021-02-21 hives Hives primarily on left side of face/cheek. Just observed, about 4 hours after it diminished 75%, ... Read more
Hives primarily on left side of face/cheek. Just observed, about 4 hours after it diminished 75%, I took one Benadryl at bedtime just in case, next morning it was gone.
57 2021-02-21 itchy skin Pt. presents today with itching post receiving 1st pfizer covid vaccine on 2/22/21 to right arm on 2... Read more
Pt. presents today with itching post receiving 1st pfizer covid vaccine on 2/22/21 to right arm on 2/22/21 at 14:38 pm/ Pt. states that she started having itching shortly afterwards. Pt. denies shortness of breath, denies
57 2021-02-21 skin burning sensation Rapid heart rate Burning through body Cold sweat Felt low blood pressure
57 2021-02-22 rash developed rash 56 hours after covid vaccine and it lasted 24 hours. Rash was on both legs. she als... Read more
developed rash 56 hours after covid vaccine and it lasted 24 hours. Rash was on both legs. she also had fever, chills aches 10 hours after the vaccine and that lasted 24 hours.
57 2021-02-23 redness Both eyes very bloodshot with redness in skin around eyes and slightly swollen , resolved by next da... Read more
Both eyes very bloodshot with redness in skin around eyes and slightly swollen , resolved by next day. I never get bloodshot eyes.
57 2021-02-23 injection site pain Days 1-3 pain at site of injection much more than other vaccines that subsided but to this date has ... Read more
Days 1-3 pain at site of injection much more than other vaccines that subsided but to this date has not gone away completely. Low grade fever and fatigue for about a week, lots of sleeping! Mild wheezing and sinus congestion, headaches. Day 4 I developed swelling in the lower legs and feet, that lasted about a week, still some fatigue and ongoing sinus congestion but feeling better, then a few days later in the 2/16 developed sudden onset moderately severe pain and tenderness in the upper right abdominal quadrant in the area of the live, gallbladder and pancreas up near and under the ribs and around to the flank and a small aspect of the back, with abdominal swelling belching and bile diarrhea and indigestion
57 2021-02-23 skin burning sensation I felt like I was going to pass out; suddenly all over my body under my skin was burning everywhere;... Read more
I felt like I was going to pass out; suddenly all over my body under my skin was burning everywhere; my heart was pounding so fast; dizzy; seeing blurry; tongue was stinging; eye lids were burning; I didn't feel right the whole rest of the night.; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231/212080597001), the first dose, via an unspecified route of administration on 31Dec2020 18:30 at single dose for covid-19 immunisation. Medical history included High Cholest. Type 2 Diabetes, High Blood Pressure, Fatty Liver, Overweight, and allergies to medications: Penicillin. Concomitant medication included levothyroxine sodium (UNITHROID), olmesartan medoxomil (BENICAR), rosuvastatin, empagliflozin, linagliptin (GLYXAMBI), escitalopram oxalate (LEXAPRO). After injections (on 31Dec2020) when to sit down, suddenly all over my body under my skin was burning everywhere and my heart was pounding so fast I thought it was going to come out of my chest. I got dizzy and was seeing blurry. At the end my tongue was stinging and my eye lids were burning. I felt like I was going to pass out. Then finally subsided but I didn't feel right the whole rest of the night.Therapeutic measures were taken as a result of all events. The outcome of events was recovered.Prior to vaccination, the patient did not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19. The case considered non-serious (Seriousness criteria-Results in death: No;Life threatening: No;Caused/prolonged hospitalization: No;Disabling/Incapacitating: No;Congenital anomaly/birth defect:No). Follow-up attempts are completed. No further information is expected.
57 2021-02-23 itchy skin, injection site pain Site: Pain at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Me... Read more
Site: Pain at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium
57 2021-02-24 itchy skin, hives General fatigue, severe swelling in arm with pain, hives on scalp with horrible itching, diarrhea, s... Read more
General fatigue, severe swelling in arm with pain, hives on scalp with horrible itching, diarrhea, stomach pain, severe back pain, nausea.
57 2021-02-24 shingles SHINGLES: UPPER LEFT SCALP
57 2021-02-24 rash, injection site rash, rash macular pt reported perfect white circles or splotches on right arm after injection around injection site up... Read more
pt reported perfect white circles or splotches on right arm after injection around injection site up her arm to her neck, chest, and around her back and down to her elbow they did not itch were not red or raised
57 2021-02-27 injection site hardening, injection site swelling, injection site redness COVID arm, red, swollen, hard at and around the injection site.
57 2021-03-01 injection site pain, injection site swelling injection site pain, injection site swelling, muscle pain, chills, swollen lymph nodes, nausea
57 2021-03-02 hives seems to have an autoimmune response; She has hives wrapped around her entire left ankle; Other medi... Read more
seems to have an autoimmune response; She has hives wrapped around her entire left ankle; Other medical history: Graves disease; Other medical history: Graves disease; this is her ankle is swollen and not very comfortable; this is her ankle is swollen and not very comfortable; This is a spontaneous report from a contactable other health professional (patient). A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, pending clarification), via an unspecified route of administration (at the age of 57-year-old) on 12Jan2021 (also reported as 19Jan2021, pending clarification) at a single dose for COVID-19 immunization. Medical history included Graves disease and COVID-19. Concomitant medication included metoprolol. Patient completed the report online at Pfizer, but does not have a reference number for that report. She is scheduled to get second shot tomorrow, however, she seems to have an autoimmune response. She has hives wrapped around her entire left ankle on 22Jan2021. She wants to know if she should get second dose or not. She works in a nursing home. She has been noticing here and there little dots of hives that were not a big deal and this is her ankle is swollen and not very comfortable. The patient would like to know if it would be safe for her to have the second dose given her autoimmune response to the first dose. No treatment received for the event "She has hives wrapped around her entire left ankle". The outcome of the events was unknown. The patient was not pregnant. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine in four weeks. Not COVID tested post vaccination. Information on the lot/batch number has been requested (clarification).
57 2021-03-03 skin warm Client reported warm feeling/ sensation on the left arm immediately after getting the vaccine; foll... Read more
Client reported warm feeling/ sensation on the left arm immediately after getting the vaccine; followed by left shoulder/ back pain after 5 min. pain scale of 4/10. Client is A/O x 4, no respiratory distress observed; was able to tolerate and drink water. Client was observed through discharge; stated initial symptoms were improved/ resolved. V/S on discharge: BP of 140/80, HR of 62 bpm, O2 saturation of 98% on RA. Client ambulated independently out of the vaccine clinic.
57 2021-03-03 hives Hives on both arms about 5 hours after second injection. Spread to my legs 5 days later; This is a s... Read more
Hives on both arms about 5 hours after second injection. Spread to my legs 5 days later; This is a spontaneous report from a contactable other healthcare professional (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249 and expiration date not provided), via an unspecified route of administration in the left arm on 27Jan2021 13:45 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no allergies to medications, food or other products. Concomitant medications included metformin, colecalciferol (VITAMIN D), biotin and multivitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) on 06Jan2021 13:45 in the left arm at the age of 57 years old for Covid-19 Immunization. On 27Jan2021 18:00, the patient experienced hives on both arms about 5 hours after second injection which spread to the patient's legs 5 days later. The patient saw her PCP today and she felt it was related to vaccine. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included antihistamine. The outcome of the event was not recovered. The reporter assessed the event as non-serious.
57 2021-03-03 injection site pain reports having soreness in left arm at site of injection site. developed loss of appetite that afte... Read more
reports having soreness in left arm at site of injection site. developed loss of appetite that afternoon after receiving vaccine. noticed shortness of breath while walking the dog. sunday evening, developed left axillary lymph node swelling. also with fever 99.8 - 100.2 degrees F. had night sweats saturday evening (2/27/2021 PM). also with headache after vaccine.
57 2021-03-04 injection site hardening, injection site warmth, injection site swelling I was fine but the next day I had a cough and I started hyperventilating from all the coughing. I we... Read more
I was fine but the next day I had a cough and I started hyperventilating from all the coughing. I went to the Urgent care and my O2 levels were in the 60s. They told me if they didn't improve I'd be sent to the hospital. O2 improved. My arm swelled up at the injection side and it was hot and hard under the site. I put ice packs on it for 2 days and its gone way down.
57 2021-03-04 rash with redness, itchy skin Patient received vaccine at 12:01, she stated that approximately 12:30 she noticed her right palm f... Read more
Patient received vaccine at 12:01, she stated that approximately 12:30 she noticed her right palm felt itchy and she noticed red bumps on the inside of her right wrist. She reported the symptoms to the onsite paramedics. She stated that she was placed on a stretcher and given 60 mg of liquid benadryl by the paramedics. She stated she started feeling dizzy, but after 3 minutes the dizziness resolved. She stated that soon after that the itchy right palm resolved, and the red spots on her right wrist diminished. She stated the paramedics took her blood pressure, 150/100 and placed her on oxygen. She stated she was monitored until 1:30 pm, then was discharged, at the time of discharge she had no dizziness, no itching, and only slight red bumps on her wrist. When she got home she stated her eyes felt itchy at about 5:30 pm, she took 2 OTC benadryl tablets, the symptoms resolved. She has been asymptomatic since that time.
57 2021-03-05 shingles Diagnosed with shingles on 3/4/2021. Had gone to urgent care on 3/2/2021, but at that time the diagn... Read more
Diagnosed with shingles on 3/4/2021. Had gone to urgent care on 3/2/2021, but at that time the diagnosis was neuromuscular. Pain increased severely by 3/4/2021 so I returned to urgent care (ibuprofen 600 was not addressing the pain after 2 hours). Had a classic shingles rash on the back of my neck (mostly right side, small bit just left of center) into my scalp wrapping around to right side, plus very faint rash on right cheek and inside part of right eye, and right ear is swollen. Ironically, I had postponed my Shingrix vaccine March 2020; was planning to get this a few weeks after the Pfizer vaccine second dose, once it was recommended to do so.
57 2021-03-05 itchy skin Itching on right forearm. BP 129/83 (pulse 80), O2 sat 98%.
57 2021-03-05 itchy skin, rash Rash to neck and left hand dorsum at digits 3,4 with mild edema and itching. Symptoms started about ... Read more
Rash to neck and left hand dorsum at digits 3,4 with mild edema and itching. Symptoms started about 24 hours moted to have rash on right side of neck that developed into two papules by the next day, 36 hours after vaccine started with rash to dorsum of right hand at digits 3,4 with mild edema at base of fingers.
57 2021-03-06 rash Patient arrived for her first dose of pfizer covid vaccine. She received it at 1708 in the left delt... Read more
Patient arrived for her first dose of pfizer covid vaccine. She received it at 1708 in the left deltoid and, was escorted to the 15 minute observation area. She noted feeling burning sensation in her chest and bilateral arms after a few minutes. Patient brought to EMS for evaluation. EMS obtained several sets of vital signs, notable for hypertension (170's/90's). Patient placed on stretcher. She was flushed, had a dry/thick tongue, developed rash on bilateral arms, began shaking and shivering but stated she was not cold only nervous. She was given 50 mg benadryl IM, 18 g IV started in her right antecubital. She declined solumedrol due to past experience with steroids. Her flushing and rash began to resolve, patient stated her tongue felt better. Patient was transported by EMS for evaluation. She had her phone with her, but her husband took her other belongings and will meet her there.
57 2021-03-06 shingles Shingles
57 2021-03-07 injection site pain, itchy rash Rash with severe itching. Lasted 3 days. The first night was the worst which was the next night aft... Read more
Rash with severe itching. Lasted 3 days. The first night was the worst which was the next night after the vaccine I was awake all night. My arm where I had the injection was really sore for 3 days.
57 2021-03-07 itchy skin Stated often has panic attacks when receives shots or has IVs placed. Stated after vaccination, tong... Read more
Stated often has panic attacks when receives shots or has IVs placed. Stated after vaccination, tongue started to feel bigger and to itch at the back, throat also started to feel tight. Monitored by EMTs in parking lot. Given oral Benadyl. Was not transported to hospital. Husband came to pick her up. Stated a few hours later felt pressure in windpipe at level of clavicles & had difficulty breathing. Stated sleep the rest of the day. Denies HA, fever, or chills. Stated throat felt better the next day though still feels pressure at base of throat. Also complaining of occasional "brain zap" (zing in brain that then causes eye to twitch). States that since tongue started feeling big she has had trouble talking--words coming out funny. States that is still happening.
57 2021-03-08 hives, itchy skin, rash Anaphylaxis - rash and hives from head to toes, severe itching, difficulty breathing, and chest pain... Read more
Anaphylaxis - rash and hives from head to toes, severe itching, difficulty breathing, and chest pain. Oxygen Saturation was at 87 when I arrived. Treated with dexamethasone sod phosphate PF last given at 5:45 PM, diphenhydrAMINE (Benadryl) last given at 5:45 PM, EPINEPHrine last given at 5:45 PM, famotine last given at 6:08 PM, GI cocktail oral suspension last given at 6:44 PM, hydrocortisone last given at 8:18 PM, LORazepam last given at 5:48 and 6:45 PM, ondansetron last given at 5:48.
57 2021-03-08 injection site pain Injection side tenderness, tiredness, feeling unwell
57 2021-03-09 injection site pain Pfizer-BioNTechCOVID-19 Vaccine EUA Sore Throat, fatigue, soreness at ejection site and low grade fe... Read more
Pfizer-BioNTechCOVID-19 Vaccine EUA Sore Throat, fatigue, soreness at ejection site and low grade fever
57 2021-03-09 injection site vesicles Pt developed large blister around shot (about 12 inches in diameter)
57 2021-03-09 injection site pain Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild,... Read more
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient did not have any anaphylaxis, main complaint was mild tightness under chin between jaw and lymph nodes 20 minutes post immunization lasting for a max of 30 minutes. Also mild tingling in forearm a few minutes after injection.
57 2021-03-09 vaccination site warmth, vaccination site redness, vaccination site itchiness fever; chills; back pain; injection site redness w/ itching & heat; injection site redness w/ itchin... Read more
fever; chills; back pain; injection site redness w/ itching & heat; injection site redness w/ itching & heat; injection site redness w/ itching & heat; injection site redness w/ itching & heat; swelling under arm; head ache; This is a spontaneous report from a contactable other healthcare professional (patient). A 57-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: F19264), via an unspecified route of administration on 05Feb2021 09:45 at a single dose for COVID-19 immunization. The patient's medical history included hypothyroidism and sulfer allergy. The patient was not pregnant at the time of vaccination. Concomitant medication included thyroid (ARMOUR THYROID) and rosuvastatin. The patient previously took the first dose of bnt162b2 (lot number: EL1283) in the right arm on 15Jan2021 at the age of 57 years old for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 05Feb2021 20:30, the patient experienced fever, chills, back pain, injection site redness with itching and heat, swelling under arm, and head ache. No treatment was received for the adverse events. Outcome of the events was recovering.
57 2021-03-10 rash, itchy skin 57 year old female who was seen today for her second dose of the COVID 19 vaccination. She was g... Read more
57 year old female who was seen today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience itching. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , rapid progression of symptoms and skin changes. PMH: prediabetes, copd. ALLERGY REVIEW OF SYSTEMS: Patient complains of itching of skin Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes itching, eye redness, cough, chest tightness, shortness of breath, wheezing, rash and dizziness Previous Reactions: none. Did well with 1st dose of Pfizer but did have a headache that lasted for 5 days. Objective Vitals Vitals: 03/08/21 0906 03/08/21 0916 BP: 136/88 120/76 BP Location: Right arm Patient Position: Sitting Pulse: 97 90 SpO2: 96% 96% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Pharynx: Oropharynx is clear. Eyes: Conjunctiva/sclera: Conjunctivae normal. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Findings: No rash. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines Pepcid and Zyrtec Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) Generalized itching. She was observed in the medical bay for approx 15 minutes. She responded really well to the antihistamines. No further itching reported. No rash or other symptoms noted. She feels well to go home. Given handwritten instructions on medications received and when she can repeat if needed along with Benadryl use. Pt voiced appreciation of her care today. PT walked out by pharmacist.
57 2021-03-10 shingles Diagnosed with Shingles 7 days after vaccine. Symptoms appeared 6 days after receiving vaccine.
57 2021-03-10 itchy skin Patient is a 57 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the C... Read more
Patient is a 57 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience itching. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , rapid progression of symptoms and skin changes. PMH: prediabetes, copd. ALLERGY REVIEW OF SYSTEMS: Patient complains of itching of skin Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes itching, eye redness, cough, chest tightness, shortness of breath, wheezing, rash and dizziness Previous Reactions: none. Did well with 1st dose of Pfizer but did have a headache that lasted for 5 days. Objective Vitals Vitals: 03/08/21 0906 03/08/21 0916 BP: 136/88 120/76 BP Location: Right arm Patient Position: Sitting Pulse: 97 90 SpO2: 96% 96% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Pharynx: Oropharynx is clear. Eyes: Conjunctiva/sclera: Conjunctivae normal. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Findings: No rash. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines pepcid and zyrtec Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) Generalized itching. She was observed in the medical bay for approx 15 minutes. She responded really well to the antihistamines. No further itching reported. No rash or other symptoms noted. She feels well to go home. Given handwritten instructions on medications received and when she can repeat if needed along with benadryl use. Pt voiced appreciation of her care today. PT walked out by pharmacist.
57 2021-03-10 rash, itchy rash, rash with redness SEVERE RASH FROM NASAL AREAS, UNDER NOSE, AROUND MOUTH AND CHIN. IT WAS RED, WEEPING, SORE AND IT... Read more
SEVERE RASH FROM NASAL AREAS, UNDER NOSE, AROUND MOUTH AND CHIN. IT WAS RED, WEEPING, SORE AND ITCHED. I WENT TO DERMATOLOGIST AND WAS PRESCRIBED METRONIDAZOLE, IVERMECTIN, AND FLUOCINOIDE.
57 2021-03-12 shingles 6 days after second dose....diagnosed with shingles of face scalp and eye
57 2021-03-12 injection site redness, injection site warmth, injection site rash, injection site pruritus, injection site swelling COVID Arm- Red rash and arm swollen at the site of the injection. Feels warm and is itchy. Started 1... Read more
COVID Arm- Red rash and arm swollen at the site of the injection. Feels warm and is itchy. Started 1 week after second dose of Pfizer vaccine.
57 2021-03-12 injection site swelling Racing heart, elevated heart rate within 15 minutes Chills, feverish within 2 hours Fatigue same day... Read more
Racing heart, elevated heart rate within 15 minutes Chills, feverish within 2 hours Fatigue same day and entire next day Swelling at injection site within 12 hours
57 2021-03-14 hives . Caregiver for my 78 y/o Day 1: 3/9/21 - low grade headache. Day 2: 3/10/21 - headache stronger (... Read more
. Caregiver for my 78 y/o Day 1: 3/9/21 - low grade headache. Day 2: 3/10/21 - headache stronger (took Tylenol); Day 3: 3/11/21 - debilitating headache. Couldn't work. Eyes hurt. Headache felt like hammers hitting the side of my head. I was so concerned I wanted to go to the hospital. The headache stopped around 2pm on March 11. Day 5: 3/14/21 - face has welts on my left cheek (shot was in the left arm).
57 2021-03-14 rash, redness Caused a flare up of rosacea on both sides of my face and nose. I had bumps and redness. I noticed i... Read more
Caused a flare up of rosacea on both sides of my face and nose. I had bumps and redness. I noticed it the day after the injection. Today is day 3 and it is slowly getting better but still there.
57 2021-03-14 hives, itchy skin, redness Flushing, pruritis Pt was in COVID Vaccination clinic and c/o itching, chest reddened, small hives... Read more
Flushing, pruritis Pt was in COVID Vaccination clinic and c/o itching, chest reddened, small hives noted on chest, ears itching, no respiratory symptoms or difficulty. Speech clear, no stridor noted. Pt stated does have a significant allergy history and sees an allergist. Medicated with Benadryl 50 mg po and immediately to ED, registered right away, pt then c/o head and back itching, and taken into triage for assessment by triage nurse. Per Hospital Note: Patient initially developed hives and itching with progression in symptoms to include shortness of breath and throat tightening. She reported feeling as though her tongue were swelling and having difficulty speaking and having difficulty swallowing. Concerns of impending loss of airway prompted administration of IV Solu-Medrol, Benadryl and 2 doses of intramuscular epinephrine which were unsuccessful and therefore emergent intubation was performed. Patient apparently has had prior anaphylactoid reactions in the past including bee stings and shellfish.
57 2021-03-14 rash, shingles Patient contacted her employer 2 days after vaccination with complaint of new onset rash. Was seen ... Read more
Patient contacted her employer 2 days after vaccination with complaint of new onset rash. Was seen by her PCP and was reportedly being treated for Shingles. Missed work week of 8-12 March for same. When didn't report to work today (3/15/21), supervisor went to home to conduct a safety check and found the patient dead in her home.
57 2021-03-14 rash, hives Pt reports waiting 30 min post injection at clinic and leaving without any s/s. States about 1.5 hou... Read more
Pt reports waiting 30 min post injection at clinic and leaving without any s/s. States about 1.5 hours later, noticed hives on chest and abdomen as well as a headache and reports her "mouth was raw". She did not take any medications or seek medical attention then. The next day around 10 am, she took one dose of Benadryl. The rash on her chest resolved thereafter, but patient states she then noticed a rash under her panus, the top of her legs, and upper buttocks. Pt states rash totally resolved by Monday. Reports headache was worst on Saturday and Sunday. Reports taking Excedrin Migraine as part of her daily routine for other chronic pain and reports headache relief. Denies SOB, tongue swelling, or dyspnea.
57 2021-03-14 itchy skin, hives Severe itching, hives, facial and neck swelling, breathing trouble
57 2021-03-14 injection site pain, skin peeling, injection site swelling, injection site pruritus, injection site redness, injection site bruising Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection... Read more
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Skin peeled off around injection site-Medium
57 2021-03-14 shingles Unsure if related to vaccine lowering immunity but came down with shingles on the left side of my f... Read more
Unsure if related to vaccine lowering immunity but came down with shingles on the left side of my face three weeks after my second vaccine. Thought I should report just in case.
57 2021-03-14 rash, shingles, injection site pain, pain of skin Vaccination burned slightly, some arm soreness, but no other immediate reactions. Eight days after ... Read more
Vaccination burned slightly, some arm soreness, but no other immediate reactions. Eight days after vaccination I developed skin tenderness on L forearm. Days 9-13 have resulted in rash in several areas on forearm and additional tenderness on upper arm. At regularly scheduled dermatologist appt they advised it was shingles and prescribed an anti-viral medication (Valcyte HCL 1000mg).
57 2021-03-15 redness, itchy skin, shingles Had a shingles outbreak on left mid/lower back. Reddened raised lesions, pain & itching. Prescribe... Read more
Had a shingles outbreak on left mid/lower back. Reddened raised lesions, pain & itching. Prescribed Acyclovir for 10 days. Symptoms subsided over time. Some residual itching at times still
57 2021-03-15 itchy skin, rash papular, rash I was woken up at around 2:40am, after 4.5 days of getting the 1st doze of the Pfizer vaccine, by in... Read more
I was woken up at around 2:40am, after 4.5 days of getting the 1st doze of the Pfizer vaccine, by intense itchiness under the arms. Then, realized that I had rashes all over the body, around the neck, and legs/hands. Raised patches, extremely itchy. I called my Dr to let her know. She didn't think it was related to the vaccine. However, I did nothing different from every day; no new food, no new circumstances. The itchiness lasted for about 3 days. (I took Benadryl two nights in the row). Today is 9th day, no more itchiness, but the body still has pink areas here and there, indicating that rashes were there. I'm actually worried if I should get the second doze. It its scheduled for April 2nd. I did take pictures of the rashes.
57 2021-03-16 injection site redness 1) slight pain in shoulder area starting a few hours after and lasting about a day limiting some ran... Read more
1) slight pain in shoulder area starting a few hours after and lasting about a day limiting some range of motion (was able to tolerate without pain relief) 2) redness around injection area starting next day and lasting about 2 days (not painful)
57 2021-03-16 injection site pain My entire left arm has been stiff and sore ever since injection. Pain has traveled from injection si... Read more
My entire left arm has been stiff and sore ever since injection. Pain has traveled from injection site down to my fingertips. Weeks later I am in moderate pain.
57 2021-03-16 injection site pain Very sore left upper arm by evening. Pain not noticed by day 3 after injection. No redness or shot ... Read more
Very sore left upper arm by evening. Pain not noticed by day 3 after injection. No redness or shot site swelling.
57 2021-03-17 hives Hives developed in bilateral inguinal folds and upper posterior thighs
57 2021-03-18 pain of skin Chills, muscle aches, joint soreness, headache, sore skin across entire body.
57 2021-03-18 redness, itchy skin Itchy face, red inflamed and itchy hands, ringing of the ears
57 2021-03-19 injection site pain - Slightly elevated temperature of 99.9 degrees F - Diarrhea - Nausea - Chills - Headache - Soreness... Read more
- Slightly elevated temperature of 99.9 degrees F - Diarrhea - Nausea - Chills - Headache - Soreness at vaccine site - Dizziness
57 2021-03-19 hives 3/20/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination ... Read more
3/20/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: urticaria around mouth. Assessment : Time of assessment 1105am. Alert and oriented. No visible redness , rash, or swelling visualized. Actions taken: Benadryl 12.5 mg tablet given Po x 1 per standing orders, VS taken with BP- 130/72, P-75, O2 sats- 100%, VS recheck at 1115, BP-122/68, P-72, O2- 100%. Medications administered: Diphenhydramine (Benadryl) 12.5 ml (25 mg) by mouth. Time: 1105. Administered by RN. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/20/2021 10:40 AM 0.3 mL 12/11/2020 Intramuscular
57 2021-03-19 redness, itchy skin My arm 2 days after the second dose started to itch terribly and became red and swollen
57 2021-03-19 rash, itchy rash Slightly itchy rash on inside of right arm between hand and elbow - 4 square inch patch
57 2021-03-20 rash nausea, headache,rash on inner thighs, pt has been applying neosporin
57 2021-03-21 hives 3 DAYS AFTER VACCINE PATIENT DEVELOPED HIVES, CHEST PAIN AND THROAT SWELLING.
57 2021-03-21 injection site pain 57y/o female presents with mild throat tightness ~15min after receiving Pfizer vaccine into the left... Read more
57y/o female presents with mild throat tightness ~15min after receiving Pfizer vaccine into the left arm. She states that it feels as though something small got stuck in her throat and is causing mild discomfort. She reports associated injection site pain, body cramps, and headache. She denies itching, difficulty breathing, shortness of breath, chest pain, palpitations, blurry vision, presyncope, difficulty swallowing water, or lip/tongue swelling. She reports no change in symptoms after 40min. post-injection. Physical Exam: Heart Rate 66bpm, Blood Pressure 115/74, Repeat Blood Pressure at 40min post-injection 120/80 Cardiac: regular rate and rhythm Lungs: unlabored breathing, clear to auscultation bilaterally Skin: no injection site erythema or swelling. No rash. No lip/tongue swelling or narrowing of oropharynx. Plan: Patient reports that her symptoms have improved at 1hr post-injection and would like to leave. I advised her that she should wait until all of her symptoms have resolved as throat tightness is a concerning adverse reaction. I provided her with options including contacting EMS right now to take her for observation at the hospital, however, the patient declined and said she would not go in the ambulance. She insisted that she wanted to go home and that her husband was driving and would take her to the emergency room if her symptoms worsen. Patient was well-appearing when she left the vaccination site.
57 2021-03-21 redness Skin redness and minor swelling. 25mg Benadryl PO
57 2021-03-22 itchy skin 4 days after vaccination, burning, itching right middle back and front torso, transient burning patc... Read more
4 days after vaccination, burning, itching right middle back and front torso, transient burning patches on left thigh at top and top of left foot: side of neck and ear
57 2021-03-22 skin burning sensation, itchy skin, skin irritation Day after vaccine, the left side of my face between my nose and mouth it felt very irritated, burnin... Read more
Day after vaccine, the left side of my face between my nose and mouth it felt very irritated, burning and itchy. No rash was seen. I was advised by doctor to take Benedryl.
57 2021-03-22 redness Large red dot under left eye. Not itchy and not a pimple.
57 2021-03-22 rash, itchy skin, hives Within minutes my head started to itch, then I was itching all over s time went on, I thought it was... Read more
Within minutes my head started to itch, then I was itching all over s time went on, I thought it was just because I was nervous to get the vaccine- But I went back to work and brushed it off-I had long sleeves and long pants so I did not look but later on I had rash and hives all on my arms, trunk, legs, and back this lasted a few days- It was very itchy and I tried not to take anything because I wanted to make sure I got the full benefit of the vaccine.
57 2021-03-23 itchy skin, hives Face became numb, had mild hives, continue itchiness for 2 days
57 2021-03-23 itchy skin Horseness, SOB and itching
57 2021-03-23 rash I had a fever of 103 degrees for 24 hours. I had body aches, chills, headache and rash over most of... Read more
I had a fever of 103 degrees for 24 hours. I had body aches, chills, headache and rash over most of my body.
57 2021-03-23 rash Patient reports disoriented, cold feeling to chest, Heart Palpitations, numbness in fingers, tongue ... Read more
Patient reports disoriented, cold feeling to chest, Heart Palpitations, numbness in fingers, tongue thickness, "feels weird". Macular Rash mid sternum noted by on site physician. No respiratory distress noted. No epinephrine administered.
57 2021-03-23 injection site pain, injection site redness, injection site swelling Redness, pain, elevated temperature and swelling at the injection site. Symptoms were present appro... Read more
Redness, pain, elevated temperature and swelling at the injection site. Symptoms were present approximately 5 to 6 hours after injection. Slept more than usual. Woke up next day with more pain, redness, elevated temperature and swelling at the injection site. Used Vicks vapor rub and Salompass pads to control pain and discomfort. Symptoms were gone by the third day.
57 2021-03-23 vaccination site swelling Sick stomach; headache; bruised injection spot and swollen; bruised injection spot and swollen; This... Read more
Sick stomach; headache; bruised injection spot and swollen; bruised injection spot and swollen; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EN6198) via an unspecified route of administration, administered in arm left on 13Feb2021 14:15 as single dose for COVID-19 immunization. The patient medical history was not reported. Patient has no known allergies. Patient is not pregnant. Concomitant medications included Fluoxetine, Estrodial, calcium carbonate/colecalciferol (VITAMIN D 2000), magnesium sulfate, fish oil. The patient experienced sick stomach, headache, bruised injection spot and swollen on 13Feb2021 15:45. No treatment received. There is no other vaccine received in four weeks. The patient did not have COVID prior vaccination. No COVID tested post vaccination. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
57 2021-03-23 injection site swelling, itchy skin, rash, redness, injection site redness, injection site pruritus Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Inject... Read more
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: Redness and swelling of both arms starting at wrists and itching on left arm. Subsided after about 45 minutes. Advised Benadryl, but wanted to wait until she got home as she had a bit of a drive and didn't want to drive drowsy.
57 2021-03-23 injection site pain Site: Pain at Injection Site-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension... Read more
Site: Pain at Injection Site-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe
57 2021-03-23 itchy skin dizziness and itching....progressed to anxiety and chest pain.
57 2021-03-23 vaccination site pain felt soreness in the area of the injection site; first dose of BNT162B2 on 01Feb2021/ second dose of... Read more
felt soreness in the area of the injection site; first dose of BNT162B2 on 01Feb2021/ second dose of BNT162B2 on 18Feb2021; first dose of BNT162B2 on 01Feb2021/ second dose of BNT162B2 on 18Feb2021; This is a spontaneous report from a contactable consumer. A 57-Years-Old female patient (pregnant: No) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9266), via an unspecified route of administration in left arm on 18Feb2021 at single dose for covid-19 immunisation. The relevant medical history was not reported. Concomitant medications included atorvastatin calcium (LIPITOR). The patient previously received first dose of BNT162B2 on 01Feb2021 at the age of 57 years old for COVID-19 immunisation (lot number=EL9262, vaccine location=Left arm, dose number=1). The patient felt soreness in the area of the injection site on 20Feb2021. No treatment received for the event. No COVID prior vaccination and no COVID tested post vaccination. No other vaccine in four weeks. The outcome of the event felt soreness in the area of the injection site was recovering.
57 2021-03-23 injection site rash, injection site redness rash, red hot under shot arm. Swollen glands under shot arm
57 2021-03-24 itchy skin, rash macular A few minutes after my Pfizer COVID vaccine injection in my left arm, while in the observation area,... Read more
A few minutes after my Pfizer COVID vaccine injection in my left arm, while in the observation area, I felt an itching sensation on my left forearm which was followed by the same itching feeling on my neck. Then a couple of minutes later my lips felt slightly swollen and my throat was a little scratchy. I told a nurse and she moved me to a chair closest to an oxygen tank. I?m a retired paramedic so I knew I was having a mild allergic reaction. There was never any wheezing. I also had a headache and felt lightheaded. The nurses monitored me 15 minutes longer than the required 15 minutes. I asked them if I should take some Benadryl for the symptoms. They asked if I was driving and said to take it once I got home. The symptoms continued for an hour with added swollen tongue, red lips and blotchy skin spots on my face and feeling tired. Once I took 50mg of Benadryl the symptoms gradually dissipated over 4 hours. I?m concerned about how I will react with my second dose. My MD recommended 25mg of Benadryl before my second Pfizer vaccine and 25mg after if needed.
57 2021-03-24 hives, itchy skin About 27min after receiving vaccine, client began feeling itchy all over and hives were observed. Be... Read more
About 27min after receiving vaccine, client began feeling itchy all over and hives were observed. Benadryl was given to pt. About 15min after receiving benadryl client began to feel better. No hives were observed and she was not have any difficulty breathing. Client deemed safe to go home per RN.
57 2021-03-24 itchy rash, rash with redness, itchy skin Beginning four hours after injection, began developing rashes: initially left middle finger became i... Read more
Beginning four hours after injection, began developing rashes: initially left middle finger became itchy, raised erythematous, weeping, progressed to eventual desquamation down to dermal layer. Over several days to week developed facial rash appearing atopic, weeping. Bilateral nipple rashes: pruritic, lichenified, weeping. Bilateral thighs with annular erythematous pruritic, now lichenified lesions. Initially thought to be herpetic whitlow when just affecting finger--HSV culture sent, rxd antiviral. Ultimately was rx'd prednisone course (5d 40 mg) today, 5 weeks out.
57 2021-03-24 vaccination site rash, vaccination site mass Heart shaped rash appeared 6" below injection site; excruciating lymph node pain; pain in tricep, un... Read more
Heart shaped rash appeared 6" below injection site; excruciating lymph node pain; pain in tricep, under arm; hard lump at injection site; Swelling down to hand and fingers; 99.3 fever; pain in tricep, under arm; This is a spontaneous report from a contactable healthcare professional (patient). This non-pregnant 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the right arm on 21Feb2021 at 14:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history or concomitant medications. The patient reported she had allergies to medications, food or other products. Prior to vaccination the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (lot number unknown) on 31Jan2021 at 16:00 (at the age of 57-years-old) in the right arm for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 21Feb2021 at 22:00 the patient experienced a heart shaped rash six inches below the injection site 8 hours after the shot. 10 hours later the patient had excruciating lymph node pain and pain in the tricep, under arm and hard lump at injection site. She also experienced swelling down to hand and fingers and 99.3 fever. The events were reported as non-serious and didn't require hospitalization. No treatment was provided for the events. The clinical outcomes of heart shapes rash six inches below injection site, excruciating lymph node pain, pain in tricep under arm, hard lump at injection site, swelling down to hand and fingers, and 99.3 fever were reported as not recovered. It as also reported that since vaccination the patient had not been tested for COVID-19.
57 2021-03-24 hives Initially intense headache, body aches, irritability, chills followed by severe angioedema of lips a... Read more
Initially intense headache, body aches, irritability, chills followed by severe angioedema of lips and face with urticaria
57 2021-03-25 injection site tingling Patient felt tingly arm in injection arm 20 minutes after injection. Patient was given 25mg Benadryl... Read more
Patient felt tingly arm in injection arm 20 minutes after injection. Patient was given 25mg Benadryl and reported feeling much better and left on own accord.
57 2021-03-25 hives, rash with redness erythematous hives around neck, tongue tingling.
57 2021-03-26 itchy skin 4pm, 1 hour after shot, throad swelling, stuffy headache, heart bm 99 to 87 to 96, started itching o... Read more
4pm, 1 hour after shot, throad swelling, stuffy headache, heart bm 99 to 87 to 96, started itching on left arm near wrist, arm where shit was. etc., For next 3 hours. Took antihistamine chlortrimitron 2, mucinex 1, drank water. 6pm, hbm 87, 78, felt like palpations, throat more swollen. Kept clearing throat to keep open. 9pm, bm 82, 78, 93, throat not worse, drank water. With heart rate so high, I didn't take epipen. 9:10pm went to bed 12am woke up throwing up intensely. Took prescription promethazine let dissolve in mouth, went to bed. 9am woke up with little nausea, light headache, swollen raw throat. 4:30pm, 25+ hours after shot, throat still really swollen, arm sore, tired.
57 2021-03-26 injection site pain, injection site pruritus, injection site redness, injection site hardening Itching, redness tenderness and induration at injection site beginning on day 8 after vaccination.
57 2021-03-27 injection site pain Chills, fever of 101, body aches, sore arm of injection, and very tired
57 2021-03-27 injection site pain On day after shot, Low grade fever (100°), chills, slight headache, shot location arm pain, extreme... Read more
On day after shot, Low grade fever (100°), chills, slight headache, shot location arm pain, extreme fatigue (slept for hours) Second day fever was gone and only slightly tired. By 3rd day only thing was a little pain at shot site.
57 2021-03-27 blister, vaccination site swelling, rash macular, shingles left scars to her left breast still, that look like white crust on them/scars on her left breast; le... Read more
left scars to her left breast still, that look like white crust on them/scars on her left breast; left scars to her left breast still, that look like white crust on them; bumps on her chest that won't heal up; skin blistered up like shingles centered to her left breast in the middle; spots were white and puffy, and some left a bump around; pain in her left chest still from the middle to her arm down to her elbow; pain goes from her front to the back of her shoulder blade and around; nerve pain; every once in a while she loses her grip with her left hand though not too much and she can grab again what was slipping; bumps on the left side of the chest/still has lumps, some were white and some have busted open; broke out with what thought as a nurse was shingles; arm swelling after the injection; pain/stabbing pain/nagging pain; pain in her arm that went to her chest area/Under her arm and going down she feels a pinching sensation; Her left arm was swollen at the injection site; This is a spontaneous report from a contactable nurse (patient) from the medical information team. A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, administered in the left arm on 22Jan2021 at a single dose (at the age of 57-years-old) for COVID-19 immunisation. The patient was given the vaccine in a pharmacy/drug store. Medical history included diabetes and hypertension. There were no concomitant medications. The patient experienced arm swelling after the injection, then a little later on in the day experienced pain. The next day or so, she got bumps on the left side of the chest. Thought it was shingles and was given medicine for shingles but ended up not being shingles. She still has lumps, some were white and some have busted open, approximately 4. She still had arm pain and back. Arm was still swollen. Went back to doctor on 10Mar2021 and gave another round of antibiotics. Still has a stabbing pain from the from to the back. "1 cm to 1.5 cm." She had scheduled for a breast screening done. She was still having pain almost 2 months later. The patient provided further information: the patient only got her first dose of the vaccine. Her side effects began that day then gradually got worse. Her left arm was swollen at the injection site since 22Jan2021 and was still swollen at the time of the report. A couple of hours afterwards as the day went on, she had pain in her arm that went to her chest area. The next day (23Jan2021), she broke out with what thought as a nurse was shingles, but was just in one little spot, so she went to the doctor and gave her medicine, antibiotics, and then she took those for 7 days three times a day. The first antibiotic she was on when they thought it was shingles was azithromycin (ZITHROMAX). After then, the pain would not go away and has left scars to her left breast still, that look like white crust on them. She has pain in her left chest still from the middle to her arm down to her elbow. She has two different types of pain, and when she went back to the doctor a day before (10Mar2021), she was given more antibiotics. The pain goes from her front to the back of her shoulder blade and around and was a stabbing pain. Under her arm and going down she feels a pinching sensation that won't go away, and was all the time. They wouldn't give her the second vaccine dose while she was on antibiotics that appointment reached its due. The pharmacist came on 05Mar2021 which would be her third appointment to get the vaccine and told the pharmacist her reaction to the COVID shot. The pharmacist asked to look at her injury and then wouldn't give the vaccine to her. Her doctor gave her some pain medication that would be good for nerves. She can't take gabapentin and doesn't like to take pain pills for the nerve pain, so she does paracetamol (TYLENOL) and ibuprofen every other time to relieve the pain. She says she has been taking paracetamol 500mg extra strength twice a day by mouth, and ibuprofen 400mg twice a day by mouth. She was wondering if there was any information on if her pain would get better since she doesn't want to stay the same or for it to get worse that what it is. It was a nagging pain that she can't seem to get rid of and every once in a while she loses her grip with her left hand though not too much and she can grab again what was slipping. The gabapentin for her nerve pain gave her side effects, she was taking 300 mg one pill four times a day. She took about three days worth and starting in Feb2021 she thought. The new antibiotic given on 10Mar2021 that she takes for the bumps on her chest that won't heal up was cefdinir 300 mg. She says after her vaccine her skin blistered up like shingles centered to her left breast in the middle, which she thought originally would spread all around but it didn't, it stopped right there. She says that the spots were white and puffy, and some left a bump around in them where they healed up. She says her doctor wanted her to get a mammogram done, which is scheduled for the first Monday in Apr2021. No labs were done, "they just looked at them". The patient felt bumps on the left side of the chest was medically significant because the scars and bumps have been there a while and several were not healing well. The patient has not recovered from the events. Information on the lot/batch number has been requested.
57 2021-03-28 redness, itchy skin, skin warm, hives Vaccine recieved at 8:10am. At 11:00 am noticed hives on neck and red. Throat felt tight so looked... Read more
Vaccine recieved at 8:10am. At 11:00 am noticed hives on neck and red. Throat felt tight so looked in mirror. Tongue was 3 times typical size! Ears hot and itching. Airway compromised. Tongue continued to enlarge and throat tighter. Hives on face.
57 2021-03-30 injection site swelling, injection site pain Pain n swelling on the injection site on the left arm; Pain n swelling on the injection site on the ... Read more
Pain n swelling on the injection site on the left arm; Pain n swelling on the injection site on the left arm; This is a spontaneous report received from a contactable consumer (Patient). A 57-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number/ expiration date: unknown) via unspecified route of administration at left arm on 10Feb2021, 01:00 at single dose for COVID-19 Immunization. The patient's medical history included Diabetes dm. Concomitant medications were not reported. No known allergies reported. The patient did not receive any other vaccination within 4 weeks. No Covid-19 prior vaccination and covid tested post vaccination yes. On 12Jun2020 the patient was tested for COVID-19 (Nasal-swab) result negative. On 10Feb2021 at 01:00 PM, the patient had Pain and swelling on the injection site on the left arm. The patient did not receive any treatment for the event. Outcome of the event was not resolved. Information on the lot/batch number has been requested.
57 2021-03-30 injection site redness red mark in the right arm; This is a spontaneous report from a contactable consumer (self-reported).... Read more
red mark in the right arm; This is a spontaneous report from a contactable consumer (self-reported). A 57-years-old female patient received First dose of BNT162B2 (Pfizer-biontech covid-19 vaccine, Formulation: solution for injection, Lot number EL3246) via unspecified route of administration in Arm Right on 22Jan2021 in afternoon as single dose for covid-19 immunisation. Medical history included thyroid cancer from 2011. concomitant medication was not reported. Patient reported 3 days before she got her first COVID-19 Vaccine dose, she got a Shingles vaccine on 19Jan2021. Patient had blood work done recently because she has to go every once in a while to an endocrinologist. Patient reported that, her doctor was against her getting her Shingles shot. She said she had asked her doctor to get the Shingles shot because she had seen a Shingles vaccine commercial that said people over 50 years old should get the Shingles vaccine. She said her doctor told her she didn't need the Shingles vaccine. She said she decided to get the Shingles vaccine on her own because she had worked for a lady who had Shingles. On 22Jan2021, patient noticed that the red mark in the right arm, from the first dose, is still there. She asked if it will ever go away. She stated it has been 3 weeks and if it stays another 20 days she will be concerned. On 11Feb2021, patient got second COVID-19 Vaccine shot on left arm and showed the red mark on her right arm to the staff after the vaccine facility. She said none of the staff could tell her anything about the red mark on her right arm at the first COVID-19 Vaccine. The outcome of the event was not recovered.
57 2021-04-01 itchy rash, hives, skin warm 3/15/21: Rash and Hives on Neck in a few spots 3/20/21: Rash and Hives - very itchy and very hot c... Read more
3/15/21: Rash and Hives on Neck in a few spots 3/20/21: Rash and Hives - very itchy and very hot covering full front of neck and across chest; some hives on stomach; a few hives that were extremely itchy outside of nose and around mouth.
57 2021-04-09 redness face and chest turned "really red"/get real bright red like a tomato/her chest and face were bright ... Read more
face and chest turned "really red"/get real bright red like a tomato/her chest and face were bright red; felt some fluttering later in the evening/flutters in pacemakers; This is a spontaneous report from a contactable consumer (patient's husband). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via intramuscular route, administered in right arm on 05Mar2021 at 03:30, at the age of 57 years, at a single dose for COVID-19 immunization. Medical history included pacemaker placed 20 years ago to prevent her from easily passing out, during surgery they punctured heart wall and she started bleeding out into her heart wall and they had to do surgery and relief the bleeding in her heart, she has fought pericarditis ever since. The patient was allergic to sulfas. There were no concomitant medications. It was reported that 20 minutes after receiving the first dose of the vaccine, at 03:50, the patient's face and chest turned "really red." She had no other symptoms and did not notice the redness until her husband pointed it out. She was fine and then get real bright red like a tomato. They were concerned, stated there were no hives, just her chest and face were bright red. They called the paramedics and recommended Benadryl but she did not take any, states when they got home and settled down, it disappeared. As patient was allergic to sulfas, she waited 30 minutes not 15 minutes. Patient has had a pacemaker for 20 years, and felt some fluttering later in the evening after the first shot (05Mar2021) but it went away. The patient was nervous about this afternoon (26Mar2021) as she was getting the second shot, hence the reporter was seeking guidance on what do to about the second dose. The events were reported as non-serious, and did not require a visit to the emergency room nor the physician's office. The events recovered on 05Mar2021. Information on lot/batch number has been requested.
57 2021-04-10 itchy skin, rash Severe Abdominal Pain and skin rash in face, neck, chest and left arm for over ten days. Other symp... Read more
Severe Abdominal Pain and skin rash in face, neck, chest and left arm for over ten days. Other symptoms: lack of taste, muscle pains in lower extremities/back/arm, ringing ear, itching, throat narrowing/shortness of breath, weight loss, extreme fatigue and weakness for several days; brain fog, dizziness, difficulty swallowing/sleeping.
57 2021-04-12 rash, hives Blood pressure was elevated; Started with sweating then light headed nausea and dizzy. 30 minutes a... Read more
Blood pressure was elevated; Started with sweating then light headed nausea and dizzy. 30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; Started with sweating then light headed nausea and dizzy. 30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; Started with sweating then light headed nausea and dizzy. 30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; Started with sweating then light headed nausea and dizzy. 30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; Started with sweating then light headed nausea and dizzy. 30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 57-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Ep7533) via an unspecified route of administration at arm left on 30Mar2021 10:00 as single dose for COVID-19 immunization. The patient has other medical history and concomitant medications was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Patient had known allergies. The patient experienced started with sweating then lightheaded nausea and dizzy, 30 minutes after injection broke out with hives on neck and chest rash on face and blood pressure was elevated on 30Mar2021 10:15. Therapeutic measures were taken as a result of started with sweating then lightheaded nausea and dizzy 30 minutes after injection broke out with hives on neck and chest rash on face and blood pressure was elevated and was taken to hospital for observation. The outcome of the events was recovering.
57 2021-04-13 injection site pain Patient awoke in the middle of the night (1:20am) with severe discomfort in the neck and throat. Ex... Read more
Patient awoke in the middle of the night (1:20am) with severe discomfort in the neck and throat. Excess saliva. As the pain persisted the pain radiated to the left arm/shoulder. We sought help at our local emergency department where she was found to be in new onset atrial fibrillation. A battery of tests were ordered including a troponin which was noted to be: 1.48. She was transported via ambulance to the hospital to be admitted and undergo left heart cardiac catheterization with the presumptive diagnosis of NSTEMI.
57 2021-04-17 redness, skin discolouration tip of left ring finger turned white and numb/finger was completely white and the rest of her hands ... Read more
tip of left ring finger turned white and numb/finger was completely white and the rest of her hands were blue and red and white and yellow; tip of left ring finger turned white and numb; her finger felt funny; Reynauds phenomenon; sore arm; fever; chills; headache; swollen lymph node in the armpit of the arm she got her Covid 19 vaccine in; swollen lymph node started with a sharp pain and it's very sore; left foot, it was pulsing and throbbing all night; feet were modeled red, blue; feet were modeled red, blue; very sick; needed her glasses trying to give her primary care doctor's phone number; has something like gout in her foot; The swollen lymph node started with a sharp pain and could be a blood clot as far as she knows; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 57-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EW0150; expiry: 31Jul2021), via an unspecified route of administration in left arm on 31Mar2021 01:30 as single dose for covid-19 immunisation. The vaccination facility type was a warehouse. The vaccine was not administered at a military facility. No previous immunization with the Pfizer vaccine considered as suspect. No vaccines administered on same date with the Pfizer vaccine considered as suspect. No prior vaccinations (within 4 weeks) and no following prior vaccinations. Medical history included covid-19 in Nov2020. The patient had no concomitant medications. The patient had the first dose of bnt162b2 on 31Mar2021 and 12 hours later (on 01Apr2021), sore arm, fever, chills and headache. Got a swollen lymph node in armpit, same arm as injection left side, today tip of left ring finger turned white and numb. She thinks it was Reynauds phenomenon. The patient called and told nurse in her doctor's office and they said if it was painful, it could be a pain clot. It was painful at first, that lymph node started 24 hours later with a sharp pain, and then she just assumed it could be a lymph node. Swollen lymph node started with a sharp pain and it was very sore. The nurse told the patient to call Pfizer. The patient was fine until the tip of her finger happened. The patient said If it was painful it could be a blood clot, would need an x ray and asked if did the shot cause this. The complete ring finger left hand, the patient looked it up and it said it could happen to her feet and she looked, and her feet were modeled red, blue it was bizarre. Never happened before. The patient was not happy about getting the vaccine, she already had covid in November of last year (2020). The patient wouldn't have called if it wasn't for her finger. Not just her feet, her hands got like this too. The patient didn't want to get the second shot. The patient asked if there was any information or mandate on timing information for the second dose, should she needed to postpone it. The patient asked if what was the efficacy after first dose as she felt like she was immune because she had the virus and now the vaccine. She was very hesitant to get the Covid 19 vaccine. She thinks her body created Covid 19 antibodies. A couple days ago she was very sick. The swollen lymph node started with a sharp pain and could be a blood clot as far as she knows (in 2021). Even putting on deodorant she can tell it's there, it was very sore and there's a lump. Today (on 01Apr2021), she noticed the tip of her finger got white it was numb. She looked it up online and she thinks it was Reynaud's phenomenon. She has a picture if Pfizer needed it. The finger was on the same arm that she received her vaccine in. It was the ring finger on left hand. Once it started happening her finger felt funny and felt numb. She put her finger under warm water. She reported that the white color was maybe a third of the way down towards her knuckle. She was asking if this was normal or has this been reported. She had called her doctor today and spoke with the nurse who told her to call the CDC and report her symptoms. She needed her glasses trying to give her primary care doctor's phone number. The patient wanted to add that she has something like gout in her foot and on that side too, the left foot, it was pulsing and throbbing all night. She's had this pain in her left foot, she thinks its gout because it was all the symptoms of gout and she had it for a while, it hurts off and on but that night it was hurting and throbbing. She has not been diagnosed with gout in that left foot. She still has a headache but today she felt good except for her finger turning white and going numb. The lymph node in her armpit hurts. Her doctor's nurse told her if its painful to the touch it could be a blood clot so she was nervous about that. The tip of her finger was completely white and the rest of her hands were blue and red and white and yellow. She reported that her finger was back to normal now. She didn't want to get too inoculated since she also had the Covid 19 virus. The events did not require visit to emergency room nor physician office. The outcome of the events was unknown for thrombosis, Raynaud's phenomenon, erythema, cyanosis, illness, visual impairment, and gout while for the remaining events was recovering.
57 2021-04-22 rash, hardening Indurated rash
57 2021-04-22 rash, vaccination site swelling, vaccination site pain Swelling lymph nodes in armpit and clavicle; swelling and pain at injection site; swelling and pain ... Read more
Swelling lymph nodes in armpit and clavicle; swelling and pain at injection site; swelling and pain at injection site; a little rash in right forearm; This is a spontaneous report received from a non-contactable consumer (patient). A 57-years-old female patient received second dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 57-years-old, via an unspecified route of administration, administered in Arm Left on 06Apr2021 09:30 AM (Lot Number: EW0151) as single dose for covid-19 immunisation. Medical history included Diabetes, Hypertension, Neuropathy, Radiculopathy. No allergies to medications, food, or other products. Concomitant medications included metformin hydrochloride; losartan; atorvastatin (LIPITOR); clonidine (CATAPRESS); clonazepam (KLONOPIN). Patient received first dose of BNT162b2, at the age of 57-years-old, administered in Arm Left on 03Mar2021 10:15 AM (Lot Number: EN6207) for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swelling lymph nodes in armpit and clavicle on 07Apr2021 21:00 with outcome of recovering, swelling and pain at injection site on 07Apr2021 21:00 with outcome of recovering, a little rash in right forearm on 07Apr2021 21:00 with outcome of recovering. No treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
57 2021-04-23 vaccination site pain Moderate tenderness at injection site; Malaise; Headache; This is a spontaneous report from a contac... Read more
Moderate tenderness at injection site; Malaise; Headache; This is a spontaneous report from a contactable nurse, the patient. A 57-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: en5318) via unknown route on 28Jan2021 09:30 AM as a single dose at left arm for COVID-19 immunisation. The patients medical history was not reported. No drug allergies were reported. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient had not been tested for COVID 19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ej1686) via unknown route on 07Jan2021 09:45 AM as a single dose on left arm for Covid-19 immunization. After second dose on 28Jan2021 03:00 PM, the patient experienced moderate tenderness at injection site starting at 6 hours posts vaccine. Next day general malaise and headache for several days. The outcome of the events were recovered on an unknown date in 2021.
57 2021-04-23 vaccination site pain Sore injection site; This is a spontaneous report from a contactable consumer (patient). A 57-years-... Read more
Sore injection site; This is a spontaneous report from a contactable consumer (patient). A 57-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 05Feb2021 10:00 (at the age of 57 years old) (Batch/Lot Number: EL3247) as SINGLE DOSE for covid-19 immunization. Medical history was none. Concomitant medication(s) included ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported. The patient received ibuprofen within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Allergies to medications, food, or other products was none. The patient experienced sore injection site on 05Feb2021 15:00. No treatment received for the adverse event. Reporter assessed the event as non serious. Outcome of the event was recovering.
57 2021-04-24 vaccination site swelling Swelling at the injection site; Her arm was the size of an egg and it was hard; A significant drop i... Read more
Swelling at the injection site; Her arm was the size of an egg and it was hard; A significant drop in her platelet level; She was tired for 24 hours; This is a spontaneous report received from a contactable consumer (patient) and via a Pfizer-Sponsored program. A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 25Mar2021 (at the age of 57-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 27Mar2021 the patient experienced a significant drop in her platelet level and on unspecified dates the patient experienced swelling at the injection site, her arm was the size of an egg and it was hard and she was tired for 24 hours. The patient stated that she received the first dose of the Pfizer COVID-19 vaccine on 25Mar2021 and she then had routine blood work done on 27Mar2021 (also reported as 29Mar2021) which showed a significant drop in her platelet level. She stated that she normally had a platelet count on the lower side, but the platelets were quite a bit lower than the last bloodwork she had done. She stated that she had blood work last on 24Mar2021 which is why she knew. She stated that her platelets dropped after she got the first dose. She checked the internet for side effects of the vaccine and she did see that some people had reported that a lowered platelet count could happen. She stated that she was doing research to investigate if this was truly a side effect of the vaccine. She wanted to know if this had been reported before. She would like to know before she got the second vaccine. The patient also stated that she also had swelling at the injection site, her arm was the size of an egg and it was hard, and she was tired for 24 hours. The patient wanted to know if she would still need to wear a mask after having received both doses if she decided to go out in public or visit others and she wanted to know how effective the first dose was if she decided not to receive the second dose. The clinical outcomes of the events a significant drop in her platelet level, swelling at the injection site, her arm was the size of an egg and it was hard and she was tired for 24 hours were all unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
57 2021-04-27 rash 4/24/21 1:05pm first dose Pfizer vaccine 1:10pm huge allergic reaction, felt like pre-anaphylaxis,... Read more
4/24/21 1:05pm first dose Pfizer vaccine 1:10pm huge allergic reaction, felt like pre-anaphylaxis, like I was going to die 1:13pm took 2 Benadryl 25mg 5:30pm took 1 Benadryl 25 mg Loose stools all day, stayed home as Benadryl was working 4/25/21 12:30am took 1 Benadryl 25mg (weird feeling in my tongue) 1:25pm took 1 Benadryl 25mg for pain in my cheekbones & teeth and rash on both cheeks below eyes 1:58pm took 1 Benadryl 25mg " " 2:19pm took 1 Benadryl 25mg " " 2:49pm checked into hospital emergency room as allergic reaction would not subside 4:30pm got IV with Benadryl 25mg, Methylprednisolone & Pepcid (throat felt strange) 7:26pm discharged from ER 4/26/21 Medrol 24g 4/27 Medrol 20g
57 2021-04-30 vaccination site pain Low blood pressure (87/46mmHg); hot flashes little by little; Headache; Arm was also sore; Fever; Th... Read more
Low blood pressure (87/46mmHg); hot flashes little by little; Headache; Arm was also sore; Fever; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 12Apr2021 10:30 am (Lot Number: EW0158) as single dose for covid-19 immunisation. Medical history included anxiety attack. The patient's concomitant medications were not reported. The same day that she received the Covid 19 vaccine on 12Apr2021, she had a little bit of fever but the next day the fever was gone. On the 13Apr2021 she had a headache, she took some Tylenol and the headache went away that same day. Her arm was also sore on the first and second day. Patient reported she did have a headache but she thought it was related to the weather because the weather affected her sometimes. She did not think her headache today was related to the vaccine. On 13Apr2021, she started getting hot flashes little by little. She is doing fine now. She has had hot flashes for the last 2 days. She also had low blood pressure. She reported she had taken her blood pressure and gotten the following results. 94/60mmHg, 99/63mmHg, 87/46mmHg. This morning (unspecified) her blood pressure was 99/63mmHg and now it's 107/65mmHg. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. No emergency room and physician office required. No prior vaccinations within 4 weeks. The event outcome for low blood pressure (87/46mmHg) was recovered on unspecified date, for hot flashes little by little was recovered on 15Apr2021, for fever and headache was recovered on 13Apr2021, for arm was also sore was unknown.; Sender's Comments: A contributory role of BNT162B2 to the event headache cannot be excluded based on a compatible temporal relation and known safety profile of suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
57 2021-04-30 redness She had problems with her heart; lot of stress; Swelling and redness of face; Swelling and redness o... Read more
She had problems with her heart; lot of stress; Swelling and redness of face; Swelling and redness of face; Triglycerides over 400; Severe vertigo; Blood pressure went high/blood pressure went up to 185/115; 150/95/; Fell; Ocular migraine; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 03Apr2021 08:00 (Batch/Lot Number: ER8733) as single dose for COVID-19 immunisation. Medical history included ongoing high blood pressure. It started about 20 years ago. It was from stress. Family Medical History included her father had kidney disease, but she did not have any problems with her kidneys. She had a blood test and it was fine. The patient's concomitant medication included usual blood pressure medication. Patient went and had the first shot of the Pfizer Covid-19 Vaccine on 03Apr2021 (also reported as 04Apr2021), and she did okay on it until the following Friday (09Apr2021), 6 days later. She actually had to call her daughter to get her from work. She was suffering from severe vertigo, her blood pressure went high, she fell, and she had ocular migraine on 09Apr2021. Her blood pressure went up to 185/115 which was tested on 12Apr2021. She had problems with her heart at the time (unknown date). She broke out and had swelling of her face and redness on 13Apr2021. She went to the doctor and he had her on steroids. This was with the first dose. She was concerned about the second shot. She was due to do it again in about a week, and she was still not over the one. She had been out of work the whole time. Her blood pressure was still kind of high because she did suffer from volatile blood pressure with stress on her body. Her blood pressure would fluctuate, but it had never been that high. It happened when her body was under a lot of stress. It was still high, but not as high. It was about 150/95. That was normal for her. It was like bam, it all hit her hard. Triglycerides over 400 on 12Apr2021. The migraine had gotten better. It's gone. Her migraine was completely gone. As far as the problems with her heart, her blood pressure was fluctuating and would go up and all of a sudden drop. It was not often, it did it when she was under a lot of stress. She just didn't know if the shot had put her body under stress. The swelling and redness on her face was still there. Outcome of severe vertigo, blood pressure went high was resolving. Outcome of fall, problems with her heart and stress was unknown. Outcome of ocular migraine was recovered on 09Apr2021. Outcome of swelling and redness of face was not recovered. No Follow-up attempts are needed. No further information expected.
57 2021-04-30 vaccination site rash, vaccination site itchiness, vaccination site swelling feeling unwell; Just stayed in bed and rode it out.; slight rash at injection sight/red rash; inject... Read more
feeling unwell; Just stayed in bed and rode it out.; slight rash at injection sight/red rash; injection site itchy; armpit swollen/armpit swollen; 103 fever; sweats; severe pounding headache; no energy; tired; chills; wiped out/weak; nausea; diarrhea; no appetite; This is a spontaneous report from a contactable consumer or other non hcp. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: ER8729) dose 2 via an unspecified route of administration, administered in right arm on 07Apr2021 11:00 as SINGLE DOSE for covid-19 immunization. Medical history included Blood pressure, Diabetic, potassium and some known allergies of Sulfa, Bees. Historical vaccine was covid 19. The patient's concomitant medications were not reported. On 08Apr2021 at 12:00 AM, the patient experienced chills, sweats, up to 103 fever, severe pounding headache, no energy, tired/wiped out/weak, nausea, diarrhea, no appetite, red rash at injection site, itchy, armpit swollen, started about about 12 hours after shot. The patient stated that first 3 days was roughest. Everything above lasted for 4 days. Day 5 just little energy, feeling unwell and slight rash at injection sight/sight swelling armpit and no appetite. Just stayed in bed and rode it out. The outcome of the events was reported as recovering. The action taken in response to the events for bnt162b2 was not applicable.
57 2021-04-30 bruising headache; nausea; light headed/ dizziness; unsteady gait; vomiting; chills; sweats; superficial bloo... Read more
headache; nausea; light headed/ dizziness; unsteady gait; vomiting; chills; sweats; superficial blood clot; pain to back of Rt knee; bruising; swelling; This is a spontaneous report from a contactable Nurse. A 57-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly, administered in Arm right on 31Mar2021 (Batch/Lot Number: EW0150) (at age of 57-year-old) as single dose for COVID-19 immunisation. Medical history included osteoarthritis, and migraines. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2, intramuscularly, administered in left Arm on 10Mar2021 (at age of 57-year-old) (Lot number: EN6207) for COVID-19 immunisation. It was unknown if other vaccine in four weeks. It was unknown if COVID prior vaccination. The patient experienced onset of pain to back of Rt knee, bruising, and swelling on 06Apr2021. She called doctor on 09Apr2021, provider diagnosed her with superficial blood clot. Treating with applying warm compress to area. Client had onset of headache, dizziness, nausea, light headed, unsteady gait, vomiting, chills and sweats on 10Apr2021. Patient called doctor on 14Apr2021, they recommended covid-19 testing, results are negative on 12Apr2021. Symptoms ongoing since 14Apr2021. The outcome of events was not resolved.; Sender's Comments: Based on plausible temporal association, a causal association between the reported event thrombosis and suspect drug bnt162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
57 2021-04-30 redness, vaccination site pain swollen submandibular lymph nodes; swelling/swelling went to the back, the shoulder blade up the lef... Read more
swollen submandibular lymph nodes; swelling/swelling went to the back, the shoulder blade up the left side of her neck; swelling/swelling went to the back, the shoulder blade up the left side of her neck; redness; pain started at injection site; pain went from her elbow to shoulder and then up her shoulder and up to the neck; pain went from her elbow to shoulder and then up her shoulder and up to the neck/she still has arthritic type pain in left arm socket.; couldn't lift her left arm at all; deep ache/ to her back; crying; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 12Apr2021 at 16:30 (lot number reported as "EN or W 0161, EN0161 or EW0161") at a single dose for COVID-19 immunisation. Medical history included diabetic from 2008, blood clots , COVID-19 (reported as April; year unknown), insulin dependent in 2014 , Protein S deficiency, genetic disorder that makes her have blood clots, neuropathy. Concomitant medications included warfarin sodium (COUMADIN) taken for Protein S deficiency, genetic disorder that makes her have blood clots from 2007 to an unspecified stop date; gabapentin taken for neuropathy from Sep2019. Patient stated that she gets a mild case of the flu when she gets the flu vaccine, but she doesn't remember back to childhood. She got an MMR booster about 20 years ago and had no problems then. Family Medical History: both parents had diabetes; mother has Protein S deficiency as well that causes blood clots. The vaccine was administered at healthcare facility. The patient did receive previous immunization with a Pfizer vaccine. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient received her first shot on Monday 12Apr2021 and was fine until 12 hours later. Her arm swelled up and she couldn't lift it. Then the swelling went to the back, the shoulder blade up the left side of her neck. She could feel her lymph nodes and so she was icing it, taking Tylenol and the swelling has gone down. The redness was gone but she still has arthritic type pain in left arm socket. She can lift and move the left arm, but it hurts, and it also hurts when she turns her head to the right. She received the Pfizer COVID vaccine in her left arm. The pain started at injection site and then went from her elbow to shoulder and then up her shoulder and up to the neck. Her family was commenting on her neck being swollen. She received her shot at 4:30 PM on 12Apr2021. The redness and swelling started at around 5:00 AM on 13Apr2021. A couple hours after Pfizer COVID vaccine injection the pain started. She waited for 30 minutes because she takes coumadin for a history of blood clots, nurse wanted to wait to make sure her arm wouldn't bleed. She has been taking Benadryl ointment and icing it for 3 days as treatment for the events. She got up at two this morning to go to the bathroom and noticed she could still feel the pain when she turns her head to the right. She had swollen submandibular lymph nodes and could feel two of them before. When she woke up, she could not feel her lymph nodes. Everything has recovered except for the pain. The patient stated that on the first day the symptoms were disabling, and she couldn't lift her left arm at all. They got better once she started icing it and rested instead of doing chores. She keeps popping Tylenol every 6 hours, Benadryl and refilling ice bag with one ice bag on neck and one ice bag on arm. There was a deep ache right now in the socket that goes up her neck and down the shoulder blade to her back. Right now, she doesn't like to be in any pain and would say the pain was mild compared to how it was, the pain was so bad she was rocking and crying. Her brother gave her one of her mother's pain pills, one Vicodin because she was in so much pain. She can control the pain now with the extra strength Tylenol. She got the Pfizer COVID vaccine for lots of reasons. She has a lot of health problems, she had COVID virus last April and that was why she was having this reaction since she already has antibodies. She takes care of her mother who was sicker than she was. She was out in the real world and she doesn't want to bring anything home or get anything herself. She thought gabapentin would have made it to where she did not have the arthritic pain from vaccine. She takes gabapentin for neuropathy. She was diabetic and that may have something to do with it too. Patient stated that everyone else in her family got Johnson and Johnson and nobody had reactions. She was supposed to get at the Johnson and Johnson shot first but with the shortage it was switched over the to Pfizer COVID vaccine. This was her first dose of the Pfizer COVID vaccine. Redness and swelling started at around 5:00 AM 13Apr2021. Pain started around 6:30 PM. The events did not require emergency room visit or hospitalization. She was at the urgent care yesterday where she gets her INR checked and the nurse said she didn't see any swelling but believed she was in pain because the she didn't want to lift the left arm. The reporter assessed the events swelling, redness, and pain were considered serious (disabling). Outcome of the events vaccination site pain, neck pain, arthralgia, and back pain was recovering, for event crying was unknown, for event swollen submandibular lymph nodes was recovered on unspecified date, while for events swelling, joint swelling and redness was recovered on 16Apr2021. Information on the lot/batch number has been requested.dft; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate
57 2021-05-09 injection site swelling Swelling of site arm, increased heart rate, dizziness and weakness, hospitalization
57 2021-05-09 shingles first dose was administered Late Summer 2020 / second dose approximately two months later / On April... Read more
first dose was administered Late Summer 2020 / second dose approximately two months later / On April 12, 2021 shingles / suspected vaccination failure; shingles / "on the inner lip of my crotch" moving outward; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and TOZINAMERAN (COVID-19 VACCINE PFIZER) for prophylaxis. The patient's past medical history included chickenpox (experienced at 15 year age). On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On 12th April 2021, the patient received the 1st dose of COVID-19 VACCINE PFIZER. In April 2021, less than a year after receiving Shingrix and less than 9 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. Additional details were reported as follows: This case was reported by patient herself. The age at vaccination for 1st dose was 56 years and for 2nd dose could be 56 or 57 years. In late Summer of 2020, the patient received 1st dose and approximately 2 months later, the patient received 2nd dose of Shingrix. Several days later after receiving Pfizer COVID-19 vaccine, the patient developed shingles. The patient reported that the outbreak was on the inner lip of her crotch moving outward and the patient admitted to being unable to use the correct anatomic terminology to describe the outbreak. The shingles outbreak had improved, though symptoms persist, and the patient was seeing the healthcare professional on day after reporting date. On 4th May 2021, the patient received the 2nd dose of Pfizer COVID-19 vaccine and planned to report the shingles outbreak to the CDC (Centers for Disease Control and Prevention) for monitoring purposes. It was unknown if the reporter considered the vaccination shingles related to Pfizer COVID-19 vaccine. The reporter consented to follow up. This case was considered as suspected vaccination failure as detail regarding laboratory test confirming herpes zoster was unknown at the time of reporting.
57 2021-05-10 injection site pain About 2 to 3 hours after shot, I felt woozy and then very nauseous. It was strong, came in waves. Bu... Read more
About 2 to 3 hours after shot, I felt woozy and then very nauseous. It was strong, came in waves. But I did not throw up. Ate a little, took some alive (two tablets). Was tired but not overly fatigued. My arm really hurt at injection site, pain traveled up to my neck. Unable to lay on arm at all. Then I just felt buzzing in waves. I went to bed (no chills) but couldn't go to sleep. Body felt wired and tired. Finally fell asleep at 8:30 am. Day after shot: Arm still sore but not as much. Still experience nausea but not as strong. Tired but not overly so. Later in evening (around 12:30 pm) developed some chills and had four sneezes in a row causing me to have a stuffy head. Not sure if that is allergies or a cold coming on.
58 2020-12-31 rash Face flushing about 30 minutes after vaccine followed by torso rash -- noticed on day after, which t... Read more
Face flushing about 30 minutes after vaccine followed by torso rash -- noticed on day after, which totally cleared by third day post-vaccine.
58 2020-12-31 rash macular, redness, itchy skin Hands turned red with slight swelling. Face and chest with red blotches. Nausea and pounding heart ... Read more
Hands turned red with slight swelling. Face and chest with red blotches. Nausea and pounding heart rate. This is the same symptoms I experience if I drink alcohol. I drank water and it got better in an hour. At night, my scalp was itching all nite. My scalp was red on the right side only which was the site of the vaccine. It is now 2 days later; the itching is gone but scalp has red blotches although they have faded at lot.
58 2021-01-02 rash, hives, redness, itchy skin Itching on various areas of body with hives and welts, redness. Took 50 mg Benadryl, 12 mg methylpre... Read more
Itching on various areas of body with hives and welts, redness. Took 50 mg Benadryl, 12 mg methylprednisolone, and applied hydrocortisone. Had to reside after 4-5 hrs, and again the next morning. Went to urgent care clinic and received 60 mg depo-prednisolone and went home and took more Benadryl and applied more hydrocortisone cream. Rash all over the body.
58 2021-01-03 rash, hives 12/26/2020 developed rash on back of neck and behind ears. She took cetirizine twice that day. 12/3... Read more
12/26/2020 developed rash on back of neck and behind ears. She took cetirizine twice that day. 12/31/2020 developed hives on abdomen, back and thighs. She started diphenhydramine 1/2/2020 and rash still seemed to be worse
58 2021-01-03 rash A rash appeared on my lower left arm and has spread a bit to my upper arm. Each day the rash is mor... Read more
A rash appeared on my lower left arm and has spread a bit to my upper arm. Each day the rash is more widespread although there is no fever, no itching, no raised bumps. I contacted my doctor who provides care management for lymphedema, and provided pictures of the rash. He agrees it is not a cellulitis infection but can provide no further information and did not ask me to come for an appointment.
58 2021-01-03 skin warm, rash, itchy rash Face rash, itchy for 2 days, (face and neck) Face warm to touch, Seen by NP no treatment
58 2021-01-03 redness, skin burning sensation, itchy skin S: Employee received Covid vaccination on 12/28/20. Employee reported noticing "itching all over my ... Read more
S: Employee received Covid vaccination on 12/28/20. Employee reported noticing "itching all over my body". The following day she experienced nausea and moderate joint pain. She then also experienced redness on forehead, ears and "felt like they were on fire." B: Covid vaccination on 12/28/20. Employee contacted advice nurse and was instructed to report to ACC A: Employee reported to ACC on 12/29/20 and received solumedrol shot R: Reporting for tracking purposes
58 2021-01-03 injection site pain The day of the vaccine I had a initial diarrhea and headache, minimum pain on the site of the inject... Read more
The day of the vaccine I had a initial diarrhea and headache, minimum pain on the site of the injection but at 2AM on the 22nd I woke up from my sleep with chills, and shaking even my teeth were clacking. Took Tylenol and it got better around 30 min later. Felt very fatigued and still nauseated almost threw up. By the end pf the day it resolved itself.
58 2021-01-04 itchy skin Flush; Itching; felt like she was going to wet herself; This is a spontaneous report from a contacta... Read more
Flush; Itching; felt like she was going to wet herself; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730 and Expiration Date: unknown), intramuscularly in the upper left arm on 22Dec2020 at 08:48 at 58-years-old at a single dose for COVID-19 immunization; which was received at a hospital. The patient stated the hospital had a line for employees to drive up and receive the vaccine, she was in her car when the vaccine was administered. Medical history included ongoing allergy to sulfates from an unknown date (diagnosed at least 20 years ago). The patient had an allergy to sulfates. The patient had a bad reaction to sulfamethoxazole and trimethoprim (BACTRIM) many years ago. The patient did not have the Lot and NDC numbers, or expiration date to provide. The patient stated the reaction was so bad she had to receive multiple injections because her throat was closing off and she had big hives. This occurred years ago. There were no concomitant medications. The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) and experienced bad reaction, throat was closing off and big hives from an unknown date to an unknown date. On 22Dec2020, the patient experienced: flush, itching, and felt like she was going to wet herself; all assessed as non-serious. The patient called about the COVID-19 vaccine. The patient was wondering if there was any sulfa in the vaccine. The patient had the vaccine on 22Dec2020, and she was fine for the first hour and then she became flush and started itching an hour later. The patient stated " you know when you get a CT scan and the contrast makes you feel warm down there", states she got that same feeling where she felt flush and where she was warm down there and she felt like she was going to wet herself. The patient stated, "the bladder feeling came on so harsh and fast." The patient took diphenhydramine hydrochloride (BENADRYL) for two days and she felt better. The patient later clarified that she recovered completely as of 25Dec2020. Therapeutic measures were taken as a result of flush and itching. The clinical outcome of the events, flush and itching, was recovered on 22Dec2020. The clinical outcome of the event, felt like she was going to wet herself, was unknown. There was no history of previous immunization with the Pfizer vaccine considered as a suspect. There were no additional vaccines administered on the same date of the Pfizer suspect. The events did not require a visit to an emergency room or physician office. The patient did not receive any prior vaccinations within 4 weeks of the suspect vaccine. There were no adverse events (AEs) following prior vaccinations. There were no relevant tests performed.
58 2021-01-05 rash Initial reaction: rash on chest; muscle, joint pain; muscle, joint pain; urge to run; inability to s... Read more
Initial reaction: rash on chest; muscle, joint pain; muscle, joint pain; urge to run; inability to sleep; Irritable mood; Muscle spasms; dry eyes; Dry mouth; brain fog, inability to multitask; This is a spontaneous report from a contactable nurse. A 58-years-old non-pregnant female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Lot number: EJ1685; intramuscular in left arm on 18Dec2020 at 14:45 (at the age of 58 years-old) as a single dose for COVID-19 immunization. The vaccine was given in a hospital. The patient did not receive any other vaccines in the past 4 weeks. Medical history included asthma, mitral valve prolapse and an allergy to latex. Concomitant medication included calcium (CALCIUM), metoprolol (METOPROLOL), magnesium (MG [MAGNESIUM]), ergocalciferol (VIT D). The patient previously took penicillin and experienced an allergy. The patient did not receive any other vaccines in the past 4 weeks. She did take other medications (concomitant) in the past 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. In Dec2020, at 14:45, the patient experienced rash on chest followed by muscle, joint pain, urge to run, inability to sleep, irritable mood, muscle spasms, dry eyes, dry mouth, brain fog, and an inability to multitask after 1 week following COVID-19 vaccine. The patient was not hospitalized for the events and no treatment was administered. The outcome of the events: rash on chest followed by muscle, joint pain, urge to run, inability to sleep, irritable mood, muscle spasms, dry eyes, dry mouth. brain fog, inability to multitask, was recovering. Since the vaccination, the patient had not been tested for COVID-19.
58 2021-01-05 injection site pain Metallic taste; injection site pain Narrative:
58 2021-01-05 shingles SHINGLES
58 2021-01-05 vaccination site itchiness, vaccination site pain, vaccination site swelling injection site tenderness/it is a little tender; swollen at injection site/It is swollen at the inje... Read more
injection site tenderness/it is a little tender; swollen at injection site/It is swollen at the injection site; itchiness at injection site; This is a spontaneous report from a contactable consumer. A 58-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration (upper left arm) on 21Dec2020 (between 9:00AM and 9:30AM) at single dose for Covid-19 immunization. Medical history included allergic to dust mites and grass, summertime allergies (haven't been diagnosed but she has sneezing and watery eyes during the summer), obese at 190, and flu vaccine in Oct2020, and smoker. Her mother passed from COPD and stated that more than likely she has that because she is a smoker. Her father had congestive heart failure. Concomitant medications were not reported. The patient previously took flu vaccine vii and experienced migraine; also, previously took Novocaine (probably 10 to 15 years ago) out of the blue she had a reaction. "Eons ago" when she was probably 25 she had a reaction to the very first flu shot that she got. The reaction was a migraine and she could not get out of bed. The patient wanted to know if it was normal to have side effects a week later after receiving Covid vaccine. She received vaccine on 21Dec2020 and today (29Dec2020 5AM) she was experiencing injection site tenderness, appearing swollen at injection site, and itchiness at injection site. It was further reported that she woke up this morning and her arm is itchy. It is swollen at the injection site. It is about the size of a fifty-cent piece. It is itchy and it is a little tender. The patient added, "It is a little tender": it was a little sore the first day like a flu shot. It is annoying like a bug bite itch. The swelling has been the same throughout the day. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of events was not recovered. Information on the Lot/batch number has been requested.
58 2021-01-06 injection site pain "By around 7p that evening 12/17/20, i was unable to life my arm to undress. the next morning the i... Read more
"By around 7p that evening 12/17/20, i was unable to life my arm to undress. the next morning the injection site was a little tender but i could move the arm"
58 2021-01-06 rash, hives 2days after my 1st Covid vaccine I broke out into a rash with hives requiring me to go to the ER; 2d... Read more
2days after my 1st Covid vaccine I broke out into a rash with hives requiring me to go to the ER; 2days after my 1st Covid vaccine I broke out into a rash with hives requiring me to go to the ER; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EH9899, expiry date was not provided) solution for injection, via an unspecified route of administration on left arm on 17Dec2020 08:00 at a single dose for Covid-19 immunization. Medical history included eczema, chronic kidney disease, thyroid disease. Patient had known allergies. The patient was not pregnant. Concomitant medications included apixaban (ELIQUIS), allopurinol (ALLOPURINOL), levothyroxine (LEVOTHYROXINE), iron (IRON), magnesium (MAGNESIUM). The patient reported that 2 days after her 1st Covid vaccine, she broke out into a rash with hives requiring her to go to the ER on 19Dec2020 12:00. She also visited a physician. She was treated with steroids, Atarax, and Epi shot. The events were reported as non-serious. Outcome of the events was not recovered. No follow-up activities are needed. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of urticaria and rash due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
58 2021-01-06 skin burning sensation Vaccinated on December 21, 2020. No arm pain, nothing. On December 27th at 4:00 PM sudden onset wors... Read more
Vaccinated on December 21, 2020. No arm pain, nothing. On December 27th at 4:00 PM sudden onset worst bone pain ever unrelieved with Tylenol, malaise and nausea. December 28th at 1:00 AM awoke in pain and "on fire" I have never been so hot, truly felt like my skin was on fire. Tympanic thermometer 99.0F. Awoke feeling fine and went to work thinking this was SE however symptoms recurred later that morning so I went for testing as I could not differentiate between SE vs illness. Covid negative. If this was a delayed response to vaccine, wanted to report: severe bone pain unrelieved w Tylenol , malaise, nausea, 48 hours. thanks, NP
58 2021-01-06 rash, hives hives on her legs; a slight rash on abdomen (started morning on the next day when she woke up) and i... Read more
hives on her legs; a slight rash on abdomen (started morning on the next day when she woke up) and it spread to her legs (leg rash started 2 days later in the morning); This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly at left arm on 29Dec2020 10:30 at single dose for COVID-19 Immunization. No medical history. No family medical history. There were no concomitant medications. Patient received first dose last Tuesday, 29Dec2020, at the hospital. The next day, she had a slight rash on abdomen (started morning on the next day when she woke up) and it spread to her legs (leg rash started 2 days later in the morning). It was a pretty severe case of hives on her legs now (31Dec2020). Spread to legs and now has hives on legs was reported as worsened. Physician's office visit involved. She had a question. Her doctor prescribed a dosing pack of prednisone to get rid of the hives and her question was, will it affect the effectiveness of the vaccine if she takes it, also, is it ok to get 2nd dose in 2 weeks. She confirmed she had not taken the prednisone yet. There was no prescriber. She received it because she is a healthcare worker. Patient asked if there is any recommendation on getting pre medicated with ex: Benadryl before getting the vaccine. No previous history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect product. No medications prior vaccinations (within 4 weeks). No test done. This is a serious report. The slight rash on abdomen, spread to legs and now has hives on legs was considered medically significant per reporter. The outcome of the events was not recovered. Information about lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events rash and urticaria cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
58 2021-01-06 hives hives, burning sensation around mouth
58 2021-01-07 redness 5 minutes after injection, face red, sudden onset of flushing sensation in chest followed by dizzine... Read more
5 minutes after injection, face red, sudden onset of flushing sensation in chest followed by dizziness and a feeling of rapid heart beat. Throat tightness and difficulty swallowing. Flushing sensation and feeling of rapid heart beat resolved within a few minutes, but left with nausea, flushing and difficulty swallowing/throat tightness.
58 2021-01-07 skin spots Approximately 2 days after receiving the vaccination patient reported red petechial like rash beginn... Read more
Approximately 2 days after receiving the vaccination patient reported red petechial like rash beginning on her legs and spreading to abdomen and arms.
58 2021-01-07 rash macular Blotchy rash on chest, neck, shoulders and arms; mild tingling tongue and fingers; mild tingling ton... Read more
Blotchy rash on chest, neck, shoulders and arms; mild tingling tongue and fingers; mild tingling tongue and fingers; This is a spontaneous report from a contactable physician (patient). A 58-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 02Jan2021 at 09:45 at single dose in right arm for covid-19 immunisation. Medical history included hypertension, migraines. Concomitant medication included losartan 100mg/d, ergocalciferol (VIT D) 4000u/day, ascorbic acid (VIT C) 1000 /day. The patient experienced blotchy rash on chest, neck, shoulders and arms on 02Jan2021 at 10:05, mild tingling tongue and fingers in Jan2021. No urticarial lesions. Rash noted 20 minutes post injection. Took 25mg Benadryl and rash resolved. The outcome of the events was resolved in Jan2021. There was no other vaccine in four weeks. The patient was not diagnosed with COVID 19 prior vaccination, and was not tested for COVID 19 post vaccination. This case was reported as non-serious by reporter.
58 2021-01-07 itchy skin Itching of skin generalized and controlled with Benadryl
58 2021-01-07 rash, itchy skin, hives Rash & UrticariaPruritus
58 2021-01-07 rash Rash on neck and chest; Rash on my face across my nose and cheeks; This is a spontaneous report from... Read more
Rash on neck and chest; Rash on my face across my nose and cheeks; This is a spontaneous report from a contactable other HCP (healthcare professional) who reported for herself. A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot #: EK5730) via an unspecified route of administration on 28Dec2020 at 15:00 (at the age of 58-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included arthritis, hypothyroidism and chronic back pain and arthritis in back; all from unspecified dates and unspecified if ongoing. It was reported that the patient did not have any allergies to medications, food or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unspecified date. Concomitant medications (taken in two weeks) included duloxetine hydrochloride, levothyroxine, nortriptyline and methocarbamol (ROBAXIN); all taken for unspecified indications from unspecified dates. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Dec2020 at 19:00 the patient experienced a "rash on my face across my nose and cheeks" and on 30Dec2020 the patient experienced "rash on neck and chest". It was reported that "the evening after my vaccine I developed a rash on my face across my nose and cheeks. The next day I developed a rash on my neck and chest and the rash on my face was gone. I still have a rash on my neck and chest. No fever or other symptoms." It was reported that the adverse events were non-serious and did not require treatment nor hospitalization. The clinical outcome of the event "rash on my face across my nose and cheeks" was recovered/resolved on an unspecified date and the outcome of the event "rash on neck and chest" was not recovered/not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
58 2021-01-07 itchy skin, hives Rash; Itching at different spot at different time; Hives; This is a spontaneous report from a contac... Read more
Rash; Itching at different spot at different time; Hives; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on 02Jan2021 at single dose as reported for "Indication: Consumer stated, "Because I work in Covid testing, in healthcare." Medical history included hypertension and allergy. Concomitant medication included amlodipine, lisinopril, metoprolol, hydrochlorothiazide (HYDROCHLORZIDE), desloratadine and montelukast. The patient stated, "had the first dose of the Pfizer vaccine yesterday for the Covid 19, 2 hours after I started itching and it has been different places all over my body. I do not know has it anything to do with the way that it goes through the body, I do not know. I have had to take a lots of Benadryl. I have had to take some steroids that I had here at the house I never had started and I thought it was okay. Last night my husband put hydrocortisone cream (later clarified as treatment) on areas I was itching and had hives. I slept all night I did not have any problem since I got up this morning I started itching in other place. So, I have done the whole thing again. I am going to has to go. I did not want to go ER because I am not having trouble on breathing or anything like that but I have got various places it is like different places every time it starts. So, I need to I am going to go and have a probably a strong steroid shot and have strong steroid given to me, not for oral but I just want to let you know if that is a side effect and I do not know whether I am going to take the second one or not?" I have taken Benadryl and I have taken Methylprednisolone and I have used on the Cortisone Cream, the topical cream". The outcome of the events was unknown.; Sender's Comments: A causal association between BNT162B2 and the events rash, pruritus and urticaria cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
58 2021-01-07 rash Severe Headache Rash starting on neck and chest Chills Fever Vomiting
58 2021-01-07 injection site redness, injection site swelling, injection site pain Vaccine injected too low on injection site, causing pain, redness and swelling.
58 2021-01-07 injection site redness, injection site warmth, injection site swelling Vaccine injected too low, causing redness, warmth, swelling and pain at injection site.
58 2021-01-07 vaccination site pain severe neck pain; muscle pain that was almost like a horse in the muscles above her hips and in her ... Read more
severe neck pain; muscle pain that was almost like a horse in the muscles above her hips and in her back; muscle pain that was almost like a horse in the muscles above her hips and in her back; muscle cramping; pain in her arm; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number 5K5730/expiration date unknown), dose number 1, via an unspecified route of administration on 18Dec2020 at a single dose on the left arm for COVID Prevention. The patient had no relevant medical history. Historical vaccine included flu vaccine for immunisation which caused arm pain. The patient had no concomitant medications. She had no other vaccines on the same day as the COVID vaccine. The patient received her first dose of the COVID vaccine on 18Dec2020, and at first, she just had pain in her arm. It started getting sore in the evening of 18Dec2020. She suspected that would happen, because she gets that with the flu shot too. A few days after receiving the vaccine, she had pretty severe neck pain, and at first she just thought that maybe she slept wrong, but she still had neck pain. She was sitting with hand warmer packs on her neck because the pain was at the point bad enough that she could barely turn her neck. She experienced muscle pain that was almost like a horse in the muscles above her hips and in her back. The pain in her hips and back is bad enough that it almost takes her down. The patient also experienced muscle cramping. She further stated that she had not done anything different; she did not got to the gym. She remembered that when she signed off to get the vaccine, there was something about not taking the vaccine if someone had ever had a side effect to a lipid. The outcome of the events was recovered on 20Dec2020 for pain in her arm, recovering for neck pain, not recovered for muscle pain that was almost like a horse in the muscles above her hips and in her back, unknown for muscle cramping.
58 2021-01-09 pain of skin 10 hours after shot - sore arm, 2 hours later headache, 2 hours later fever, muscle ache, chills, ba... Read more
10 hours after shot - sore arm, 2 hours later headache, 2 hours later fever, muscle ache, chills, basically flu like symptoms. My skin hurt everywhere
58 2021-01-09 hives Hives on both arms upper torso Benadryl every 4 hours is planned
58 2021-01-10 hives Friday morning after the vaccination - fever, chills, body aches & nausea. Saturday morning, went to... Read more
Friday morning after the vaccination - fever, chills, body aches & nausea. Saturday morning, went to the ED with hives that went into her mount & swollen tongue - resolved as of 1/11/2021
58 2021-01-10 rash Rash arms, thighs, lower back
58 2021-01-10 injection site pain Second COVID immunization from Pfizer at 0930 sat. (No symptoms at all with first immunization) Sym... Read more
Second COVID immunization from Pfizer at 0930 sat. (No symptoms at all with first immunization) Symptoms of fatigue began approx. 12 hrs. late, then fever after midnight, chills, body aches, severe headache, abd cramping, and extreme fatigue. Highest fever recorded was 101.8 the next day (Sunday) around 4pm. Didn't take Tylenol or Motrin. As of writing this (Monday 12:07 pm) my fever is gone but headache and extreme fatigue remain. Injection site still sore and today I notice I have a very swollen and painful lymph node left axilla opposite injection site. I had to call in sick today and possible will tomorrow if the extreme fatigue and headache don't go away.
58 2021-01-10 injection site swelling, injection site redness significant redness and swelling at site of injection, gradually spread up to top of shoulder, over ... Read more
significant redness and swelling at site of injection, gradually spread up to top of shoulder, over 4 days Patient had previously had COVID 19 disease, and recovered, in August 2020
58 2021-01-10 vaccination site pain tired; no energy; low back pain; her fingers are hurting; passed out on toilet; Nauseated; hit head ... Read more
tired; no energy; low back pain; her fingers are hurting; passed out on toilet; Nauseated; hit head on wall, head just hurts; hit head on wall, head just hurts; Chills; she was very cold; could not sleep good; site of vaccine was sore; Muscle pain; Joint pain; This is a spontaneous report from a contactable consumer. A 58-year-old female patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EK9231) by injection once to left arm, via an unspecified route of administration on 04Jan2021 12:30 at single dose for covid-19 immunisation. Medical history included thyroid disorder. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder; patient started it after she had her son, and her son is 18 years old. The patient had her vaccine yesterday (04Jan2021) at 12:30, and at nighttime, around 22:00, she started having chills, she was very cold, so she went to bed, she could not sleep good, she kept waking up, and the site of vaccine was sore, she had muscle pain, joint pain, she didn't have fever, but she got up late today (05Jan2021), around 11:00, and had breakfast and felt nauseated, so she stopped eating, and she went to the bathroom and passed out on the toilet, when she woke up, she had her nightgown inside the toilet, it was all wet, she felt better, so she stood up and then she woke up again, and was inside the tub, her legs were inside the basin, she was lying down with her back inside the tub, she thinks she hit her head on the wall, and it just hurts, it didn't bleed or nothing. The patient stated she had the paper she was given. Again stated she can not even function. Patient still feels Chills a little bit, not as bad as last night. She is awake now, but she feels very very tired, like she has no energy, she is laying down on couch right now. She kept waking up and noticed this morning, she had low back pain, in the muscles, even her fingers are hurting. Regarding hitting her head on the wall, states she has a terrible headache, not a little pain, she thinks it is because she hurt her head. The patient is supposed to get second vaccination on 25Jan2021. The outcome of events Chills, Joint pain and nauseated was recovering; of events site of vaccine was sore and muscle pain was not recovered; of other events was unknown.
58 2021-01-11 injection site pain, injection site pruritus immune deficiencies; She said the joint pain felt like "flu" joint pain; She said she was really swe... Read more
immune deficiencies; She said the joint pain felt like "flu" joint pain; She said she was really sweaty, so much so, that she had sweat under her eyes; thyroid problems; feels shaky inside; Numbness facial; Exhaustion; Foggy feeling in head/feeling rundown; felt exasperated; sweating like crazy and then gets chills; felt yucky/she didn't feel good at all; Joint pain; Nausea; Chills; after receiving the COVID-19 Vaccine on (Dated), she had left upper shoulder pain.; She clarified she had some injection site pain; and the injection site was a little itchy; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3246), via an unspecified route of administration on 02Jan2021 14:30 at single dose in the left upper arm for COVID-19 immunization. Medical history included Pernicious anaemia from 2006 and ongoing, Hashimoto's disease ongoing, stated she was diagnosed with Hashimoto's disease in either 1994 or 1995. Psoriatic arthritis from Nov2020 and ongoing. Potassium low ongoing, reported she has had low potassium off and on for years. She said she can't remember when she didn't have low potassium. She said she normally finds out her potassium is low when she has blood work done. She stated she has had low potassium most of her adult life. IgA deficiency from Feb2019 and ongoing, Psoriasis ongoing, paralysis in her left trapezius muscle. Concomitant medication included B-12 for pernicious anemia. She said she had the typical reactions that one might get with a vaccine. She clarified she had some injection site pain and the injection site was a little itchy on 02Jan2021. She stated on the second day (03Jan2021) she had joint pain, felt yucky, had nausea, and chills. She said the next day (04Jan2021) she felt a little better, but still had chills. She said yesterday (05Jan2021) she thought she was feeling better, but by yesterday, clarified as late afternoon and evening, she crashed. She said she has a lot of autoimmune issues and immune deficiencies, saying she has pernicious anemia and Hashimoto's disease. She said yesterday evening she experienced extreme body temperature issues. She said she was really sweaty, so much so, that she had sweat under her eyes. She said she would get really hot and had chills. She said she was feeling really bad and was feeling shaky inside. She said she thought it was important that she report what she was experiencing to Pfizer. She stated she has psoriatic arthritis, too. Reported after receiving the COVID-19 Vaccine on 02Jan2021, she had left upper shoulder pain. She clarified that she had a previous history of paralysis in her left trapezius muscle and had surgery in 1998 on her left shoulder. She said she had a weird feeling that went around where her scar was from the surgery on the back of her left shoulder. She said maybe the left shoulder pain had to do with how she held her left shoulder. She said on Monday, 04Jan2021, she had a little bit of pain in her left shoulder and by yesterday night, 05Jan2021, there was not much pain at all. Clarified her joint pain was in her ankles, wrists, hips, neck, back, and knees. She said the joint pain felt like "flu" joint pain. She stated she normally has joint pain with the other issues she has, but this joint pain felt different. She said the joint pain she experienced after taking the COVID-19 Vaccine was all over her body. She said yesterday (05Jan2021) her joint pain felt so much better, but later in the afternoon she didn't feel right. She said she has pernicious anemia, and thought maybe she needs her B-12 shot. She said yesterday (05Jan2021) she experienced a lot more symptoms. She said she had numbness in her face, felt extremely exhausted, had a foggy feeling, and felt exasperated. She said the symptoms didn't start until late in the afternoon into the evening of 05Jan2021. She said she did not feel well and went to bed at 8:45PM, which is early for her. She said she did give herself a B-12 1mcg/ml shot intramuscularly yesterday. She provided the B-12 1mcg/ml NDC Number: 7006900510, Lot Number: C0495, and Expiration Date: Aug2022. She said the name (company name) was listed on the B-12 1mcg/ml packaging. She said she gives herself a B-12 shot every 10 days. She said she still has some joint pain, but the joint pain is not like it was on 03Jan2021. She said she still has a tiny bit of heaviness in her joints with a constant throbbing pain, which is a different joint pain from her normal. Reported last night (05Jan2021) she didn't feel good at all. She said she felt horrible, and had to go to bed. She said she felt shaky inside all night, and still feels that way now. She said she was sweating like crazy, and then would get chills. She clarified she is used to being hot and cold in her normal life because of her thyroid problems, but stated what she experienced last night was beyond that. She said her hot and cold issue was bumped up several levels last night. She said she was chilled or sweating all the time last night, but did not have a temperature. She clarified her normal body temperature is 96.7, and when she checked her temperature at one point, her temperature was 98 degrees. Reported the hot and cold with sweating and chills, and nausea come and go. She said if she has nausea, it is a mild feeling of nausea. Clarified if Sunday, 03Jan2021. was a work day, she would have called out sick. She said Monday (04Jan2021) and Tuesday (05Jan2021) she did go to work. Reported she has low potassium and made herself an electrolyte cocktail. Reported if her system feels off, she said her electrolytes maybe off. She said her heart felt like it may be shaky, so she ate a banana to get potassium in her system. She said she does her little routine before she would call her doctor to get blood work done. She said she had her blood work done not too long ago. She said she wasn't feeling this way before she had the COVID-19 Vaccine, and is feeling rundown now. She said she was feeling good before she had the COVID-19 Vaccine. She said she feels like something is going on with her body now. Reported her last blood work was done on 04Dec2020 and everything was kind of normal. She clarified her thyroid was a little off, and her doctor adjusted her medication. She said her potassium was a little down. Reported she was told when she got the COVID-19 Vaccine shot she has to be a little more careful, and she might not be as protected as some people. She said she was told there have not been enough studies on the COVID-19 Vaccine. She clarified she was told that information by a person at the site where she received the COVID-19 Vaccination, saying the person was helping her with the COVID-19 Vaccination authorization form. Reported she thought she was doing OK after she received the COVID-19 Vaccine, until after last night and yesterday afternoon. She said if she continues feeling the way she is, she will see her doctor. She said her system seems off. She said she normally tries everything she knows first, like drinking a lot of water, and drinking electrolytes, and will take potassium to see if that is the issue. She said those are her own things that she does before she calls her doctor. Clarified sometimes she has numbness in her face due to not having her B-12. She said she still has a little numbness in face. She said on 05Jan2021, the numbness went across her face from the bridge of her nose down through to her mouth. She said the numbness was nothing like paralysis in her face, but her face was really hot at the same time she had the numbness. Reported she took Tylenol (clarified as (company) brand Tylenol, stating she doesn't have the UPC, Lot and Expiration Date). She said the Tylenol wasn't kicking in, so she took Ibuprofen (clarified as (company)brand Ibuprofen, and she doesn't have the Ibuprofen NDC, Lot and Expiration date). She said she took her normal medications. Outcome of events "She clarified she had some injection site pain" "and the injection site was a little itchy" and Shoulder pain were recovered on an unspecified date, "Chills" and "feels shaky inside" were not recovered, "Joint pain" "Nausea" "Numbness facial" were recovering, while outcome of other events was unknown.
58 2021-01-11 injection site pain, itchy skin, hives, injection site swelling, injection site redness lymph node swelling and lymphedema in the right forearm side and the right upper arm; lymph node swe... Read more
lymph node swelling and lymphedema in the right forearm side and the right upper arm; lymph node swelling and lymphedema in the right forearm side and the right upper arm; cold blister on lip; significant swelling on the right side of the base of her neck near her clavicles; slightly itchy scalp; redness, swelling, tenderness at injection site; redness, swelling, tenderness at injection site; redness, swelling, tenderness at injection site; This is a spontaneous report from a contactable Registered nurse reporting for herself. A 58-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine (Batch/lot number: EL0140), in Hospital, by intramuscular route in right upper arm on 23Dec2020 at 08:30, at 58-year-old of age, at single dose for COVID-19 immunization. The patient had no relevant medical history. She didn't receive any prior vaccinations within 4 weeks. There were no concomitant medications. The patient reported that it has been 2 weeks since she received the COVID-19 Vaccine now and she still has a considerable amount of lymph node swelling and lymphedema in the right forearm side and the right upper arm. The nodes on the right side of her neck around the clavicle have been quite swollen for about 2 weeks. She has the list of side effects so she was not concerned, as this was listed but now she's not sure. When she got the vaccine she had the expected redness, swelling and tenderness at injection site (onset reported as 23Dec2020). On the evening of the 24Dec2020 she had an itchy scalp but she didn't see any rash and that only lasted a short time. On 29Dec2020 the patient had a significant swelling on the right side of the base of her neck near her clavicles that wrapped around to the posterior of her neck and was assessed as medically significant. She treated it by putting ice on it in the evening. On 30Dec2020 the swelling seemed to be slightly decreased but it is still a visible lump, the nodes are firm and there is swelling around those and it has not improved since the 30Dec2020. On 30Dec2020 she noticed a little cold blister or hive on the center of her lower lip and that was resolved by 03Jan2021, she did not have fever and did not feel sick, but her main problem is the swollen lymph nodes around base of neck around clavicle and it is considerably swollen there. The patient reported that last night (06Jan2021) it looked like her right arm was swollen, she thinks she is having lymphedema on the right arm, her right forearm is half an inch circumference larger than her left arm and was measured at her work. The patient reported she is seeing her new primary care doctor on 26Jan2021 and will follow up with the doctor. The patient wanted to know if she should get the second dose scheduled for the next week or should wait until the swelling resolves. Moreover the patient asked how long do the side effects usually last (specifically systemic side effects). The events "redness, swelling and tenderness at injection site" and "slightly itchy scalp" resolved on 25Dec2020, the event "Cold blister on lip" resolved on 03Jan2021. The event "Swelling on the right side of the base of her neck near her clavicles" had not resolved yet at the time of the report. All the reported events were assessed as related to the COVID-19 Vaccine by the Primary Source Reporter (Method of assessment:Agency).; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events swelling and lymphadenopathy cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
58 2021-01-11 injection site pain sore arm where injection was given shortly after.
58 2021-01-11 rash papular, skin discolouration, injection site swelling, injection site pruritus, injection site pain, injection site redness swelling and painful at injection site within first 24hrs in left arm. Red, itchy raised rash after ... Read more
swelling and painful at injection site within first 24hrs in left arm. Red, itchy raised rash after 7 days post injection that increased in area. Burning sensation experienced. Skin still discolored more than 20 days after 1st shot. 2nd dose in right arm: same reaction within 48hrs. redness, burning , itchiness sensation spreading to upper arm.
58 2021-01-12 injection site pain ON 12/31/20, DEVELOPED MID BACK PAIN, JOINT PAIN, MASSIVE HEADACHE, AND INJECTION SIGHT PAIN. LASTE... Read more
ON 12/31/20, DEVELOPED MID BACK PAIN, JOINT PAIN, MASSIVE HEADACHE, AND INJECTION SIGHT PAIN. LASTED 48-72 HOURS BEFORE RESOLVING.
58 2021-01-12 injection site pain ON 12/31/20, DEVELOPED MID BACK PAIN, JOINT PAIN, MASSIVE HEADACHE, INJECTION SITE PAIN LASTING 48-7... Read more
ON 12/31/20, DEVELOPED MID BACK PAIN, JOINT PAIN, MASSIVE HEADACHE, INJECTION SITE PAIN LASTING 48-72 HOURS.
58 2021-01-12 vaccination site swelling, vaccination site warmth, vaccination site redness Red, hot and raised at injection site.; Red, hot and raised at injection site.; Red, hot and raised ... Read more
Red, hot and raised at injection site.; Red, hot and raised at injection site.; Red, hot and raised at injection site.; Chills; Low grade fever; Fatigue; Body ache; This is a Spontaneous report from a contactable nurse (reported for herself). A 58-year-old female patient (not pregnant at the time of vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELO140), intramuscular on 04Jan2021 12:30 at single dose at right arm for COVID-19 immunization. Medical history included Vasculitis, no Allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included azathioprine (IMURAN [AZATHIOPRINE]), chlorthalidone, duloxetine hydrochloride (CYMBALTA), hydroxychloroquine. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Jan2021 14:00, the patient experienced red, hot and raised at injection site. 18 hours after receiving, she developed chills, low grade fever, fatigue and body ache on 05Jan2021. Treatment received for the adverse events included Tylenol. This report was non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovering.
58 2021-01-12 rash was told by occupational health that rash reporting was mandatory. Rash noted over entire trunk and... Read more
was told by occupational health that rash reporting was mandatory. Rash noted over entire trunk and all extremities, sparing head, hands, and feet
58 2021-01-13 injection site pain "I received the second does of the Pfizer vaccine on Jan 8th with no adverse reaction that day. When... Read more
"I received the second does of the Pfizer vaccine on Jan 8th with no adverse reaction that day. When I awoke on Saturday the 9th my arm was very sore at injection site but later went away. I had a dull headache, nausea, I was yawning all day, muscle fatigue, esp my quads, lightheaded enough to lay on the floor a few times during day. These symptoms did not stop me from painting, but I did feel horrible but I pushed through it. Sunday still nauseous, just feeling not my self..... I awoke on Monday morning and I was 100% fine!"
58 2021-01-13 skin irritation, rash Employee had irritated skin and rash extending down her trunk area and sides. Employee took liquid b... Read more
Employee had irritated skin and rash extending down her trunk area and sides. Employee took liquid benedryl for the minor allergic reaction.
58 2021-01-13 injection site pain Heart Palpatations started first lasted about 15 minutes, then sore throat, congestion, body aches ... Read more
Heart Palpatations started first lasted about 15 minutes, then sore throat, congestion, body aches and severe fatigue, injection site pain and chills.
58 2021-01-13 skin peeling Two days after taking the vaccination, the skin on the palms of my hands started peeling off. I hav... Read more
Two days after taking the vaccination, the skin on the palms of my hands started peeling off. I have a Stevens-Johnson's Syndrome reaction to certain antibiotics. This experience was less severe but very similar in appearance.
58 2021-01-13 hives sick to stomach and headache within 15 minutes, then about 1/2 hour later broke out in hives and had... Read more
sick to stomach and headache within 15 minutes, then about 1/2 hour later broke out in hives and had to go to emergency room and get some Benadryl and stay and be monitored for hour.
58 2021-01-13 skin swelling, redness, skin warm swelling, redness, warmth
58 2021-01-14 skin burning sensation, itchy skin After 15 minutes felt dizzy when got up to walk. Sat back down for about half hour. Still felt dizz... Read more
After 15 minutes felt dizzy when got up to walk. Sat back down for about half hour. Still felt dizzy, but went home. Began to feel nauseated and headache which continued from Saturday through currently. On Wednesday 4:00 a.m woke up to feeling of itchyness in chest. It spread to stomach, then legs, arms, face, back head in about an hour and a half. Took a shower and then felt burning. called doctor next morning at 10:30 and told to start benadryl and allegra. Stared about 1:00 pm. very drowsy and increased headache and nausau. Could still feel burning. Continued with about 3 does. Work up 12:38 on Thursday morning with increased burning and itching and benadryl was last taken 7 and half hours before. Did not take benadryl on Thursday due to drowsyness. Did not work Wednesday or Thursday. Friday early morning hours, woke up several times with itchiness and burning. This is all over my body. No rash at any time. Continued headache and nausea.
58 2021-01-14 skin burning sensation Within 10-12 hours after vaccine administration, Pain/burning in left arm and severe body/muscle ach... Read more
Within 10-12 hours after vaccine administration, Pain/burning in left arm and severe body/muscle aches (8/10 on pain scale). Headache (4/10). Fatigue. Temperature 100.1. Took Ibuprofen and Tylenol 1st through 5th day. Temperature was under 99.0 by 4th day. Above side effects were bearable with Ibuprofen by 4th day and only arm soreness by 5th day. **Of note, I was diagnosed with COVID on September 11, 2020 and had since recovered.
58 2021-01-16 injection site swelling, skin warm, redness, itchy skin Immediately after injection, felt itching. I had taken 400 mg ibuprofen prior to my injection. 12hr... Read more
Immediately after injection, felt itching. I had taken 400 mg ibuprofen prior to my injection. 12hrs later, stiffness in right upper trapezius and shoulder, took 440 mg naproxen and felt great! 24 hours after 2nd dose, redness. Itching and swelling at injection site. Tired, cold, temp 100.4. Applied ice 20 min on/off throughout day, took ibuprofen 1/16/21. Today 1/17/21, still red, warm to touch and itchy. I took a photo because I couldn?t tell if red area bigger. temp 99.4, slight headache
58 2021-01-17 itchy rash, rash, rash papular 1/17 had a rash at the site starting at 9 am . Now my whole body has a red raised rash . Face is the... Read more
1/17 had a rash at the site starting at 9 am . Now my whole body has a red raised rash . Face is the worst. Swollen and itches
58 2021-01-17 rash Patient developed tongue tingling 30 minutes after receiving first dose of Pfizer covid vaccine. Pat... Read more
Patient developed tongue tingling 30 minutes after receiving first dose of Pfizer covid vaccine. Patient also reports that she experienced tongue swelling, lip swelling, difficulty swallowing and rash on her back that developed 1 hour after vaccine. Patient did not seek immediate medical treatment and will receive treatment at Occupational Health.
58 2021-01-17 itchy skin Rec'd 1st dose on 1/9/2021 in the morning. By Sunday afternoon, face started burning and itching. on... Read more
Rec'd 1st dose on 1/9/2021 in the morning. By Sunday afternoon, face started burning and itching. on 1/11/2021 was seen in the ED for bilateral eye swelling, right side greater than left.
58 2021-01-17 injection site pruritus Sore arm x 2-3 days, itching arm started on 1/15 through 1/16, tingling lips for the first hour afte... Read more
Sore arm x 2-3 days, itching arm started on 1/15 through 1/16, tingling lips for the first hour after vaccine, felt fatigued the day of the vaccine for about an hour after, On 1/14 at 0530 woke up with a horrible right calf cramp was relieved by massage. Sat at side of bed began feeling extremely nauseated, diaphoretic then syncopal episode that lasted approximately 5 seconds.
58 2021-01-17 itchy skin, rash awakes around 3 am with severe itching on my legs; awakes around 3 am with severe itching on my legs... Read more
awakes around 3 am with severe itching on my legs; awakes around 3 am with severe itching on my legs; huge rash on her legs front and back but not on torso only on neck; This is a spontaneous report from a contactable nurse (patient) reported that a 58-year-old female patient received the second dose BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies. Concomitant medication included omeprazole magnesium (PRILOSEC). The patient did not have COVID-19 prior to vaccination. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, EL1284) on 18Dec2020 at 6:00 AM on the right arm. The patient reported that on a cupid days (as reported) after vaccine, she broke out in huge whips and rash from her face to the bottom of torso, it did this twice, so severe had she had to be put on a dose pack. The patient then received her second dose 08Jan2021 and awakes around 3 am with severe itching on my legs and this time huge rash on my legs front and back but not on torso only on neck on 08Jan2021 (as reported). The patient took Benadryl. The outcome of the events pruritus and rash was recovered while the outcome of the event was unknown. The patient had not been tested for COVID-19 post vaccination. Information on the lot/ batch number has been requested.
58 2021-01-18 rash Fever 101.5, chills, headache, muscle aches and diarrhea-1/13/21. Fever 100.7 headache, muscle aches... Read more
Fever 101.5, chills, headache, muscle aches and diarrhea-1/13/21. Fever 100.7 headache, muscle aches 1/14/21. Abd pain 1/16, 1/17 ER admission- abdominal pain 1/18. Discharge home. Rash and abd pain 1/19
58 2021-01-18 rash Late Entry 0952: Patient not feeling well. Reports shortness of breath, tongue tingling and has a ra... Read more
Late Entry 0952: Patient not feeling well. Reports shortness of breath, tongue tingling and has a rash to left upper arm. 0954: O2 sats 99%, HR 130 bpm, BP 150/90. Offered PO Benadryl per vaccine standing orders for adverse reactions. Patient refused PO Benadryl. O2 at 2L/NC applied at this time. EMS notified and in route. 1000: Patient remains very anxious and complains of dry mouth, dizzyness and tingling tongue. Attempted to administer EpiPen per vaccine standing orders for adverse reaction. Patient refused EpiPen. 1002: EMS on site. Patient continues to refuse EpiPen. O2 sats 99% on 2L/NC, HR 123 bpm, and BP 137/76. Patient ambulated with EMS personnel outside. After ambulating with EMS personnel, patient stated she felt better and refused to be transported to the hospital. Returned inside for follow up and monitoring. Late Entry 1025: Patient waiting to sign AMA form and had another episode in the hallway. Patient stated she did not feel right and squatted in the hallway. Staff assisted her to a chair. EMS notified and in route. Dr. notified. 1028: O2 sats 99%, HR 94 bpm and BP 138/102. Patient refused EpiPen at this time. Patient complains of feeling dizzy and short of breath. O2 at 2L/NC applied for comfort. 1032: O2 sats 98% on 2L/NC, HR 88 bpm, and BP 128/84. 1035: Dr. at bedside assessing patient. 1040: EMS here. Patient agreed to be transported to the local hospital for evaluation. O2 sats 98% on 2L/NC, HR 86 bpm, and BP 140/81.
58 2021-01-18 hives Patient noticed hives developing in middle of chest Sunday(1/17/21) evening. Next day (1/18/21) she... Read more
Patient noticed hives developing in middle of chest Sunday(1/17/21) evening. Next day (1/18/21) she presented at work (PCP office), and hives had spread throughout body, and patient did not feel well. Pt was prescribed a prednisone taper, triamcinolone 0.1% cream, Xyzal and diphenhydramine to manage symptoms.
58 2021-01-18 itchy skin Severe generalized muscle pain and weakness, general bone pain, general organ pain, short of breath,... Read more
Severe generalized muscle pain and weakness, general bone pain, general organ pain, short of breath, itching, severe chills alternating with fever, chest pain, facial nerve numbness, blurry vision, sore throat, nausea, diarrhea. Treatment was a Medrol Dose pack for 6 days. Outcome was severe symptoms decreased after 4 hours of taking first dose (6 tabs) of prednisone. As the prednisone dose decreases each day there is increased muscle pain and shortness of breath/lung tightness with activity, and severe fatigue
58 2021-01-18 rash TORSO, ARMS AND LEGS ARE COVERED IN A RASH
58 2021-01-19 redness 1/4/21- Patient stated she had tenderness on the back of her left lower leg with redness then 1/8/21... Read more
1/4/21- Patient stated she had tenderness on the back of her left lower leg with redness then 1/8/21 started to have shortness of breath and made a doctor's appointment for 1/13/21. Seen by provider on 1/13/21 and was sent to ED and admitted to the hospital [ICU] with NSTEMI, acute deep, occlusive venous thrombosis left femoral vein and saddle embolus of pulmonary artery. Transferred to another acute care hospital for removal of thrombosis. Patient started on Eliqus and no intervention for removal of the thrombosis.
58 2021-01-19 hives 1:55 sitting in chair in observation area, began feeling a "burning" sensation in her arms. 2:06 mo... Read more
1:55 sitting in chair in observation area, began feeling a "burning" sensation in her arms. 2:06 moved via w/c to private observation with EMT on site in Gave patient ice packs for both arms. States that the ice reliefs to burning. attendance. HR 78; O2 97%. Unable to obtain BP due to obesity. Per exam noted on Left lower arm a solid red raised area about 3 inches in diameter about 1/8 cm height. States it burns. Has mildly red scattered hive like areas on right lower arm. 2:15 Gave patient ice packs for both arms. States that the ice reliefs to burning.. Denies any burning or swelling in throat. BBS CTA per EMT assessment. No shortness of breath note; 2:25 States she drove on her own and lives in a senior adult complex. EMT recommended ambulance for further evaluation. Patient declined. EMT instructed patient to contact medical physician or emergency if problems persist or if symptoms worsen. Patient agreed and left ambulatory to private vehicle.
58 2021-01-19 itchy skin, redness Approximately 1.5 hours after receiving the vaccine, she noticed redness on her arms, upper chest an... Read more
Approximately 1.5 hours after receiving the vaccine, she noticed redness on her arms, upper chest and back of her neck which was mildly itchy and burning. She took Benedryl 25 mg prior to the vaccine and 25 mg after the symptoms appeared. Symptoms resolved within about 24 hours.
58 2021-01-19 injection site pain Chills, seizure like activity, body aches, injection site soreness
58 2021-01-19 itchy skin I started out with an itchy chin. The itch then went to my forehead, scalp, cheeks and left ear pin... Read more
I started out with an itchy chin. The itch then went to my forehead, scalp, cheeks and left ear pinna. The tip of my tongue also became numb. Symptoms lasted for 45 minutes.
58 2021-01-19 rash Systemic: Rash (other than injection site)-Mild, Systemic: Nausea-Severe, Systemic: Vertigo-Severe
58 2021-01-20 itchy skin, rash with redness Both arms, upper chest, back of neck and cheeks became bright red and felt like a first-degree sunbu... Read more
Both arms, upper chest, back of neck and cheeks became bright red and felt like a first-degree sunburn. Some slight itching. Had pre-treated with 25 mg of Benadryl prior to the vaccine and took an additional 25 mg of Benadryl when symptoms started
58 2021-01-20 vaccination site swelling, vaccination site pain Headache; extreme fatigue; all over body aches; stomach pain; diarrhea; unable to move R arm due pai... Read more
Headache; extreme fatigue; all over body aches; stomach pain; diarrhea; unable to move R arm due pain and swelling; unable to move R arm due pain and swelling; unable to move R arm due pain and swelling; This is a spontaneous report from a contactable healthcare professional (patient). A 58-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK-9231 and expiration date not reported), intramuscular on the right arm, on 07Jan2021 at 07:15 at a single dose for Covid-19 immunization. Medical history included fibromyalgia and chronic fatigue syndrome. The patient has no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient is not pregnant at the time of vaccination. Concomitant medications included vitamin D, niacin, hydrocodone bitartrate, paracetamol (NORCO), and paracetamol (TYLENOL). On 07Jan2021 at 11:00AM, the patient experienced headache, extreme fatigue, all over body aches, stomach pain, diarrhea, and unable to move R arm due pain and swelling. The patient did not receive treatment for the adverse events. The patient underwent Covid test post vaccination (Antigen and PCR) and result was SARS-CoV-2 test negative on 11Jan2021. The outcome of the events was recovered/resolved in Jan2021. The reporter assessed the events as non-serious.
58 2021-01-20 itchy skin Shortly after the injection she was dizzy and very thirsty. She had itching and her tongue was numb ... Read more
Shortly after the injection she was dizzy and very thirsty. She had itching and her tongue was numb for 3 days.
58 2021-01-20 injection site pain Vaccine received at 7:45. First symptoms was sore arm injection site and headache about noon. At 3 i... Read more
Vaccine received at 7:45. First symptoms was sore arm injection site and headache about noon. At 3 in the afternoon, chills, fever 101, and severe fatigue. The morning of the 21 of January fever and chills continued.
58 2021-01-21 rash with redness, pain of skin, itchy rash, blister, rash Morning after vaccination noticed rash of small red areas and blisters on bilateral upper arms. Thur... Read more
Morning after vaccination noticed rash of small red areas and blisters on bilateral upper arms. Thursday rash had spread to legs, back, and neck. Pruritic rash that is tender to touch. Diarrhea began Thursday, 4-5 episodes in 1 day. Fatigue also began Thursday. Has tried 25mg benadryl on Wednesday and Thursday with no relief. No fever.
58 2021-01-21 vaccination site itchiness, vaccination site warmth, vaccination site pain, vaccination site mass, vaccination site redness, itchy skin, redness This is a spontaneous report from a contactable other healthcare professional (Patient). A 58-year-o... Read more
This is a spontaneous report from a contactable other healthcare professional (Patient). A 58-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number provided as: LAB-1451-0.7), via an unspecified route of administration on 06Jan2021 14:30 at single dose in Left arm for COVID-19 immunization. Medical history included covid-19 from Mar2020 to an unknown date (the patient was sick with the COVID and was super tired). There were no known allergies. The patient's concomitant medications were none (there were no other medications received in two weeks). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced Itching more in the arm in the shot area, extreme joint pain, bones pain, headache, first 2 days dizziness, tiredness extreme, a little cough which all started from 06Jan2021 14:30. The patient also had pain on 2nd and 3rd day (onset date: 07Jan2021). The patient experienced heart beat fast everyday which started from 06Jan2021 14:30. The patient still had her left arm itching and hot as of 11Jan2021 but better with other side effects. Event onset date for her left arm hot was in Jan2021. No treatment received for the adverse events Itching more in the arm in the shot area, extreme joint pain, bones pain, headache, dizziness, tiredness extreme, a little cough, pain, heart beat fast, left arm hot. The patient stated she got the vaccine on Wednesday (06Jan2021) and after that she was feeling this thing but she was thinking was because of the Normal Saline, but in a little bit in the night she was very tired, super tired. Next day on 07Jan2021 she was to getting pain in her bones, very hard on her leg like when she was sick with the COVID last. The next day on 08Jan2021, she was having pain in her joints and her bones and muscles and she got the pain in her arm where she got the vaccine and was red and was like a big bump in her arm there. And next day she thought it was a Sunday morning on 10Jan2021, she had a little red, she had like redness in her face and itchy all her arms. So, and the patient feel very tired, super tired like when she was sick with this COVID-19 last March. She felt much better on 10Jan2021, the pain was a little less and her arm was much better and still itchy. The patient underwent lab test which included heart beat: fast on an unknown date. The outcome of events heart beat fast, got the pain in arm where the patient got the vaccine and was red and was like a big bump in her arm there and Redness of face, pain in muscles was unknown, the outcome of event itchy all her arms was not recovered, the outcome of the other events was recovering. This case reported as non-serious.
58 2021-01-21 itchy skin itching all over my face; elevated blood pressure; increased breathing rate
58 2021-01-22 injection site pain Started with general aches/pains lead to severe joint and muscle aches all over my body with fever, ... Read more
Started with general aches/pains lead to severe joint and muscle aches all over my body with fever, headache and fatigue lasted about 30-35 hours Also included pain at injection site that still continues but improves with motrin
58 2021-01-22 redness, skin swelling, itchy skin, blister injection given in the right arm and a couple days later she starting having some itching on her arm... Read more
injection given in the right arm and a couple days later she starting having some itching on her arm and there was a bright red 50 cent size mark on her skin along with some swelling. Patient also noted some blistering and today one of the blisters popped No treatment provided as of now
58 2021-01-23 injection site warmth, injection site pruritus, injection site pain, injection site hardening, injection site redness Hard, red, itching, tender and warm area measuring 9cm x 5 cm located 3cm below injection site
58 2021-01-23 injection site pruritus, injection site redness Headache, itching, redness at injection site and fatigue
58 2021-01-24 itchy skin 9:20 Feeling Itchy Heart rate 80 Blood pressure 112/68 9:30 symptoms better, apple juice given 9:3... Read more
9:20 Feeling Itchy Heart rate 80 Blood pressure 112/68 9:30 symptoms better, apple juice given 9:37 heart rate 80 blood pressure 108|68 symptoms have stopped 9:40 No rash, hives or difficulty breathing. Works at hospital to inform supervisor for any further problems
58 2021-01-24 hives On the second day on 12/29/2020 in the afternoon I started feeling fatigue, I hade nose bleeding, fe... Read more
On the second day on 12/29/2020 in the afternoon I started feeling fatigue, I hade nose bleeding, fevers & headaches. On the third day on 12/30/2020 I had hives I had them in my face they were the size of a dime they are lumping I had them on my eyebrows & on my right cheek, & continued nose bleeding, fever continued, fatigue continued, headaches continued, pain on my arm & I felt with no energy. I had a lot of nose bleeding. On 12/30/2020 I called the doctor and they gave me an appointment for 12/31/2020 & they gave me a zoom meeting. The doctor said every symptom I had was a normal reaction to the covid vaccine except the nose bleeding. The symptoms continued but the nose bleeding is the only thing it has stopped.
58 2021-01-24 skin warm, skin discolouration, redness Right arm noted yesterday to be swollen, warm reddened and purple employee states seem to be getting... Read more
Right arm noted yesterday to be swollen, warm reddened and purple employee states seem to be getting worse. m Vaccinated on Friday
58 2021-01-24 rash Slight swollen lips, hive like rash on legs, Nausea and vomiting: all went away with in 24 hours sev... Read more
Slight swollen lips, hive like rash on legs, Nausea and vomiting: all went away with in 24 hours severe vertigo with this for 2 days, vertigo is still happening on 3rd day but has lessened did not seek medical attention: took benadryl 1st day only and it took care of the symptoms except vertigo Started Meclizine 25 mg over the counter on day2 and it makes vertigo tolerable but still persitant at this point
58 2021-01-24 injection site pain Usual: aches, pain at site, headache Unusual: fever >103, gross hematuria (no history of UTIs or ki... Read more
Usual: aches, pain at site, headache Unusual: fever >103, gross hematuria (no history of UTIs or kidney stones)
58 2021-01-25 itchy skin PT REPORTED ITCHING, TINGLING AROUD HER MOUTH, AND LIGHTHEADEDNESS. SHE WAS PLACED IN A LOUNGE CHAI... Read more
PT REPORTED ITCHING, TINGLING AROUD HER MOUTH, AND LIGHTHEADEDNESS. SHE WAS PLACED IN A LOUNGE CHAIR AND VITALS WERE TAKEN. ALLERGIST CONTACTED AND ADVISED THE PT TO TAKE ZYRTEC NOW AND BID FOR THE NEXT 3 DAYS,. PT TOOK THE DOSE AND UNDERSTOOD THE INSTRUCTIONS. VITALS IMPROVED AND HER ITCHING SUBSIDED. HER ONLY REMAINING SYMPTOM WAS A HEADACHE THAT DEVELOPED AFTER TAKING THE ZYRTEC. SHE WAS GIVEN ICE PACK FOR HER HEAD AND ENCOURAGED TO DRINK FLUIDS. PT STATED SHE FELT FINE AND WANTED TO LEAVE TO RETURN TO HER UNIT SO SHE LEFT OBSERVATION AT 1:31PM.
58 2021-01-25 vaccination site pain Tiredness/exhausted; injection site pain in her right arm; This is a spontaneous report from a conta... Read more
Tiredness/exhausted; injection site pain in her right arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, unspecified lot number, reported as EH9899 or TH9899), intramuscularly at site of right arm at 10:00 on 20Dec2020 at single dose for COVID-19 immunization. Medical history included ongoing hypothyroidism for the last 15 years. The patient's concomitant medications included ascorbic acid, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, magnesium, malpighia glabra fruit, manganese, molybdenum, nicotinamide, pantothenic acid, phytomenadione, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTIVITAMIN ACTIVE WOMAN, lot number: 300045; Expiration date: May2022) from Jan2021. The patient previously took cetirizine hydrochloride (ZYRTEC) daily for allergies forever. Clinical course: Patient received the first dose of the BNT162B2 on 20Dec2020, and was tired afterwards, she didn't feel tired continually. She began to feel tired on 21Dec2020, she was just exhausted, she was so tired and she just slept, she couldn't get out of her own way. On 22Dec2020, she was fine, but on 23Dec2020, she began to feel tired and exhausted again. By 24Dec2020, her symptoms were over. She also experienced injection site pain in her right arm that started on 21Dec2020 and resolved by the evening of the same day. No treatment received for this event. Vaccination Facility Type was in hospital. No vaccine administered at Military Facility. No emergency room visit needed. It was unknown that physician office visit needed. No prior vaccinations within 4 weeks. Adverse event(s) following prior vaccinations was N/A. Family medical history relevant to adverse event(s) was not provided. Relevant tests were none. The outcome of event 'tiredness/exhausted' was recovered on 24Jan2021; of event 'injection site pain in her right arm' was recovered on 21Dec2020. Information on the Lot/Batch number has been requested.
58 2021-01-25 hives hives from head to toe/Her Hives are on her ears, lips, neck, going all the way down to her toes/Hiv... Read more
hives from head to toe/Her Hives are on her ears, lips, neck, going all the way down to her toes/Hives are worse; first dose on 21Dec2021, second dose on 08Jan2021; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the second dose of BNT162b2 (Lot: EL3246), via an unspecified route of administration in right arm on 08Jan2021 08:45 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included meloxicam. The patient previously received the first dose of BNT162b2 (Lot: EK5730), at the age of 58-year-old, via an unspecified route of administration in right arm on 21Dec2020 at single dose for covid-19 immunization. She is not allergic to anything at all. She got the 2nd shot on Friday (08Jan2021) 8:45 and then on Sunday (10Jan2021) she had hives from head to toe. She has not tried anything new, no food, products, or detergents. She has no hives at the injection site. Her Hives are on her ears, lips, neck, going all the way down to her toes. At 4 o'clock on 10Jan2021 if when the hives began and by 6 the hives had exploded. Her Hives are worse now. She has had No Positive tests for Covid prior to the vaccine. She has had no antibody test prior to the vaccine. She has had No issues with vaccines in the past. She is using Benadryl to treat her Hives, however it puts her to sleep in 30 minutes and so she cant do that at work. The patient received the first dose on 21Dec2021, second dose on 08Jan2021. The outcome of the event hives was not recovered.
58 2021-01-26 vaccination site pain Intense pain in left injection arm; Fever; Could not sleep; aches all over; other vaccine same date ... Read more
Intense pain in left injection arm; Fever; Could not sleep; aches all over; other vaccine same date vaccine date on 04Jan2021; Day 6 -10 migraines hit; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm at 23:30 on 04Jan2021 at single dose for COVID-19 immunization and other vaccine same date vaccine date on 04Jan2021 on left arm. Medical history included allergies to penicillin, allergy to bananas, wheat (patient do eat products w wheat), dairy; Melanoma 3rd degree 1987 & 2005, allergies, sinus surgery resolved problems. Concomitant medication included venlafaxine, omeprazole, bupropion hydrochloride (WELLBUTRIN). It was reported that patient had no other vaccine in four weeks. The patient previously took ampicillin and experienced drug allergy. No issues until middle of night of first injection. The patient experienced intense pain in left injection arm; fever; could not sleep, other aches all over on 05Jan2021. Used ice packs & Motrin. Fever left after two days. Intense pain continued. 5th day switched to heating pad & took 2 tablets of Tylenol every 6 hours. Called patient's doctor on days 6 & 8. Suggested patient alternate Tylenol & Motrin every 6 or 8 hours. Day 6 -10 migraines hit. The outcome of event fever was recovered on 07Jan2021. The outcome of events migraine and Product use for unapproved combination was unknown. The outcome of rest events was not recovered. Information on the LOT/Batch number has been requested.
58 2021-01-26 injection site pain extremely sore at the injection site. I had overnight chills starting at 9pm on 1/21/2002 through ... Read more
extremely sore at the injection site. I had overnight chills starting at 9pm on 1/21/2002 through morning. I took my temp on 1/21 at 9am and it was normal. (98.4) Body aches, and nausea most of the day on 1/21/2021. treatment: Ibuprofen 600mg BID X 2 days.
58 2021-01-26 rash maculo-papular, redness maculopapular rash on abdomen; redness covering trunk and extremities, sparing head, hands, and feet... Read more
maculopapular rash on abdomen; redness covering trunk and extremities, sparing head, hands, and feet; This is a spontaneous report from a contactable healthcare professional (patient). A 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL246 and expiry date: unknown), via an unspecified route of administration, left arm on 11Jan2021 09:45 at a single dose for COVID-19 immunization. The first dose was received on 21Dec2020 10:30 (lot number: EJ1685) on the left arm. Medical history included mild asthma GERD (gastrooesophageal reflux disease, and allergies to certain antibiotics causing a rash. Patient was not pregnant. Concomitant medication included montelukast sodium, omeprazole, and colecalciferol (VITAMIN D). The adverse events began as maculopapular rash on abdomen now redness covering trunk and extremities, sparing head, hands, and feet on 12Jan2021. Outcome of the events was not recovered. No treatment for the events was received. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
58 2021-01-27 injection site pain Fever, fatigue, soreness at injection site
58 2021-01-27 rash Headaches daily on an off, specifically left eye, for approximately 10 days starting on 1 day of vac... Read more
Headaches daily on an off, specifically left eye, for approximately 10 days starting on 1 day of vaccine Diarrhea approximately 14 days starting on day 1 Dizziness on and off for approximately10 days starting on day 1 Rheumatoid arthritis flare up, left shoulder 2 days, unable to move shoulder, day 7 & 8 after vaccine Small rash on left chin starting day 10 after vaccine Was seen by my primary care physician on day 11. Was advised to restart my hyrdroxychoroquin medication 200mg 2x's daily for rheumatoid arthritis ( I had not been taking this for several months) Was given Medrol dose pack which was started on day 15 after vaccine All symptoms subsided after finishing Medrol pack. I continue to stay on the Hydroxychloroquin 200mg 2X's daily for rheumatoid arthritis I was advised by my physician not to receive the 2nd dose Was advised to get J&J vaccine when available (I find this questionable)
58 2021-01-27 injection site pain Weak Dizzy sleepy pain at injection site feels like she is going to get the flu
58 2021-01-28 injection site pain 2 to 3 hours after the shot was given the area around where the shot was given was extremely sore (l... Read more
2 to 3 hours after the shot was given the area around where the shot was given was extremely sore (level 9). I began taking Tylenol which caused the pain to subside to a reasonable level. I took Tylenol every 6 hours to keep the pain in my arm, which seemed to cause some neck stiffness, down to a 2 or 3 level (10 being the worst pain). The next morning pain was down to 1 or 2 level, I took Tylenol again. By noon the second day pain was gone.
58 2021-01-28 hair loss After COVID vaccines (first 12/17/20) she started having her hair come out in clumps in the shower, ... Read more
After COVID vaccines (first 12/17/20) she started having her hair come out in clumps in the shower, and shedding an excessive amount when brushing. She started noticing this about 1-2 weeks after her first vaccine, and it got worse after the second vaccine on 1/7/21 (Pfizer Lot#EK9231). It is an even thinning, no patches of hair loss. She was diagnosed with COVID on 10/7/20 which resulted in hospitalization. Reporting fatigue, continued loss of sense of taste and smell, decreased appetite, and hair loss. Experiencing fatigue and decreased energy, worse in the evening, falls asleep easily when she gets home after work, started when she got COVID.
58 2021-01-28 injection site pain Arm pain at injection sight 6 hours later along with swollen glands. Four days later a migraine hit... Read more
Arm pain at injection sight 6 hours later along with swollen glands. Four days later a migraine hit around 2:00 pm and lasted at least 12 hours. Also swollen shoulders and shoulder and back pain. The following week I experienced sudden shortness of breath that last for approximately 10 minutes while I was at work with profuse sweating on my lower back. The shortness of breath occurred agin the next day while working around the home. and lasted about 5 minutes.
58 2021-01-28 injection site pain Fever blister on upper lip (herpes simplex1) Slight tenderness at injection site
58 2021-01-28 hives Patient stated she was extremely thirsty and felt she had a really really dry mouth? Then stated the... Read more
Patient stated she was extremely thirsty and felt she had a really really dry mouth? Then stated the top of her head felt funny. At this point on site ARNP was called over to Patient. and both myself and ARNP noticed flushing on face and neck and hives on neck area. On site EMS notified and came over. Patient then self medicated with 2-25 mg Benadryl. Patient exhibited mild cognitive slowing with some mild speech and thought degradation...felt funny....not sure what she felt.... Physical symptoms noted above showed some mild sign of improvement? Clinicians insisted that patient should be taken to hospital of choice via ambulance. Patient was taken to clinic where she was under observation, put on IV saline and administered IV steroid, dexamethasone. After approximately two hours patient was released and instructed to take over-the-counter Benadryl every six hours for six days and one Pepcid per day for six days.
58 2021-01-28 injection site warmth, injection site swelling, injection site redness, skin mass experienced body aches and chills the 1st 24hr and now the injection site is hot, red and swollen. A... Read more
experienced body aches and chills the 1st 24hr and now the injection site is hot, red and swollen. A knot under the skin got a little bit bigger than silver dollar, felt like a huge knot. She feels nurse was administering vaccine while pushing in needle. The initial vaccine the nurse did not push in dose until needle was in arm.
58 2021-01-28 redness flushing, redness, right hand sign of face, ear and right arm 45 minutes post vaccine; took Benadryl... Read more
flushing, redness, right hand sign of face, ear and right arm 45 minutes post vaccine; took Benadryl; over the course of time, no worsening of symptoms; pt took another Benadryl on advice of visiting nurse about 4 hours after 1st dose
58 2021-01-28 vaccination site pain sore body and muscles, vaccine site extremely sore headache and fatigue.
58 2021-01-29 injection site pain Aching all over Low grade fever Chills Headache Pain at site
58 2021-01-29 injection site pain Experienced the typical symptoms described on fact sheet, fever, chills, tiredness, headache, inject... Read more
Experienced the typical symptoms described on fact sheet, fever, chills, tiredness, headache, injection site soreness, and body aches. My body aches were severe and I had severe episode of my fibromyalgia symptoms to reoccur. I was totally wiped out for a full day (literally stayed in bed) my arms and legs were heavy and hard for me to lift so I was extremely weak; and thus far for today I am still not 100% as the pain is still very noticeable and I?m totally exhausted. Fibromyalgia symptoms are still present and just don?t feel well at all.
58 2021-01-30 injection site pain Had stiffness and pain radiating from site up to jaw and into wrist. Difficult to open mouth immedia... Read more
Had stiffness and pain radiating from site up to jaw and into wrist. Difficult to open mouth immediately after injection. They sent me to doc on site and applied ice. After 29 minutes symptoms started to subside. By the evening pain moved across back of shoulders blades. Increased headache with chills and alternating fever. Could not sleep due to pain. Next morning,today. Had abdominal pain cramping and diarrhea. Unable to sit up or walk much due to weakness and feel will pass out.
58 2021-01-31 hives Face swelling, fever, vomiting muscle and joint pain. I also have what looks like hives on my eyelid... Read more
Face swelling, fever, vomiting muscle and joint pain. I also have what looks like hives on my eyelid. I?ll still achy.
58 2021-01-31 skin warm, redness Had Shot on Thursday. My arm is still red and sore. Hot to the touch. Worried it might be infected.
58 2021-01-31 shingles Increased fluid in left eye with significant decreased vision started 1 week post immunization; and ... Read more
Increased fluid in left eye with significant decreased vision started 1 week post immunization; and shingles started 1/29/2021
58 2021-01-31 hives, redness, rash macular Jan 31, 430 pm - Red splotches front part of neck, chest, shoulders. A red welt above Left clavic... Read more
Jan 31, 430 pm - Red splotches front part of neck, chest, shoulders. A red welt above Left clavicle, did not itch, but burning sensation. Small node swelling in the clavicle space. Asthmatic flare in the evening and at midnite. Feb 1 - Less redness on skin, but, welt still present. Having chest tightness in the morning and continues as of this report.
58 2021-01-31 itchy skin Patient received the Pfizer COVID vaccine dose #1 on 1/14/2021 and within 5 minutes of administratio... Read more
Patient received the Pfizer COVID vaccine dose #1 on 1/14/2021 and within 5 minutes of administration the patient developed itching and a flushed feeling, tingling lips, racing heart rate, and headache. Patient reports these symptoms lasted several hours and then resolved.
58 2021-01-31 injection site swelling Severe pain and swelling in the lymph nodes of the left armpit. Swelling in the area of the vaccine.... Read more
Severe pain and swelling in the lymph nodes of the left armpit. Swelling in the area of the vaccine. The pain started on Friday night and today Monday continues. It has decreased in intensity but I am also having discomfort in the lymph nodes of the right arm and some discomfort in the breasts.
58 2021-01-31 rash chest tightness, shortness of breath, then went to throat sore throat, hoarseness patient received E... Read more
chest tightness, shortness of breath, then went to throat sore throat, hoarseness patient received EPIPEN 0.3 mg 3 doses 5 min apart. then went to ER had two breathing treatments, albuterol, epinephrine, solumedrol one injection, 50 mg Benadryl reports rash at IV site from (Benadryl?) No rash anywhere else. Prednisone tapering dose and Benadryl 50 mg at night and 25 during day time. To follow up with PMD. Headache.
58 2021-02-01 vaccination site redness, vaccination site pain, vaccination site swelling felt a strong pain in the chest; injection site was color purple; injection site was color red, swol... Read more
felt a strong pain in the chest; injection site was color purple; injection site was color red, swollen and with pain; injection site was color red, swollen and with pain; injection site was color red, swollen and with pain; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number not reported, via an unspecified route of administration from 14Jan2021 to 14Jan2021 as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that 2 days after the administration, the injection site was color red, swollen and with pain; 3 days after the administration the injection site was color purple; and 4 days after the administration she felt a strong pain in the chest. The outcome of the events was unknown. Information on lot/batch has been requested.
58 2021-02-01 hives felt extremely thirsty; facial flushing; Mild hives on face neck and upper chest; Mild cognitive and... Read more
felt extremely thirsty; facial flushing; Mild hives on face neck and upper chest; Mild cognitive and speech slowing; Mild cognitive and speech slowing; Felt strange sensation on top of head; This is a spontaneous report from a contactable Other Health Professional (patient). A 58-year-old female (not pregnant) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on 14Jan2021 04:00 PM (vaccine location: right arm) at single dose for COVID-19 immunisation.The patient's medical history included hashimotos, fibromyalgia, known allergies to sulfa drugs and extreme shellfish. There is no other vaccine in four weeks. The concomitant drug included levothyroxine sodium (SYNTHROID), Amitriptyline, Valsartan, Vitamin D. After about 12 mins from shot on 14Jan2021 04:15 PM, patient felt extremely thirsty. Then spouse noted facial flushing and called an advanced registered nurse practitioner (ARNP) on site to eval. Mild hives on face neck and upper chest developed then. Then increase flushing on face. Mild cognitive and speech slowing. Felt strange sensation on top of head. Self medicated with 50 mg Benadryl capsule. Emergency medical technician (EMT) and ARNP insisted should go to emergency room (ER), in ambulance not with spouse. Other treatment included OTC ongoing Benadryl and Pepcid. The outcome of events was recovered in Jan2021. Information on the batch number has been requested.
58 2021-02-02 itchy skin, injection site swelling 3 February 2021@1130-Today-HA, itchy upper body, rt deltoid area swollen-she said Reminded to go to... Read more
3 February 2021@1130-Today-HA, itchy upper body, rt deltoid area swollen-she said Reminded to go to the ER if her symptoms get worse-call her PCM also
58 2021-02-02 injection site pain feel unwell most of the day; extreme fatigue 3 days in bed, for days 4-15 extreme fatigue so only wo... Read more
feel unwell most of the day; extreme fatigue 3 days in bed, for days 4-15 extreme fatigue so only worked 3 hours/day; pain in injection site, spread within 6 hours to all joints; pain in injection site, spread within 6 hours to all joints; headache; severe pain all muscles; nausea; This is a spontaneous report from a contactable other health professional (patient herself). A 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via an unspecified route of administration on 31Dec2020 12:30 in right arm at single dose for covid-19 immunization. Medical history included asthma, fibromyalgia, perimenopause issues. The patient was known allergies: amlodipine; yellow jackets/hornets. The patient had COVID-19 prior vaccination. No other vaccine in four weeks were taken. Concomitant medication in two weeks included fluticasone propionate, salmeterol xinafoate (ADVAIR), zolpidem tartrate (AMBIEN), estradiol, mepolizumab (NUCALA) and oxycodone. Facility type vaccine was nursing home/senior living facility. On 01Jan2021, patient experienced pain in injection site, spread within 6 hours to all joints, then within 24 hours had headache, severe pain all muscles, nausea, and extreme fatigue 3 days in bed, for days 4-15 extreme fatigue so only worked 3 hours/day. All symptoms persist. Day 18 not in bed, but patient felt unwell most of the day on 18Jan2021. Lots of rest was required not normal for her. Events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included COVID-19 antibody test: positive on an unspecified date and nasal swab: negative on 15Jan2021. No treatment was received for events. Outcome of events at the reporting time were recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the fatigue and other reported events due to temporal relationship. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
58 2021-02-03 rash with redness Raised, red rash over trunk, arms, scalp; This is a spontaneous report from a contactable other hcp.... Read more
Raised, red rash over trunk, arms, scalp; This is a spontaneous report from a contactable other hcp. A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EK923), at single dose into the left arm on 30Dec2020 at 03:45 PM for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included diphenhydramine hydrochloride (BENADRYL) 25g and gabapentin 300mg. On 31Dec2020 at 06:00 PM the patient experienced raised, red rash over trunk, arms, scalp. The outcome of the event was recovered. It was reported that the patient received the second dose of BNT162B2 on 20Jan2021 at 07:45 AM in the Left arm.
58 2021-02-03 injection site pain injection site pain
58 2021-02-03 itchy skin severe itching, especially eyes, ears and throat
58 2021-02-03 rash with redness, rash papular, itchy rash small red itchy bumpy rash on chest and arms; small red itchy bumpy rash on chest and arms; small re... Read more
small red itchy bumpy rash on chest and arms; small red itchy bumpy rash on chest and arms; small red itchy bumpy rash on chest and arms; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL1284) via an unspecified route of administration in the right arm on 02Jan2021 at a single dose as Covid vaccine. Medical history included hypothyroid. The patient had no known allergies. Concomitant medication included thyroid (ARMOUR THYROID) (other medications in two weeks). The patient had no other vaccine in four weeks. It was reported that the next day after receiving the vaccine, the patient developed a small red itchy bumpy rash on chest and arms on 03Jan2021. Treatment was not received for the events. She had no Covid prior to vaccination. She did not have Covid tested post vaccination. The outcome of the events was recovered with sequelae (reported as recovered with lasting effects) on Jan2021.
58 2021-02-04 shingles, blister Developed Shingles lesions on my right lower leg. Blisters/vesicles. I noticed this at 1:00am Thur... Read more
Developed Shingles lesions on my right lower leg. Blisters/vesicles. I noticed this at 1:00am Thursday, February 4, 2021. Went to my local Urgent Care facility on Thursday , 2/4/21 morning, 9:20am. Diagnosed with Shingles. Prescribed Valacyclovir 1gm BID. Started first dose on Thursday, 2/4/21 at approx. 10:45am. Currently experiencing burning sensation in the area of lesions. Swollen lymph node in right groin area with pain/ache feeling surrounding the right groin lymph node.
58 2021-02-04 injection site swelling Site: Swelling at Injection Site-Medium
58 2021-02-04 injection site warmth, injection site tingling Warmness and tingling moving from injection site across upper body (compared to sensation after rece... Read more
Warmness and tingling moving from injection site across upper body (compared to sensation after receiving contrast dye). Denies shortness of breath, chest pain and respiratory symptoms.
58 2021-02-05 injection site pain Fever 100.9, started about 10 hours after vaaccine. Lasted all night and most of next day. I fina... Read more
Fever 100.9, started about 10 hours after vaaccine. Lasted all night and most of next day. I finally took Tylenol about 24 hours after vaccine. chills, started about 10 hrs after vaccine and lasted 5 hours. aches all over body, lasted from 10 hrs after to 30 hours after Extremely sore arm at injection site. Started about 8 hrs after vaccine and lasted til 24 hrs after vaccine headache, fatigue, started 8 hrs after vaccine and lasted for 36 hrs after vaccine.
58 2021-02-05 itchy skin Patient's whole body was extremely itchy. This feeling started 20 minutes after the Pfizer vaccine w... Read more
Patient's whole body was extremely itchy. This feeling started 20 minutes after the Pfizer vaccine was administered. Other than whole body itching, she did not have any shortness of breath or swelling. This sensation has happened to her before when she had morphine. EMS told her to take a non-sedating anti-histamine to help with the itching when she got home. All vitals were stable.
58 2021-02-05 injection site pain Two hours after injection severe soreness, next day loss of range of motion, persistent pain around ... Read more
Two hours after injection severe soreness, next day loss of range of motion, persistent pain around shoulder, radiating pain down arm and tingling in fingers which continues into sixth day. Unable to sleep, loss of appetite, taking Tylenol prn, was taking Motrin prior.
58 2021-02-06 injection site pruritus, injection site redness, injection site swelling, injection site warmth Severe headache, backache all over body aches Nausea Fever Chills Fatigue Site of injection 2 day... Read more
Severe headache, backache all over body aches Nausea Fever Chills Fatigue Site of injection 2 days after: red, hot, swollen and itching
58 2021-02-06 injection site pain Soreness at injection site which subsided after several days with only mild tenderness. Muscle pain... Read more
Soreness at injection site which subsided after several days with only mild tenderness. Muscle pain at injection area started getting tender again to touch around 5 days after injection then shoulder pain becoming sore enough on Friday 2/5 to interfere with sleep. Shoulder pain on movement of arm today 2/7 and muscle feels very tender to the touch.
58 2021-02-07 itchy skin Itchy, swollen skin around eyes, face, ears, neck, under left breast, and arms.
58 2021-02-07 injection site pain, injection site warmth, skin discolouration, injection site redness, injection site reaction PATIENT AWOKE SATURDAY MORNING WITH A SORE ARM AND MILD PINK AREA SURROUNDING INJECTION SITE. OVER T... Read more
PATIENT AWOKE SATURDAY MORNING WITH A SORE ARM AND MILD PINK AREA SURROUNDING INJECTION SITE. OVER THE WEEKEND, THE SORENESS AND REDNESS HAVE INTENSIFIED TO PAIN LEVEL OF ABOUT 3 OUT OF 10 AND PT'S DENTIST ADVISED HER TO LET US KNOW ABOUT THE REACTION. PT'S DELTOID IS RED AND WARM TO THE TOUCH, IN PYRAMID SHAPED TRIANGLE ABOUT 2.5 INCHES HIGH AND 4 INCHES ACROSS AT WIDEST POINTS. PT DID TAKE IBUPROFEN THE OTHER DAY AND TRIED BENADRYL. SHE STATES "I DON'T REALLY THINK IT DID ANYTHING". AREA OF REDNESS HAS GROWN OVER THE WEEKEND.
58 2021-02-08 skin infection at injection site Starting day 5: extremely painful and inflamed lymph nodes, particularly under arms. Day 9: develop... Read more
Starting day 5: extremely painful and inflamed lymph nodes, particularly under arms. Day 9: developed Cellulitis in left upper arm at injection site
58 2021-02-09 vaccination site pain, vaccination site swelling Chills; Muscle and joint ache; Muscle and joint ache; Headache; Injection site pain; Tingling; Numbn... Read more
Chills; Muscle and joint ache; Muscle and joint ache; Headache; Injection site pain; Tingling; Numbness; Muscle weakness; Swelling and pain in left arm; Swelling and pain in left arm - all the way down to hand; Swelling and pain in left arm - all the way down to hand; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL3248) at single dose, in the left arm, on 21Jan2021, at 11:45 AM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Relevant medical history included allergies to sulfa drugs and to wasps, fibromyalgia (autoimmune issues), rosacea, rheumatoid arthritis (RA) and frozen shoulder (L). Concomitant medications, received within 2 weeks of vaccination, included cannabidiol (CBD OIL), vitamin D (ergocalciferol), biotin and meloxicam (MEL). On 21Jan2021, at 03:00 PM, the patient experienced chills, muscle and joint aches, headache, injection site pain, tingling and numbness, muscle weakness, swelling and pain in left arm - all the way down to hand. No treatment was received. The patient did not recover from the events at time of this report. The case was assessed as non-serious (seriousness criteria-results in death: no, seriousness criteria-life threatening: no, seriousness criteria-caused/prolonged hospitalization: no, seriousness criteria-disabling/incapacitating: no and seriousness criteria-congenital anomaly/birth defect: no). Post the vaccination, the patient has not been tested for COVID-19.
58 2021-02-10 hives Client reports "hive-like" rash to chest the size of a inch, onset approximately 2 weeks after dose ... Read more
Client reports "hive-like" rash to chest the size of a inch, onset approximately 2 weeks after dose 1. Reports widespread "hives" to chest, ribcage, and shoulder blades onset 2/6/2021. Reports first attributed the reaction to a new necklace/nickel allergy. Prescription steroid cream to site has helped with symptoms.
58 2021-02-11 hives facial/ tongue swelling, hives, shortness of breath, trouble swallowing
58 2021-02-13 injection site pain My right arm has been extremely painful ever since. To date I have been to 4 Dr's. I have had a MRI... Read more
My right arm has been extremely painful ever since. To date I have been to 4 Dr's. I have had a MRI, steroid injections, 4 medications. All with no relief. My arm shoots numbess feeling, tingling, tightness from shoulder to fingertips. It is getting worse. I am unable to do my job and household work.
58 2021-02-15 rash, blister, skin irritation, skin peeling Presented from clinic with 3-4 days of extensive rash. There were multiple areas of skin sloughing ... Read more
Presented from clinic with 3-4 days of extensive rash. There were multiple areas of skin sloughing on bilateral upper extremities and abdominal wall.
58 2021-02-15 itchy skin, redness Pt reported feeling symptoms approx 10 minutes after receiving injection. She complained of mild sho... Read more
Pt reported feeling symptoms approx 10 minutes after receiving injection. She complained of mild shortness of breath and "itchy throat." She was questioned about having any other symptoms and immediately escorted to the medical attention tent. She was seated, and EMS began evaluation; her vital signs were taken: RR 22, HR 82, BP 156/102, PULSE OX 98%. She then reported an increase in symptoms, as face itching, increased tightness in her throat. Objective symptoms observed by myself and EMS: cough/clearing of the throat, increased SOB/labored breathing, facial erythema, hoarseness. EMS asked for her consent to give her Benadryl and Epinephrine. She repeatedly refused this, and refused any attempt at IV placement. She eventually agreed to IM Benadryl, of which 50mg were administered by EMS. Both EMS and I suggested more than once that she allow us to transfer her to the hospital for further management and preparation in the event that she needs further care. I explained that she was having symptoms of anaphylaxis. She repeatedly refused transfer. She reported a decrease in symptoms, saying she felt well enough to go home. Her objective symptoms observed by myself: continued hoarseness and clearing of the throat. VS were repeated: RR 18, HR 68, BP 160/98, PULSE OX 99%. Airway remained patent and clear. Patient again requested to leave, and agreed to EMS escorting her to her car.
58 2021-02-16 injection site swelling, injection site redness Large area of redness and swelling at injection site, on day 5 symptoms continue but improving
58 2021-02-16 skin mass On 1/13/21 my 2nd injection I was fine the next day I felt fine but in the afternoon around 2:30 I n... Read more
On 1/13/21 my 2nd injection I was fine the next day I felt fine but in the afternoon around 2:30 I noticed my left side of my neck was swollen so I had asked 2of the M.D.'s and a N.P. to check it and they felt 2 lumps along with the swelling and asked me to keep a eye on it, After a few days the swelling in my neck was gone but the lumps were still there so they asked me to contact my PCP which I did and a few days later she ordered a ultra sound which I had done on 2/4/21 and the results showed there were 3 lumps. I was asked by my PCP to wait 2-3weeks to see if they subside and if not she will order a new ultra sound(which I am waiting to hear back from her)
58 2021-02-16 rash with redness, itchy skin, skin discolouration Patient received COVID-19 vaccine. AFter 5 minutes of observation she got itchy and started getting ... Read more
Patient received COVID-19 vaccine. AFter 5 minutes of observation she got itchy and started getting a red rash on her throat area. She was very calm and asked for help. Paramedics noticed she was turning discolored and provided Benadryl p.o 4mL. They asked to transport her to a nearby hospital and she agreed. They were in transport at 4:35pm to the hospital to get her treatment for adverse reaction.
58 2021-02-16 injection site pain The morning after 2nd dose of Pfizer. I was weak and actually couldn't get my legs to go forward the... Read more
The morning after 2nd dose of Pfizer. I was weak and actually couldn't get my legs to go forward they gave out and I was on the floor unable to get back up on my own without staff assistance. I was very sweaty very dizzy and disorientated. not knowing who was around me. I had pain at injection site, no headache no body pain. Very tired slept took tylonal.
58 2021-02-16 injection site pain bad swollen lymph node under right arm pit injection swelling low fever really bad chills headache ... Read more
bad swollen lymph node under right arm pit injection swelling low fever really bad chills headache injection pain tired cough cold low fever pain
58 2021-02-17 shingles flare up of shingles; disease recurrence; This initial case was missing the following minimum criter... Read more
flare up of shingles; disease recurrence; This initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow up information on 30Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer and nurse based on information received by Pfizer from A 58 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 18Jan2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included ongoing psoriatic arthritis and shingles. Previous therapy included VIOXX and methotrexate, both for psoriatic arthritis. Concomitant medications included etanercept (ENBREL) for psoriatic arthritis. On 20Jan2021 two days later after received the vaccine the patient had a flare up of shingles. At the time of the reporting event outcome was unknown. No follow-up attempts are possible, information about batch number cannot be obtained
58 2021-02-18 itchy skin, hives Two days after the vaccination I developed itching and a temporary patch of hives on my back
58 2021-02-21 hives, itchy rash, injection site pain The first symptoms was pain in the injection site. Then felt pain traveling down to my left arm and ... Read more
The first symptoms was pain in the injection site. Then felt pain traveling down to my left arm and fingers. I was told I was only to stay 15 minutes after the shot. On my way home from the vaccination about 30 minutes after the shot, I felt sick. I had a rapid heart rate and itch red hives on my left chest and left palm of my hand. My husband stopped along the road and gave me benadryl. I still had hives the next day. On the third day I had vaginal spotting and I am in menopause and I had extremely bad pain in my left hip, left thigh and left buttocks for 2 weeks. I could not sit or stand up to get relief. I cried with pain and thought I would never recover. I visited a urgent care and he suggested I see a neurologist for the pain. I was tested for covid at that time and was negative. I went to an allergist to see if I am allergic to the PEG in the vaccine. I am not allergic to the compound. She believes my body had a very strong immune response to the vaccine which caused all the symptoms described above. All symptoms were strictly limited to just the left side of my body. I do not know what to do about taking the second dose because I am afraid it will be worse.
58 2021-02-21 injection site pain soreness at injection site. then a mild migraine the following evening.
58 2021-02-22 injection site discolouration, injection site pain Nausea, Diarrhea, Headache (4 weeks), Joint Pain (Ongoing), Injection Site Injury - Skin Discolorati... Read more
Nausea, Diarrhea, Headache (4 weeks), Joint Pain (Ongoing), Injection Site Injury - Skin Discoloration/Scab (On Going), Pain Injection Site (Ongoing)
58 2021-02-22 rash, shingles shingles; Bump on nose; It is painful; broke out in rash/rash under right eye; pretty sick; This is ... Read more
shingles; Bump on nose; It is painful; broke out in rash/rash under right eye; pretty sick; This is a spontaneous report from a contactable nurse (the patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left upper arm on 19Jan2021 at 11:15 to 11:30 (at the age of 58-years-old) as a single dose for Covid-19 immunization. Medical history included COVID-19 in Mar2020 and was reported as recovering (ongoing). The patient's concomitant medications were reported and none. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Feb2021, the patient experienced a bump on her nose and later got a rash under the right eye and broke out in a rash; on 08Feb2021, the patient was diagnosed with shingles; on an unknown date in Feb2021 she experienced she was pretty sick now; not feeling well and it was painful. The patient went to the emergency room about 3:40am on 08Feb2021. The events were considered serious per disabling since she was not able to return to work until blisters were crusted over. Has missed a couple days of work. Her only concern was that it was not in her eye and she was good. Treatment was given for the shingles which included Acyclovir. The clinical outcome of the events herpes zoster, rash, illness, skin disorder and pain was not recovered. The reporter stated she was supposed to get her second dose but cannot now. The reported considered the events herpes zoster, rash, illness, skin disorder and pain related to BNT162B2. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
58 2021-02-23 skin warm Within a few minutes of vaccination, flushing/sweating, throat swelling to a level of discomfort wi... Read more
Within a few minutes of vaccination, flushing/sweating, throat swelling to a level of discomfort with swallowing. I took 1 Benadryl and then another 15 minutes later, then drove home once rxn seemed to stabilize. Took 2 more Benadryl through the course of the evening as flushing stopped but still had throat discomfort and new headache. Also took Tylenol. In AM, allergic symptoms were resolved, but had significant arm pain (upper arm around site was very firm and warm to the touch), mild headache, moderate fatigue, and diarrhea. This continued for another 24 hours. Took Tylenol 3 times. Felt fine by Wednesday (2 days after vaccination).
58 2021-02-23 vaccination site pain, vaccination site swelling had trouble raising her arm; numbness and pain in my left hand/hurts to touch the upper part of that... Read more
had trouble raising her arm; numbness and pain in my left hand/hurts to touch the upper part of that arm; left arm she was vaccinated on was incredibly sore; left arm she was vaccinated on was incredibly sore, swollen; Patient do have autoimmune issues; Patient do have autoimmune issues; numbness and pain in my left hand; getting pins and needless; left wrist is a little swollen; whole arm hurts, including elbow joint, and shoulder joint; headache; chills; maybe slight fever, never took my temperature; body aches all over; kind of muscle weakness in her whole arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 21Jan2021 11:49 at a single dose for COVID-19 immunization. Medical history included fibromyalgia, rheumatoid arthritis, rosacea, periarthritis and frozen shoulder prior a little over a year ago. The patient's concomitant medications were not reported. Patient was vaccinated on Thursday morning, and her left arm she was vaccinated on was incredibly sore, swollen, she has pins and needles, her hand was going numb, she has a lot of pain, and kind of muscle weakness in her whole arm and it hurts to touch her arm still on Jan2021. The initial side effects in her left arm at injection site. The injection site symptoms started within an hour of getting it at 11:49 am on 21Jan2021. Patient received the vaccine and probably around 1pm on 21Jan2021 in the afternoon it was really sore, and had trouble raising her arm, and it hurts to touch the upper part of that arm. The pain was not exactly at the injection point, it's just below, where it hurts. On Jan2021, patient was getting pins and needless and numbness and pain in her left hand. It's like it's swollen, it has that tight swollen feel to it, even though it doesn't look like it, although her left wrist is a little swollen on Jan2021. Her whole arm hurts, including elbow joint, and shoulder joint. Once patient got the vaccine, it all of a sudden exacerbated what ever was going on. She was doing good until she got the injection, and now she feel like,it's gone backwards and has effected the muscles in her arms now. Patient do have autoimmune issues. She also had headache, chills, maybe slight fever, never took my temperature, body aches all over, joints hurt incredibly bad on Jan2021. Most effects were gone away, mostly concerned about the arm. Her concern was the arm. Outcome of the events was unknown. Patient was asking if she can use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. The reporter considered the events non-serious. Information on lot/batch has been requested.
58 2021-02-24 itchy skin 1435- Received vaccine 1437- Pt developed ear and lower leg itching, no other symptoms 1440- Pt was ... Read more
1435- Received vaccine 1437- Pt developed ear and lower leg itching, no other symptoms 1440- Pt was brought back to assessment area. Vitals checked 1450- 142/82 1506- 133/90 Recommend diphenhydramine for symptoms- Pt refused treatment recommendation. Emergency Response Team called to discuss with Pt. Pt signed recommendation refusal form and left clinic.
58 2021-02-25 skin spots, rash macular I saw bright red dots &dot clusters on both legs; Petechiae; This is a spontaneous report from a con... Read more
I saw bright red dots &dot clusters on both legs; Petechiae; This is a spontaneous report from a contactable consumer reported for herself. A 58-years-old female patient (not pregnant at the time of vaccination) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL9262, via an unspecified route of administration on 02Feb2021 13:30 in left arm at single dose for covid-19 immunisation. Medical history included known allergies: Amoxicillin (all penicillin family), she had AT III deficiency (a hereditary blood clotting disorder) that she had been taking warfarin for 23 years never any issues or clots since. she had never had a reaction to any vaccines before. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included warfarin for AT III deficiency and 1 multi vitamin. The patient previously took amoxicillin and experienced allergies. On 02Feb2021 the patient got the vaccine at 1:30pm. At 5:30 pm, she saw bright red dots and dot clusters on both legs (not sure when it started, reported as 02Feb2021 05:00 PM) all dots were under the surface of her skin. They didn't itch nor hurt and were not detectable by touch. She took a few pictures. Next day they were still there and hadn't increased or decreased. The next day Thursday, she went to her PCP Dr (Name) got blood work and results came back normal. He thought it to be petechiae but not sure why. Each day the red dot/clusters turned more purple and within 5-7 days had faded away. Dr. (Name). said if with the second vaccine dose, she got worse dot/clusters that worry her, she was to come back. On 12Feb2021 she had an appt with her hematologist Dr (Name), after discussing and looking at the pictures (knowing that she had never had this before) she said it was not related to her medical condition-AT3 deficiency, it didn't look like petechiae. She said it was a reaction to the vaccine, to report it and get advice from you folks before got the second dose. There was no treatment received. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolved in Feb2021. The events were reported as non-serious by the reporter.
58 2021-02-25 rash rash 30 minutes after COVID #2
58 2021-02-27 injection site swelling, injection site warmth, injection site redness Bright redness, minor swelling, minor warmth at injection site ? not present yesterday
58 2021-02-27 itchy skin, rash Numbness in face 10 minutes after injection. This lasted 15 minutes but has returned intermittently ... Read more
Numbness in face 10 minutes after injection. This lasted 15 minutes but has returned intermittently since vaccination. Intermittently have had some rashes and itching on neck and torso.
58 2021-02-27 injection site rash Rash at site; fever,chills
58 2021-02-28 itchy skin, itchy skin 1/12 11:00 p.m. symptoms began (chills, fever, runny nose, sore throat) - treated with Tylenol, symp... Read more
1/12 11:00 p.m. symptoms began (chills, fever, runny nose, sore throat) - treated with Tylenol, symptoms gone by morning 1/13 headache, fatigue, muscle/body aches lasting 1 day intermittent itchiness lasting 1 week from date of vaccination - treated with Benadryl
58 2021-02-28 injection site rash, hives HIVES AND RASH ALL AROUND VACCINATED AREA ON BACK
58 2021-02-28 itchy skin, injection site mass, rash with redness, skin warm I received my 2nd dose of COVID 19 vaccine at around 1 p Thursday afternoon. Saturday around noon m... Read more
I received my 2nd dose of COVID 19 vaccine at around 1 p Thursday afternoon. Saturday around noon my arm started to itch a little and when I scratched it there was a large hard lump a little bigger than a golf ball under my skin. The skin was mildly rashy in appearance. It was red and warm to the touch. The affected area was approximately 3 inches below the injection site. The lump got smaller on Sunday and is smaller today. It is still red, warm to the touch, and sore when I rub over it. I did not seek medical treatment wanting to observe the area first. Since the lump has gotten smaller I will continue to observe it. I was advised by a friend who is a nurse that if it gets larger to seek medical treatment. That will be my plan.
58 2021-03-01 injection site redness, rash, injection site warmth Broke out it a hot rash the first night. Both my knees exhibited excruciating pain to where it fel... Read more
Broke out it a hot rash the first night. Both my knees exhibited excruciating pain to where it felt I was having knee surgery without anthesis nothing helped with the pain. General aches through out whole body settling in the joints. Fatigue, migraine headache, loss of smell on and off through day. Loss of appetite on and off. Injection site has a large redden area warm to touch approximate size of a silver dollar if not bigger, lymph node under left arm pit is swollen and sensitive to the touch, movement aggravates the arm pit. Evening time body breaks down in an allergic rash.
58 2021-03-02 itchy skin, rash High temp, ache all over, severe headache,, head to toe all over body edema, systemic body rash and ... Read more
High temp, ache all over, severe headache,, head to toe all over body edema, systemic body rash and itching. Took Benadryl and caused elevated b/p. Went to ER and had steroids.
58 2021-03-02 itchy skin Itching everywhere
58 2021-03-02 hair loss Large amounts of hair falling out
58 2021-03-02 rash, hives, itchy skin Swollen tongue, tingling and pain in tongue, difficulty swallowing, heaviness in chest and upper bac... Read more
Swollen tongue, tingling and pain in tongue, difficulty swallowing, heaviness in chest and upper back within 5-10 minutes of injection 1-2 days after, continued tingling, pain, and swelling in tongue, hives/rash on face with itching and difficulty swallowing Benadryl was administered at the testing site. Continued Benadryl with Zyrtec and Pepcid daily for adverse reaction through 3/3/21. Called PCP?have appt 3/4/21.
58 2021-03-02 itchy skin, skin discolouration, skin peeling lip swelling 3 times the normal size, skin peeling to right forearm, both hands itching, swelling of... Read more
lip swelling 3 times the normal size, skin peeling to right forearm, both hands itching, swelling of both hands. unable to grasp with both hands, dark spot in middle of hand.
58 2021-03-02 vaccination site swelling, vaccination site redness slight swelling; arm redness at injection site; chills; fever 103.8; weakness; headache; This is a s... Read more
slight swelling; arm redness at injection site; chills; fever 103.8; weakness; headache; This is a spontaneous report from a contactable other health professional (patient). A 58-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL9262 and expiry date unknown, via unspecified route of administration at the left arm on 28Jan2021 11:15 at single dose for Covid-19 immunization in a hospital. Medical history included high blood pressure, depression, asthma, wheat allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included lisinopril, paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]), cyanocobalamin (VIT B12), ergocalciferol (VIT D); all from unspecified date for unspecified indication. The patient previously took amoxicilin, morphine, vicodin; all experienced drug allergy. Historical vaccine included first dose of BNT162B2 lot number EH9899 at the left arm on 07Jan2021 11:15 AM for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Jan2021 19:00, the patient experienced chills, fever 103.8 (temperature), weakness, headache, until 30Jan2021 6:30 am. Then again, on 30Jan2021 11 pm, the patient experienced fever, chills headache until 6:30 am. On 30Jan2021, the patient experienced arm redness at injection site. On 31Jan2021, the patient continued to experience redness and slight swelling (injection site). The patient has the patient been tested for COVID-19 since the vaccination. The patient did not received treatment for the events. The outcome of the events was recovering. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.
58 2021-03-03 itchy skin Developed generalized pruritis, especially over arms. no visible rashes. spontaneously resolved with... Read more
Developed generalized pruritis, especially over arms. no visible rashes. spontaneously resolved without intervention. no SOB, GI distress. No lightheadedness, lungs clear to auscultation bilaterally. patient advised to follow-up with PCP.
58 2021-03-03 rash Left arm developed a rash: Rash was from her left deltoid to her left wrist. Onset provider evaluate... Read more
Left arm developed a rash: Rash was from her left deltoid to her left wrist. Onset provider evaluated the patient and 50 mg of Diphenhydramine was given orally
58 2021-03-03 injection site pain, rash felt fatigued arm pain at inn site a rash appeared on back of both hands and left side of face al... Read more
felt fatigued arm pain at inn site a rash appeared on back of both hands and left side of face also had elbow joint pain. after a week not improved saw an allergist she recommended topical steroid treatment for hands it has not improved on hands rash on face is faint elbow pain less intense but persists
58 2021-03-04 injection site swelling, injection site pain Brain fog, malaise, fatigue, swelling and pain at injection site. Sore/scratchy throat. Arm pain o... Read more
Brain fog, malaise, fatigue, swelling and pain at injection site. Sore/scratchy throat. Arm pain occurred first. Exhaustion a few hours later and exists two days later. Throat became scratchy and swelling came on the next day. Second day (today) brain fog as evidenced by a lack of energy and poor test taking .
58 2021-03-04 injection site pain Dizzy, nauseous, headache, fatigue, muscle aches, site soreness no redness.
58 2021-03-04 hives Patient developed urticarial rash and some facial swelling. She took oral antihistamines with relief... Read more
Patient developed urticarial rash and some facial swelling. She took oral antihistamines with relief. She was given cetirizine to take after she was examined the day following her vaccine.
58 2021-03-04 shingles herpes zoster recurrence--typical neuropathic pain in right abdominal region. As I'm a physician who... Read more
herpes zoster recurrence--typical neuropathic pain in right abdominal region. As I'm a physician who is immunosuppressed and have experienced this previously and had valtrex on hand, I started it immediately and the pain resolved within three days. No rash developed due to rapid treatment.
58 2021-03-05 rash Rash to chest area (mild) Evaluated by EMS-Cleared
58 2021-03-06 rash macular, itchy skin Patient experienced chest tightness and itching/splotching on right forearm. She was given 50 mg of... Read more
Patient experienced chest tightness and itching/splotching on right forearm. She was given 50 mg of oral liquid diphenhydramine.
58 2021-03-07 injection site mass, injection site pruritus Large (egg size lump at the injection site with itching to hat has lasted until 3//8/2021
58 2021-03-07 rash patient developed a rash that began with Herald spot around 2 weeks after first vaccine - and then f... Read more
patient developed a rash that began with Herald spot around 2 weeks after first vaccine - and then full body rash that has persisted - she believes it may be "inverse pityriasis rosea"
58 2021-03-08 itchy skin My skin around my eyes swelled about 45 mins after vaccine. I had a prickly itchy sensation on my ba... Read more
My skin around my eyes swelled about 45 mins after vaccine. I had a prickly itchy sensation on my back, the back of my neck & under my right arm pit. My throat felt itchy. I took benadryl & the swelling around my eyes went down considerably within a few hours. The itchiness persisted until my 2nd dose of benadryl. When I woke up this morning, I was fine.
58 2021-03-08 injection site pain Patient was given Pfizer Covid vaccine in left arm and immediately said she could feel the injection... Read more
Patient was given Pfizer Covid vaccine in left arm and immediately said she could feel the injection being injected and that it was painful. She then complained of pain around injection site, followed by pain in the neck. She was evaluated by 2 pharmacist and given a cold compress and informed to stay to be monitored for at least 30 minutes. After about 10 minutes she said the pain was no longer in her neck but had traveled to the left side of her back. She showed no other symptoms during the event besides injection site pain, followed by neck pain then back pain. She stayed for about 40 minutes before she said she was feeling fine and left.
58 2021-03-08 rash, rash with redness, itchy rash Red rash on underside of left forearm in the shape of a "P". It itches a little bit.
58 2021-03-08 itchy skin a week after vaccination I have been itching like crazy taking allegra, zyrtec and beneadryl its li... Read more
a week after vaccination I have been itching like crazy taking allegra, zyrtec and beneadryl its like im itching in the inside, no outward rash had to go to ER itching so bad have an appointment with allergist(0even private itching
58 2021-03-09 vaccination site pain Heart palpitations; sore injection site; body aches in the back; headache; This is a spontaneous rep... Read more
Heart palpitations; sore injection site; body aches in the back; headache; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 58-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: 013L20A) via an unspecified route of administration on 05Feb2021 08:45 in left arm at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. There was no other vaccine in four weeks. The patient had heart palpitations after vaccine - only lasting a few seconds, sore injection site and body aches in the back - both of which were relieved with naproxen sodium (ALEVE), small headache - went away shortly after getting out of bed. Event onset date reported as 05Feb2021 12:30. Treatment received for the events. The outcome of the event heart palpitations was recovered on 05Feb2021, of other remain events was recovered in Feb2021.
58 2021-03-09 injection site mass pt came in 3/10 reporting the lump on her left arm. at her injection site. shot was given 3/08 at th... Read more
pt came in 3/10 reporting the lump on her left arm. at her injection site. shot was given 3/08 at the pfizer shot clinic
58 2021-03-10 shingles Developed shingles 10 days after 2nd dose was received. Diagnosed 3/11/2021 and prescribed Famciclo... Read more
Developed shingles 10 days after 2nd dose was received. Diagnosed 3/11/2021 and prescribed Famciclovir @ Dr. office.
58 2021-03-10 hives Dizzy light headless nausea hives around neck arm pain
58 2021-03-10 injection site pain I experienced the following side effects on 02/27/2021: extreme fatigue aches and pains in my joint... Read more
I experienced the following side effects on 02/27/2021: extreme fatigue aches and pains in my joints sore arm at the injection site low grade fever ( I felt warm ) sweating profusely slept a lot bowels were a bit looser than usual I stayed home from work one day.
58 2021-03-10 injection site pain Slight shortness of breath lasting 15-20 minutes occurring 2 hrs. after injection Joint stiffness/... Read more
Slight shortness of breath lasting 15-20 minutes occurring 2 hrs. after injection Joint stiffness/soreness early next morning in limbs, with need to stretch, resulting in muscle soreness, lasted 2 hrs . Subsided after sleeping 1-2 hrs. (Possibly attributable to MEcfs symptoms, similar symptoms in past) Injection site stiffness/soreness during movement, early next morning, lasting 1-2 hrs (same time frame as above). Experienced no side effects with initial injection other than very slight tenderness to touch night of injection
58 2021-03-10 itchy skin Tremors, Itching, Tongue feeling numb,
58 2021-03-11 shingles Constant fatigue since one day post vaccine. Developed shingles 02-10-21.
58 2021-03-11 injection site pain Fever, body aches, fatigue, nausea, soreness at site of vaccine. It lasted approximately 24 hours.
58 2021-03-11 itchy skin Person stated she was itching and felt she was having difficulty breathing. Person was taken to the ... Read more
Person stated she was itching and felt she was having difficulty breathing. Person was taken to the ED for evaluation.
58 2021-03-11 rash macular Pt received vaccine and 10 minutes in reported red blotches on arm and that her "teeth hurt". She wa... Read more
Pt received vaccine and 10 minutes in reported red blotches on arm and that her "teeth hurt". She was moved to an observation area via wheelchair and monitored for 30 minutes. Vitals: 1107 142/112, 98%, HR 69; 1129 159/114, HR 71. Pt reported she did not feel dizzy or have SOB and that her "blood pressure is normally high". Pt left ambulatory from vaccine center to home.
58 2021-03-13 skin warm, rash with redness About 2 days after vaccine my arm developed a red rash, not raised, just within the tissue . Oval in... Read more
About 2 days after vaccine my arm developed a red rash, not raised, just within the tissue . Oval in shape and slight spread down bicep area . Not itchy, but a slight warm as well as slight burning sensation. 5 days later still present but slowly disappearing.
58 2021-03-14 rash 3-9-21 6:39PM HAS RASH TO BOTH ARMS X 10 MIN. 6:40PM BENADRYL 50MG GIVEN PO. NO SOB/DYSPNEA, NO DIFF... Read more
3-9-21 6:39PM HAS RASH TO BOTH ARMS X 10 MIN. 6:40PM BENADRYL 50MG GIVEN PO. NO SOB/DYSPNEA, NO DIFFICULTY SWALLOWING. A/O, PINK, W/D, RESP REG WITH EASE. 6:48PM DECREASED REDNESS NOTED. 6:55PM RASH IS BETTER NOW. HUSBAND HERE TO DRIVE HER HOME. 3-10-21 8AM TC: PT STATES RASH ISGONE ALMOST COMPLETELY NOW AND IS 'FEELING GOOD'.
58 2021-03-14 hives, itchy skin I have a history of acute and delayed allergic reactions to food and drugs. I received Pfizer vacc... Read more
I have a history of acute and delayed allergic reactions to food and drugs. I received Pfizer vaccine at approx. 12:00 Noon on 13MAR2021. I experienced minor lower lip swelling at 9:30 PM (the lower lip, left side only). Went to bed approx. 10:30 PM and experienced mild chills. I woke up at ~3:30 AM with full facial swelling (forehead, brow, eyes, under eyes, facial lines, jowls and full lower lip only - now right side engaged and more pronounced than the left side) and mild full body hives. I took a Zyrtec. The itching of hives subsided in approx. 30 minutes. The facial swelling and lower lip swelling subsided in approx. 12-hours. I took and have photos of my face and lips.
58 2021-03-14 shingles She had symptoms of shingles last Sunday; She noticed burning and tingling on the left side of her h... Read more
She had symptoms of shingles last Sunday; She noticed burning and tingling on the left side of her head; She noticed burning and tingling on the left side of her head; Shingles was reported as worsened; This is a spontaneous report from a contactable consumer (patient herself) via Medical information team. A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL0140) via unknown route of administration on 12Jan2021 14:00 PM at single dose in left arm for COVID-19 immunization at nursing home. Medical history included ongoing high blood pressure. Ongoing concomitant medication included metoprolol orally at 50 mg, once a day taking for 10 years and hydrochlorothiazide orally at 25 mg, once a day taking for 3 years both for high blood pressure, mecobalamin (B12) orally at 1000 ug, once a day taking 6 years for low b, colecalciferol (D3) orally at 100 ug, daily (50mcg; take two daily by mouth) taking for 6 years for low d. Patient received the first dose of the Pfizer covid vaccine on 12Jan2021 and her second dose was scheduled 02Feb2021. She had symptoms of shingles last Sunday on 29Jan2021 and was given famciclovir and was advised to not take the scheduled second dose of the vaccine. The next time that the vaccine will be given in their facility is on 22Feb2021-23Feb2021, and she wants to know if she can get the vaccine despite having shingles. However she came down with shingles. Adds she is being treated with Famciclovir 50mg; take three times daily by mouth. Her doctor recommended she not get the next dose of the Pfizer COVID 19 vaccine on 02Feb2021 so she stayed home and did not get it. Should she get the second dose? She noticed burning and tingling on the left side of her head in Jan2021 and then shingles on 29Jan2021 on the left eyebrow and hairline. Also shingles was reported as worsened in 2021. Adverse events required a visit to physician or ER was reported as Urgent care but not to the hospital. No Prior Vaccinations (within 4 weeks). The outcome of events shingles and condition worsened was not recovered, while for other events was unknown. No follow-up attempts are possible. No further information is expected.
58 2021-03-15 itchy skin, redness FACE AND THORAX REDNESS AND PRURITUS.
58 2021-03-15 rash Hypersensitivity and rash under left arm pit and down left side of back
58 2021-03-15 injection site pain The adverse event occurred the next morning when the pain from the injection sight on the left upper... Read more
The adverse event occurred the next morning when the pain from the injection sight on the left upper arm felt like it moved into my armpit and left side lymph nodes. Very painful accompanied it. The day after that the lymph nodes in my left collarbone area became swollen and painful with an increased fever, chills, headache that lasted for a week. I got the vaccine on a Thursday (3/4/21) and went to my doctor on Monday (3/8/21) to get checked out. This was only my first vaccine. I had a bad case of Covid-19 in June-July 2020 and my husband passed from Covid-19 at that time. I still have swelling in my left collarbone lymph nodes today.
58 2021-03-16 injection site pain I few hours after I received a shot my arm hurt, within 12 hours right above where I received a shot... Read more
I few hours after I received a shot my arm hurt, within 12 hours right above where I received a shot waas incredibly painful. I took Tylenol ,it subsided it has continued to hurt since then. If I touch the spot above my shot it hurts worse. When I received a shot it did hurt when she stuck me, but I do have upper arm muscles .I am in shape, no fat on my arm. Some wondering if injecting it into my muscle is the reason why my arm hurts so bad. I compared notes with my friend whose 40 also in shape and his arm hurts like heck also.
58 2021-03-16 rash with redness, rash Numbness in face, neck and mouth. Red Rash on face and neck. Dizzy.
58 2021-03-16 rash, rash vesicular Pt called to have VV when she noticed a blistering rash on her L thigh. Not classic but rash looks ... Read more
Pt called to have VV when she noticed a blistering rash on her L thigh. Not classic but rash looks most c/w shingles.
58 2021-03-16 injection site pain, rash Rash developed on face and neck. Severe arm pain at the injection site. Papule development.
58 2021-03-16 injection site pain, injection site swelling SEVERE RIGHT ARM PAIN AND INTO SHOULDER. SWELLING AT INJECTION SITE. PAIN TO EVEN TOUCH MY ARM AT ... Read more
SEVERE RIGHT ARM PAIN AND INTO SHOULDER. SWELLING AT INJECTION SITE. PAIN TO EVEN TOUCH MY ARM AT SITE.
58 2021-03-16 skin burning sensation Swelling, pain, burning sensations under skin, sore/tight muscles, headache, nausea, irritability, t... Read more
Swelling, pain, burning sensations under skin, sore/tight muscles, headache, nausea, irritability, tired
58 2021-03-17 itchy skin Chest pain, shortness of breath, pain in the left arm, joints , head and neck. She also had itching ... Read more
Chest pain, shortness of breath, pain in the left arm, joints , head and neck. She also had itching all over, as well as a sore throat. She did not go to the ER. She treated symptoms with Tylenol. Symptoms were intermittent and lasted 2 weeks
58 2021-03-17 rash macular, rash Within 10 minutes of taking shot, I had an allergy attack - my nose became stuffy and was hard to br... Read more
Within 10 minutes of taking shot, I had an allergy attack - my nose became stuffy and was hard to breathe. Medic came to my car to assist. Told me to keep window down and take deep slow breathes. This worked, but maybe to minutes later it happened again. My blood pressure and oxygen level was taken. I was given a banana to eat. I ended up calling my husband to pick me up. On the evening of Sunday 3/14, I noticed a red patch on my chest. Monday, 3/15 when I woke up, red patches were on my arms, hands , neck and face. Tuesday, 3/16 the red patches had spread up my arm and my eyes were puffy. I went back to the vaccination site and reported it to a medic. I was told to take Benadryl. Wednesday, 3/17 my right eye was swollen more and puffiness under my eye. My left eye was swollen but not as much. I went to clinic and was given Benadryl and prednisone, and told to go to the emergency room if it gets worse. Today 3/18 blotches still on arms, hands, neck and chest. Swelling on right eye lid has gone down some.
58 2021-03-18 itchy skin Patient complains of extreme joint pain and states the inside of her stomach is itchy. Symptoms reli... Read more
Patient complains of extreme joint pain and states the inside of her stomach is itchy. Symptoms relieved with ice and peppermint oil
58 2021-03-18 itchy skin, rash arm sore to touch; swollen/puffed up underneath her arm, thinks is a swollen lymph node; swollen/pu... Read more
arm sore to touch; swollen/puffed up underneath her arm, thinks is a swollen lymph node; swollen/puffed up underneath her arm, thinks is a swollen lymph node; Itchy; restless; seems like she has a rash in her upper chest neck area, neckline; This is a spontaneous report from a contactable consumer (patient) and a contactable physician. A 58-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EK9231) via an Intramuscular route of administration on 27Jan2021 at single dose on left arm for covid-19 immunization. The patient medical history included allergies. The patient concomitant medications were not reported. On 27Jan2021, in evening patient was really restless that night because she was itchy. Physician stated that patient has been experiencing some itching, but it seems like she has a rash in her upper chest neck area, neckline. The itching/rash has stayed the same so far. On 28Jan2021, next day morning It was really sore to touch, like when patient was putting deodorant on, its all puffed out underneath her arm that she had the vaccine administer in. It's swollen, but patient thinks its her lymph node. It doesn't feel like its effected any other one, but just that one lymph node. The outcome of the event Itchy, rash was not recovered while outcome of rest all events was unknown.
58 2021-03-18 hives, itchy skin hives, itching, facial swelling. woke up next morning after vaccine with just one or two hives, prog... Read more
hives, itching, facial swelling. woke up next morning after vaccine with just one or two hives, progressed by evening of that day, lips swelled and were numb feeling, felt like a lump in my throat, throat felt swollen but no pain or difficulty breathing. Took 2 Benadyl(generic) at 9:30pm and again at 3:30am
58 2021-03-19 hives Shot at 2 pm, immediate pain in left side of neck and headache on left side of head. 4 pm got hives.... Read more
Shot at 2 pm, immediate pain in left side of neck and headache on left side of head. 4 pm got hives. 7 pm chest tightness. 8 pm trouble breathing, so went to ER. Had an EKG and other heart related tests. Had blood work and chest xray. Gave Benadryl. Had taken Pepcid at 4 pm
58 2021-03-20 rash with redness Severe red rash and swelling on right side of the of my face/Spreading gradually to other areas of m... Read more
Severe red rash and swelling on right side of the of my face/Spreading gradually to other areas of my face and scalp; Severe red rash and swelling on right side of the of my face; extremely tender and hot to the touch/ very painful; Extremely tender and hot to the touch; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9265), via an unspecified route of administration in left arm at the age of 58-years (non-pregnant at the time of vaccination), on 10Feb2021 at 08:30 AM at single dose (dose number: 1) for COVID-19 immunization. The patient's medical history included alopecia areata and allergy to Xatham gum. Concomitant medication included valsartan at 160 mg. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received any other vaccines within 4 weeks prior to the COVID vaccine was reported as no. It was reported that on 10Feb2021 at 03:00 PM, "severe red rash and swelling on right side of my face. Extremely tender and hot to the touch. Spreading gradually to other areas of my face and scalp. Very painful". The adverse events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received diphenhydramine (BENADRYL) and 20 mg prednisone for 5 days and paracetamol (TYLENOL) as treatment for the events. The outcome of the events was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
58 2021-03-20 blister Shingles like blisters on torso
58 2021-03-20 hives hives; This is a spontaneous report from a contactable Other HCP (patient). A 58-year-old female pat... Read more
hives; This is a spontaneous report from a contactable Other HCP (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number: EL1283 and EL9261) via an unspecified route of administration on 14Jan2021, 02:45 AM and 04Feb2021, 02:45 AM at single dose in the left arm for COVID-19 immunization. The patient's medical history included allergy of Bac-trim. Concomitant medications was not reported. It was reported that the patient had not received other vaccine in four weeks and had received other medications in two weeks. The patient was not tested for Covid prior vaccination. The patient was not tested for Covid-19 post vaccination. The patient experienced hives for 24 hours 10 days after the first dose and hives for 48 hours, 3 days after the second dose which was on 07Feb2021. Treatment medications included loratadine and hydrocortizone cream. The outcome of the event was recovering.
58 2021-03-21 itchy skin, hives 3/19/21 Patient called Health Department to report an allergic reaction to her vaccination with Pfiz... Read more
3/19/21 Patient called Health Department to report an allergic reaction to her vaccination with Pfizer COVID vaccine on 3/17/21. She attended the Vaccination Clinic. Her appointment was at 1:35 PM. She states she had no symptoms that day. However, she woke up on 3/18/21 with two small hives in groin area which were itchy. By late afternoon her lips became tingly and she developed itchy hives on her arms which then spread to her trunk. By evening her lips with swollen. She took 2 tabs of Benadryl at 9:30 PM and went to bed. She woke up at 3:00 AM with her lips doubled in size and she felt like there was something stuck in her throat. She took two more tabs of Benadryl and went back to bed. She woke up on 3/20/21 with her throat feeling better and no more swelling of the lips. However, the hives remained spread over her arms and trunk. She called her PCP (who she had not seen in eight years) to report her allergic response and they did not want to see her in the office but encouraged her to go to ER or Urgent Care. Patient stated that she felt better by then and did not go to ER or Urgent Care. RN encouraged patient to go to Urgent Care due to seriousness of the original allergic response. Patient instructed to go to ER if symptoms such as the swollen lips or difficulty swallowing resume as they are more severe allergic signs and may require more urgent medical care. Patient verbalized understanding. Patient also encouraged to follow up with PCP and get a referral for allergy testing as appropriate. Patient states she will follow up with physician prior to her next dose of the Pfizer vaccine in 21 days. Patient also states that she has filled out a VAERS report of her own (Report # 366931).
58 2021-03-21 redness, rash macular As I was driving home my face started to burn like a bad sunburn. When I got home my face was blotc... Read more
As I was driving home my face started to burn like a bad sunburn. When I got home my face was blotchy and my eyes started to swell. I took benedryl and applied a cool pack. Redness and swelling around mybeyes lasted for 2+ days. Still not feeling well and have scheduled a doctor appointment for tomorrow.
58 2021-03-21 rash Cough, short of breath, rash
58 2021-03-21 injection site warmth, injection site pruritus I had intense itching and heat at injection site. Delayed onset and lasted for five days.
58 2021-03-21 vaccination site pain sore arm at site of injection; This is a spontaneous report from a contactable consumer. A 58-year-o... Read more
sore arm at site of injection; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 17Feb2021 13:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included dupuytren's contracture, and allergies: Latex. Concomitant medications included acetaminophen; and colecalciferol (VITAMIN D 3); taken for unspecified indications, start and stop dates were not reported. The patient experienced sore arm at site of injection on 17Feb2021 17:00. The patient did not receive treatment for the event. The outcome of the event was recovering. Information on the lot/batch number has been requested.
58 2021-03-22 hives, itchy skin Hives, extremely itchy
58 2021-03-22 injection site pain I sat, clinician stood. Shot felt weird when it happened - Deep, numb feeling but no feeling of bein... Read more
I sat, clinician stood. Shot felt weird when it happened - Deep, numb feeling but no feeling of being pricked by needle. Seemed to take a little longer than expected. (I had seen my dad get his and counted to 3 each time and I kept counting with mine, not sure when it was over.) I felt that the injection was too high on my shoulder and told clinician this after. I said it felt weird. She said I should feel stinging and that it went into the muscle. I never felt a stinging. After 15 minutes, I asked a different worker if the injection was too high and she said 2 or 3 fingers was appropriate and that it seemed okay. (Injection looks to be at about where the third finger would be from my shoulder bone. It is higher than I have had shots before. There was a little discomfort but real pain set in about two hours later and has continued. Upper and forearm pain. Tried a heating pad. Holding arm still. it doesn't hurt but does feel sore. Movement means sharp pain, especially in the upper arm. Would like to take Ibuprofen but not sure if it will hurt vaccine's effectiveness.
58 2021-03-22 injection site numbness, injection site pain Patient received first dose Pzifer vaccine on 3/2/21. On 3/6/21, patient went to emergency room with... Read more
Patient received first dose Pzifer vaccine on 3/2/21. On 3/6/21, patient went to emergency room with right side body numbness, wheezing, and high anxiety. She was given nebulizer treatment , prednisone, and an albuterol inhaler. She was tested for covid and flu, and both were negative. She also states that since her dose, she has had "covid arm", which consists of pain at the injection site and hand/lower arm numbness.
58 2021-03-22 redness Patient reported muscle spasms starting 3/14/21 in evening, on 3/17 patient reported a red spreading... Read more
Patient reported muscle spasms starting 3/14/21 in evening, on 3/17 patient reported a red spreading area on arm below the site of injection. Patient sought medical help that day and initial diagnosis was possible cellulitis.
58 2021-03-22 rash Rash over upper torso, both arms and upper back
58 2021-03-22 injection site redness, injection site pruritus Red at injection site and itching, not painful unless touched directly
58 2021-03-23 shingles Shingles
58 2021-03-23 injection site swelling, injection site pain, injection site bruising Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Swelling at Injectio... Read more
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: the only rxn was swelling at injection site and bruising no other symptoms
58 2021-03-24 rash macular, hives, itchy skin Client reported feeling flushed shortly after being vaccinated. Described itchy "red blotches", hiv... Read more
Client reported feeling flushed shortly after being vaccinated. Described itchy "red blotches", hives on face and chest. Client with hx of Lupus and multiple allergies to various medications. Client stated hives resolved after taking Benedryl. Client with no other symptoms or complaints at this time.
58 2021-03-24 rash Rash all over body, body aches, teeth hurting Right leg numbness tingling swelling pain From day ... Read more
Rash all over body, body aches, teeth hurting Right leg numbness tingling swelling pain From day one
58 2021-03-24 rash Rash on face and body, burning sensation and hot flashes: began the evening after shot and mostly re... Read more
Rash on face and body, burning sensation and hot flashes: began the evening after shot and mostly resolved by day 4, took Benadryl Mild shortness of breath: began the evening after shot and only lasted 24 hours Severe nausea and diarrhea: developed that evening and better by day 4
58 2021-03-24 itchy skin Situation: Pt here for covid vaccine #2. After vaccination pt experienced reaction. Background: ... Read more
Situation: Pt here for covid vaccine #2. After vaccination pt experienced reaction. Background: @ 0815 TEAM ALERT was called to covid vaccine clinic. This RN arrived @ 0818 to find pt sitting in chair in observation room. Received report from RN, pt received covid vaccine #2 and began experiencing cough, clearing throat, runny nose, and chills. Benadryl 25mg PO given @ 0810. Overall discomfort 1/10. 0818: VS: BP 132/98. HR 63. R 14. O2 Sat 98%. Pt c/o clearing throat, chills, coughing, itchy throat, itchy chest. Pt alert & oriented. 0820: overall discomfort 3/10. 0828: VS: BP 124/92. HR 63. O2 Sat 100%. Still experiencing above symptoms plus dizzines, lip numbness and discomfort in diaphragm region. "feels like it won't go down. Like something is stuck there." pt moved to gurney in hallway. 0842: VS: BP 122/86. HR 63. O2 Sat 100%. Pt still feeling diaphragm discomfort. States other symptoms are resolving. Noted pt no longer clearing throat. States lip numbness improved and diaphragm discomfort improving. Pt alert & oriented. 0855: Manager, spoke to pt. Advised pt she may go home when she feels okay. Pt states she feels well enough to go home. This RN advised pt to go home and relax for the remainder of the day, benadryl will make her feel sleepy. Advised pt to watch for symptoms of shortness of breath, difficulty breathing, and chest pain and go to ED if she experiences any of those symptoms. Pt verbalized understanding. VS: BP 118/72. HR 63. O2 Sat 100%. 0857: Pt left covid vaccine clinic ambulatory in stable condition. COVID Vaccine Worksheet 1. Did the patient have an immediate allergic reaction of any severity such as urticaria, angioedema, respiratory distress, or anaphylaxis (<4 hours following administration of the COVID vaccine)? Yes 2. Did the patient previously have an immediate allergic reaction of any severity to polysorbate or polyethylene glycol? No 3. Has the patient had prior anaphylactic reactions from another vaccine, medication or any other cause? No 4. Did the patient have an allergic reaction >4 hours after administration? OR have an expected side effect of the COVID vaccine? No Assessment: Pt had reaction to covid vaccine. Pt reported previous reaction to first dose with similar symptoms. After close observation and benadryl 25mg PO pt symptoms resolved and pt was able to leave clinic ambulatory in stable condition.
58 2021-03-24 itchy skin Within 2 or 3 minutes my left arm was itching, within 10 minutes my head, chest and other arm were i... Read more
Within 2 or 3 minutes my left arm was itching, within 10 minutes my head, chest and other arm were itching. I got lightheaded and for an instant felt like I was going to black out but didn't, in 15 mins my entire body was itching. I was given 1 Benedryl capsule orally and told to wait 15 more mins. The itching kept spreading, I started feeling like I was going into an asthma attack. They had me wait 15 more mins. It seemed to stop getting worse as quickly. They gave me another Benedryl and I left since I did have an Epi-pen with me. I got home and took another Benedryl about an hour later and about every 6 hours. I got up the next morning and felt horrible and was still itching so took more Benedryl. Tuesday night it felt like it was getting a little better but felt like I was having a slight asthma attack but my inhaler wasn't helping. On Friday I went to my family doctor and was put on a short dose of Prednisone, 20 mg twice a day for 5 days. It did help. Since I've gotten the shot, when I eat it's like my stomach bloats up and diarrhea and generally don't feel like myself. I was really tired until I got on the Prednisone. Each day I feel more like myself but not back to 100% yet. I started taking my Brio again to see if it would help.
58 2021-03-25 rash macular After receiving her vaccine client stated she has a red spot on her right lower arm. BP 130/78, HR ... Read more
After receiving her vaccine client stated she has a red spot on her right lower arm. BP 130/78, HR 87, O2 Sat 97%. Client states she feels better Client discharged home.
58 2021-03-25 skin peeling, redness Breast swollen, red and hot to the touch. This is the area where I previously had radiation. Area ... Read more
Breast swollen, red and hot to the touch. This is the area where I previously had radiation. Area where lymph nodes were removed were sore and tender
58 2021-03-25 injection site swelling Dizziness Bad Head ache Body pain Inability to lift my arm to his full extension without pain In... Read more
Dizziness Bad Head ache Body pain Inability to lift my arm to his full extension without pain Injection Site swelling
58 2021-03-25 pain of skin Fever 102+, headache, stomache ache, ear ache, body and muscle pain, skin hurt, chills, muscle pain
58 2021-03-25 injection site pain Headache, Congestion, Stuffy nose, Ear ache, Left Auxilia Swollen - Can not bring arm down Pain on l... Read more
Headache, Congestion, Stuffy nose, Ear ache, Left Auxilia Swollen - Can not bring arm down Pain on left arm injection site
58 2021-03-25 itchy skin On Wednesday morning I had slightly raised skin in the small of my back and itching. This went away ... Read more
On Wednesday morning I had slightly raised skin in the small of my back and itching. This went away in a day. However, i continue to get raised spots on my chest that sre moderately itchy. I also had a spot on my right jaw that got itchy but no raised skin...i think right over a lymph node mid-jaw on right.
58 2021-03-25 injection site pain Soreness/dull pain at injection site (left arm) on day of vaccine (Saturday 3/20), soreness continue... Read more
Soreness/dull pain at injection site (left arm) on day of vaccine (Saturday 3/20), soreness continued on Sunday and Monday (3/21 and 3/22) and then started to subside. Almost no soreness on Tuesday and Wednesday (3/23 and 3/24). Thursday evening (3/25) it started to feel sore/painful again and has continued through Friday (3/26), six days after vaccine injection. Discomfort is about the same level as the day after getting the vaccine.
58 2021-03-26 injection site pain Injection site pain, tiredness, severe headache for two days, muscle pain, chills, joint pain, low g... Read more
Injection site pain, tiredness, severe headache for two days, muscle pain, chills, joint pain, low grade fever, mild nausea
58 2021-03-27 hardening Arm, neck and shoulder felt very tight and hard as a rock. Had chills and body aches.
58 2021-03-27 itchy skin, hives Hives, swelling, itching started at 10:15am.
58 2021-03-27 rash Patient had 30 minute observation period and departed. Returned approximately 15 minutes later (45 m... Read more
Patient had 30 minute observation period and departed. Returned approximately 15 minutes later (45 minutes after vaccine) c/o rash on back, chest and legs. No angioedema, lungs cear 16:15BP 194/116 P101 R 19 O2 100% Benedryl 50mg Transfer to EMS, to ED.
58 2021-03-27 rash, rash vesicular Pt. showed up with rash outbreak, appears to be shingles but she states she has never had a shingles... Read more
Pt. showed up with rash outbreak, appears to be shingles but she states she has never had a shingles outbreak before, all along the L side of her body, vesicular rash along dermatomes.
58 2021-03-27 itchy skin itching, oral Benadryl 25 mg administered by NP, ice pack, observation, discharged 10:59 resolution ... Read more
itching, oral Benadryl 25 mg administered by NP, ice pack, observation, discharged 10:59 resolution of sympt. by NP
58 2021-03-28 injection site pain First dose was only pain at the injection site. During the 2nd dose injection, the needle became di... Read more
First dose was only pain at the injection site. During the 2nd dose injection, the needle became disattached from the syringe during the injection process. The needle stayed in my arm and had to be pulled out manually. There was no way to note how much of the vaccine was actually delivered. I am, however confident that I received enough of the dosage to cause me some uncomfortable side effects starting within 12 hours. I had a low grade fever, chills and a pretty significant headache that lasted about 18 hours. After that point, I took an alleve and the symptoms resolved within an hour. These are all typical side effects so I wasn't going to fill this form out, but I have noticed something unusual that I haven't seen much about. My taste is way off. I am now 5 days out from my 2nd vaccine and still nothing tastes right. Not bad or like anything specifically, it's just that nothing has any flavor. I can still smell just fine and can minimally taste my food but it just doesn't taste normal.
58 2021-03-28 redness, rash, itchy skin pt states that her ears started itching and became red. She noticed her back, legs, and arms were r... Read more
pt states that her ears started itching and became red. She noticed her back, legs, and arms were red and very itchy. She says her skins is raised like a rash. Her voice became strange and she lips were swollen. She went to bed and when she got up her lips were more swollen. She took Benadryl for her symptoms and went back to bed. She says she has some itching but feels like she seems to be improving.
58 2021-03-28 itchy skin slight neuropathy in fingers; Very itchy - almost painful itchy zings in my elbow area, face and leg... Read more
slight neuropathy in fingers; Very itchy - almost painful itchy zings in my elbow area, face and legs; Very itchy - almost painful itchy zings in my elbow area, face and legs; Very itchy - almost painful itchy zings in my elbow area, face and legs; Very itchy - almost painful itchy zings in my elbow area, face and legs; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 13Mar2021 11:15 (Batch/Lot Number: EN6203) as single dose for covid-19 immunisation at a Pharmacy or Drug Store. The patient has no medical history. The patient has no Covid prior to vaccination. The patient had other medications in two weeks but no other vaccine in four weeks. On 13Mar2021 11:30, the patient experienced very itchy, almost painful itchy zings in her elbow area, face, and legs. The patient also had some slight neuropathy in fingers. This has continued for three days and started immediately after receiving the vaccine. The patient was not tested for Covid post vaccination. The events were not treated. The outcome of the events was not recovered.
58 2021-03-30 vaccination site pain Pain at injection site; This is a spontaneous report from a contactable consumer reported for hersel... Read more
Pain at injection site; This is a spontaneous report from a contactable consumer reported for herself. This 58-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El3247) via an unspecified route of administration in the left arm on 01Mar2021 02:45 PM at 58 years old at single dose for COVID-19 immunisation. Medical history was unknown. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included daily vitamins received within 2 weeks of vaccination. The patient experienced pain at injection site on 02Mar2021 at 12:00 PM. No treatment was received for the adverse event. Since the vaccination, the patient had not been tested for COVID-19. The patient had no covid prior vaccination, no covid tested post vaccination. Outcome of the event was recovered. Seriousness was reported as non-serious.
58 2021-03-30 vaccination site pain Pain at injection site; severe headache soon after injection; severe lower back pain; This is a spon... Read more
Pain at injection site; severe headache soon after injection; severe lower back pain; This is a spontaneous report from a contactable consumer (patient). A 58-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route of administration, administered in Arm Right on 08Feb2021 14:45 (Batch/Lot Number: EL3248) as single dose for covid-19 immunisation. Medical history included Diabetes and asthma from an unknown date and unknown if ongoing. The patient received unknown concomitant medication. The patient previously took BNT162B2 (Lot number: EL3248) on 19Jan2021 at 02:45 PM administered in Right arm for covid-19 immunisation and also patient took DEMEROL and experienced drug Allergies. The patient experienced pain at injection site, severe headache soon after injection and severe lower back pain on 08Feb2021 15:00. The patient did not received COVID tested post vaccination and COVID prior vaccination. The patient did not received treatment for the events. The outcome of the events was reported as recovering.
58 2021-04-09 redness developed acute delirium; redness in arm; Right arm swelling; After that very wild, I was screaming.... Read more
developed acute delirium; redness in arm; Right arm swelling; After that very wild, I was screaming. Very scary. My memory was gone; she passed out at home; she is very depressed has anxiety; she is very depressed has anxiety; panic attack; gained 16 pounds; vomited; loss of appetite; body ache/pain; This is a spontaneous report from a contactable Other HCP (patient). A 58-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: NN6206 and expiration date: Not available), via an unspecified route of administration in the right arm on 04Mar2021 12:00 as a single dose for COVID-19 immunisation. Medical history included removed brain tumor, she has sciatic nerve damage on left arm and left leg and is paralyzed, coma, chronic body aches, seizures, bad vision, high blood pressure and three brain surgery, short term memory. The patients historical vaccine included Flu vaccine injection in right arm deltoid muscle. The patient's concomitant medications included Oxycodone (5mg three times a day tablet) been taking for 3 years since she has brain tumor removed and for chronic body aches and Lyrica. On an unknown date, the patient gained 16 pounds. In Mar2021, the patient experienced she passed out at home and she was very depressed, anxiety, panic attack, body ache/pain, vomited and loss of appetite. On 04Mar2021, the patient experienced right arm swelling, screaming, scary, memory was gone. On an unknown date, she experienced developed acute delirium. On 06Mar2021, the patient had redness in arm. The patient was in the hospital for 4 days and was admitted on 14Mar2021. Her memory came back little by little and side effect of vaccine it says that if she had side effects from first one do not take second dose because it is worse and she is scared to be admitted to the hospital and does not want to experience that again. She was taking pain medication and did not tell her she cannot take Tylenol of course with body aches they did not tell her. It was not specific acute delirium it is a psychiatric disorder and she was wild and has never been like that before, she was tied up to the bed. The reporter states that she is disabled. She has bad vision and she is by herself at home. She is 5 1/2 already going down. She is not going to get the second one until get report results because it is ridiculous, and she is very nervous as she was admitted at night to the hospital. Body ache happened 24 to 36 hours after vaccine not that severely unusual as it went away, and she has a chronic illness and is in a wheelchair from chronic pain. Reporter stated she could not swallow liquid or eat food and she was scheduled for a cat scan, but she could not go since she has been on the phone with Pfizer to get truth and fairness. Reporter stated yesterday this started getting better. Reporter stated was discharged from hospital last Tuesday but had pain at home. Developed acute delirium: stated when she woke up in the ER the next day in few hours she was admitted and in the ER she was crazy and tried running even though she cannot run because she is paralyzed and she did not remember nothing. Reporter stated no she did not get it that when she was discharged, it had been 48 hours. Pain started 48 hours after the vaccine. She has chronic pain the pain is not that excruciating, and it has stopped. She could not remember what happened but just knew it was redness and hurt a lot. Her memory and everything came back. States she had MMR (as provided by Reporter ) done, because of pain in her whole body and everything came back negative. She had terrible pain, she asked to be given pain medication, and was given pain medication. Reporter stated it disappeared about one week now it disappeared and has recovered completely. Reporter stated black and blue inflammation and it does not hurt and the pain it went away. She was discharged from the hospital and discharge paper said second vaccine on 26Mar2021. She has been taking Oxycodone pain medication, reporter thinks she even got a higher dose since the pain was excruciating. The patient did not take any vaccines with 4 weeks. No Relevant Tests were performed. While providing an AE for the COVID vaccine she took Tylenol and Motrin as treatment, on top of it, but the pain didn't go away. She has been taking Oxycodone pain medication, reporter thinks she even got a higher dose since the pain was excruciating. The clinical outcome of events gained 16 pounds, passed out at home, depressed, anxiety, panic attack, body ache/pain, vomited and loss of appetite, right arm swelling, screaming, scary, developed acute delirium, redness in arm was unknown whereas of memory gone it was recovering/resolving.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events peripheral swelling, amnesia, delirium, loss of consciousness, depression, anxiety, panic attack, and erythema and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
58 2021-04-14 injection site pain, injection site swelling, injection site redness After first dose, pt had persistent L deltoid pain. Within 24h after second dose, she had fever and ... Read more
After first dose, pt had persistent L deltoid pain. Within 24h after second dose, she had fever and worsening redness and swelling of the L deltoid. She eventually was admitted and found to have a sub deltoid bursitis that required incision and drainage. Fluid was inflammatory but cultures off of antibiotics remained negative.
58 2021-04-17 shingles Shingles; This is a spontaneous report from a contactable consumer or other non-health care professi... Read more
Shingles; This is a spontaneous report from a contactable consumer or other non-health care professional. A 58-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6204) via an unspecified route of administration on 17Mar2021 as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included Metoprolol, Atorvastatin, Gabapentin, Ondansetron, Norco; thrice a day, Cymbalta, Topiramate; 100mg and Zantac; 50mg. On 20Mar2021, patient experienced shingles. Patient contacted her Primary Care Physician, he confirmed it and patient was given Prednisone and Acyclovir as treatment. Patient was due to have second dose on 7April at 3 o'clock. Outcome of the events was unknown. No follow attempts are needed. No further information is expected
58 2021-04-21 injection site pain Headache, stiff neck, body aches, stiff and sore arm (injection arm) , fatigue began 4 hours after i... Read more
Headache, stiff neck, body aches, stiff and sore arm (injection arm) , fatigue began 4 hours after injection and lasted 2 days following injection.
58 2021-04-24 itchy skin Hard to swallow; Voice went hoarse; Scalp itched/ Insider ear canals itched; face went numb; This is... Read more
Hard to swallow; Voice went hoarse; Scalp itched/ Insider ear canals itched; face went numb; This is a follow-up spontaneous report received from a contactable consumer (patient). A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 intramuscularly, administered in left arm on 24Feb2021(at the age of 58 years old) at 16:15 (Batch/Lot Number: EM9809) as a single dose for COVID-19 immunization. Medical history included ongoing asthma (10 years) and ongoing fibromyalgia (40 years). Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.The patient previously received dose 1 of BNT162B2 intramuscularly in the left arm on 03Feb2024 at 16:00 (Batch/Lot number: EL9262) and 1 hr. after dose, tongue, lips and cheeks went numb. Last 30 min went away (recovered same day). On 24Feb2021, 5min after 2nd dose, her face went numb, it was hard to swallow, her voice went hoarse, her scalp itched, and inside inside ear canals itched. She called over paramedics who monitored me for an hour. The events did not get worse and she went home. After 2 and half hours passed since getting the vaccine, all events resolved (on 24Feb2021) except itch (not recovered). She took Benedryl and woke up fine. The patient assessed the Pfizer product had a causal attribution to the events. The reporter assessed the events as medically important. No follow-up attempts are possible. No further information is expected.
58 2021-04-24 hives, itchy skin Shortness of breath; itching; hives; face swollen; This is a spontaneous report from a contactable c... Read more
Shortness of breath; itching; hives; face swollen; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered on the left arm on 26Mar2021 09:45 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included thyroid disease, HBP (high blood pressure), mild depression, ADD (attention deficit hyperactivity disorder), and migraines. Patient was not pregnant. There no other vaccine in four weeks. Other medication were taken in two weeks. The patient previously took sumatriptan (IMITREX) and zolmitriptan (ZOMIG) and experienced allergy. The patient experienced shortness of breath, itching/hives, face swollen on 27Mar2021 14:00 that resulted in clinic/ emergency room visit. Patient was given IV steroid, Benadry, Prilosec at hospital. Patient was not diagnosed with covid prior to vaccination and had been tested (nasal swab) post vaccination on 28Mar2021 with negative result. Outcome of the events was recovered with sequel.
58 2021-04-26 injection site pain Minimum soreness around injection site; Some chills; muscle ache; This is a spontaneous report from ... Read more
Minimum soreness around injection site; Some chills; muscle ache; This is a spontaneous report from a contactable consumer (Patient) self-reporting. A 58-year-old female patient (who was not pregnant at the time of vaccination), received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: BNT162), via an unspecified route of administration, administered in Arm Right on 23Feb2021 as SINGLE DOSE for covid-19 immunisation. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. The patient medical history and concomitant medications were not reported. On 24Feb2021 the patient experienced minimum soreness around injection site, some chills and muscle ache. The outcome of the event was recovered.
58 2021-04-27 itchy skin after vaccine working arm, all blood in head rushed to feet, lightheadedness, felt like she was goin... Read more
after vaccine working arm, all blood in head rushed to feet, lightheadedness, felt like she was going to drop or die, tremors, body felt like it was growing fur, lymph nodes under tongue, fingers, toes, started to swell.teeth chattering, restless legs, itching legs, sugar swings
58 2021-04-28 vaccination site pain a big jolt immediately following in my heart/My heart feels sore off and on; shot was put in my arm ... Read more
a big jolt immediately following in my heart/My heart feels sore off and on; shot was put in my arm with some force and I felt a jolt in my arm; fatigue; body aches; coughing; headache; This is a spontaneous report from a contactable Other Health Professional (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 58 years of age), dose 2 via an unspecified route of administration, administered in arm left on 13Apr2021 15:15 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included high cholesterol, exercise-induced asthma and penicillin allergy. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]), montelukast sodium (SINGULAIR), fluticasone propionate, salmeterol xinafoate (ADVAIR), estradiol and progesterone, all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 dose 1 in the left arm on 23Mar2021 04:00 PM (at 58 years of age) for COVID-19 immunisation. The patient was not pregnant. The patient had no other vaccine in four weeks prior to covid vaccine. The patient had no covid prior vaccination. She has not been tested for Covid post vaccination. The patient reported that the shot was put in the arm with some force and she felt a jolt in her arm and a big jolt immediately following in her heart. She mentioned that her heart felt sore off and on in that spot the following day 14Apr2021. No other unusual symptoms just the expected ones including fatigue, body aches and some coughing and headache. The events started on 13Apr2021 15:30 with outcome of recovering. The patient did not receive any treatment for the events. Information about the Lot/batch number has been requested.; Sender's Comments: Based on the available information, and on a plausible temporal association, the Company considered that a reasonable possibility could not be completely excluded that the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) contributed to the occurrence of the reported event Big jolt immediately following in my heart. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
58 2021-04-30 vaccination site redness, vaccination site warmth, vaccination site swelling, vaccination site pain A-Fib; The Pfizer covid vaccine made her heart worse; anxiety; injection site was swollen, red, and ... Read more
A-Fib; The Pfizer covid vaccine made her heart worse; anxiety; injection site was swollen, red, and warm to the touch; injection site was swollen, red, and warm to the touch; injection site was swollen, red, and warm to the touch/her arm at the injection site was swollen, red, hurting and tender to touch; injection site was swollen, red, and warm to the touch/her arm at the injection site was swollen, red, hurting and tender to touch; heart rate also went up because she is scheduled for chemo, radiation and has an a-flutter/Fast heart beat; heart rate also went up because she is scheduled for chemo, radiation and has an a-flutter; Extreme tiredness; Bad headache; Fever of 99.4, 99.7, and 100.8; Chills; feeling yucky; Body aches; Feeling unwell; sick all day the day after but was fine by Sunday; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8729), via an unspecified route of administration, administered in arm left on 09Apr2021 at 11:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included neuropathy on the bottom of her feet, cancer and cannot sleep from an unknown date and unknown if ongoing. Concomitant medication included metoprolol succinate at 275 mg, daily (125mg of metoprolol succinate in the morning and 150mg of metoprolol succinate in the evening) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 on 19Mar2021 at 10:00AM (at the age of 58-years-old) in left upper arm for COVID-19 immunisation. The patient received her 2nd dose of the Pfizer COVID Vaccine on 09Apr2021. She was sick all day the day after (10Apr2021) but was fine by Sunday. On Monday, 12Apr2021, she mentioned that she underwent radiation therapy, then noticed that her injection site was swollen, red, and warm to the touch on 13Apr2021. On 10Aapr2021, her heart rate also went up because she is scheduled for chemo, radiation and has an a-flutter. She mentioned that the COVID shot made it go up. She is asking how long these side effects should last and for what to do. She mentioned that the nurse at her doctor's office told her to contact Pfizer on what to do. She is a high-risk cancer patient. She received her second dose of the COVID vaccine on 09Apr2021. The next day, she experienced tiredness, a headache, chills, and body aches. She also had a fever of 99.4, 99.7, and 100.8. She was feeling unwell. Then she got a fast heartbeat. She has been having that problem. She has A-Fib and A-Flutter. She has been doctoring every week about her A-Fib and A-Flutter. Then she was fine. On Monday, she had radiation. After radiation, on Tuesday, 13Apr2021, her arm at the injection site was swollen, red and hurting. Then her heartbeat started back beating fast. She has had a headache on and off. She had a headache on Monday, Tuesday and Wednesday. She does not look at her weight. She has gained so much weight since cancer. She retains liquids because of her cancer. She is probably about 230 pounds. She has been tired because of her cancer. But this was different, this was extreme tiredness. Began on Saturday, 10Apr2021 whenever she woke up. With her cancer, she cannot sleep. After the second dose of the covid vaccine, she was so tired, she actually rested well. She was feeling yucky, with chills, a headache and a fever. She is grateful that she was able to get some sleep. It was completely resolved on Sunday morning, 11Apr2021 whenever she woke up. Bad headache began on Saturday, 10Apr2021 whenever she woke up. Sleeping relieved her headache. She took some Tylenol even though she is not supposed to take Tylenol because of her chemotherapy. Tylenol could affect her liver because of the chemotherapy. She took the Tylenol for her fever and to help her headache. Her headache is on and off, but it is a lot better since her first headache. Her headache was the worst on the first day. She thought her symptoms were clear until her arm at the injection site was swollen, red and hurting. It was also hot to touch. Chills, body aches and fever of 99.4, 99.7, and 100.8, feeling unwell began on Saturday, 10Apr2021 whenever she woke up. Completely resolved on Sunday morning, 11Apr2021 whenever she woke up. Her heart started racing on Saturday, 10Apr2021. Then it resolved on Sunday, 11Apr2021. Then her fast heartbeat came back whenever her arm at the injection site started to get swollen, red and hurting. She thinks that her fast heartbeat could be anxiety too. She has anxiety. She takes heart medications that are supposed to slow her heart down. The medications are not working. Chemotherapy makes her heart worse. She called her doctor about her heart beating fast. She has not heard back from her doctor yet. Usually her doctor will up her mediations. Now tomorrow, she will be filling her body with poison. Chemotherapy makes her heart worse. Chemotherapy name, lot number, NDC and expiration date: Not provided. The Pfizer covid vaccine made her heart worse. She is supposed to get chemotherapy tomorrow. She does not know what will happen tomorrow. She thinks that her doctor is going to have to up her medications. She has been seeing her heart doctor every week. Because of radiation, she has not seen her as much. She is going to see her heart doctor on Tuesday. Her heart doctor has been doctoring her for forever, and she sees her every week since she was diagnosed with cancer. She prefers for Pfizer to contact her heart doctor if there are any follow up questions. She had to have surgery, and after that she went into A-Flutter. Her heart doctor has been on it since. Clarified that her heart medications normally do work. She thinks that the COVID vaccine counteracted her heart medications. Normally her heart rate is under 100. After the COVID vaccine, at 7:00PM, her pulse was 104. On Saturday, at 4:30PM, her heart rate was 111. At 8:00PM, it was 109. On Sunday, it got better. At 7:30AM, it was 96. At 6:00PM, it was 90. On Tuesday, whenever the injection site turned red, was hurting and swollen, her heart rate was 104. Currently her heart rate is 94. She has A-Fib and A-Flutter. She has been doctoring that every week about that. After that she was fine. On Monday, 11Apr2021, she had radiation. After radiation, on Tuesday, 13Apr2021, her arm at the injection site was swollen, red, hurting and tender to touch. Her heart started beating fast again. The redness is the whole width of her arm. She is asking how long she can expect this redness to last. She does not know if radiation triggered this. It happened right after radiation that she started on Monday. Her daughter told her that this is normal, and a lot of people have this happen. The day before the second dose of the COVID vaccine, she had internal radiation. That was her third radiation treatment. She told her oncology doctor about the COVID vaccine and her doctor talked to her about it. Her doctor told her to go on and get the COVID vaccine, and that people like her needed the vaccine. She did not have radiation with first dose of the COVID vaccine. Therapeutic measures were taken as a result of bad headache and fever of 99.4, 99.7, and 100.8. The outcome of the events sickness, fever, chills, feeling abnormal, body aches and feeling unwell was recovered on 11Apr2021, headache was recovering, while of the rest was unknown.
58 2021-04-30 itchy skin difficulty breathing/breathing problems; increased blood pressure/blood pressure really high; itchin... Read more
difficulty breathing/breathing problems; increased blood pressure/blood pressure really high; itching incessantly; This is a spontaneous report from a contactable other health professional (patient) received via Medical Information Team. A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 12Mar2021 at 09:30 (Lot Number: EN6198) (at the age of 58-year-old) as single dose for COVID-19 immunisation. Medical history included a couple of surgeries, prediabetic, breaking out with blisters on chin, hormone replacement, insomnia, muscle pain, blood pressure abnormal, depression, iron deficiency, allergies and itching, all from an unknown date and unknown if ongoing. Concomitant medications included metformin (formulation: tablet) oral at 500 mg once a day taken for prediabetic from 2019 and ongoing; acyclovir at 400 mg twice a day taken for breaking out with blisters on chin from an unspecified start date and ongoing; estradiol (formulation: tablet) at 1 mg once a day taken for hormone replacement from 2019 and ongoing; medroxyprogesterone acetate (PROVERA) at 2.5 mg once a day taken for hormone replacement therapy from 2019 and ongoing; trazodone HCl (formulation: tablet) at 100 mg once a day taken for insomnia from 2016 and ongoing; meloxicam at 15 mg once a day taken for muscle pain from 2016 to an unspecified stop date; hydrochlorothiazide at 50 mg once a day taken for blood pressure abnormal from 2016 and ongoing; buspirone (formulation: tablet) at 10 mg thrice a day taken for depression from 2016 and ongoing; ferrous sulfate (FEROSUL, formulation: tablet) at 65 mg twice a day taken for iron deficiency from 2016 and ongoing; cetirizine (formulation: tablet) at 10 mg once a day taken for allergies from Feb2021 and ongoing; hydroxyzine (formulation: tablet) oral at 25 mg taken for itching from Feb2021 and ongoing. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left on 19Feb2021 (Lot Number: EN6200) (at the age of 58-year-old) as single dose for COVID-19 immunisation. The patient reported that blood pressure was really high on 09Apr2021. On 10Apr2021 she woke up from sleeping due to difficulty breathing/breathing problems and went to the emergency room (ER) at 03:00. Caller stated they found out in the ER that her blood pressure was high. She stated that in the ER they didn't do anything but took her blood pressure and watched her blood pressure. Caller stated she was not admitted, she was there for 4 hours and sent home. Caller stated her blood pressure was over 200 and they still let her go home. Caller stated she went into the doctor on 12Apr2021 at 15:00 and got some medicine for the itching, at that time her blood pressure was down. Patient stated that itching could have been a reaction from one of the drugs she was given. Therapeutic measures were taken as a result of the blood pressure, the patient started a new medication, LOSARTAN at 50mg one time a day and got some medicine for the itching. The patient outcome of difficulty breathing/breathing problems and increased blood pressure/blood pressure really high was recovering and of itching was not recovered. No follow-up attempts are needed. No further information is expected.; Sender's Comments: The contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EN6198), to reported events is possible. Tis case will be reassessed if follow-up information is received.
58 2021-05-02 rash 1 day after vaccine lumps under arms and along collarbone, migraine, chills, fatigue, breast enlarge... Read more
1 day after vaccine lumps under arms and along collarbone, migraine, chills, fatigue, breast enlargement. 3rd day after vaccine left ear pain, difficulty swallowing, but could breath, fever,migraine, chills, ,fatigue, tender breast, breast enlargement. My primary said not to get second dose. Also rash on right arm.
58 2021-05-03 shingles, rash Rash on face after first injection. Still have a rash. It comes and goes Shingles after 2nd shot. ... Read more
Rash on face after first injection. Still have a rash. It comes and goes Shingles after 2nd shot. Dizziness for two weeks. Near syncope 24 hours after shot. And 4 days later.
59 2021-01-01 injection site pain I received the Pfizer COVID-19 vaccine at six 17:06. Starting at - 18:00 and for the subsequent 24 h... Read more
I received the Pfizer COVID-19 vaccine at six 17:06. Starting at - 18:00 and for the subsequent 24 hours I felt soreness at a level of 2-3/10 at the injection site. Starting at - 19:00 the pain radiated down toward my elbow and up into my neck and base of skull. The soreness in my neck and base of skull was at a lever of 4/10. By 12/24/20 at approximately 18:00 the side effects had dissipated.
59 2021-01-02 hardening Large soft as well as hard swollen lymph glands and nodes in neck and clavicular region and severe ... Read more
Large soft as well as hard swollen lymph glands and nodes in neck and clavicular region and severe muscle aches and pains in upper body and neck.
59 2021-01-04 injection site pruritus, injection site redness, itchy skin, hives Dizziness, Anaphylaxis, UrticariaPruritus & NauseaVomiting Narrative: Patient complained of nausea ... Read more
Dizziness, Anaphylaxis, UrticariaPruritus & NauseaVomiting Narrative: Patient complained of nausea and numbness and tingling in fingertips 5 minutes after administration of vaccine and proceeded to bathroom. Patient with unwitnessed vomiting prior to RN assessment. RN assessed patient and taken safely to private evaluation room. AED pads applied per protocol. Epi-Pen administered. EMS called. Vital signs stable. Patient complained of itching and erythema in left arm around injection site. MD evaluated patient and advised to be further assessed in ER. Patient continuously evaluated by RN and EMS. Patient transported to ER in stable condition.
59 2021-01-04 injection site pain Fatigue, sinus pain, nausea , vomiting , Chills, Body Aches, Fever. Headache, Diarrhea, runny nose ... Read more
Fatigue, sinus pain, nausea , vomiting , Chills, Body Aches, Fever. Headache, Diarrhea, runny nose Tenderness at the injection site.
59 2021-01-04 rash with redness Fine raised red rash over her body; throat swelling; diarrhea; high pitched cough productive with cl... Read more
Fine raised red rash over her body; throat swelling; diarrhea; high pitched cough productive with clear thin secretions; This is a spontaneous report from a contactable nurse (patient herself). A 59-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on left arm from at 12:30 PM on 23Dec2020 at single dose for COVID-19 immunization. Medical history included depression. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), triazolam (HALCION), fluoxetine hydrochloride (PROZAC), paracetamol (TYLENOL). The patient previously took Lamictal and experienced rash, codeine and experienced hallucination, lamictal for drug allergy, codeine and experienced drug allergy. On 24Dec2020 mid-day (11:00 AM), the patient developed the following S/S (signs and symptoms, which were similar to a Lamictal rash): Fine raised red rash over her body, but significantly heavier to face, neck and lower legs; throat swelling with a high pitched cough (with no difficulty breathing) productive with clear thin secretions; diarrhea. The patient took 6 Benadryl every 4-6 hours, Pepcid twice daily, and had an epi pen available (but did not need it). The cough and rash resolved by late Sunday evening (27Dec2020). The patient did not report to ED because she felt the symptoms were manageable at home. All events reported as non-serious. The outcome of events red rash and cough were recovered on 27Dec2020, the outcome of rest events was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19.
59 2021-01-04 vaccination site itchiness Itching at injection site; This is a spontaneous report from a contactable Other health care profess... Read more
Itching at injection site; This is a spontaneous report from a contactable Other health care professional (HCP) reporting for herself. A 59-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 23Dec2020 at 06:30 PM at single dose for COVID-19 immunization. Medical history included breast cancer (Currently healthy). Concomitant medications included Tamoxifen and vitamin D. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 25Dec2020 patient experienced Itching at injection site. No treatment was received for the event. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient had not recovered from the event at the time of the report. Information about lot/batch number has been requested.
59 2021-01-04 injection site swelling, injection site pain, injection site redness Patient's reaction(s) noted during COVID vaccine observation period: Redness, swelling, or pain at t... Read more
Patient's reaction(s) noted during COVID vaccine observation period: Redness, swelling, or pain at the injection site, extending >2cm diameter area(states it feels like it's in her bones). Pain worse with movement. No redness/swelling. Actions Taken: VS taken and WNL, with the exception of BP being a little high for her. She was offered the opportunity to go to ED and declined saying that it is manageable and will take Tylenol.   Disposition: Patient declined ED visit
59 2021-01-04 itchy skin STATES SHE DEVELOPED INTENSE ITCHING. SHE AND HER DOCTOR THINK IT IS FROM THE VACCINE. STARTED ON ST... Read more
STATES SHE DEVELOPED INTENSE ITCHING. SHE AND HER DOCTOR THINK IT IS FROM THE VACCINE. STARTED ON STEROIDS TODAY.
59 2021-01-04 shingles developed shingles outbreak 4 days later; This is a spontaneous report from a contactable consumer. ... Read more
developed shingles outbreak 4 days later; This is a spontaneous report from a contactable consumer. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on 22Dec2020 at single dose in the upper arm via unspecified route of administration. The patient had not medical history. Concomitant medications were not reported. On 26Dec2020 the patient developed shingles outbreak. The outcome of the event was not recovered. Information on the lot/batch number has been requested
59 2021-01-04 vaccination site pain pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit ... Read more
pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; It goes up and down, feels sort of like catching the flu; This is a spontaneous report from a contactable Pharmacist reporting for herself. A 59-years-old female patient received bnt162b2 (BNT162B2) vaccine , intramuscular in the left upper arm on 23Dec2020 10:30 at single dose for Covid-19 immunisation . Medical history included ongoing hypertension , Covid-19 from 25Mar2020 to an unknown date treated with azithromycin. In Jun2020 she had antibodies against COVID-19. Concomitant medication included hydrochlorothiazide (HYDROCHLOROTHIAZIDE). The patient experienced pain/soreness at the injection site, swelling, chills, muscle and body aches, headache and feels sort of like catching the flu on 23Dec2020 with outcome of not recovered. The soreness started about 4 hours after the injection and during that night it progressed with the chills and body/muscle aches. Did take Tylenol to help and took it throughout the night and the day after and drinking fluids. Stated if condition goes on much longer or worse then she will have to go to the hospital. Lot/Batch and Expiration date has been requested.
59 2021-01-05 injection site pain 1/5/20: 6:15 pm Became tired, chilling, afebrile, cold touch, soreness at injection site. 9:00 ... Read more
1/5/20: 6:15 pm Became tired, chilling, afebrile, cold touch, soreness at injection site. 9:00 pm dizziness, tightness around right upper arm, swelling in right axilla. afebrile. 1/6/20: 5:00 am; chilling subsided. dizziness, weakness and jittery feeling in both legs, soreness at injection site, no redness, swelling in axilla slightly improved. Heart rate 72, respirations 16, 02 sat 96%. bp 129/75. 9:00 am: dizziness, right axilla swelling gone. Soreness in right axilla, weakness in lower extremeties improving. 11:00 am : weakness and jiters subsided, right axilla remains sore.
59 2021-01-05 skin tightness 6:15 pm Chilling, cold to touch, afebrile. 10 pm woke up still chilling afebrile. Swelling in righ... Read more
6:15 pm Chilling, cold to touch, afebrile. 10 pm woke up still chilling afebrile. Swelling in right axilla. Tightness around upper arm/axilla area. No redness at injection site. 5 am weakness in lower legs, shakey/jittery, and dizziness. Bp 129/75, HR 65, resp 16, O2 say 96. 9 am dizziness subsided 11 am weakness in legs subsided, axilla swelling subsided, soreness remains.
59 2021-01-05 rash with redness, injection site pain, itchy skin, rash On day after vaccine had chills and fever(99.7) for ~ 24 hours. Also had muscle and joint pain, very... Read more
On day after vaccine had chills and fever(99.7) for ~ 24 hours. Also had muscle and joint pain, very sore arm at injection site, mildly swollen lymph nodes. All noted on handout to be possible side effects. ***Day 2 after vaccine has very red rash all over neck, chest, abdominal and back areas with some itching that lasted ~ 72 hours but was less visible each day after initially noted. No medical treatment sought as resolved on its on
59 2021-01-05 itchy skin, hives UrticariaPruritus
59 2021-01-05 rash generalized rash. resolved in 2 days with benadryl.
59 2021-01-06 redness Angioedema swelling and redness of face; eyes swollen Narrative: Employee was seen in the clinic the... Read more
Angioedema swelling and redness of face; eyes swollen Narrative: Employee was seen in the clinic the following day and symptoms had resolved.
59 2021-01-06 itchy skin Half of day after receiving the shot the left arm was sore after vaccine. Itchy on right on red ,ho... Read more
Half of day after receiving the shot the left arm was sore after vaccine. Itchy on right on red ,hot and swollen after the allergy shot . Itching whole body and also the roof of mouth and the back of throat was itching . Head aches . No new symptoms.
59 2021-01-06 rash papular, rash raised rash on right arm
59 2021-01-06 hives stomach cramps, nausea, dizziness, subjective fevers, bilateral swelling cervical nodes, denies sore... Read more
stomach cramps, nausea, dizziness, subjective fevers, bilateral swelling cervical nodes, denies sore throat, mild headache, denies respiratory difficulties. States that with 1st vaccine had hives inside rt elbow and wrist,
59 2021-01-07 itchy skin, redness HEADACHE STARTED1/7/2021 STARTED1/8/2021 WITH FACIAL AND NASAL REDNESS, PRURITUS NO SOB WAS TOLD TO... Read more
HEADACHE STARTED1/7/2021 STARTED1/8/2021 WITH FACIAL AND NASAL REDNESS, PRURITUS NO SOB WAS TOLD TO TAKE BENADRYL 50MGS STAT AND IF WORSENS WILL GO TO ER
59 2021-01-07 injection site pain Mild headache and injection site soreness
59 2021-01-07 injection site pain Mild headache and injection site tenderness
59 2021-01-07 itchy rash Rash with itching. 01/04/2021 prednisone 60mg, 40mg, 20mg-3 day taper.
59 2021-01-07 itchy skin Very tired, nausea, extremely sore left arm, drained of energy. Unable to work the next day. Left ar... Read more
Very tired, nausea, extremely sore left arm, drained of energy. Unable to work the next day. Left arm a little itchy. Took Benadryl , slept and then felt better. Did fine with first shot.
59 2021-01-07 hives sore throat and hives still from Covid vaccine bodyaches, sore throat, chills just doesn't feel well... Read more
sore throat and hives still from Covid vaccine bodyaches, sore throat, chills just doesn't feel well, hives
59 2021-01-08 skin discolouration Developed fever/chills next day and following day which resolved but also began having having purple... Read more
Developed fever/chills next day and following day which resolved but also began having having purple/blue fingertips - both pads and nails - when my hands are cold. This began on day after vaccine and continues to date.
59 2021-01-08 injection site pain soreness and stiff yat the die if injection for 2 days took tylenol to treat pain
59 2021-01-09 redness, injection site pain, rash, rash with redness, rash papular I received the vaccine at 0615 am on 1/8/21. Had no symptoms (not even injection site pain). At 210... Read more
I received the vaccine at 0615 am on 1/8/21. Had no symptoms (not even injection site pain). At 2100 on 1/8, began to develop a lot of pain at the injection site. Within 2 hrs of that time, I developed other symptoms, which include total body (bone and joint) pain (especially in my knees), and what I would describe as a "bad sunburn type" rash across my cheek bones, bridge of my nose, and orbital area. Small raised bumps to this area, with swelling, and a feeling of pins and needles stabbing me all across my face. My airway was fine, and at no time did I feel shortness of breath. I was unable to sleep due to the bone and joint pain, and felt the need to walk continually (it was more painful to stay in one position). These symptoms persisted throughout the day (Saturday 1/9/21), noting at 5pm I described myself "miserable" to my friends and family. All symptoms described above, were at their most elevated intensity between the hours of 1700 - 0400. At 0400 Sunday (1/10/21) I felt a gradual release of the body aches, enough so that I could sleep until 0800. At this time, 1300 (Sunday 1/10) I note that I still feel "flu type" body aches, but constant pain has diminished in intensity by estimated 50%. The sunburn type redness and swelling across my face/orbital area has also less by 50% (there is still redness, mild swelling, warmth, and some raised bumps across this area; pins and needles feeling is gone).
59 2021-01-09 injection site pain Lower back pain and slight fever beginning at 1am 14.5 hours after shot. Just tired and back achy by... Read more
Lower back pain and slight fever beginning at 1am 14.5 hours after shot. Just tired and back achy by 4:30 pm the day after the shot For a few hours about 8 hours after shot, arm where shot was given was quite sore, but that went away
59 2021-01-09 injection site pain Reaction site pain, fatigue, chills and joint pain
59 2021-01-09 injection site pain Six hours after being administered by the vaccine I started to feel soreness around the site. Within... Read more
Six hours after being administered by the vaccine I started to feel soreness around the site. Within the hour it progressed to pain in my left upper arm radiating down to my lower arm. By this time, I had difficulty raising my arm and limited ROM. This continued for three days. The symptoms eased up a little bit but there was constant pain whenever I raised my affected arm. When I went to work on the night of the Jan third, I felt my arm hurting during the night. I took ADVIL for the pain and continued to do so. Jan 6 and 7 At night, I was awoken with excruciating pain on the same arm. This lasted for approximately a couple of mins. I sought a virtual consultation with my PCP who advised me to take ten days off from work. I am currently on medical leave. I haven't experienced the same excruciating pain as I had those two nights. However, my ROM is still limited because there is still moderate pain involved. I've stopped taking Advil since it has started to upset my stomach.
59 2021-01-09 injection site pain Temperature 99.4, severe body aches, chills, soreness at injection site
59 2021-01-10 itchy skin, injection site pruritus 25 min after injection and said she had itching all over her body started at the injection site then... Read more
25 min after injection and said she had itching all over her body started at the injection site then spread throughout her body. She was sent to an NP for evaluation. They advised her to take a BENADRYL and see if that resolved. She came back at 1700 to let us know she was somewhat better but would go home and take an additional BENADRYL. Recommended she contact her primary if symptoms persist or go to UC.
59 2021-01-10 itchy skin, injection site redness, injection site swelling Arm sore over night Sunday to Monday and began to itch. Area still itches and is red and swollen ar... Read more
Arm sore over night Sunday to Monday and began to itch. Area still itches and is red and swollen area where shot was given
59 2021-01-10 injection site pain In afternoon had chills headache fatigue injection sit deltoid sore down to elbow
59 2021-01-10 rash Rash entire body, throat swelling, extreme nausea.
59 2021-01-10 itchy skin She is having an allergic reaction; Itching was reported as worsened/Swelling was reported as worsen... Read more
She is having an allergic reaction; Itching was reported as worsened/Swelling was reported as worsened/loss of appetite was reported as worsened; From the time she got the vaccine to now, she has lost 20 lbs; shake/shaking; swelling in the lips, throat, and eye lids; swelling in the lips, throat, and eye lids; swelling in the lips, throat, and eye lids; She has been sick since Wednesday; itching all over from head to toe; loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 30Dec2020 at single dose for COVID-19 immunization. Medical history included hypertension and allergic to ace inhibitors. There were no concomitant medications. Patient was calling about the Covid Vaccine. She was having an allergic reaction. She did not know what to do to stop it. She went to the ER yesterday (04Jan2021). She had been sick since Wednesday (30Dec2020), she was itching all over from head to toe since 30Dec2020, she got a prescription for Prednisone, she took 2 doses yesterday, 1 dose today, and would take another this evening. She took Benadryl, an hour ago and had an episode, and so she had to jump in the shower and let the cold water run to stop itching, the itching did not stop but it has minimized. She put Benadryl gel and she was still itching, she had taken enough Benadryl. Patient asked what is the best way and if she needed an IV of something, she went to ER on Sunday, she was not seen by doctor, it was a nurse practitioner, she didn't do anything but just listen to her and she only looked at ankles to check for swelling. Patient stated that she had been drinking water and urinating, she had no appetite and lost 20 lbs. Patient confirmed that she got her first dose of the Covid vaccine on 30Dec2020 at 1 o clock, the itching started the same day at 5 o clock, the itching was from head to toe. She experienced swelling in the lips, throat, and eye lids, which started 02Jan2021. She began losing her appetite on 30Dec2020. From the time she got the vaccine to now (05Jan2021), she has lost 20 lbs. An hour ago (05Jan2020) she had an episode, which made her shake, and she did not have the shakes before, this was the first date she started shaking. Itching was reported as worsened/Swelling was reported as worsened/loss of appetite was reported as worsened. Her 2nd dose was scheduled in 21 Days. However, she may not get the second dose, patient stated that she could not get through this no more. She had no positive test for Covid prior to vaccine. She had no antibody test prior to the vaccine. She had not any issues with vaccines in the past. Patient stated that if she was still feeling this way, she would go to a different hospital. When she went to the ER, she was not hospitalized, they sent her back home the same day. Patient would like to know if there was anything that can remove the vaccine from the body. The outcome of the events itching all over from head to toe, loss of appetite, swelling in the lips, throat, and eye lids was not recovered, of the other events was unknown. Information about lot/batch number has been requested.
59 2021-01-10 rash, itchy skin That evening developed itching and had a rash over upper body and arms, still on arms in AM, went aw... Read more
That evening developed itching and had a rash over upper body and arms, still on arms in AM, went away on it's own, since then have episodes of chills and a trigger finger developed while sleeping on right #4 digit of Right hand, tightness in chest and last night developed pain in left arm and fingers that was very painful and did not respond to 800mg of Ibubrofen. Not sure if related.
59 2021-01-10 itchy rash, rash with redness red rough rash, itchy onset 01/06/21 seen PCP treated with Kenalog injection and MEDROL DOSE PACK 6... Read more
red rough rash, itchy onset 01/06/21 seen PCP treated with Kenalog injection and MEDROL DOSE PACK 6 DAY
59 2021-01-10 injection site pain sore arm at injection site. Swollen and painful L shoulder on site of injection
59 2021-01-10 injection site pain soreness around the injection site; Had severe arm pain; Had a fever on the night of the 31Dec2020 o... Read more
soreness around the injection site; Had severe arm pain; Had a fever on the night of the 31Dec2020 of 101.3; I have painful lymph nodes/the swollen lymph nodes under her right arm, the armpit area had swollen and painful lymph nodes; I have painful lymph nodes/the swollen lymph nodes under her right arm, the armpit area had swollen and painful lymph nodes; had joint pains/knees and hip joint pain; severe fatigue; muscle pain; This is spontaneous report from a contactable nurse (patient). A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration in right arm on 30Dec2020 14:15 at first single dose (0.3 cc, but really uncertain of dose) for covid-19 immunization. Medical history included COVID virus from Nov2020 to 2020 (The patient was not hospitalized. It was a mild case and lasted about 10 days. she had any positive antibodies at that time. Was off work for about 12 days and was very lucky to have had a very light case with fever, cough, cold, and super fatigue). The patient's concomitant medications were not reported. The patient did not receive any other vaccines at the same time or 4 weeks prior. No problems with vaccinations in past or events. Caller reported she had the first injection of the Pfizer BioNTech COVID-19 vaccine on the 30Dec2020 and having some side effect symptoms and her supervisor recommended for her to report these things, they are not life threatening, obviously, but things were still lingering. Side effect of severe fatigue started on the 31Dec2020 and lasted for 72 hours. It was so severe, now it is mild. The patient reported soreness around the injection site. Had a fever on the night of the 31Dec2020 of 101.3 and had that for 6 hours then it dissipated and was gone. Had never had a fever after injections before. Had severe arm pain that usually goes along with an injection. It started also that night of 31Dec2020. She had rolled over in the middle of the night and it hurt. That lasted for about 48 hours, but it has improved. Had some muscle aches since 31Dec2020 but that had improved and had joint pains since 31Dec2020. What was worrisome was the swollen lymph nodes under her right arm, the armpit area had swollen and painful lymph nodes, since 31Dec2020. The patient was still having that and that is why she was so concerned because shouldn't that have gone away after a week. Had knee and hip joint pain, but that had improved. Again, mentioned she had never had that before with an injection. The patient received vaccine at her workplace. Some of her coworkers got it the same day and no one else has this. Mentioned she did have COVID virus back in Nov2020 and wonders if this correlates with her getting the vaccine. Was not hospitalized or notified she had any positive antibodies at that time. Was off work for about 12 days and was very lucky to have had a very light case with fever, cough, cold, and super fatigue. This is the same way she felt back when she had the virus back in November. The patient was concerned about having these side effects would it be okay for her to get the next injection in 3 weeks. AEs did not require a visit to emergency room and physician office. No further details provided. Outcome of the events Fever was recovered, of event swollen and painful lymph nodes was not recovered, of events knees and hip joint pain, fatigue, muscle pain, severe arm pain was recovering, of event soreness around the injection site was unknown. The reporter considered the events severe fatigue, fever, swollen lymph nodes and pain under right arm, knees and hip joint pain as serious (medically significant). The reporter considered the events severe fatigue, fever, severe arm pain, muscle ache, swollen lymph nodes and pain under right arm, knees and hip joint pain as related to BNT162B2.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
59 2021-01-11 rash, hives 2nd Injection received approx. 11:05 AM on Wednesday 1/6/2021. First symptoms of reaction seen betwe... Read more
2nd Injection received approx. 11:05 AM on Wednesday 1/6/2021. First symptoms of reaction seen between 8-10pm on Saturday, 1/9/2021 which included hives around neck and covering chest torso and arms. Treated with topical Benadryl. Rash/hives continued to persist spread to entire body, head, neck, face, torso, arms, legs, feet. On early Monday, 1/11/2021 - Contact with Employee Health Nurse and PCP Dr. and advised to take Benadryl as the only symptom was the rash/hives - no facial swelling or shortness of breath. Tuesday, 1/12/2021 after taking advice of Employee Health Nurse and PCP symptoms are nearly fully resolved.
59 2021-01-11 rash macular After receiving the vaccine on 1/5/21 that night i had hard chills during the night, on 1/6/21 I dev... Read more
After receiving the vaccine on 1/5/21 that night i had hard chills during the night, on 1/6/21 I developed a goose egg size swelling under my left armpit, numbness, tingling in my hands, and feet that proceeded with coldness and parlor of my hands, this has occurred daily along with headaches, reddish blotchy patches on my skin. My symptoms progressed on 7 Jan to needle prick sensations all over my body, to include the numbness and tingling, cold hands and feet. On 8 Jan I went to see my doctor and explained my symptoms, labs were drawn. 12 Jan i was placed on Medrol Dose pack, symptoms stills present.
59 2021-01-11 hives Arm aching Fatigue Minor hives for three days Treated with Zyrtec and Benedryl
59 2021-01-11 injection site redness, injection site mass, injection site warmth noted hard lump at injection site, warm, redden, sore Headache, very tired
59 2021-01-11 rash rash that started on her face and now it is going everywhere; temperature is 98.2/slight fever; This... Read more
rash that started on her face and now it is going everywhere; temperature is 98.2/slight fever; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date unknown), intramuscularly on 05Jan2021 injection in left arm at single dose for preventative since she works in nursing home. The patient's medical history and concomitant medications reported as no. The patient was experiencing a rash that started on her face and now it was going everywhere on 05Jan2021. Rash was reported as worsened. She just took diphenhydramine hydrochloride (BENADRYL). Patient stated it was not serious at this point. She just took her temperature before she called and her temperature was 98.2 on 05Jan2021 and stated this was a slight fever since she was normally 97.4. The outcome of the event rash was not recovered, outcome of slight fever was unknown. The report was reported as non-serious. Information on the lot/batch number has been requested
59 2021-01-12 itchy skin, rash Dose #2 received on 1/11 at 11:30. Pt began to feel itchy all over at 1500. She noticed a rash under... Read more
Dose #2 received on 1/11 at 11:30. Pt began to feel itchy all over at 1500. She noticed a rash under both of her breasts as well as her face, scalp. She felt " flushed". No tongue or lip swelling, No wheezing. she had arm soreness and muscle " weakness" in the left arm after dose #1 and completed a VAERS form at that time but had completely recovered prior to receiving injection #2
59 2021-01-12 injection site pain Fatigue. Injection site pain. Chills. Body aches, headache, nausea. Resolved.
59 2021-01-12 hives, itchy skin Generalized itching, hives, after receiving second dose of COVID 19 vaccine today, 1/11/2021 at 11:3... Read more
Generalized itching, hives, after receiving second dose of COVID 19 vaccine today, 1/11/2021 at 11:30 in right deltoid. Pt tolerated dose #1 in left deltoid. She developed mild arm " weakness" and soreness that lasted several days. She completed a VAERS report after her first dose. She began to feel " itchy all over" at 15:00. She noticed hives under her bilateral breasts. She felt " flushed" and her scalp and face felt itchy as well. No SOB or CP. NO wheezing. She has a hx of allergies to KEFLEX/PCN.
59 2021-01-12 itchy skin Patient called at 12pm to inform us that about 3 hours after her 1st Covid vaccine she was moving he... Read more
Patient called at 12pm to inform us that about 3 hours after her 1st Covid vaccine she was moving her arms around to prevent soreness and then both arms began to feel itchy, tingling, & burning & this moved up into her neck. She was encouraged to come in and be seen, but she does not feel that is necessary at this time. She reported her symptoms have since improved and that she had a similar reaction when she received the shingles vaccine. I encouraged patient to monitor her symptoms and to come be seem if she gets worse. She reported that she is feeling much better at the end of our phone call.
59 2021-01-12 rash, injection site redness Rash and swollen lymph node on my left side of my neck very painful to touch .Day before I had a ... Read more
Rash and swollen lymph node on my left side of my neck very painful to touch .Day before I had a check up with my doctor with no symptoms.. Injection on left high upper arm redness around . Muscles pain and tremors of my hands , tired Diarrhea for two days and sweats.
59 2021-01-13 injection site redness, injection site warmth, injection site pain Erythema at site, tender and warm to touch from 8 hours after injection through today. Myalgia?s an... Read more
Erythema at site, tender and warm to touch from 8 hours after injection through today. Myalgia?s and chills 12 hours after injection lasting for 48 hours after. Took 800mg ibuprofen every 6 hours through 48 hours post injection with relief of myalgia?s and chills.
59 2021-01-13 injection site pain Injection site pain/soreness, body ache.
59 2021-01-13 rash macular, itchy skin Multiple red, itchy spots on hands and feet
59 2021-01-13 skin spots, rash rash, petechia all over body, spread and got redder and redder
59 2021-01-14 vaccination site pain 4 hours after vaccine, soreness at injection site; severe whole body chills; whole body aches; This ... Read more
4 hours after vaccine, soreness at injection site; severe whole body chills; whole body aches; This is a spontaneous report from a contactable other hcp. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiry date unknown, intramuscular on the left arm on 07Jan2021 17:45 at a SINGLE DOSE and intramuscular on the left arm on 17Dec2020 18:45 at a SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. Concomitant medication included escitalopram oxalate (LEXAPRO). On 07Jan2021, it was reported that 4 hours after vaccine, there was soreness at injection site. 14 hours following vaccine, the patient experienced sudden onset of severe whole body chills and whole body aches lasting up to 18 hours. The outcome of the events was recovered. Information on the lot/ batch number has been requested.
59 2021-01-14 injection site redness, injection site warmth, injection site hardening Diarrhea, chills on 1/12/21 - 1/14/21. Symptoms have stopped. On injection site there is a half doll... Read more
Diarrhea, chills on 1/12/21 - 1/14/21. Symptoms have stopped. On injection site there is a half dollar size red area which is hot to the touch with hardness or a knot at injection site. tHIS IS STILL PRESENT.
59 2021-01-14 itchy skin, skin burning sensation Five minutes after receiving injection patient experienced shortness of breath, itching and burning ... Read more
Five minutes after receiving injection patient experienced shortness of breath, itching and burning in left arm and hand, right arm. She reported taking 2 puffs of her Proair inhaler. She worried she would pass out as she was walking. She reported her condition to NP who did an assessment. At 9:40AM the patients vitals were BP: 147/104, HR=109, O2=98%, She was advised to lie down and was placed under observation for 15 minutes. Vitals were taken again at 9:55AM - BP=142/92, HR=103, O2=95%. The patient moved to the Travel, Immunization, and Allergy Clinic for further observation. Dr. examined the patient. He Heart rate was 116. The patient drank some water and juice and took an antihistamine (Claritin). She didn't want Benadryl as she didn't like the way it made her sleepy. After resting for 40 minutes, she stated that she felt better. Dr. checked on her again and said that she could go back to work if she felt OK and to be monitered by RN for the next hour. She rested and was checked at 10:30, 11:00, 11:30 AND 12:15 and reported feeling better.
59 2021-01-14 injection site bruising I received 2nd injection of Pfizer COVID-19 Vaccine at 1015AM on 1-12-21 and was doing great. I had ... Read more
I received 2nd injection of Pfizer COVID-19 Vaccine at 1015AM on 1-12-21 and was doing great. I had taken one 325mg Tylenol and one 200mg Ibuprofen approximately 60 minutes prior to receiving vaccine (which is what I did prior to the first vaccine). I was doing great initially following the vaccine. I took another 325mg Tylenol and 200mg Ibuprofen when I went to bed at 2000 1-12-21. At 0300 1-13-21 I woke up feeling nauseated and when attempting to turn over to my right side I moaned loudly because I could not hardly move my left arm. My husband was woken and turned on the bedroom light and we noted a 3 inch bruise and large knot on my left deltoid at the injection site. He told me that I felt warm. I took my temperature that was 101.2 degrees. I took 650mg Tylenol and that time. At 0500 1-13-21 I was having chills, muscle and joint aches. I could not fully close my hands into a grip. My "brain" hurt, not a headache but literally it hurt to move my head. I would occasionally get a sharp pain in the front and back of my head. My temperature went to its highest at approximately 1500 1-13-21 to 102.5 degrees. I continued to offset Tylenol with Ibuprofen throughout the day. At 2000 1-13-21 my temperature was 101.8 and began to trend downward. I went to bed and when I woke up on 1-14-21 I felt 100% better with just a little fatigue from the inability to sleep the day prior.
59 2021-01-14 injection site pain Injection site soreness 8/10, unable to raise arm laterally more than 25%. Body aches, low posterior... Read more
Injection site soreness 8/10, unable to raise arm laterally more than 25%. Body aches, low posterior head and neck ache, and chills.
59 2021-01-14 vaccination site pain muscle soreness at greater injection site; This is a spontaneous report from a contactable other hea... Read more
muscle soreness at greater injection site; This is a spontaneous report from a contactable other healthcare professional. A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number=EJ1685), intramuscular in left arm on 20Dec2020 16:00 at a single dose for Covid-19 immunization. Medical history included diabetes and hypertension. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Patient has no allergies to medications, food or other products. The patient's concomitant medications included prescribed medication (unspecified). The patient experienced muscle soreness at greater injection site on 21Dec2020 at 06:00 AM. No treatment was received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered.
59 2021-01-14 injection site pain soreness at injection site and sharp headache pain over my right eye that radiated to the back of my... Read more
soreness at injection site and sharp headache pain over my right eye that radiated to the back of my head, both started the night of the injection and through the next day
59 2021-01-15 injection site pain Shot was administered too high, into shoulder joint. Shot was painful itself and 1 to 2 hours later ... Read more
Shot was administered too high, into shoulder joint. Shot was painful itself and 1 to 2 hours later severe pain in L shoulder with marked restriction in movements. Persisting pain in L shoulder which wakes me up at night. Unable to do my daily workouts and yoga.
59 2021-01-16 itchy skin, hives, rash with redness Noted prior to having drug reaction and was planned to wait 30min post-vaccine. She felt "pins and n... Read more
Noted prior to having drug reaction and was planned to wait 30min post-vaccine. She felt "pins and needles" 20minutes after vaccine admin and then began itching. Presents to observation unit with red rash, 3-4 hives across upper and mid-back. Endorses itching on scalp as well as trunk. No rash noted on hands, arms, or face. Benadryl given after pt consulted with Dr. mild relief of symptoms. MDs spoke extensively with patient. She was ok to go home after her spouse arrived to drive her.
59 2021-01-16 itchy skin, rash with redness Vaccine administered approx. 1320, she was waiting in the observation area and about 20-25 minutes s... Read more
Vaccine administered approx. 1320, she was waiting in the observation area and about 20-25 minutes she started to feel a "pins and needles" sensation on her arms and head. Right after that, pt describes diffuse puritis on scalp, across upper and lower back. Itching continues down extremities while being observed. Red rash, 4-5 hives on upper and mid-back. She is visibly scratching her neck, head and back and appears restless because of the intense itching. Assessed by Dr (IM) and Dr(ID); 50mg po Benadryl ordered and given to pt. She endorses mild relief from symptoms.
59 2021-01-16 itchy skin, redness, rash, rash with redness, hives left arm became red with rash that was raised like small pimples, I felt like something was prickin... Read more
left arm became red with rash that was raised like small pimples, I felt like something was pricking me from the inside out then felt a little uneasy and face was itching with a small hive on my right cheek. My arm became bright red, I took a 25 mg benadryl which subsided some of the redness. I finished my shift and drove home about 5 pm still felt like I had prickly heat I took another 25 mg benadryl slept. I was extremely tired the next day which I could not tell if it was from the vaccine or benadryl or both. I work in a doctors office .
59 2021-01-17 rash, skin burning sensation Developed a rash on her upper body on 01-14-21. Patient states the rash burns, making wearing cloth... Read more
Developed a rash on her upper body on 01-14-21. Patient states the rash burns, making wearing clothing uncomfortable. She took antihistamines over the weekend per her medical providers' recommendation. Her rash has not improved.
59 2021-01-17 injection site pruritus, injection site redness, injection site warmth, injection site mass Patient's left arm at the site became increasingly itchy and week later hot and red wheel 2 inch in ... Read more
Patient's left arm at the site became increasingly itchy and week later hot and red wheel 2 inch in diameter was visible and on January 15 th site developed a hot and hard lump. The lump has gone down but still red and itchy. Advised not to scratch or irritate the siye further.
59 2021-01-17 hives hives right lower arm, both lower and upper legs; starts in mornings looking like hives, as day prog... Read more
hives right lower arm, both lower and upper legs; starts in mornings looking like hives, as day progresses turns into small red bumps slightly raised
59 2021-01-18 hives Date for the next shot: 22Jan2021; I broke out in hives all over; This is a spontaneous report from ... Read more
Date for the next shot: 22Jan2021; I broke out in hives all over; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration first dose on 04Jan2021 at single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medication included montelukast sodium for Allergy and simvastatin for Cholesterol. 06Jan2021, the patient stated that "I called my doctor yesterday and said that I had an reaction from the shot, the first one. And they told me at my doctor's office to call this number to let you know that I had a reaction from it." The patient stated experienced "I broke out in hives all over." The patient took the first one on 04Jan2021 and date for the next shot was 22Jan2021. The patient was treated with Prednisone. The outcome of the events was unknown. Information on the lot/batch number has been requested.
59 2021-01-18 injection site pain, blister Difficulty breathing, high blood pressure and heart rate. Very sick for the next 3 days...bedridden... Read more
Difficulty breathing, high blood pressure and heart rate. Very sick for the next 3 days...bedridden due to sickness; nausea, shaking, weakness, muscle aches, joint aches, severe headache, stomach pain, skin blisters, fever and chills, injection site pain, tiredness, dizziness. By the 4th day I am still weak and now I have skin blisters on my body in various places. Today is the 5th day and I still feel weak and slightly sick, nausea and fatigue and more skin blisters, fever.
59 2021-01-18 redness Eight hours after receiving vaccine, a fever of 100-102 lasted for 40 hours. Body aches, fatigue, h... Read more
Eight hours after receiving vaccine, a fever of 100-102 lasted for 40 hours. Body aches, fatigue, headache, arm redness, under arm soreness were additional symptoms.
59 2021-01-18 shingles, injection site pain Hours after shot my upper arm started hurting. The pain went around to my upper left chest and upper... Read more
Hours after shot my upper arm started hurting. The pain went around to my upper left chest and upper left back and up my lest side of next. Two days later I broke out in shingles. Dr put me in dexamethasone and famciclovir
59 2021-01-18 injection site pain, injection site bruising Pt developed injection site tenderness and bruising three days after vaccine. Pt has been self admin... Read more
Pt developed injection site tenderness and bruising three days after vaccine. Pt has been self administrating Benadryl at home. Pt also has bilateral lymphadenopathy in her armpits.
59 2021-01-19 itchy skin, redness 0825 - complained of itchy right forearm, one 0.5 cm flat red area noted, has history of allergies (... Read more
0825 - complained of itchy right forearm, one 0.5 cm flat red area noted, has history of allergies ( stinging insects, crab). Given 25 mg benadryl po. 0855 - no further symptoms, area on right arm unchanged, no other itching, no respiratory symptoms. Not working today - MD in practice. Feels well enough to leave. Will follow up with her allergist.
59 2021-01-19 redness, injection site pain, itchy skin, rash macular, hives Experienced weakness and dizziness immediately after the injection, which subsided in about 20 minut... Read more
Experienced weakness and dizziness immediately after the injection, which subsided in about 20 minutes. Two hours later, itching began on left leg and arms. Noted red blotches to these areas. Face began to feel very prickly and flushed, felt lower lip swelling and left eye began to feel funny. Observed one hive to cheek. Was able to take a Benadryl 25mg capsule within about 10-15 minutes after this developed. Symptoms began to subside after this. Felt back to normal the next day. Just moderate injection site pain for 1-2 days.
59 2021-01-20 injection site pain Chills Fatigue Headache injection site soreness
59 2021-01-20 injection site pain Pain at injection site Arm, shoulder, neck pain Headache Fatigue Chills Nausea
59 2021-01-20 vaccination site pain severe heartburn; Soreness at injection site; Fatigue; Fever up to 101.8; achenes and weakness; ache... Read more
severe heartburn; Soreness at injection site; Fatigue; Fever up to 101.8; achenes and weakness; achenes and weakness; first dose of BNT162B2 on 20Dec2020/second dose on 06Jan2021; This is a spontaneous report from a contactable other healthcare professional (HCP, patient). A 59-year-old female patient (pregnant: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) intramuscular at left arm on 06Jan2021 13:00 at single dose for COVID-19 immunization. Medical history included diabetes and hypertension. no allergies to medications, food, or other products. other medications in two weeks included hydrochlorothiazide, lisinopril, atorvastatin, metformin and colecalciferol (D3) and fish oil, tocopherol (OMEGA 3 [FISH OIL;TOCOPHEROL]). the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously took first dose of BNT162B2 (brand=Pfizer, Lot number: EJ1685) on 20Dec2020 04:00 PM via intramuscular at left arm at single dose for COVID-19 immunization (59 years old) and had muscle soreness at greater injection site. Patient experienced soreness at injection site, Fatigue, Fever up to 101.8, severe heartburn, achenes and weakness, all on 07Jan202101:00 AM. Prior to vaccination, the patient was not diagnosed with COVID19. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the events. Patient was recovering from the events. It was non serious case. Not results in death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating nor congenital anomaly/birth defect.
59 2021-01-21 injection site pain Mild myalgia, malaise, soreness of injected arm
59 2021-01-21 injection site redness, injection site pain, injection site warmth, injection site hardening Pfizer-BioNTech COVID-19 Vaccine EUA: Patient presents to the emergency department with redness, ind... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Patient presents to the emergency department with redness, induration, pain, warmth, and tenderness in right arm where vaccinated one day earlier. Patient prescribed antibiotics and advised to take acetaminophen, ibuprofen, and diphenhydramine as needed. Patient discharged stable to home.
59 2021-01-21 shingles Pt received dose 1 of Pfizer vaccine on 12/23/2020. Starting 1/4/2021, pt develped numbness and ting... Read more
Pt received dose 1 of Pfizer vaccine on 12/23/2020. Starting 1/4/2021, pt develped numbness and tingling of left arm, cheek, and tongue lasting 1.5-2 minutes. Numbness starts in elbow and radiates up and down arm. These episodes happen at various times thorughout the day. Sometimes her arm feels heavy. Has had an episode involving lip numbness that affected her seaking. Sometimes gets hot flashes lasting a few seconds. She contacted PCP to re-establish care on 1/11/21 after about 2 weeks of consistent, infrequent episodes. Never experienced this before. On 1/14 pt had an in person visit where she was evaluated by PCP. At ambulatory visit, BP 174/96. Other vital signs normal. Upper extremity exam: wrist (left, Phalen's test positive, Tinel test positive, no deformity, no crepitus), wrist (right, normal range of motion, Phalen's test negative, Tinel test negative), hand grips 5/5 bicep 5/5 tricep 5/5. Differential diagnosis: TIA, carpal tunnel syndrome, transient neurological event, shingles, hypertensive urgency. Anxiety could be component as well. Pt started ASA 81 mg QD and amodipine 5 mg QD. Plan to get carotid Dopplers to rule out TIA/stroke. Consider MRI in the future. 1/16/21: Pt developed left arm/leg numbness and tingling 0530 and reported to ED with stroke-like symptoms. During this encounter, pt states that she experiences these 1-3 minute episodes of tingling/numbness every hour or so (initially only had 1-2 per day, became more frequent in days immediately preceding 1/16). Pt reports not being able to stand that morning due to weakness in lower extremeties, though the symptoms resolved after sitting down. The patient denies any weakness to the right side, along with any family hx of stroke or headache. She takes omeprazole, amlodipine, and a baby aspirin daily. She does not currently follow up with a neurologist. The patient had lab work done yesterday and also recently had a US of her carotid artery which was unremarkable. She denies any weakness, numbness, or tingling currently. There are no other concerns at this time. The onset was 3 weeks ago. The course/duration of symptoms is worsening and episodic: lasting 3 minutes and with a frequency of every hour. Location: Left face, left upper extremity, left lower extremity. The character of symptoms is weakness, tingling and numbness. SBP 182/86. Temp 97.6 F. CT head ngative, bloodwork unremarkable, chest X-ray negative. Pt admitted for MRI of brain and C-spine. 1/17/21: Hospital notes note that symptoms apear to worsen when pt is stressed or she talks about it. MRI of brain w/ and w/o contrast completed and unremarkable. Pt declined C-spine MRI with and without contrast. Pt discharged. 1/19/21: Pt presented to outpt ambulatory appointment to follow up with worsening episodes of tingling in left arm/leg, numbness and tingling in mouth - is now effecting balance. Considering testing for other diseases such as syphilis, Lyme disease, multiple sclerosis, Guillaine-Barre. Priority status on referral to neurologist.
59 2021-01-21 rash, rash with redness, itchy skin Received 1st dose of vaccine on 12/21/2020. Developed rash and itchiness on (R) hand between (2) m... Read more
Received 1st dose of vaccine on 12/21/2020. Developed rash and itchiness on (R) hand between (2) middle and (3)ring finger a couple days afterward. Started to go away. Received second dose of COVID-19 on 1/11/2021. Rash continued to worsen. Noticed red rash on neck starting around 1/17/2021. Describes as "just a few red bumps and really itchy". "It felt like poison ivy itching". 1/20/2021, rash appeared to look like hives, swelling, and itchiness intensified. 1/22/2021, swelling subsided some, continues with rash and itchiness.
59 2021-01-21 injection site pruritus, injection site redness, injection site warmth, injection site swelling WITHIN 24 HOURS I DEVELOPED A MILD HEADACHE AND THE INJECTION SIGHT IS RED, WARM, SWOLLEN AND THE SI... Read more
WITHIN 24 HOURS I DEVELOPED A MILD HEADACHE AND THE INJECTION SIGHT IS RED, WARM, SWOLLEN AND THE SIZE OF AN HALF DOLLAR. THE LYMPH NODE ON MY RIGHT SIDE IS ALSO SWOLLEN. ON DAY 2, I HAD FLU LIKE SYMPTOMS WITH A FEVER OF 100.8 THAT SUBSIDED WITH TYLENOL. THE INJECTION SITE BECAME ITCHY ON DAY 3 AND IS STILL RED, WARM, SWOLLEN AND THE SIZE OF AN EGG AND MY LYMPH NODE IS STILL SWOLLEN AND SORE.
59 2021-01-23 injection site pain, injection site swelling, injection site redness 8 days after the vaccine was given , injection site became sore, swollen and red. There had been no ... Read more
8 days after the vaccine was given , injection site became sore, swollen and red. There had been no problem when vaccine was given 8 days earlier other that a heavy feeling in arm for a few hours, but then all S/s disappeared.
59 2021-01-23 dry skin Swollen bottom Lip, tongue, prickly skin, burnining nostril, headache, fatigue
59 2021-01-24 injection site pain PAIN INJECTION SITE, HEADACHE, CHILLS,PAIN ON JOINTS, TIRED,FEVER BODY PAIN. SINTOMES FOR 3 DAYS.
59 2021-01-24 injection site swelling Patient submitted MyChart message as below detailing her adverse reaction to COVID-19 vaccine: "Hell... Read more
Patient submitted MyChart message as below detailing her adverse reaction to COVID-19 vaccine: "Hello, I received my first Pfizer COVID vaccine on Friday Jan 22 at a health care program. On Friday I felt no arm discomfort, but had a stomach ache all day. Saturday I was very tired and in the evening I noticed my left shot shoulder/arm pit area, bra line area was swollen and uncomfortable. Woke up in the night feeling like my left arm pit, and breast area was more swollen and if I had to paint it I would describe it as tiny bubbles all enlarged underneath my skin. Guessing it is my lymph nodes? This unusual feeling has since spread to the left side of my neck inside my throat and out. It is not painful, I have taken a warm shower, only wearing loose, comfy clothing and am sitting with a warm bean pillow on my neck. I just wanted to report how I am feeling if others are having similar reactions."
59 2021-01-24 hives hives started 30 minutes after vaccine administered, then she started feeling wheezy and tongue th... Read more
hives started 30 minutes after vaccine administered, then she started feeling wheezy and tongue thickness. Rapid response team notified. Epinephrine given and patient transported to ER
59 2021-01-24 injection site bruising, injection site swelling, injection site pain soreness at injection site x 2 days, bruising, and edema at site of injection x ~ 1 week, Diarrhea ... Read more
soreness at injection site x 2 days, bruising, and edema at site of injection x ~ 1 week, Diarrhea x 5-8 days, colon pain/inflammation x 3-4 days, indigestion/chest heaviness continue til yesterday not as bad worse the first 3 to 8 days, now briefly during day
59 2021-01-25 itchy rash Pruritus / Rash.
59 2021-01-25 shingles Shingles; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored pr... Read more
Shingles; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A 59-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Dec2020 at 12:00 at single dose in left arm for COVID-19 immunisation at the age of 59-year-old. Lot number was EJ1686. Medical history and concomitant medications were unknown. Patient received SHINGRIX in 2020 and shingles vaccine in 2011 (also reported in 2020), flu shot in 2020 (Sep2020 or Oct2020); all vaccines received for immunisation. On 12Jan2021, the patient developed Shingles; the patient did not visit the emergency room. The patient was due for the second dose of suspect vaccine on the 19Jan2021. The patient did not recover from the event.
59 2021-01-26 hives, itchy skin 1/19/21 headache, sore throat, muscle and bone pain, neck pain, nausea. Everything resolved on 1/20... Read more
1/19/21 headache, sore throat, muscle and bone pain, neck pain, nausea. Everything resolved on 1/20 and 1/21. 01/22/21 awakened at 4am with "head itching", dizzy, headache, numbness in arms, nausea. In the evening hives started on hands/back/legs. 01/23/21 Went to Urgent Care because hands "felt like I had them on a hot plate, burning".
59 2021-01-26 injection site inflammation Headache, left hand numbness, injection site inflammation and pain to right elbow, right scapula pai... Read more
Headache, left hand numbness, injection site inflammation and pain to right elbow, right scapula pain, diarrhea x2, nausea,
59 2021-01-26 hives, itchy skin Started itching all over her body mainly neck and back underneath hairline around 8:00 PM, when she ... Read more
Started itching all over her body mainly neck and back underneath hairline around 8:00 PM, when she got home still itching but worse. Got up to look in the bathroom and had hives on side of neck, back of neck, down her back, right leg and hands were itchy, feet itchy but no hives. Right now her hands are itchy and the bottom of her hands are itchy. Took Benadryl and the other symptoms have resolved. Fell asleep after the Benadryl. No markings at this time, just the palms of her hands and feet itching.
59 2021-01-26 injection site pain, injection site nodule, redness Throat tightness/numbness; Throat tightness/numbness; Shortness of breath w/min exertion; Dull chest... Read more
Throat tightness/numbness; Throat tightness/numbness; Shortness of breath w/min exertion; Dull chest pain; Right calf pain/cramping; Right calf pain/cramping; Fever; Chill; Body aches; Severe headache; Left arm swelling; left arm swelling, redness, knot; left arm swelling, redness, knot; Pain at injection site; Fatigue; This is a spontaneous report received from a contactable nurse (who is also the patient). A 59-year-old female patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown), intramuscular in the left arm, on 11Jan2021 07:30, at single dose, for COVID-19 immunization, in the hospital. Medical history included COVID-19 (COVID prior vaccination: Yes) and known allergies to penicillin and erythromycin. There were no concomitant medications. Historical vaccine included the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date: unknown), intramuscular in the left arm, on 23Dec2020 07:15, for COVID-19 immunization. The patient experienced shortness of breath w/min exertion, right calf pain/cramping, fever, chill, body aches, severe headache, left arm swelling, redness, knot and pain at injection site, dull chest pain, fatigue, throat tightness/numbness on 11Jan2021. The events resulted to emergency room/department or urgent care visit. The patient did not receive treatment for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events was not recovered.; Sender's Comments: The 59-year-old patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021, and experienced shortness of breath w/min exertion, dull chest pain, throat tightness/numbness and other symptoms on the same day. Considering plausible temporal relationship, the events were probably related to the second dose of BNT162B2. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
59 2021-01-26 vaccination site pain chills; achy back; low fever; injection site pain; This is a spontaneous report from a contactable o... Read more
chills; achy back; low fever; injection site pain; This is a spontaneous report from a contactable other health care professional. A 59-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el 3248 and expiration date not provided), intramuscular (right arm) first dose on 12Jan2021 12:00 at single dose for covid-19 immunisation. The patient's medical history included psoriasis, seasonal allergies, and If COVID prior vaccination: Yes. The patient's concomitant medication included oxymetazoline hydrochloride (CLARITIN EYE ALLERGY RELIEF), ergocalciferol (VIT D), vitamin c [ascorbic acid], and zinc. On 13Jan2021 07:00, the patient experienced chills, achy back, low fever, injection site pain. No treatment was given to the events. The outcome of the events was not recovered. No other vaccine was taken within four weeks and not tested for Covid post vaccination.
59 2021-01-27 injection site swelling Back and joint pain Lymph node swelling Injection site swellingf Fever
59 2021-01-27 vaccination site pain, redness Covid vaccine- injection site pain; her face and neck is red like a sunburn; her face stings; This i... Read more
Covid vaccine- injection site pain; her face and neck is red like a sunburn; her face stings; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number not known) via an unspecified route of administration on 11Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had been allergic to Bactrim since that age of 20 and she had she blisters on her lips. The patient had her first dose of Pfizer Covid vaccine on Monday, 11Jan2021 and after that in Jan2021, her face and neck were red like a sunburn. She said she had injection site pain, her face stings and it has been two days out. She wanted to know if she should get her second shot. The outcome of the events was unknown. Information about lot/batch number has been requested.
59 2021-01-27 hives, rash Exacerbation of exema on hands Hives on both inner forearms ,back and chest
59 2021-01-27 injection site bruising, injection site pain bruising to site, painful, next day very tired with blurry vision, aching pain
59 2021-01-28 itchy skin Initially itching arms, legs, chest Lose of voice Shortness of breath Headache After 12 hours fever... Read more
Initially itching arms, legs, chest Lose of voice Shortness of breath Headache After 12 hours fever and tiredness
59 2021-01-28 injection site pain Pain in the arm pit of the arm vaccinated, painful to sleep with tired feeling next morning. Took ... Read more
Pain in the arm pit of the arm vaccinated, painful to sleep with tired feeling next morning. Took Aleve which minimized the pain.
59 2021-01-28 redness Swelling and redness of the arm, the size of an orange; Swelling and redness of the arm, the size of... Read more
Swelling and redness of the arm, the size of an orange; Swelling and redness of the arm, the size of an orange; Headaches; Tiredness; Feeling unwell; This is a spontaneous report from a contactable other health professional. A 59-year-old female patient (pregnant: No) received second dose of bnt162b2 (lot number: EL1283), intramuscularly in left arm on 12Jan2021 16:00 at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included sertraline hydrochloride (ZOLOFT), ibuprofen. The patient previous received first dose of bnt162b2 (lot number: EK5730) intramuscularly in left arm on 21Dec2020 11:30 AM for COVID-19 immunization. The patient experienced swelling and redness of the arm, the size of an orange, headaches, tiredness, feeling unwell on 13Jan2021 06:00. No treatment received. The outcome of events was resolving. The event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No covid prior vaccination. No covid tested post vaccination. Not known allergies. Facility type vaccine was hospital. No other vaccine in four weeks.
59 2021-01-29 hives, itchy skin Hives began 5 minutes following injection, located on upper arm at site of injection. This spread t... Read more
Hives began 5 minutes following injection, located on upper arm at site of injection. This spread to opposite arm within 5 minutes. BP at this time was 148/98, HR 90, no difficulty breathing, chest pain, SHOB, headache. Over following 45 minutes this spread to patient's back, abdominal area, then to upper legs, then lower legs. 25mg Benadryl chewable given to patient at 15 minutes following start of hives. No change in level of itching associated with hives, or progression of hives to other parts of her body. Additional 25mg Benadryl chewable given to patient 15 minutes after initial dose. 30 minutes after second dose of Benadryl, patient experienced reduction in itching in upper body.
59 2021-01-30 itchy skin, redness Patient exhibited red and itchy face and eyes. Was given 50 mg of Benadryl P.O. symptoms decreased a... Read more
Patient exhibited red and itchy face and eyes. Was given 50 mg of Benadryl P.O. symptoms decreased and B/P 180/104. H/R 120. Discharged 170/98 B/P HR 111 bpm. Discharged with her husband driving. Advised to follow up with hospital and to follow up with her PCP before anymore immunizations.
59 2021-01-31 injection site pain Date of symptom onset ? 1/29/21 at 5:45 PM? Symptoms ? EE reports approximately 1 hour after vaccin... Read more
Date of symptom onset ? 1/29/21 at 5:45 PM? Symptoms ? EE reports approximately 1 hour after vaccine she began feeling dizzy, lightheaded and pain at injection site. EE denies syncope. + nausea without emesis On Saturday, EE reports continued dizziness and lightheadedness, denies syncope. + joint pain. On Sunday, improvement in symptoms. On Monday, + lightheadedness, no syncope. EE denies fever, recent travel or exposure to COVID-19 without proper PPE. Last day of work and shift - ? 2/1/21 currently at work Home remedies? - rest Any improvement? - yes Recommendation? EE educated to increase fluid intake for hydration and to take ibuprofen as directed in the Medical for joint pain. EE educated to continue to monitor her symptoms and to contact vaccine support line for further questions or concerns. EE educated to manage her symptoms per the TCH Illness in the Workplace Policy. EE verbalized back understanding and denied further needs at this time.
59 2021-01-31 injection site pain Fatigue sent in @ 8:00 pm. Soreness at site of injection, chills, over all muscle/body ache & heada... Read more
Fatigue sent in @ 8:00 pm. Soreness at site of injection, chills, over all muscle/body ache & headache set in around 1:00 a.m. 1/29. All five symptoms persisted throughout day of 1/29, relieved w/ x-strength Tylenol (1000 mg) & ibprophen (400 mg) taken simultaneously 2x that day. 1/30, injection site cont. to be sore and experienced general "logey" feeling all day. 1/31, injection site still sore, but no other malaise.
59 2021-01-31 itchy skin Patient developed pruritis on arms/back and felt some minor throat tightness. Minutes later, itchin... Read more
Patient developed pruritis on arms/back and felt some minor throat tightness. Minutes later, itching had spread but no tightness in airway. Patient was sent to ER for further evaluation and discharged without complication after brief observation.
59 2021-01-31 injection site bruising Severe bruising all around injection site, and diarrhea with blood in the discharge both starting on... Read more
Severe bruising all around injection site, and diarrhea with blood in the discharge both starting on 01/29/2021
59 2021-01-31 rash with redness, bruising red rash; bruise; slight nausea; slight feeling of fever but temp registered normal; This is a spont... Read more
red rash; bruise; slight nausea; slight feeling of fever but temp registered normal; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number BNT162b2), at age of 59-year-old via an unspecified route of administration in left arm on 31Dec2020 11:00 at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included levothyroxine sodium (SYNTHROID), valsartan, rosuvastatin (ROSUVASTATIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. The patient was not pregnant at Time of Vaccination. The patient experienced red rash, bruise, slight nausea, slight feeling of fever but temp registered normal on 12Jan2021 01:00 with outcome of recovering. The patient received topical antibiotic, diphenhydramine (BENADRYL) for treatment. The events resulted in doctor or other healthcare professional office/clinic visit.
59 2021-02-01 injection site pain Next day following 2nd dose of Pfizer vaccine, developed a sore left arm at the injection site. that... Read more
Next day following 2nd dose of Pfizer vaccine, developed a sore left arm at the injection site. that evening felt exhausted after work, fell asleep around 6:30 pm woke up around 8 pm and went to bed around 9:30 pm took Aleve for achy body. Friday morning, Jan 27th woke up with left arm pit and side of left breast swollen, tender to touch. and left arm very sore to lift up. Apply cold packs, taking Tylenol and area of tenderness lasting multiple days.
59 2021-02-02 itchy skin, hives PATIENR RECEIVED 2ND DOSE AT AROUND 11 AM, CAME BACK AT AROUND 1230 PM COMPLAINNING OF ITCHINESS ALL... Read more
PATIENR RECEIVED 2ND DOSE AT AROUND 11 AM, CAME BACK AT AROUND 1230 PM COMPLAINNING OF ITCHINESS ALL OVER HER BODY. PATIENT WAS ASSESSED AND COULD SEE SMALL HIVES ON HER ARMS. ASKED PATIENT IF SHE IS EXPERIENCING DIFFICULTY BREATHING AND SHE DENIED. ADMINISTERED ONE DOSE OF BENADRYL LIQUID PROVIDED BY THE FACILITY. MONITORED PATIENT FOR AN ADDITIONAL 30 MINUTES AFTER RECEIVING BENADRYL. SHE SAID HER ITCHINESS WAS RELIEVED AND FELT GOOD ENOUGH TO RETURN BACK TO WORK.
59 2021-02-02 itchy skin Roscia-major flare occured in eyes/Continued to worsen over next 24 hours; severe itchiness; This is... Read more
Roscia-major flare occured in eyes/Continued to worsen over next 24 hours; severe itchiness; This is a spontaneous report from a contactable other Health Professional (patient). A 59-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on 18Jan2021 08:15 at single dose in left arm for COVID-19 immunization. Medical history included non allergic rhinitis and vestibular migraines. The patient had not known allergic, but very sensitive to SE. Concomitant medications included "sensimist", naproxen sodium (ALEVE), progesterone, estradiol. The patient had no covid prior vaccination and did not had covid tested post vaccination. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 28Dec2020 08:45 at single dose in left arm for COVID-19 immunization. No other vaccine was received in four weeks. The patient experienced roscia-major flare occurred in eyes within 2 hours of second vaccine on 18Jan2021 09:00. Continued to worsen over next 24 hours. Necessitated a trip to eye dr. Have never had a flare this serious. In addition, severe itchiness day vaccine given. Took antihistamine (Allegra) second day which solved issue. The event was resulted in doctor or other healthcare professional office/clinic visit. The patient received Neomycin & Polymyxin B Sulfates & Dexamethasone Op as treatment. The outcome of the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
59 2021-02-03 rash, itchy skin, injection site pain "Pfizer-BioNTech COVID - 19 Vaccine EUA" Developed a rash approximately one day after the injectio... Read more
"Pfizer-BioNTech COVID - 19 Vaccine EUA" Developed a rash approximately one day after the injection. Worse on the top half of my body. But itchy everywhere. Upper chest and lower next is a visible rash. The rest I can feel bumps and they itch but not visible to the eye. Itching is worse on my face and neck, including my eyes and nose. I do not appear to have any other symptoms besides site pain.
59 2021-02-03 itchy skin, hives, rash Patient reported itching/hives and an "itchy throat" during observation period post COVID vaccine. D... Read more
Patient reported itching/hives and an "itchy throat" during observation period post COVID vaccine. Denied throat swelling, SOB or respiratory distress. Patient was immediately given epi and IM Benadryl. Patient observed for 30 min. Vital signs were stable the entire observation period. Rash improved at discharge.
59 2021-02-04 vaccination site swelling Headache; Body aches; Swelling at site; This is a spontaneous report from a contactable nurse. A 59-... Read more
Headache; Body aches; Swelling at site; This is a spontaneous report from a contactable nurse. A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 20Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 30Dec2020 for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the Nursing Home/Senior Living Facility. On 20Jan2021, the patient experienced headache, body aches and swelling at site. The patient did not receive treatment for the events. Outcome of the events was recovering. The patient underwent nasal swab on 21Jan2021 and showed a negative COVID test result. Information about lot/batch number has been requested.
59 2021-02-04 vaccination site pain Sore at injection site; Severe nausea; vomiting; diarrhea starting 6 hours after injection; This is ... Read more
Sore at injection site; Severe nausea; vomiting; diarrhea starting 6 hours after injection; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Pfizer brand; lot number: Ek3246), via an unspecified route of administration on 13Jan2021 10:15 on left arm at a single dose for COVID-19 immunization. Medical history included psoriasis, lymphocytic colitis and allergies to pistachios (anaphylaxis). The patient's concomitant medications were not reported. The patient experienced sore at injection site, severe nausea, vomiting and diarrhea starting 6 hours after injection (pending clarification); all on 13Jan2021 14:30 (as reported). Then the same symptoms starting 22Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was at the hospital. The report was non-serious. The outcome of the events was recovered with sequelae.
59 2021-02-04 injection site pain Symptoms started a few hours after vaccination. Initial symptoms were injection site pain and tired... Read more
Symptoms started a few hours after vaccination. Initial symptoms were injection site pain and tiredness. I later developed a mild headache, moderate muscle and joint pain, to which I applied a heating pad. I then developed a low fever and chills. Temp was 99.7 11:30pm on Feb 4, and 99.9 at 10:20 on Feb 5. I then began to feel nauseous and generally terrible, so I went to the bathroom, where I fell and may have passed out.
59 2021-02-05 itchy skin, rash with redness, rash Red itchy spot rash on mid chest, both arms (more), and legs(less).
59 2021-02-06 rash Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest. T... Read more
Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest. Treatment: dexAMETHasone sodium phos (PF) given at 4:49 pm. diphenhydrAMINE (Benadryl) given at 4:46 pm. famotidine (PEPCID) given at 4:47 pm.
59 2021-02-06 itchy skin, hives Hives on back, itch and burn
59 2021-02-06 itchy skin, injection site pain, hives Pain, swelling (hive), itching, photophobia in Left eye, and pain in injection site Right arm.
59 2021-02-07 vaccination site pain Headache; Pain in the left arm; This is a spontaneous report from a contactable consumer (patient). ... Read more
Headache; Pain in the left arm; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration in the left arm on 25Jan2021 at 14:30 at 59-years-old at a single dose for COVID-19 immunization; administered in an unspecified facility (reported as "other"). The patient medical history was not reported. The patient did not have allergies to medications, food, or other products. Concomitant medications were unspecified; and the medications were received within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Jan2021 at 04:15, the patient experienced headache (non-serious) and pain in the left arm (non-serious); for which no treatment was received. The patient underwent lab tests and procedures which included polymerase chain reaction (PCR): negative on 21Dec2020, Nasal Swab (SARS-CoV-2 test): negative on 21Dec2020. The clinical outcome of the events was unknown. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19; no results were provided.
59 2021-02-07 vaccination site pain Mild agitation; soreness at injection site; Head/Brain Fog for 24 hours after injection; feeling "ou... Read more
Mild agitation; soreness at injection site; Head/Brain Fog for 24 hours after injection; feeling "out of it" and inability to concentrate fully; This is a spontaneous report from a contactable Consumer. A 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 11:00 at left arm at single dose for covid-19 immunization. The patient's medical history had allergic to other vaccine ingredients, particularly influenza vaccine ingredient. The patient's concomitant medication included Dietary Supplements. The patient received the first dose of BNT162B2 on 28Dec2020 14:00 at left arm for covid-19 immunization. The patient was not pregnant. The patient experienced mild agitation, soreness at injection site, head/brain fog for 24 hours after injection and feeling "out of it" and inability to concentrate fully on 19Jan2021 16:00. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events mild agitation, soreness at injection site and 'feeling "out of it" and inability to concentrate fully' was recovered on an unknown date in Jan2021, the outcome of the event head/brain fog was recovered on 20Jan2021 16:00. Information on the lot/batch number has been requested.
59 2021-02-08 itchy skin Tingling of tongue, facial itching.
59 2021-02-10 itchy skin 7:00am- 1- 24 hr zyrtec & 2 tylenol 8:07 received shot 8:10 immediate intense shooting shocks throug... Read more
7:00am- 1- 24 hr zyrtec & 2 tylenol 8:07 received shot 8:10 immediate intense shooting shocks through left arm down to fingertips... 8:30- shooting shocks through left arm and starting to throb down through hand ... shooting up through next and base of head 9:00am- random shocks throughout my whole body. shoulder pain. 10:30- shocks stopped somewhat, shoulder and arm still achy, extreme fatigue/weakness, fogginess, blurry vision 11:30- extreme fatigue/weakness, fogginess, kind of blurry vision, severe shaking rt hand, had to sit down. Needed to hang on to things to walk. 12:00pm- continued severe fatigue and brain fogginess & still minor blurry vision, and a few shooting shocks in arm, shoulder , neck, 1:00pm? still great fatigue/weak, body aches-more like shocks than aches Neck is especially sore? back of neck up through head 1:10pm- severe fatigue, eyes hurt, foggy vision and cannot focus? off and on? chest pain for a period of time 1:40pm- twinges through body, still extreme fatigue? fogginess, back of neck is super sore.. Shoulder is slightly sore? 2:00pm- shoulder sore, severe fatigue but other symptoms seem to be getting less?. 2:45pm- shocks in left arm? 4:00pm- went home from work? hard to drive and focus.. severe fogginess, disorientation, 4:20- laid on the couch? slept in between nausea, buzzing in my head, severe arm pain going down into my hand, random shocks throughout my body, could not focus, brain was fuzzy, random severe itching, neck pain, eye pain, extremely irritable, extremely thirsty, bad taste in my mouth, extremely cold, no fever, super sensitive to sound & touch, no appetite, trouble peeing, felt extremely dehydrated. Needed to hang on to things to walk. Fri, Feb 5 6:00am- next day? better, but still buzzing, ringing in my head, extremely exhausted & weak, arm pain radiating to hand, hard to focus, coughing, chest heaviness like an elephant sitting on it, sore, scratchy throat, drainage out of head but not stuffed up?, eyes hurt. Severe nausea & bloating, rt hand shaking badly, no appetite 9:30am- everything is a bit better, coughing & chest discomfort gone, still bad taste in my mouth, slight nausea, bloated, eyes hurt, extremely tired, entire arm sore, buzzing in my head?random twinges or jolts in my limbs? 11:00am- still super tired, still not peeing?... weird for me who pees every 2 hrs or so? Still really bloated? still buzzing in my head, 1:30pm- feeling better, no buzzing, no zinging, super tired and drinking a lot but not much peeing? 4:00pm- home and bed.. hard to sleep because of jolts though my body.. Sat, Feb 6 Normal body aches.. finally able to pee decently, arm and hand on shot side sore (this is my good hand side), shooting pain, and hand aching. Fatigue, This has continued into Monday.. arm and hand pain are off and on. Everything is getting better?
59 2021-02-10 itchy skin, redness Pt called in our triage line experiencing redness and swelling on Lt. side of face, states had vacci... Read more
Pt called in our triage line experiencing redness and swelling on Lt. side of face, states had vaccine given thru work and did well after administration. Woke up next day with swelling in Lt. side of face and puffiness, tried applying ice but caused itchiness, no other sxs reported. Pt was advised to come in and be seen in clinic for evaluation. pt then was added to the schedule same day 2/11/2021 @ 1:45pm .
59 2021-02-10 injection site redness Site: Redness at Injection Site-Mild
59 2021-02-10 shingles This is a spontaneous report from a Pfizer-sponsored program. A contactable physician reported that ... Read more
This is a spontaneous report from a Pfizer-sponsored program. A contactable physician reported that a 59-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number requested), intramuscular on 11Jan2021 at a single dose for COVID-19 immunization. Medical history included obesity from an unknown date and unknown if ongoing and ongoing stress. There were no concomitant medications. It was reported that the patient developed Shingles on 16Jan2021, which was 5 days after receiving the first dose of the COVID-19 vaccine, on 11Jan2021. The patient received Valtrex as treatment for the event. The physician stated that she wants to say that it was not serious but she is not sure but reported that the patient is ok. This was the first time the patient was diagnosed with shingles. The physician added that the patient's lesions are getting better but she still has nerve pain and was prescribed gabapentin. It was also reported that the patient stated that there are other reasons such as stress as to why she developed shingles, like loss of a family member and loss of her client. It was clarified that the patient is stressed since she works for a senior care facility and co-workers and clients have lost their lives. She lost her mom last year and stated that she basically has stress in her life. The patient is scheduled for her second dose on 01Feb2020 and asked the physician if she could get the second dose. The physician doesn't see any reason why the patient wouldn't be able to receive it. The physician did not think it was a problem but she called Pfizer to ask if the patient should get the second dose and asked for recommendations on administering the second dose to her patient. The outcome of the event was recovering. Information on the lot/batch number has been requested.
59 2021-02-10 injection site pain first injection 01/21/2020- resulted in painful left deltoid region- similar to that after a tetanus... Read more
first injection 01/21/2020- resulted in painful left deltoid region- similar to that after a tetanus shot. swelling, pain to touch and pain with movement or when positioned onto that side. decreased over 36-48 hours second injection 02/09/2020 306 pm received injection left deltoid. Awakened at 1237 am 02/10/2020 with chills, inability to get warm, headache, lightheadedness, sensation of heart pounding, nausea and moderate site tenderness. up most of the night. Nausea resolved about 10 hours after the symptoms resolved, remained without appetite. Fatigue, overall just tired, just not feeling well. temp max about 20 hours after onset of symptoms 101.5 temp broke when awakened from sleep in sweat at 327am 02/11/2020. on /2/11/2020 7am mild- moderate intermittent headache persists. Easy fatigue-as an example- fed cat took dog out and was tired and went back to bed.. Appetite better. felt better than I had on 02/10/2020, but not normal. Noted upon awakening is left axillary lymphadenopathy moderate and mild on the right- unable to press arms down to side as increased pain. also supraclavicular tenderness.
59 2021-02-10 itchy skin, redness she had all these red dots on her shin, they were itchy and she scratched them and they bled; she ha... Read more
she had all these red dots on her shin, they were itchy and she scratched them and they bled; she had all these red dots on her shin, they were itchy and she scratched them and they bled; She had all these red dots on her shin, they were itchy and she scratched them and they bled; This is a spontaneous report from a contactable consumer, reporting for herself. A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number), via an unspecified route of administration at the left arm on 26Jan2021 12:00 at a single dose for COVID-19 immunization. Vaccination was done in a nursing home. Vaccine was not administered at military facility. Medical history included inflammation post-surgery for cataract and detached retina, from an unknown date and unknown if ongoing. Concomitant medication included ketorolac tromethamine for inflammation post-surgery for cataract and detached retina. The patient previously received a flu shot on 29Dec2020 for immunization. The patient had the vaccine on Tuesday, 26Jan2021 and didn't look yesterday but today, 28Jan2021, she noticed capillaries at the surface of her skin, red dots, itchy and when she scratched them, they bled. She was asking if this was a side effect and should she be concerned about getting the second dose? It was reported that when she got out of the shower today 28Jan2021, she had all these red dots on her shin, they were itchy, and she scratched them and they bled. The area was about five or six inches long and inch to two inches wide. After she blotted it with her towel, it stopped bleeding and it has scabbed up pretty quickly. She mentioned she has pictures to provide. The patient was scheduled to receive the second dose of the vaccine on 16Feb2021. No hospitalization.No additional vaccines administered on same date of the Pfizer suspect. The outcome of the even itchy was recovered on 28Jan2021 while the outcome of all other events was recovering. Information on the lot/batch number has been requested.
59 2021-02-11 injection site warmth, injection site nodule, injection site redness Dose 1 just got a little red at site of injection & i was a little tired. (was received on 1/18/21 @... Read more
Dose 1 just got a little red at site of injection & i was a little tired. (was received on 1/18/21 @ 9:30am) Dose 2 it got red, hot & a lump at the site of injection. Also, had lump under armpit, was told it was lymphadenopathy, had moderate pain in lower back & mild pain in other joints, also developed fever of 99.4 (my normal temp is 97.4) & chills. This was mostly on the 1st & 2nd day after the vaccine. the swelling under armpit & in arm are better but not completely gone yet & it is now day 4 after the injection (injection on 2/8/21) (was received on 2/8/21 @ 10:37am)
59 2021-02-14 rash Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; A... Read more
Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL9269), via an unspecified route of administration into left arm on 06Feb2021, at 15:15 as first single dose for covid-19 immunization. Medical history included high blood pressure from an unknown date, known allergies to peanuts, tree nuts from an unknown date (elaborated as allergies to peanuts, non-steroidal-anti-inflammatory drugs (NSAIDs), tree nuts, penicillin), from unknown dates. Concomitant medication included lisinopril (MANUFACTURER UNKNOWN) and unspecified multivitamins. No other-vaccines were given with four weeks. On 06Feb2021, at 15:45, the patient experienced adverse event: anaphylaxis reaction. high blood pressure. body shivering. rash on neck and chest. The events were serious as they were life-threatening. The events were noted as resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and was life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included blood pressure measurement: high on 06Feb2021. Therapeutic measures were taken as a result of the adverse events; dexamethasone sodium phos- diphenhydramine (BENADRYL), famotidine. No covid infection was noted prior to vaccination. No covid test has been administered post vaccination. The outcome of events was recovered in Feb2021.
59 2021-02-14 vaccination site swelling, vaccination site redness, vaccination site pain Naseau and vomiting commencing the following day and continuing for 24 hours; Naseau and vomiting co... Read more
Naseau and vomiting commencing the following day and continuing for 24 hours; Naseau and vomiting commencing the following day and continuing for 24 hours; Redness and swelling and acute pain at site of injection Aches; Redness and swelling and acute pain at site of injection Aches; Redness and swelling and acute pain at site of injection Aches; Pains in arm radiating in back and shoulder; Pains in arm radiating in back and shoulder; Pains in arm radiating in back and shoulder; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jan2021 at 16:30 at single dose in Right arm for covid-19 immunisation. Patient was not pregnant.Medical history included allergies to cefalexin (KEFLEX), codeine and sulfa.Concomitant medication included escitalopram oxalate and omeprazole (PRILOSEC) . Patient experienced naseau and vomiting commencing on 28Jan2021 at 10:00 and continuing for 24 hours. On 28Jan2021 at 10:00 patient also had redness and swelling and acute pain at site of injection, aches and pains in arm radiating in back and shoulder.No treatment given. Final outcome of the events was recovering. Information on the lot/batch number has been requested.
59 2021-02-14 injection site pain injection site pain - tiredness - headache - muscle pain - chills - joint pain - fever 101.9 - nause... Read more
injection site pain - tiredness - headache - muscle pain - chills - joint pain - fever 101.9 - nausea - feeling unwell
59 2021-02-15 redness Four hours after receiving the vaccine noticed that voice was lower and had a wet cough, "breathing ... Read more
Four hours after receiving the vaccine noticed that voice was lower and had a wet cough, "breathing was noisy. and noticeable" States breathing was not difficult but it felt like, "my chest was not right." About 12 hours later back to breathing normally. Tongue looks like all taste buds are gone on one section of tongue. Color is different than rest of tongue. Noticed metal taste on tongue on 02/11/2021 two days after vaccine. Food does not taste the same. Continues to have these concerns. 02/15/2021 chest was "pinkish, lacy redness." This was gone by 02/15/2021
59 2021-02-15 injection site redness, injection site inflammation, injection site pain, injection site swelling, hives approximately 2 hours day after receiving the 2nd vaccination ( vaccination was given approximatel... Read more
approximately 2 hours day after receiving the 2nd vaccination ( vaccination was given approximately 3:15 pm and welt on my right forehead about 530 pm) i took Benadryl and fell asleep. When I woke about 3 hours later the welt was gone. The next day redness started at the injection site. It was slight. That Sunday evening 07Feb2020, the left arm was swollen a bit painful and very red. I took ibuprofen and Benadryl. The next day, Monday, the site was inflamed, i had to take off from work that day. I iced the arm with minimal improvement. That Wednesday, it appeared as if the redness was expanding. I noticed a new area. I showed my arm to an immunologist who recommended I try Zyrtec and Motrin. I took Zyrtec for three nights . I noticed decreased redness and swelling after the first dose of Zyrtec. After the third dose my arm was better. No swelling or redness.
59 2021-02-16 injection site pain Weakness, fatigue, injection site sore, clouded thought process. Slept for 10 hours. Woke up to n... Read more
Weakness, fatigue, injection site sore, clouded thought process. Slept for 10 hours. Woke up to no other symptoms except sore arm.
59 2021-02-18 shingles reaction to that of shingles. headache, nausea, burning/tingling sensation one side of body with sma... Read more
reaction to that of shingles. headache, nausea, burning/tingling sensation one side of body with small breakout and pain in breakout area. this began approx. 2 weeks after last covid 19 dose.
59 2021-02-21 injection site redness I went to get my second Covid - 19 Pfizer- BioNTech vaccine Saturday night 2/20/21 at 7:30 pm. The... Read more
I went to get my second Covid - 19 Pfizer- BioNTech vaccine Saturday night 2/20/21 at 7:30 pm. The nurse wiped my right arm with alcohol, threw out the wrapper, and then got the vaccine. I was in the passenger side so she needed to open the door. I felt the needle go in my arm, but a line of liquid went down my arm to my wrist as she gave the shot. I asked if that was supposed to happen and the nurse said "it was the alcohol". I was concerned since the alcohol had already been wiped on my arm and I would have felt that when she wiped it. I am concerned because the liquid came out when the shot was given. I am now worried that I didn't get the vaccine. My arm is red where the injection was but I have no side effects. I need to report this since it did not seem right and I don't know if the vaccine was given to me fully.
59 2021-02-21 injection site pain Low fever, chills, slight aches in joints... sudden onset, reminded me of flu. (Pain at injection s... Read more
Low fever, chills, slight aches in joints... sudden onset, reminded me of flu. (Pain at injection site was expected!)
59 2021-02-22 injection site pain 02/13/2021 I developed mild side effects of pain at injection site & minor body aches, These resolv... Read more
02/13/2021 I developed mild side effects of pain at injection site & minor body aches, These resolved on 02/14/2021. 02/15/2021 I developed an altered sense of smell. I smell an medicinal or chemical smell. Husband does not smell this so it is not an environmental odor. Received a covid test on 02/22/2021 which was negative. The altered sense of smell is still persisting. Notified my doctor of it & she asked that I notify the CDC as it may be a potential side effect from covid vaccine.
59 2021-02-23 vaccination site pain, hives Very painful arm 6-14 hours after injection; one hive on left forearm; pain and pressure in head thr... Read more
Very painful arm 6-14 hours after injection; one hive on left forearm; pain and pressure in head through today; pain and pressure in head through today; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration on 20Jan2021 07:45 AM at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. The patient did not receive any other vaccines weeks prior to receiving bnt162b2. The patient was not pregnant. Prior vaccination, the patient was not diagnosed with covid. Medical history included prone to headaches. She had no known allergies. Concomitant medications included clarithromycin (CLARITIN), dextroamphetamine [dexamfetamine], fish oil, and "Olly multivit". On 20Jan2021 02:00 PM, the patient experienced very painful arm 6-14 hours after injection; one hive on left forearm; pain and pressure in head through today, Day 6 after vaccine, and counting. No corrective treatment was received. Outcome of the events was not recovered. The patient was not tested for covid post vaccination. Information on the lot/batch number has been requested.
59 2021-02-23 redness small sore throat; little bit of congestion; lot of aches and pains; very tired; her face was flushe... Read more
small sore throat; little bit of congestion; lot of aches and pains; very tired; her face was flushed and ordinarily she wouldn't think this was odd, but it was under her eyes, and she doesn't usually have under her eyes red too; her face was flushed and ordinarily she wouldn't think this was odd, but it was under her eyes, and she doesn't usually have under her eyes red too; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, lot number: EL1284, expiry date: 31Apr2021), via an unspecified route of administration on the left arm, on 15Jan2021 09:30, at single dose, for covid-19 immunization. Medical history included heart issues from an unspecified date, cardiac ablation in 2020, total knee replacements on 2001 (approximately 20 years ago) and 2009 (approximately 12 years ago), spinal fusion surgery in 2017 (3 fused disc in her back approximately 4 years ago). Concomitant medication included cortisone which started on 21Jan2021 (as reported, pending clarification) for an unspecified indication. In Jan2021 (reported as "Saturday morning"), the patient experienced small sore throat, a little bit of congestion, a lot of aches and pains, and felt very tired. She was calling because she didn't know if it was possible if she could be having a reaction. She stated she had one other symptom, her face was flushed and ordinarily she wouldn't think this was odd, but it was under her eyes, and she doesn't usually have under her eyes red too. Treatment for the events small sore throat, a little bit of congestion, a lot of aches and pains, and felt very tired included Mucinex Night Shift Cold and Flu syrup, Halls Relief lozenges and Advil. The patient reported that her symptoms have stayed about the same. The patient took her temperature on an unspecified date and reported that it was fine. She reported she did not any lab tests done for the events. The outcome of the events was not recovered.
59 2021-02-24 rash Difficulty breathing; swelling in face, neck, throat and tongue; swelling in face, neck, throat and ... Read more
Difficulty breathing; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; elevated heart rate; rash on face, neck and chest; Enlarged lymph nodes; dizziness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on right arm on 09Feb2021 at 15:45 at a single dose for COVID-19 immunisation in the hospital. Medical history was none. The patient had no allergies to medications, food, or other products. Concomitant medications included furosemide (LASIX) and other blood pressure meds (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. On 09Feb2021, at 16:45 the patient had difficulty breathing, swelling in face, neck, throat and tongue, elevated heart rate, rash on face, neck and chest, enlarged lymph nodes and dizziness. The patient assessed the events as non-serious. Steroids, Benadryl, Pepcid, antibiotics were given as treatment in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient was recovering from the events.
59 2021-02-24 vaccination site pain Fever 100-103; severe chills; body and joint aches; body and joint aches; weakness; fatigue; swollen... Read more
Fever 100-103; severe chills; body and joint aches; body and joint aches; weakness; fatigue; swollen lymph glands right armpit; sore injection site; This is a spontaneous report received from a contactable nurse (who is also the patient). A 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3247, expiry date: unknown), via an unspecified route of administration on the right arm, on 25Jan2021 12:30, at single dose, for COVID-19 immunization, at the workplace clinic. Medical history included penicillin allergy, hypertension (HTN), obesity, hypothyroidism, iron deficiency anemia, s/p gastric bypass in 2010 (11 years), and GERD. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination. Concomitant medications (other medications in two weeks) included amlodipine benazapril, levothyroxine and pantoprazole. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL0140, expiry date: unknown) received at 59 years of age, via an unspecified route of administration on the left arm, on 04Jan2021 12:30, for COVID-19 immunization. The patient did not receive other vaccines in four weeks. On 26Jan2021 at 01:00, the patient experienced fever 100-103, severe chills, body and joint aches, weakness, fatigue, swollen lymph glands right armpit and sore injection site. The patient was not tested for COVID-19 post vaccination. No treatment was given for the events. The patient was recovering from the events.
59 2021-02-24 injection site swelling, injection site pain injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swe... Read more
injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, nausea, feeling unwell, numbness and tingling in left hand thumb and pointer finger
59 2021-02-25 rash immediately after the MA gave injection a rash occurred B/L arms, edematous orbital rash appeared, B... Read more
immediately after the MA gave injection a rash occurred B/L arms, edematous orbital rash appeared, B/L face swelling, followed by rash on back of neck
59 2021-02-26 rash papular 2/23/21 1 week after my first dose, I started getting a pimply rash on my lower back. Since then th... Read more
2/23/21 1 week after my first dose, I started getting a pimply rash on my lower back. Since then the rash has moved to my front torso, then my legs and arms. Today it is pretty much all over. I'm a little concerned because I've had the Zika virus and the shingles virus. I've tried taking Benandryl which helps a little.
59 2021-02-27 redness Face turned red for about 2 hours, swollen face
59 2021-02-27 rash, hives Within 5 minutes developed hives rash on face, neck and chest. Upon advise of personal physician, to... Read more
Within 5 minutes developed hives rash on face, neck and chest. Upon advise of personal physician, took 50 mg of Benadryl. Medical staff on site recommended being checked out by an ambulance EMT crew, due to ongoing hives and very high blood pressure reading by them. Ambulance called by site medical personnel, ambulance crew strongly recommend transport to ER. Went in ambulance to Hospital ER. In ER for roughly 3.5 hours for observation and vital signs monitored until rash subsided and blood pressure went down.
59 2021-03-01 injection site pain Day 1-Day 5 Injection site soreness Day 1-Day 5 Deep Joint Pain Day 3-Hematuria Day 5-Headache
59 2021-03-01 hives approximately two hours after receiving my vaccination my left ear swelled, a hive came out on my le... Read more
approximately two hours after receiving my vaccination my left ear swelled, a hive came out on my left cheek and my upper lip swelled. The swelling stayed itchy for about 3 hours
59 2021-03-02 hives 20min post vaccination patient complained of numbness of tongue, flushing, with hives on chest. Pat... Read more
20min post vaccination patient complained of numbness of tongue, flushing, with hives on chest. Patient was given 50mg of PO diphenhydramine and was monitored for 60 min. Refused call to 911. Flushing and warmth had abated and left clinic under own volition.
59 2021-03-02 rash papular, itchy rash diffuse pink rash with white bumps over back and abdomen, to a smaller degree on arms. Also pruritis... Read more
diffuse pink rash with white bumps over back and abdomen, to a smaller degree on arms. Also pruritis on back abdomen arms and legs.; diffuse pink rash with white bumps over back and abdomen, to a smaller degree on arms. Also pruritis on back abdomen arms and legs.; Mild scratchy throat; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3249), via an unspecified route of administration on 29Jan2021 13:15 at single dose (right arm) for COVID-19 immunization. Medical history included occasional gastric reflux and allergies. The patient was not pregnant. Patient had unspecified concomitant medications which was received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021, at 20:00, the patient developed a diffuse pink rash with white bumps over back and abdomen, to a smaller degree on arms. Also, pruritis on back abdomen arms and legs and mild scratchy throat. The patient noticed these symptoms several hours after injection and was worse on day 2. There was no treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Outcome of events was not recovered.
59 2021-03-03 rash A rash developed on hands and feet later in the day on the day the vaccine was given . On the foll... Read more
A rash developed on hands and feet later in the day on the day the vaccine was given . On the following day it began spreading to lower extremities.
59 2021-03-03 redness, rash with redness her hands swelling and tightness; her hands swelling and tightness; underside of the forearms had a ... Read more
her hands swelling and tightness; her hands swelling and tightness; underside of the forearms had a lacey honeycomb pattern of red with white blotches; her cheeks were bright red; top of her hands to her wrist and lower arms were very red; felt light headed/faint and dizzy; tightness in her chest; the tightness that she felt the day before was in her lungs or throat; This is a spontaneous report from a contactable Physician reporting for his/her sister. A 59-year-old female patient received bnt162b2 (BNT162B2) via an unspecified route of administration at single dose in Jan2021 (12 days before reporting) for COVID-19 immunisation. Medical history included Hashimoto's autoimmune disease, enlarged thyroid, goitre. The patient's concomitant medications were not reported. In Jan2021, as soon as she got the injection, the patient felt both her hands swelling and tightness, underside of the forearms had a lacey honeycomb pattern of red with white blotches, top of her hands to her wrist and lower arms were very red, her cheeks were bright red, felt light headed/faint and dizzy, tightness in her chest and thought it was her heart. She was monitored for an hour but was told it probably wasn't an allergic reaction. Symptoms began to fade at that time. Next day she felt good and thought the tightness that she felt the day before was in her lungs or throat. The outcome of events was recovering. The events were reported as non serious. Reporter was referred to HCP or vaccination provider to determine if this was a severe allergic reaction and if she should receive the second dose of the vaccine. Information on the lot/batch number has been requested.
59 2021-03-04 injection site pruritus Nausea, shortness of breath, lightheaded, itching LUA by injection site. BP 168/87 (pulse 69), 97% O... Read more
Nausea, shortness of breath, lightheaded, itching LUA by injection site. BP 168/87 (pulse 69), 97% O2 sat. Final BP 146/74 (pulse 63), 97% O2 sat.
59 2021-03-04 injection site swelling, injection site pain, bruising Tired, feel sick all over, headache. Injection site pain, swelling, very bruised
59 2021-03-05 injection site pruritus, injection site hardening, injection site mass, injection site warmth Patient called 3/3 stating she received her second dose of the pfizer covid vaccine about 1 week ago... Read more
Patient called 3/3 stating she received her second dose of the pfizer covid vaccine about 1 week ago and had a reaction. She states that her arm is better, but thought she should call and report. She states that the day after receiving her vaccine her arm developed a hard lump about the size of a quarter that felt like a hive. She reports that it was itchy and hot to the touch. It then increased to 50 cent size and got as large as a golf ball.
59 2021-03-05 itchy skin, hives The night of the second shot I had joint aches, slight chills, fatique (which lasted for 2 days), Fr... Read more
The night of the second shot I had joint aches, slight chills, fatique (which lasted for 2 days), Friday, March 5 around 4:30pm I started to itch, and noticed welts appearing everywhere on my body, now 8am on Saturday, March 6 the hives are still showing up, itching is horrible with no end in site. I am trying to avoid an emergency room visit for this sympton, have not seen it listed anywhere. My neighbor experienced the same thing but hers was the day after her second shot, the only common denominater is the shot.
59 2021-03-06 rash Elevated HR, throat tightening, rash on chest and neck, dizziness and weak. Evaluated by EMS, transp... Read more
Elevated HR, throat tightening, rash on chest and neck, dizziness and weak. Evaluated by EMS, transported to nearest ER.
59 2021-03-06 skin warm, rash, rash with redness On March 5,2021, I started to experience a hot red rash on both my cheeks and ran a low grade fever ... Read more
On March 5,2021, I started to experience a hot red rash on both my cheeks and ran a low grade fever that evening. I took 2 Tylenol and fever went away for that day. 2 days after my vaccine, most of the redness and heat on my cheeks was mostly gone and I felt better. 3 days after my vaccine, which is today, I didn?t sleep at all the prior night because my rash returned and my checks were extremely hot. I?ve taken my temperature throughout today and my body temperature is normal but cheeks are still extremely warm and red
59 2021-03-06 hives, rash, itchy skin, redness On day ten after vaccine injection I developed an itchiness that seemed to be on hands and elbows. O... Read more
On day ten after vaccine injection I developed an itchiness that seemed to be on hands and elbows. On day Eleven I developed a red slightly painful rash and hives both small and large on my palms, tops of hands and fingers, elbows and underside of forearms this was both left and right side. In addition I also had a very large patch of redness and hives on upper left back of thigh. I took pictures, called my Doctor and discussed what was happening. Since nothing new was ingested like food or drinks or soaps or laundry detergents it was concluded that this most likely was a Delayed Skin Reaction to the Covid19 Vaccine. It also matched pictures of similar reactions on the CDC website. I was given a steroid cream and oral steroids(I did not take the oral pills) I will follow up with Dr. this upcoming week for follow up.
59 2021-03-06 injection site pain, skin burning sensation Pfizer-BioNTech COVID-19 Vaccine. 3/4/2021 pain in left are moving up arm from injection site, acros... Read more
Pfizer-BioNTech COVID-19 Vaccine. 3/4/2021 pain in left are moving up arm from injection site, across back shoulders, and down right are above elbow from 3/4/2021 at 6:00 pm through current time (3/7/2021 at 10:30 am.). 3/5/2021 at 10:00 am to current time (3/7/2021 at 10:30 am.) Burning under skin above both elbows throughout back shoulders and down back torso but not along spinal bones. Overall weakness and tiredness throughout body. Slight headache begins and feeling unwell at 3/5/2021 at 10:00 am. 3/6/2021 at 8:00 a.m. through 3/7/2021 at 8:00 a.m. Dizziness and weakness, tiredness, severe/excursiating headache/ muscle pain/chilles/fever/feeling unwell/severe ringing in ears/unable to get out of bed. No relief from advil pain reliever. 3/6/2021 at 5:00 pm nausea added to all symptoms above last 2 hours. 3/7/2021 at 8:00 am to current time (3/7/2021) Able to get out of bed. Headache managable, dizziness presists, weakness/shakey/, minimal energy/burning underskin is still occurring but reduced in level somewhat. Muscle pain in arms/shoulders/back torso and chills is occurring but at a reduced level.
59 2021-03-06 itchy skin, hives Sever itching rash and whelps all over my body. Started about 20 minutes after I got the vaccine. ... Read more
Sever itching rash and whelps all over my body. Started about 20 minutes after I got the vaccine. My hands started to itch, then is moved up my arms. By the next day my legs started itching and the my stomach and back. By Sunday my face started to itch and that when i went to the emergency room.
59 2021-03-07 rash Anaphylactic shock - throat restricting, tongue swelling, racing heart, rash predominantly on chest ... Read more
Anaphylactic shock - throat restricting, tongue swelling, racing heart, rash predominantly on chest and neck. PB was elevated, dizzy, weak. Symptoms escalated quickly. Immediately flagged help from nearby medic.
59 2021-03-07 injection site pain Fatigue, fever, injection site pain
59 2021-03-07 hives Within 2 minutes I immediately broke out in hives on inside right forearm. I started with one and h... Read more
Within 2 minutes I immediately broke out in hives on inside right forearm. I started with one and had about 5 total (unsure of exact number but those I could physically see) on both left and right arms. Went away within one hour and also within the hour took 12.5 mg. antihistamine. However 24 hours after had pain (felt like bruising) on site of first hive which has continued since then.
59 2021-03-08 rash, itchy rash Itchy rash all over body this morning
59 2021-03-09 rash, itchy skin Arm itchy and bumpy. Scratched area. Silver dollar size. Zyrtec taken and sx 90 % subsided. Pla... Read more
Arm itchy and bumpy. Scratched area. Silver dollar size. Zyrtec taken and sx 90 % subsided. Plan to follow-up with PCP.
59 2021-03-09 hives Within 24 hours patient developed generalized urticaria and a sensation of a racing heart. She took ... Read more
Within 24 hours patient developed generalized urticaria and a sensation of a racing heart. She took Benadryl and it took 2 and 1/2 days for the hives to resolve.
59 2021-03-09 vaccination site pain having a small stroke; weakness in her right hand and arm; Right arm was really sore; really tired; ... Read more
having a small stroke; weakness in her right hand and arm; Right arm was really sore; really tired; Headache; having issues with her right hand being numb/1st 2 fingers on her right hand were numb; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 01Mar2021, this case now contains serious adverse reaction. Information processed together. This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6200, expiry date was not reported) (at 59 years of age), via an unspecified route of administration in the right arm on 20Feb2021 15:49 at a single dose for COVID-19 immunisation. The patient's medical history and family medical history were none. The concomitant medications were not reported. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE, 1st dose, lot number: EL9263, injection in right arm on 30Jan2021 (at 59 years of age). There was no other vaccines administered on same date with the Pfizer vaccine and there was no any other vaccinations within four weeks prior to the first administration date of the vaccine. The patient stated that she is not an HCP, but she does work in a mental health. She stated that she is concerned. She got her 2nd dose of the vaccine on Saturday and was having weakness in her right hand and arm. She asked if this was expected. She added that when she got up yesterday, her right arm was really sore, she was extremely tired, and she had a headache. She went to bed early that night at around 5:30pm, and she woke up around 8 or 9pm that night and tried to pick up her phone and couldn't. She stated that the 1st 2 fingers on her right hand were numb. When she got up today it was fine. They are working from home, so she was typing some notes and then it felt like her fingers went numb, it felt like her 1st finger was like rubber. She stated that the numbness comes and goes. She mentioned that she doesn't have a headache right now, but it felt like it could come back. The events did not require emergency room or physician visit. On 01Mar2021, it was reported that the patient was having issues with her right hand being numb and the representative that she spoke with recommended she follow up with her PCP, which she did, and they diagnosed her with having a small stroke and also referred her to a neurologist as well. She said that her primary care provider she saw was a nurse practitioner. She said that she also saw a neurologist. It was not reported if the patient received treatment for 'having a small stroke' while no treatment received for all other events. The outcome of having a small stroke was unknown; 'weakness in her right hand and arm' was not recovered; while 'Right arm was really sore' and 'really tired' was recovering. The outcome of Headache and 'having issues with her right hand being numb/1st 2 fingers on her right hand were numb' was recovered on an unknown date.
59 2021-03-10 redness I began to feel ill on that Wednesday morning. I had had a bilateral mastectomy in Nov of 2020, and ... Read more
I began to feel ill on that Wednesday morning. I had had a bilateral mastectomy in Nov of 2020, and tissue expanders are still in place. I reached a fever of 103.6 and had pain and extreme redness in my right tissue expander. I also had all axillary lymph nodes removed from that side in December 2020. On Friday I was still feeling ill and noticed redness, so I immediately contacted my doctor and was instructed to meet him at the hospital. I was admitted and placed on antibiotics and had my tissue expander removed The next morning after no improvement from antibiotic infusion. I had a wound vac placed and stayed in the hospital for one week and had my expander replaced on that following Saturday. I am not planning on taking the second shot.
59 2021-03-10 injection site pain I woke up early the next day 3/10/21 nauseous and with diarrhea. I was tired and had a mild headach... Read more
I woke up early the next day 3/10/21 nauseous and with diarrhea. I was tired and had a mild headache. My arm hurt moderately where the injection site was, but also on the inside of my upper arm. I felt lethargic and nauseous the rest of the day. I did not sleep well. Then 3/11/21 I woke with a mild headache and some nausea, but also severe pain on the inside of my upper arm. It was very sensitive all up to my shoulder on the underarm area and somewhat on the side of my ribcage, but then also radiating down to my wrist. This pain persisted until I am writing this form, approx. 2pm 3/11/21. It has not subsided at this point.
59 2021-03-10 injection site redness, injection site rash, injection site warmth, injection site pain, injection site hardening Pfizer-BioNTech COVID-19 Vaccine EUA Woke up with severe pain in my joints, very tired, all over bod... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Woke up with severe pain in my joints, very tired, all over body aches, migraine and the chills for 2 days and sore/red/hard/hot/raised injection site. On third day the chills went away and I was feverish, but still had all the other symptoms. This lasted one more day. I still have the sore/red/hard/raised injection site, but the other symptoms finally went away.
59 2021-03-10 shingles Shingles T3-4 dermatome 3 weeks after second shot
59 2021-03-11 injection site swelling 9 hours after injection, injection site started to swell significantly. after putting a cool towel a... Read more
9 hours after injection, injection site started to swell significantly. after putting a cool towel and then trying to put covered ice pack, started having significant joint and muscle and scar tissue pain in hands knee and feet and hip. Then bicep muscles tensed up in both arms and then relaxed several times, as well as pain in collarbone and tightness up neck as well as swelling of face and top lip. I did not know if I was going to have a stroke and if I needed to go to an emergency room but the symptoms subsided. Some diarrhea next day. I understand from my therapist that multiple people have reported the significant muscle issues and it is not printed anywhere as a side effect which would help.
59 2021-03-11 rash SOB, wheezing, swelling throat, rash, tachycardia, and coughing following Pfizer COVID-19 mRNA vacci... Read more
SOB, wheezing, swelling throat, rash, tachycardia, and coughing following Pfizer COVID-19 mRNA vaccine (first dose) IM. Took to ED for evaluation. epinephrine 0.3 mg IM given in addition to methylprednisolone 125 mg IV and diphenhydramine 50 mg IV and famotidine 20 mg IV with a slight improvement in anxiety, throat tightness breath, however patient with persistent wheezing and cough. Albuterol 5 mg trialed without significant improvement in symptoms. Given persistent respiratory symptoms, repeat epinephrine 0.3 mg IM given with continued improvement in symptoms. Monitored patient for 4 hours and symptoms completely resolved. Discharged patient in care of granddaughter with outpatient epinephrine IM prescription.
59 2021-03-11 rash, shingles Week 1 - headache and light sensitivity Week 2 - Thoracic spine pain and left sided rib pain that e... Read more
Week 1 - headache and light sensitivity Week 2 - Thoracic spine pain and left sided rib pain that escalated to finally resulting in shingles outbreak. Week 3- horrible rash on left torso from t-spine to front of abdomen and excruciating pain. Week 8 - horrible torso pain continues with rash fading. I am currently at week at time of this report.
59 2021-03-12 injection site pain, injection site rash Arm soreness Rash at site of injection
59 2021-03-12 rash macular Macular rash around eyes including eyelids, on cheeks and around mouth. Itching and tingling of lip... Read more
Macular rash around eyes including eyelids, on cheeks and around mouth. Itching and tingling of lips. Treated with Benadryl 25mg x 2 doses. Duration of 1 day.
59 2021-03-12 rash initially sore arm that went away; few days later headache, rash on face which developed gradually. ... Read more
initially sore arm that went away; few days later headache, rash on face which developed gradually. could be reaction to mask or vaccine not sure. been very noticeable the last 2 days. bright red by nose and mouth not really on forehead or anywhere else, does not itch
59 2021-03-13 injection site pain, bruising I already filled out a AE report on 3/5 but I need to amend to add diarrhea that had not stopped. I ... Read more
I already filled out a AE report on 3/5 but I need to amend to add diarrhea that had not stopped. I had to go to Urgent Care on 3/13 for IV fluids and still feeling sick all-over, headaches and muscle aches. Tested negative for Covid at Urgent Care. Initial report included headaches, body aches, injection site pain, swelling and bruising.,feeling sick all-over.
59 2021-03-14 itchy skin, redness 03/04/21 - pain, swelling, redness , left arm 03/05/21 - pain, swelling, redness , left arm, fever... Read more
03/04/21 - pain, swelling, redness , left arm 03/05/21 - pain, swelling, redness , left arm, fever 101 03/06/21 - pain, swelling, redness , left arm, fever 100 - 101, fever varied 03/07/21-03/14/21 - itchy left arm , pain left arm, fatigue, loss of appetite, dizziness 03/15/21 - fatigue, dizziness, general body aches
59 2021-03-14 injection site pain 20 hours after injection, got severe back pain between shoulders and also lower back, tiredness and ... Read more
20 hours after injection, got severe back pain between shoulders and also lower back, tiredness and nauseous. Laid down about 3:30 p.m. and slept til next day 8:30 a.m. Felt better for a couple hours and then started with chills and fever 99.9. Laid down and about an hour later, it passed and I was back to normal temp. Injection site is tender but not red or rash.
59 2021-03-14 itchy skin, injection site swelling, injection site pain Due to v-safe tool text links not working to date (March 13 - March 15), I'm using VAERS to report h... Read more
Due to v-safe tool text links not working to date (March 13 - March 15), I'm using VAERS to report history back to the date of injection. To date, all side effects are Mild, so I have not needed to notify my physician. March 13, 2021: In addition to mild pain and mild swelling at injection site immediately after injection, I developed some mild itching (but no redness or rash) at the injection site around midnight (about 12 hours after the injection). March 14, 2021: Mild pain and mild swelling and mild itching at the injection site continues. No additional side effects. March 15, 2021: Minor pain (much less than yesterday) but mild swelling at injection site continues. No itching. No additional side effects.
59 2021-03-14 itchy skin Itching all over body is still occurring and it has been 3 weeks; This is a spontaneous report from ... Read more
Itching all over body is still occurring and it has been 3 weeks; This is a spontaneous report from a consumer or other non-health care professional. A 59-years-old female patient started to receive BNT162b2 (BNT162B2), via an unspecified route of administration from 14Jan2021 15:45 to 14Jan2021 15:45 at single dose for covid-19 immunisation. Medical history included asthma, crohn's disease (Crohn's disease has been in remission 13 years), food allergy and known allergies (dairy, seasonal allergy, dust allergy, allergy to animal) from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID), fluoxetine (FLUOXETINE), fluticasone propionate, salmeterol xinafoate (ADVAIR), progesterone (PROGESTERONE) and estradiol (ESTRADIOL). On 14Jan2021, the patient experienced itching all over body is still occurring and it has been 3 weeks. The action taken in response to the event for BNT162b2 was not applicable. Therapeutic measures were taken as a result of itching all over body is still occurring and it has been 3 weeks (pruritus). The outcome of event was not recovered.
59 2021-03-14 itchy skin left eyelid swollen; Itchy; A little weepy; This is a spontaneous report from a contactable healthca... Read more
left eyelid swollen; Itchy; A little weepy; This is a spontaneous report from a contactable healthcare professional (patient). A 59-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9581 and expiry date unknown), via an unspecified route of administration in the left arm on 10Feb2021 15:00 at a single dose for COVID-19 immunisation. There were no medical history. Patient is not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. Concomitant medications included vitamin D NOS and vitamin C [ascorbic acid]. Patient experienced left eyelid swollen, itchy, and a little weepy on 10Feb2021 18:30. Patient was recovering from the events. No treatment was received for the adverse events. This case was reported as non-serious.
59 2021-03-15 injection site redness 5 days later got sore arm and some redness around injection site (like a small rash) no itching, I p... Read more
5 days later got sore arm and some redness around injection site (like a small rash) no itching, I put ice on it and took Aleve
59 2021-03-15 itchy skin Patient received the first dose of the Pfizer COVID-19 vaccine and was waiting in the observation ar... Read more
Patient received the first dose of the Pfizer COVID-19 vaccine and was waiting in the observation area when she started to experience a racing heart-rate and warmth. The patient was brought water, juice, and tried to relax. Patient was stable but after drinking juice started to feel swelling of the tongue and itching around the neck. Patient was given more water and a diphenhydramine capsule. Tongue swelling and itchiness decreased and the patient went home with her husband after improving. Total course of observed reaction was around 1 hour.
59 2021-03-15 rash Patient states my throat feels numb, rashes noted around neck and chest. Patient evaluated by parame... Read more
Patient states my throat feels numb, rashes noted around neck and chest. Patient evaluated by paramedics on site. Monitored patient for 30 minutes. Patient referred to ER due to elevated BP. Patient refused and signed AMA. Patient A&O x3, accompanied by husband.
59 2021-03-15 itchy rash Small area (6? round) of itchy rash on stomach which resolved after a few hours. Tingling of itchin... Read more
Small area (6? round) of itchy rash on stomach which resolved after a few hours. Tingling of itchiness on various locations of body.
59 2021-03-15 injection site pain Sore arm at injection point Gradual fever culminating at 102.6 at 10pm on 3/13 Loss of appetite and ... Read more
Sore arm at injection point Gradual fever culminating at 102.6 at 10pm on 3/13 Loss of appetite and extreme fatigue Took 1 motto and went to sleep at 5pm - woke at 10pm - fitful sleep until noon 3/14 Fever continued through 3/14 - 100.2 at noon through 99 at 5pm - light fatigue throughout the day 3/15 - completely back to normal energy and temperature (yay!)
59 2021-03-15 vaccination site pain, vaccination site redness, vaccination site swelling arm was very sore when she got up it was swollen and red and hurt terribly; arm was very sore when s... Read more
arm was very sore when she got up it was swollen and red and hurt terribly; arm was very sore when she got up it was swollen and red and hurt terribly; arm was very sore when she got up it was swollen and red and hurt terribly; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 59 years of age), via an unspecified route of administration in the left arm on 25Feb2021 14:15 (Batch/Lot Number: Unknown) as a single dose for COVID-19 immunisation. Medical history included chronic blood clot in left leg from an unknown date and unknown if ongoing and environmental allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks prior to covid vaccine. She was not pregnant. The patient had not had covid prior vaccination and she had not been tested post vaccination. It was reported that during the night of 25Feb2021 at 11:00 PM, the patient's arm was very sore when she got up it was swollen and red and hurt terribly. So she went to the ER because she had a chronic blood clot in her left leg; there was no clot in her arm but it was still swollen, red and it hurts. She added that she have very bad environment allergies and queried if she should get the second shot. No treatment received for the events. The outcome of the events was unknown; the events resulted to emergency room visit. Information on the lot/batch number has been requested.
59 2021-03-16 injection site pain Lethargy, Fever (100.4), Tiredness, Headache, pain at injection site (right arm), Flu like symptoms ... Read more
Lethargy, Fever (100.4), Tiredness, Headache, pain at injection site (right arm), Flu like symptoms continuing past 40 hours after 2nd Covid 19 vaccine injection.
59 2021-03-16 skin warm, dry skin Per staff member, HCP, that attended to patient in observation area: " post covid vaccine note. Pt ... Read more
Per staff member, HCP, that attended to patient in observation area: " post covid vaccine note. Pt received vaccine at 1120am, 1125 while in chairs pt felt dizzy with left arm and leg numbness. Pt alert, skin warm and dry. Placed on stretcher and brought to obs area. 120/77 99% on 2 liters 76 16. Remains alert, dizziness and left extremity numbness persist along with facial numbness, bilat. No facial droop, PERL midline grasps equal. 911 called. 124/71 76 16. EMS arrived, assessed pt and decided to trans to hospital. Pt and husband agree and understood plan. Pt anxious at this time but remains alert but unable to raise left leg, speech slightly slurred. Pt left clinic via ambulance about 1155am with belongings"
59 2021-03-16 hives, rash Received first vaccine on Saturday at 11:00 am. Sunday had a sore arm. Took 1000mg Tylenol and felt ... Read more
Received first vaccine on Saturday at 11:00 am. Sunday had a sore arm. Took 1000mg Tylenol and felt better. Woke up Monday morning to a slight rash/hives on back of neck. Tuesday it seemed to be getting worse so I went to my primary Dr. He prescribed Clobetasol cream 0.5%. He also said to take 25mg benadryl every 6 hours. Wednesday morning rash spread to shoulders and both arms. Called Dr and he prescribed a taper of prednisone.
59 2021-03-17 injection site pain, injection site bruising, injection site warmth 03/16/2021 Afternoon- Bruise-like symptoms; the injection site was purple, warm, tender to touch, so... Read more
03/16/2021 Afternoon- Bruise-like symptoms; the injection site was purple, warm, tender to touch, sore, and throbbing-
59 2021-03-17 redness Approx. 8 hours after injection started having body aches within an hour developed a fever and becam... Read more
Approx. 8 hours after injection started having body aches within an hour developed a fever and became very lethargic. at midnight fever had reached 103, severe body aches and cold chills, used tylenol to lower fever but it continued up to 104. severe joint pain and when trying to walk had no muscle control. fever finally broke at 6pm the following day also experienced bright red face and headache.
59 2021-03-17 injection site pain No symptoms immediately after first shot except after 13 days later woke up with pain in arm (same a... Read more
No symptoms immediately after first shot except after 13 days later woke up with pain in arm (same arm as injection). Pain is still present after 3 days. Taking ibuprofen, ben-gay, and heating pad with essentially no effect. If I keep arm elevated the pain is slightly less. Not able to sleep due to discomfort on Day 2 and was able to sleep on Day 3 although woke up at 2am and put on ben-gay and heating pad. Constant pain limiting mobility in arm.
59 2021-03-17 injection site warmth, injection site swelling, injection site pain, injection site redness The first two days, the injection site was red, puffy and a bit sore. The soreness abated over two d... Read more
The first two days, the injection site was red, puffy and a bit sore. The soreness abated over two days. I noticed 8 days later (3/17/21) that it is still a large red circle at the site. It is a bit puffy and warm to the touch. It is not impacting my life, but I don't think it should still be red and warmer than the surrounding skin. I took ibuprofen today. The redness still exists. Not sure if I should worry or not. I have not gone to any clinic or doctor. Looking for advice as well as wanting to report this to you. Thank you.
59 2021-03-17 hives Woke on the morning after the shot 2/27/21 with a low grade fever (100), fatigue, headache, joint an... Read more
Woke on the morning after the shot 2/27/21 with a low grade fever (100), fatigue, headache, joint and muscle pain and slightly swollen lymph nodes in my neck. Within a few hours, my body was completely covered in large hives from head to toe. I rested or slept most of the day and by the afternoon, the fever had subsided. By the next day headache, joint/muscle pain and swollen lymph nodes diminished. I still felt fatigue and the hives were awful. Began taking Benadryl with no relief. Called my primary care doctor to report; increased Benadryl dosage to 2 every 4 hours. There was some relief during the day, but the large doses of benadryl were making me anxious/nervous, racing heart, shakes. Decreased following another call to Doctor and began taking Antronex; decreaed side effects, but little affect on the hives during the evening/overnight hours. At times I would be completely covered in them, other times they were localized (bottoms of my feet, face, neck, eyes). Returned call to Doctor, again suggested Prednisone. (I typically have strong reactions to steriods and wanted to avoid if at all possible) Began first dose 3/18/2021. Experiencing some relief already.
59 2021-03-18 bruising Don't still feel good; with pain in side in my head; Slowed down; Extremely tired; Have a burst on e... Read more
Don't still feel good; with pain in side in my head; Slowed down; Extremely tired; Have a burst on energy for an hour or so; and then all of a sudden I can't even hold my head up; Eyes were swollen; Back to my head very weak; My whole body feels like it is bruised; This is a spontaneous report from a contactable consumer reporting for herself. A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL9262/expiration date: not provided), via an unspecified route of administration, on 12Feb2021 at 17:30 (at the age of 59 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included rheumatoid arthritis. Concomitant medication included methotrexate 2.5 mg (8 tablets, once weekly), hydroxychloroquine 200 mg, 2x/day and folic acid UNK, 1x/day(1 tablet). On 12Feb2021 (Friday night), the patient reported that she "don't still feel good". The clinical course was as follows: On 12Feb2021, an hour after the receiving the vaccination, the patient reported "it started with pain in side in my head and within minutes it was like I was jelly. I was felt like fall on to the floor. I slowed down and I was extremely tired. I even left work early. I was off Saturday and Sunday. Today I could not even get work. It is like I have a burst on energy for an hour or so. And then all of a sudden, I can't even hold my head up. My eyes were swollen and back to my head very weak. My whole body feels like it is bruised. Treatment received for the events included ibuprofen. The consumer stated, "I took 4 on Saturday and later on like midday about 4 or 5 O'Clock. That was 200 mg each. It was total of 800mg." The outcome of the events was unknown.
59 2021-03-18 dry skin, skin tightness Face numbing, mainly in cheek and eye area, eye twitching, eyes very dry, part of lip and chin. i... Read more
Face numbing, mainly in cheek and eye area, eye twitching, eyes very dry, part of lip and chin. it started off as becoming very tight, then the tingling. it has been over 24 hours and still sum tingling in the check bone and chin area.
59 2021-03-18 vaccination site pain Had Covid fairly bad I got pneumonia with it; Super tired; 103 to 104.6 fever; Glands in neck and un... Read more
Had Covid fairly bad I got pneumonia with it; Super tired; 103 to 104.6 fever; Glands in neck and under arm on the side where got the shot swelled up; hurt quite badly; huge swollen lymph nodes; Body ache; Could barely walk; could walk to shuffle my feet; joints stiff; Horrible headaches; Diarrhea; I was dizzy and foggy; Night I break out into a horrible sweat in night like I have to change my pajamas twice; I am like wet; Arm sore/My arm was just little bit sore; This is a spontaneous report from a contactable consumer. A 59-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 27Feb2021 (Batch/Lot Number: EN6202) (at the age of 59) as a single dose, for covid-19 immunisation. Medical history included an unspecified heart condition and a flu shot un an unspecified date. Concomitant medications included levothyroxine sodium (SYNTHROID) and ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE). The patient stated, "I am calling about the side effects I had from my Covid shot vaccine. I am concerned about getting the second one because my reaction was so big. I got it on Saturday, this past Saturday about 12:45 I think 12:30 and I did fine, the shot didn't hurt at all. That night I was a little bit tired but that's it. My arm was just little bit sore. The next day I got up, I still felt good I went to work for 2 hours and then about 12 o'clock it hit me all at once. This Sunday I ran anywhere from a 103 to 104.6 fever and that was me taking Tylenol and I took Tylenol every 4 hour because my fever was still high. The glands in my neck and the glands under my arm on the side where I got the shot swelled up, they are still swollen. My whole body ached. I had Covid fairly bad I got pneumonia with it all for "two weeks" (not clarified) but my fever was not as high as got with the shot, the vaccine like I could barely walk after the vaccine because my joints were so stiff only way I could walk was to shuffle my feet, it was horrible. I had a fever yesterday all day but it was only in the 102.3 and 4, it never went back to 103. Glands in my arm and my neck hurt quite badly. My arm where I got it, it wasn't swollen but I get the same reaction when I get a Flu shot (unspecified shot) so that's not a big deal. I got horrible headaches. I had diarrhea all day Sunday and yesterday and so this morning my fever is only right around 101 like 101.1, 101.2, I am still super tired and also yesterday and day before I was dizzy and foggy. I still have a slight fever today. My lymph nodes are still swollen, my neck and under my arm, my arm where I got the shot is still swollen and sore but I can tolerate that. My joints are stiff a little bit but not nearly as bad as they were, so I don't know if I should get the second shot, everyone says the second shot is worst like all those heart palpitations start with it as well." One of my other symptom is at night I break out into a horrible sweat like I have to change my pajamas twice. It was last night and the night before. I am like really wet." The outcome of the events was not reported.
59 2021-03-18 vaccination site pain Pain at injection site; Fever of 102.7; Body aches; Lethargic; This is a spontaneous report from a c... Read more
Pain at injection site; Fever of 102.7; Body aches; Lethargic; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EM9809) via an unspecified route of administration in the Left arm on 11Feb2021 09:45 as a single dose for COVID-19 vaccination. Medical history included allergies; Prior to vaccination, the patient was diagnosed with COVID-19. The patient concomitant medications were not reported. On 11Feb2021 17: 00, it was reported patient had pain at injection site. Fever of 102.7. Body aches. Lethargic. There was no treatment received for the adverse events. the patient not received any other vaccines within 4 weeks prior to the COVID vaccine. other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The reported seriousness was non serious. The outcome of the events was not recovered.
59 2021-03-18 injection site pain Within a few hours of shot, I experienced EXTREME tinnitus (very loud), numbness in head, face and l... Read more
Within a few hours of shot, I experienced EXTREME tinnitus (very loud), numbness in head, face and lips and hardening of lymph gland in left chest. This lasted for hours. Injection site pain only lasted about 24 hours. Since then, I still have numbness on the right side top of head and intermittent EXTREME tinnitus that interferes with my ability to concentrate, communicate and sleep. It comes and goes but the volume is beyond anything I have ever experienced. Then it goes away. The right side of my head has stayed numb. Will this go away? Should I get the 2nd dose or not?
59 2021-03-19 injection site pain, injection site swelling, injection site redness, injection site hardening, injection site mass about 23 hours after the short I fell tired, weak, I got chills and a fever. That night while sleepi... Read more
about 23 hours after the short I fell tired, weak, I got chills and a fever. That night while sleeping I woke up to a pain under my arm (armpit) on the same arm as the injection. Later the next morning I had a red splotch on my arm (same as injection but not the same spot). The splotch is warm to the touch, and has a bump or hardening under the skin, it is also a little painful.
59 2021-03-20 rash macular, bruising Left leg swollen,veins in leg very pronounced,leg aching,bruising to arms and legs,right lower leg b... Read more
Left leg swollen,veins in leg very pronounced,leg aching,bruising to arms and legs,right lower leg bright red spots appeared ,headache very bad,back of head hurting like a baseball bat had whacked it,
59 2021-03-21 injection site discomfort, rash, rash with redness, itchy rash, injection site pruritus 8 days after the vaccine, my left upper arm at the site of the injection began to feel itchy and unc... Read more
8 days after the vaccine, my left upper arm at the site of the injection began to feel itchy and uncomfortable. On day 9, a red circular, itchy rash appeared. This expanded on day 10 (today). It is sore, itchy, red, has bumps, and my lymph node under my left armpit may be enlarged. Shoulder is slightly uncomfortable.
59 2021-03-21 redness, itchy skin, hives, rash papular, rash with redness, rash On March 5th (day 11 after vaccine) I awoke with red rash/hives on palms of both hands and elbows an... Read more
On March 5th (day 11 after vaccine) I awoke with red rash/hives on palms of both hands and elbows and underside of forearms and upper left thigh. The rash got worse each day spreading all over my body causing me to seek medical treatment first with primary doctor who gave me prednisone pack and injection and then my local emergency room (twice) due to swelling of throat and tongue. I was given prednisone IV treatment and sent home with a high dose of medication for inflammation and hydroxyzine for itch and famotidine for stomach upset. My doctor got me in to see immunologist for tests and treatment. That doctor took blood and diagnosed me as having a moderate to severe delayed allergic reaction post covid vaccination. My liver had elevated levels of bili-rubin my white blood count was over 16,000 and my skin was cover in red, itchy hives and rash from head to bottoms of my feet for over ten days. I was very sick and miserable.
59 2021-03-21 rash, hives, itchy skin On Thursday, March 18th I experience mild itchiness on my scalp. On Friday, March 19th I began to fe... Read more
On Thursday, March 18th I experience mild itchiness on my scalp. On Friday, March 19th I began to feel a lump in my throat and developed large itchy hives all over my body. My lips began to swell up.
59 2021-03-21 rash Rash on the back of my neck, chest and the back of my right hand
59 2021-03-21 injection site pain, injection site rash, injection site warmth Severe body aches, joint pain, muscle pain, fever (99.7), headache, extreme fatigue, sore arm (this ... Read more
Severe body aches, joint pain, muscle pain, fever (99.7), headache, extreme fatigue, sore arm (this began about Saturday morning 2:00 a.m.) fever was gone by 8:00 a.m. I had mild joint and muscle pain when I went to sleep Saturday evening, but when I woke up Sunday morning, all symptoms were gone. On Sunday evening, I began to get a throbbing headache that pulsed in my head all night. I was briefly nauseated when I got up Monday morning because of the headache. By 10 a.m. the headache was gone. I developed a slight rash and warmth at the injection site on Monday morning. As of 5:00 p.m. the rash is still there but the pain is lessening as is the warmth.
59 2021-03-21 redness patient was feeling warm and flushed, she noticed her skin on her arms and chest were turning pink/r... Read more
patient was feeling warm and flushed, she noticed her skin on her arms and chest were turning pink/red. She reported that she has a sulfa allergy and had experienced something similar. Benadryl was given when she had taken the antibiotics and the physician said that was the only thing that "saved her bacon". Patient prefers to sit vs lay down. Felt, slightly nauseated and light headed. Gave alcohol prep to help with the nausea. IM Benadryl given per standing order. 50mg IM to Rt deltoid. Patient responded well to this and started to get normal coloring back and felt good enough to go home; declined evaluation offered by paramedics to hospital.
59 2021-03-22 itchy skin Brand and lot of vaccine: EL9267 Pfizer 2nd dose, CN6200 Pfizer 1st dose given 2/26 @1400 at stadium... Read more
Brand and lot of vaccine: EL9267 Pfizer 2nd dose, CN6200 Pfizer 1st dose given 2/26 @1400 at stadium Date and time adverse event started: 3/19/2021 @1400 Did the adverse event start after the first or second vaccination? arm started getting sore in the evening, then legs feels achy, lower back pain, 99.6F, pain in armpit in injection arm left arm, itching to back then dizzy
59 2021-03-22 redness Started having a severe reaction after I received the vaccine, my symptoms started at around 6:30 PM... Read more
Started having a severe reaction after I received the vaccine, my symptoms started at around 6:30 PM I started to get very red and my face was swollen then I started to have a difficultly in breathing then I felt dizzy and I had a high fever and I started vomiting. and my blood pressure was very high. Then I called 911 and I was transferred to the Emergency hospital.
59 2021-03-24 injection site pain -sore arm at shot location, lasted about a week -mild cramps (in uterine/lower abdomen area), lasted... Read more
-sore arm at shot location, lasted about a week -mild cramps (in uterine/lower abdomen area), lasted 4 days -bloated feeling in lower abdomen, lasted a week so far -diarrhea (mild) lasted a week so far [Note: lower abdomen means below belly button area]
59 2021-03-24 itchy skin, redness, hives 10 minutes after shot had Pain in neck Then headache Then flushing (wave of heat from head down arm... Read more
10 minutes after shot had Pain in neck Then headache Then flushing (wave of heat from head down arms and hands. Skin mottled and red) Then Blood pressure observed to be was high Then hives and itching developed Then Dizziness occurred Then nurses took me from shot clinic to the ER All above symptoms within 30 minutes of shot About 9 pm experienced swollen and painful veins in left arm (shot was in right arm) as of 7pm next day still painful veins in left arm.
59 2021-03-24 dry skin, skin discolouration Client reported some feeling in the center of her chest said it was not pain, she just felt somethin... Read more
Client reported some feeling in the center of her chest said it was not pain, she just felt something and she was dizzy. 10:34 b/p110/62 Pso2 99% pulse 76 Respirations even and unlabored. Skin pink warm and dry. Re check feeling better not dizzy Pso2 98% pulse 65 10:39 symptoms gone Pso2 99% pulse 66 b/p 106/64 Patient monitored a little further then released.
59 2021-03-24 injection site swelling, injection site nodule First dose 2/28 - was fine Second dose 3/21- that evening headache dizziness took ibuprofen around ... Read more
First dose 2/28 - was fine Second dose 3/21- that evening headache dizziness took ibuprofen around 8-9pm. 3/22 - soreness in arm, headache. 3/23 - swelling on shot area leading around to underarm, hard lump side of underarm area very sore. Took ibuprofen Add ice.pack
59 2021-03-24 itchy skin, rash Itching and rash NOT at injection site: head, neck, arms, chest, stomach, legs Rash is fairly fine,... Read more
Itching and rash NOT at injection site: head, neck, arms, chest, stomach, legs Rash is fairly fine, NOT hives. Pops up on various parts of body, itchy and mild burning. This is NOT a terrible side effect, but I thought it best to report. It is not yet getting better or subsiding (got injection 5 days ago).
59 2021-03-24 rash Patient was seen in my clinic with reports of "flare" of psoriasis after having her second COVID vac... Read more
Patient was seen in my clinic with reports of "flare" of psoriasis after having her second COVID vaccine. She has a history of well controlled psoriasis BSA 2-3%, today she a rash that is not consistent with psoriasis. Rash presented within 12 hours of vaccine administration. Additionally, she reports within the first 12 hours of second vaccine administration she developed extreme anxiety, shortness of breath, anxiety, and heart palpitations that lasted intermittently for 2 days. She did not seek medical attention. On exam she is alert/oriented, no visible distress. Pending skin biopsy results.
59 2021-03-24 redness Redness on neck, tightness in throat, 25 mg diphenhydramine PO, 20 mg pepcid PO, 50 mg diphenhydrami... Read more
Redness on neck, tightness in throat, 25 mg diphenhydramine PO, 20 mg pepcid PO, 50 mg diphenhydramine IM
59 2021-03-24 rash patient experienced rapid heartbeat and a rash that spread down her arm and a bit of shortness of br... Read more
patient experienced rapid heartbeat and a rash that spread down her arm and a bit of shortness of breath. Started appx 15 minutes after vaccine, applied cool compress called 911 and observed patient. Paramedics did note PVC abnormalities on patient EKG and advised her to take 50 mg of Benadryl and follow up with medical care
59 2021-03-25 shingles Acute viral infection Shingles. Treating with valacyclovir and gabapentin.
59 2021-03-25 injection site pain Fever, injection site pain, achiness
59 2021-03-25 redness Patient had tingling sensation that started on her body immediately after injection. Her face became... Read more
Patient had tingling sensation that started on her body immediately after injection. Her face became red and she was moved into the EMS room for observation. The MD on call ordered zyrtec 10mg by mouth to be given x1 now and patient tolerated well at 1545. Apple juice was supplied to the patient at 1550. 1600 patient reported tingling sensation had decreased, denied any shortness of breath, chest pain or nausea. 1605 patient was discharged from clinic in no distress.
59 2021-03-25 rash Rash (left forearm) - appeared on March 24. Dizziness (felt as if the room was spinning). Onset was... Read more
Rash (left forearm) - appeared on March 24. Dizziness (felt as if the room was spinning). Onset was March 24 PM.
59 2021-03-26 skin warm 3 hours after shot I hit metallic taste in my mouth, I then became so severely tired and light heade... Read more
3 hours after shot I hit metallic taste in my mouth, I then became so severely tired and light headed. Got chills. Hot & cold nauseated . It?s three days later I?m still very tired. Headaches , throats feels swollen , glands swollen. I feel like I got the flu! When is this going to end ?
59 2021-03-26 injection site swelling Fever, body aches, nausea, injection site soreness for ~36 hours after injection.
59 2021-03-26 injection site pain Moderate Pain in right armpit radiated to sternum and lower rib cage on right side. Sporadic headach... Read more
Moderate Pain in right armpit radiated to sternum and lower rib cage on right side. Sporadic headache. Sweating but no fever (anxiousness perhaps??). Felt fine next day, some soreness at injection site remained.
59 2021-03-26 rash with redness, rash Night of dose 2 at 1100pm - chills; at 2:00am - chills stopped fever 100.5 & HA started; at 7:00am i... Read more
Night of dose 2 at 1100pm - chills; at 2:00am - chills stopped fever 100.5 & HA started; at 7:00am increase HA, nausea; at 10:00am fever increased to 102.5 (self treated with tylenol); at 1:00pm - exhausted slept until 5:00pm; woke up body rash (looked like a sunburn); slept from 7:00pm until 3:00am (24 Feb21) - woke with body covered in sweat - fever broke (98.7); at 5:00 am rash stopped getting worse, nausea gone; rash took 2 days to resolve, fatigue took 3 days to resolve, still getting HA on occasion
59 2021-03-26 rash, itchy skin, injection site bruising Site: Bruising at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Dif... Read more
Site: Bruising at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Headache-Mild, Systemic: Hypertension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Medium, Additional Details: Eye ball rotating
59 2021-03-26 rash palpitations, tingling over lips, rash
59 2021-03-27 injection site pain Fatigue, joint pain, muscle pain, nausea, headache, loss of appetite, chills, injection site pain
59 2021-03-27 injection site pruritus, skin swelling It?s been 9 days n now the injection site is itching n puffy it?s weird no other side affects I did... Read more
It?s been 9 days n now the injection site is itching n puffy it?s weird no other side affects I did scratch til it bled
59 2021-03-27 rash, itchy skin Patient developed a rash and itching on her right forearm, same as with first dose despite premedica... Read more
Patient developed a rash and itching on her right forearm, same as with first dose despite premedicating with 50mg of benadryl immediately after her vaccination. Patient did not want to receive any further treatment and felt like she would be fine. Left in the care of her husband. Patient says the rash/itching went away on the way home and she's felt fine ever since.
59 2021-03-27 shingles shingles
59 2021-03-30 rash with redness, rash Went to ER at 10 pm on 03/24/21 with red bumps on feet and legs with difficulty swallowing. Blood d... Read more
Went to ER at 10 pm on 03/24/21 with red bumps on feet and legs with difficulty swallowing. Blood draw showed platelet count <3,000 and transferred to Hospital ICU at 4:30 am on Thursday, 03/25/21. Diagnosed with ITP at Hospital on 03/25/21. Received two (2) bags of donor platelets, steroids, and IVIG Treatment on 03/25/21 and 03/26/21. Following treatment, platelet count rose to 48,000 on 03/26/21 and 03/27/21. Discharged from hospital on 03/27/21 with follow-up with hematologist scheduled for 04/02/21. Platelet count on recent blood draw on 03/30/21 showed platelet count at 148,000 with continued treatment using steroids only.
59 2021-03-30 bruising When she passed out; feeling real dizzy; since her leg and knee feel bruised; right eye was swollen;... Read more
When she passed out; feeling real dizzy; since her leg and knee feel bruised; right eye was swollen; felt unwell; weak; This is a spontaneous report from a contactable consumer (patient) reported that a 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Mar2021 as a single dose (at the age of 59-years-old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the Pfizer-BioNTech COVID-19 Vaccine first dose on Saturday, 13Mar2021, and was fine after the shot but had a reaction on Sunday, 14Mar2021. On 14Mar2021, she got up to make breakfast and started feeling real dizzy and the next thing she knew, she was on the floor; this happened twice. When she passed out, she must have hit something on her right side, since her leg and knee feel bruised and right eye was swollen. She felt unwell, dizzy and weak; no dizziness today (15Mar2021). She planned to discuss further with her physician. The outcome of the event dizziness was recovered on 15Mar2021 and unknown for the rest of the events. Information on the lot/batch number has been requested.
59 2021-04-03 vaccination site itchiness, vaccination site warmth eyes were itchy; hard to breath; lips felt like they were getting puffy and they were bright red; li... Read more
eyes were itchy; hard to breath; lips felt like they were getting puffy and they were bright red; lips felt like they were getting puffy and they were bright red; tongue tingled but didn't swell; heartrate was 112 / heartrate was high; dizzy / lightheaded; vertigo; brain fog; trouble focusing; right arm was itchy and hot where she got the injection; right arm was itchy and hot where she got the injection; had a hard time forming sentences; really tired and sleepy; really tired and sleepy; chills; headache/I felt like my head was kind of throbbing; where the patient's thyroid is was swollen; couldn't really walk; had no balance; ringing in my ears; lost my voice.; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old-female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 15Mar2021 (at the age of 59-years-old) as a single dose for COVID-19 immunization. Medical history included allergic to a lot of medications/ antihistamines. Concomitant medications were not reported. The patient previously took diphenhydramine (BENADRYL) and was allergic. On 15Mar2021, within 2-3 minutes of vaccination, the patient's heartrate was 112, she started getting dizzy, lightheaded, and had vertigo. Her oxygen level was okay. On 15Mar2021, the patient also had some brain fog and trouble focusing, the right arm was itchy and hot where she got the injection, her eyes were itchy. The patient was then taken back to lie down. It was hard to breathe and she had to take large deep breaths. Her lips felt like they were getting puffy and they were bright red, she had a hard time forming sentences, was really tired and sleepy, had chills and a headache (felt like her head was kind of throbbing). Also, on 15Mar2021, where the patient's thyroid is was swollen, the patient couldn't really walk and had no balance, had ringing in her ears, her tongue tingled but didn't swell, the walls started moving and she lost her voice. The patient was kept for 2 hours and was almost sent to the ER. The patient brought an epinephrine (EPIPEN) but there was concern administering it because her heartrate was high. The patient questioned whether she should receive the second dose as she almost went into anaphylactic shock after the first dose. The clinical outcome of "right arm was itchy and hot where she got the injection" was resolved on 16Mar2021, of eyes were itchy, hard to breath, lips felt like they were getting puffy and they were bright red, tongue tingled but didn't swell, heartrate was 112 / heartrate was high, dizzy / lightheaded, vertigo, brain fog, trouble focusing, had a hard time forming sentences, really tired and sleepy, chills, headache/I felt like my head was kind of throbbing, where the patient's thyroid is was swollen, couldn't really walk, had no balance, ringing in my ears, lost my voice was unknown. Information on the lot/batch number has been requested.
59 2021-04-17 rash, redness, itchy skin, hives she was in distress with her throat starting to swell, her tongue started to swell and she was cover... Read more
she was in distress with her throat starting to swell, her tongue started to swell and she was covered with the hives and rash from head to toe.; her lips and tongue began to swell; her lips and tongue began to swell; rash on her palms, hands, elbows, and left hip/rash all over her body; elbows were red; hive rash on her palm and hand and elbows and it was strange and her elbows were red and were itchy on the palms like red and itchy; developed hives/rash on her palms, hands, elbows, and left hip; WBC count was high; liver was not doing great; post COVID vaccine delayed allergic reaction; pain in her right ear; This is a spontaneous report from a contactable consumer. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 22Feb2021 11:15 (Batch/Lot Number: EL9266) as SINGLE DOSE for covid-19 immunisation. Medical history included arrhythmia, ear infection. Concomitant medication(s) included propranolol (PROPANOLOL [PROPRANOLOL]) taken for arrhythmia from Apr2020 to an unspecified stop date. The patient previously took augmentin [amoxicillin;clavulanic acid] for ear pain and experienced rash on her elbows and palm and arm. Caller stated on Friday 05Mar2021, which was the 11th day after getting the Pfizer COVID Vaccine although she noticed symptoms on the 10th day 04Mar2021 after receiving the vaccine, states she noticed she had a hive rash on her palm and hand and elbows/rash on her palms, hands, elbows, and left hip and it was strange and her elbows were red and were itchy on the palms like red and itchy and she could see the rash starting on the left inside forearm; from there as the day wore on into the next day the rash became worse and more areas of the body were covered with the rash. States she made an appointment on that Monday morning with her HCP and had gone into the HCP office at that time; states on 08Mar2021, she was in distress with her throat starting to swell, her tongue started to swell/ her lips and tongue began to swell and she was covered with the hives and rash from head to toe. Caller states she was started on Prednisone at her HCP office and it was one of those dose packs; states she has no lot numbers to provide. Later on that evening she needed to go to the emergency room and she had become more severe and had a big dose of Prednisone at the emergency room and at that time the HCP there did believe she was having what is considered a post COVID vaccine delayed allergic reaction and hives; states she was in the emergency room early and was there past midnight and thinks she presented to the emergency room on 09Mar2021 and then most recent results she has of her paperwork were from 09Mar2021 to 10Mar2021; no further details provided by the caller. Caller states she was in the emergency room rolled over to the next day on the 09Mar in the evening around 10:30pm and concluded her ER visit on the 10Mar after 12:30. Caller states the HCP gave her the 40mg dose of Prednisone by injection and she has no lot number; states then at the ER, they gave her Prednisone 125mg IV and she has no lot number; they gave her hydroxyzine which is Atarax by IV and gave her Pepcid for her stomach at the same time; no lots for the Pepcid or Hydroxyzine. States the reason for her visit was allergic reaction, allergy hives, post covid delayed reaction. States she let them know at the site that before the vaccine she felt like she might have had an ear infection and was not taking anything no vitamins or anything like that and no Tylenol or anything for a week or so prior because she wanted nothing to be in her system other than the vaccine should anything happen. Had the vaccine that day, later on that afternoon contacted her HCP felt like she had ear infection, no fever but had fullness and some pain in her right ear. Saw her HCP at that time and took a look inside her ear and felt that she did have an ear infection without fever but was painful to the touch around her ear underneath her ear; prescribed Augmentin which she has taken before. Started taking one Augmentin pill on the 23rd in evening which would be Tues 23Feb2021 for the 1st dose, 500mg and dose supposed to take following the next day was to take two tablets one tablet twice per day which she did finish up around 10 days of that on 04Mar. The day before all this started with the rash she finished Augmentin, went to the HCP and two things happened; she was taking Augmentin and had the Pfizer COVID Vaccine. States she had the rash on her elbows and palm and arm and she was like that coincides with the Pfizer vaccine but also was on Augmentin and had been on that before with no problems; thought it was either the vaccine or being on the Augmentin as the reason for the rash but narrowed it to the vaccine. States she ended up in the hospital that evening on Monday evening of 09Mar and it was something they had not seen but were prepared to see could happen and concluded the rash was from the vaccine. Caller states she went to see her immunologist at the conclusion of this event and she was still covered in hives and rash and did step her down on the Prednisone and prescribed her hydroxyzine and topical itch stuff. Caller states she has no lot numbers to provide for the topical stuff or the hydroxyzine or Prednisone. States the HCP concluded she could not receive the 2nd dose of the Pfizer COVID Vaccine or any other vaccine that comes forward and she is not a candidate because of this reaction he can't safely say it would be ok to get a 2nd dose of the vaccine; states she can't receive a 2nd dose of any covid vaccine and it worried her because she has to be ok with having had the 1st dose of the vaccine and wants to know where she stands with that and what to do and she just doesn't know. States it is not she herself saying she can't get the 2nd dose of the covid vaccine but under her HCP advice and two ER visits and many doses of Prednisone and she presented how she looked and that prompted the HCP to say no 2nd dose for her. States she was taking Prednisone started two days of 50mg then 2 days of 40mg, then 30mg, then 20mg, then 10mg and that brought down the amount in her system; states she was given Hydroxyzine 1-2 tablets every 4 hours of 25mg and has no lot numbers for the Prednisone or Hydroxyzine. Caller states instead of taking Benadryl she was taking the topical stuff because Benadryl was not really working and she took Benadryl 25mg tablets in the beginning to try to get the itching out of her system and she felt really really tired and was so tired from taking the Benadryl; caller states she has no lot numbers to provide for the Benadryl. She was given a prescription for Hydroxyzine and the thinks it tended to work better and she did not take a drastic amount of it but it could cause drowsiness and she did feel a lot better from taking it but did not have a really bad feeling of feeling really dopey and sleepy with it because she felt bad enough and did not want to feel bad. States she kept on this for the 10 days or more of a 14 day course and was feeling like until it started to subside. On an unspecified date it was reported that Her WBC count was high and her "liver was not doing great" but recent bloodwork shows it has returned to normal. The patient was hospitalized for the events developed hives/rash on her palms, hands, elbows, and left hip, elbows were red, hive rash on her palm and hand and elbows and it was strange and her elbows were red and were itchy on the palms like red and itchy, her lips and tongue began to swell, WBC count was high, liver was not doing great, post COVID vaccine delayed allergic reaction. The patient underwent lab tests and procedures which included white blood cell count: returned to normal on an unspecified date, white blood cell count: high on Mar2021. Therapeutic measures were taken as a result of the events except for WBC count high and liver was not doing great. The outcome of the events was unknown.
59 2021-04-26 bruising to make sure there is no pulmonary embolism; Shaking legs and arms; Lightheaded; PVCs (Ventricular p... Read more
to make sure there is no pulmonary embolism; Shaking legs and arms; Lightheaded; PVCs (Ventricular premature beat); Large black bruise on left breast; 40 hrs fever; throwing up/vomiting; nausea 36 hours; intermittent breathing issues/sporadic breathing issues/difficulty breathing and hard to get a breath; She was weak; severe migraine; Headache; Brain fog; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received second dose of bnt162b2 (BNT162B2, lot number ER8727, expiration date: 31Jul2021), via an unspecified route of administration in arm left on 07Apr2021 12:00 as single dose for Covid-19 immunisation. Medical history included allergy ( macro Danton, sulfa). Patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medication included Nerontin. The patient reviously received flu vaccine and had normal things, previously received first dose of bnt162b2 (Lot Number: EN5318; Expiration Date: 31May2021) in arm left on 17Mar2021 16:00 and experienced acute lymphatic response, brain fog and arm started to hurt. The pateint was calling because her doctor, who she saw yesterday 14Apr2021, told her she should let Pfizer know what was going on. She had a reaction to the Pfizer Covid19 Vaccine. she was now having PVCs. The patient added that all of the events started with a fever, and throwing up. She had a fever and threw up for 36 hours. She had to contact her physician to get medication and to stop vomiting and the nausea and everything. During that time, she was sick. She was having intermittent breathing issues which she did not think she felt too much of until after the other sickness was over. She was weak, like people get after they are sick, and had bizarre shaking legs and arms which was strange. She added that she had breathing issues and difficulty breathing and hard to get a breath. That was what she was dealing with. Treatment: caller took Pedialyte and all the proper things to get back into better shape. The breathing issue still remained. The doctor called in a rescue inhaler. She kept going downhill so he called in a rescue inhaler. Large black bruise on left breast after second vaccine: Caller added that this one will not be believed but on Monday, she woke up and got dressed again and was just weak and had breathing issues but was just doing work on the laptop. She did not fall, she did not run into anything. In the evening, she went to take a bath and saw that when she took her clothes off there was a large black bruise on her left breast, it was probably 2 inches in diameter. It is very large, but does not hurt like a bruise. She checked the rest of her body for blood issues and only saw a couple normal looking bruises. She contacted her doctor, and they questioned her thoroughly on her bruising and activity. This was on Monday. Tuesday, she still felt the same headache, weak, and breathing issues. PVCs (Ventricular premature beat) after second vaccine: Yesterday, 14Apr2021, she started declining and the doctor wanted to see her. Caller stated the doctor heard PVCs in her heart. Caller asked clarification of PVC abbreviation and does not provide. She never had heart issues ever. The doctor did blood work and a chest x-ray, and saw the bruise and was worried about her blood. Caller added that even though these are not listed as side effects of the vaccine, she was worried. Her doctor sent her to a facility for chest x-rays to make sure there is no pulmonary embolism. Caller confirmed this was on 14Apr2021. She has not yet heard back. PVCs after second vaccine: Caller added the doctor said her lungs sounded good but wanted to see what was going on to see how her breathing was because there was difficulty. The doctor wanted to cover bases and check. Today, caller can tell her heart is still not in correct rhythm and that it is in continued PVCs. She still had the same breathing issues, limbs were weak, she was shaky, and she is lightheaded. She was hoping to wake up today and feel better. Fever after second vaccine: started 3am 08Apr2021. She had a fever and was throwing up at this time. Throwing up and nausea after second vaccine: caller add that throwing up and vomiting with nausea occurred at 3 am, all of this occurred 08APR2021. The vomiting lasted 36 hours, and it ended when she took medication. The fever lasted 40 hours. Even after the medication worked for her fever, she had nausea. Around Friday was when it went away. Intermittent breathing issues after second vaccine: caller adds it started with throwing up and fever, but she did not think a lot about this or know when it started because she was dealing with the fever and vomiting. It continued, and it has not subsided or ended. As a matter of fact, there are 2 or 3 times it has gotten bad which is why she was given an inhaler. Treatments: caller took a Phenergan suppository, which she adds is the best medicine in the World for nausea and beats Zofran. She had used two or three doses and it did work. She used a rescue inhaler, Albuterol Sulfate HFA. She took Tylenol for fever. She is also now taking an aspirin daily because of the blood issues. No additional information regarding the products. Weak after second vaccine: caller adds that this started at the same time, she was over the nausea and noticed this. It felt different than what it feels like with the flu. This is still going on, she did not think too much about it but it has persisted. Sometimes there is a little bit of shaking but that is intermittent. Caller states she can not put it into words. Bizarre shaking legs and arms after second vaccine: this goes with the weakness, she is continually weak but she has a shaky feeling that will come every now and then and is random. Large black bruise on left breast after second vaccine: Monday this started, 12APR2021 and it is still there but it is the same. It has not been sore like a bruise but it is black and large. The physician has seen it now and it is bizarre and scary. It is the left breast on the outside. Headache after second vaccine: started probably an hour after the vaccine, pretty quick. There were degrees to this headache because it was an actual migraine for a good 48 hours and even after the fever was gone it was terrible. It started out just a mild headache and then was very severe for a couple of days. Then, after that it was just there but not as severe. PVCs after second vaccine: caller adds that she went to the doctor yesterday 14APR2021 and she can tell every now and again that she is having these but there is nothing she can do about it. Caller adds this is everything new she can think of, but some of it is foggy, she thinks this is the main information. Brain fog after first and second vaccine: Caller then states, by the way, after both vaccines within 2 or 3 minutes of having them her head started feeling foggy and weird. Investigations: caller has not received any results yet. She did get an EKG, Chest XRAY, blood work, and the doctor also rattled off a bunch of things the doctor was going to check. These all were on 14Apr2021 and she is waiting on results. Caller confirms the physician told her she had PVCs while listening to caller's heart. Did any AE require a visit to: Physician office? 15Apr2021 she was in contact with her physician, and the whole week they were on the phone. Yesterday 14Apr2021 the physician wanted to see her. The doctor figured out something was going on with her heart so thankfully the doctor wanted to see her. It was discussed if caller should go to the ER but caller did everything she could not to go because that is the last place she wants to go. Emergency Room: no. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of fever, vomiting, nausea was recovered, intermittent breathing issues, shaking legs and arms, weak, severe migraine, headache was not recovered, for other events was unknown. No follow-up attempts are needed. No further information is expected.
59 2021-04-27 itchy rash, rash She got her vaccine, went home and has been real sleepy, drained and tired. She has a rash on her n... Read more
She got her vaccine, went home and has been real sleepy, drained and tired. She has a rash on her neck real bad and itchy, patchy type which grew to other parts of her neck. She cannot get anything done due to the fatigue and loss of appetite. These reactions still continue as of 4/28/21. She has not taken anything for this reaction. She is going to call her PCP today.
59 2021-04-28 bruising blood clot under her eye; bright red bruise in the corner of the eye to the middle of the eye undern... Read more
blood clot under her eye; bright red bruise in the corner of the eye to the middle of the eye underneath; feeling crummy; she was down; headaches; couldn't move; arm hurt all the way below her arm pit into her breast; arm hurt all the way below her arm pit into her breast; arm hurt all the way below her arm pit into her breast; got very sick; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8737), dose 1 via an unspecified route of administration, administered in Arm Left on 05Apr2021 08:30 (at the age of 59years) as single dose for Covid-19 immunization. Medical history included ongoing rheumatoid arthritis and osteoarthritis (not bad enough that she takes treatment, but she is diagnosed; she was diagnosed way back in 2006). Concomitant products: patient stated she takes some medications (not further specified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that she had her first dose of the Pfizer Covid-19 vaccine on 05Apr2021 and got very sick. She was down for two days and after day 10 (as reported) she has a blood clot under her eye. She would like to know what would happen if does not get a second dose. She consulted if there is any talk on whether or not people should receive an additional dose of the Pfizer Covid-19 vaccine next year. The patient further reported that on 06Apr2021 she woke up feeling crummy right away and a couple of hours into that day she couldn't lift her arm, literally couldn't lift arm for 6 inches and stated it went on for 2 days. She further stated that her arm hurt all the way below her arm pit into her breast. She stated that it all ended on 08Apr2021 and she went back to work on 08Apr2021. The patient added that she was down for two days, had headaches, and stated she never knew what people meant when they said they got hit by train. She doesn't believe she had a fever and couldn't move. The patient further stated that she got pretty darn sick and this morning 14Apr2021, she woke up with a blood clot under her eye. She is an esthetician and is pretty good with skin. She stated that she doesn't know how she could get this overnight unless she injured herself in her sleep, but she is a light sleeper. She does not know if it is a clot. She also stated that she called a medical esthetician who told her to take a baby aspirin and cold compress. The patient clarified that she didn't feel so good and today she feels better. She doesn't know that it is a blood clot, it is not raised and not hard, it looks like she has a bright red bruise in the corner of the eye to the middle of the eye underneath, not in the eye. She wants to make it clear she doesn't know if it is a blood clot. She feels like if she hurt herself, that would be the reason, but it would be painful, and it is not. She added that the bruise is about the same. Therapeutic measures were taken as a result of the events (except for feeling down and couldn't move). The outcome of events thrombosis and contusion was not recovered; the outcome of other events was recovered on 08Apr2021.
59 2021-04-30 redness Low body temperature; Fatigue; Anxiety; Brain fog; High BP/Pressure in head and high blood pressure;... Read more
Low body temperature; Fatigue; Anxiety; Brain fog; High BP/Pressure in head and high blood pressure; Severe chills; Strange redness across her shoulders; Arm hurt after shot; Pressure in head; Very loose stools; Nausea; This is a spontaneous report from a contactable consumer reporting for herself. A 59-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 05Apr2021 13:30 (Batch/Lot Number: EP7533) as single dose for covid-19 immunisation (Age at vaccination: 59 years) . Medical history included liver disorder , hypersensitivity, hepatitis C from , osteopetrosis , arthropod sting allergy , drug hypersensitivity , gluten sensitivity (She is borderline celiac, and she will get really bad gastro problems for 2 or 3 days after digesting gluten) , penicillin hypersensitivity (She has itching, rash, nausea) , peanuts allergy (Keeps an EPI pen for this). Concomitant medications included d-ribose, polypeptide (TRANSFER FACTOR [D-RIBOSE;POLYPEPTIDE]) taken for hepatitis C from 2003 to 03Apr2021; ascorbic acid (VITAMIN C ACID) taken for an unspecified indication from an unspecified start date to 03Apr2021; vitamin D3 (VITAMIN D3) taken for osteopetrosis from an unspecified start date to Apr2021; probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported. The patient experienced high bp/pressure in head and high blood pressure on 05Apr2021 with outcome of unknown , fatigue on an unspecified date with outcome of unknown , severe chills on 05Apr2021 with outcome of unknown , low body temperature on an unspecified date with outcome of unknown , strange redness across her shoulders on 05Apr2021 with outcome of recovered , arm hurt after shot on 05Apr2021 with outcome of unknown , pressure in head on 05Apr2021 with outcome of unknown , very loose stools on 05Apr2021 with outcome of unknown , nausea on 05Apr2021 with outcome of unknown , brain fog on 06Apr2021 with outcome of not recovered , anxiety on an unspecified date with outcome of unknown. Hypertension was considered an Important Medical Event. The remaining events were non serious. The patient underwent lab tests and procedures which included blood pressure increased: 179/98, 170/97 on unknown date , blood pressure measurement: 152/87 on 06Apr2021 , body temperature decreased: low No follow-up attempts are needed. No further information is expected.
59 2021-04-30 redness they did an ekg and it was abnormal, I have 2 extra heartbeats; having a hard time walking moving he... Read more
they did an ekg and it was abnormal, I have 2 extra heartbeats; having a hard time walking moving her muscles; having a hard time walking moving my muscles/Every muscle and joint ached severely; having a hard time walking moving my muscles/Every muscle and joint ached severely; Redness and swelling in left arm for 2 days with pain; Redness and swelling in left arm for 2 days with pain; Redness and swelling in left arm for 2 days with pain; I have had fluttering and my heart feels like it is jumping in my chest.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Apr2021 08:45 at single dose in left arm for COVID-19 immunisation. Medical history included Hypothyroidism, fibromyalgia, Type 2 diabetes. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. Concomitant medications included atorvastatin, duloxetine, glimepiride, and levothyroxine. The patient had not received other vaccine in four weeks. The patient previously received pregabalin (LYRICA) and had allergies. On 02Apr2021 12:00, the patient had Redness and swelling in left arm for 2 days with pain. 2 days after shot (04Apr2021) she was having a hard time walking moving her muscles. Every muscle and joint ached severely nothing helped the pain. Now she was 13 days past the shot with muscle pain. She went to doctor yesterday (14Apr2021) and they did an EKG and it was abnormal. She had 2 extra heartbeats in Apr2021. Since shot she had had fluttering and her heart felt like it was jumping in her chest. The patient had Blood work in Apr2021. The outcome of all events was not resolved. Information on the lot/batch number has been requested.
59 2021-05-02 rash, bruising, itchy skin difficulty swallowing; swelling left side of throat; can't turn head to the left; overall body itchi... Read more
difficulty swallowing; swelling left side of throat; can't turn head to the left; overall body itching rash especially on neck, check and torso, which turned into large bruises
59 2021-05-05 rash with redness Got light headed 12-14 minutes after shot, at 30 minutes in car took off mask had red fire engine ra... Read more
Got light headed 12-14 minutes after shot, at 30 minutes in car took off mask had red fire engine rash on cheeks/chin and face swelling, roof of mouth felt slightly swollen and lips tingly feeling slightly swollen, pills felt stuck in back of throat. went back in facility they told me to take Benadryl and go to doctor or ER if it gets worse, took Benadryl and Zyrtec and started past allergic reactions protocol, up to 4 Zyrtec and 4 Allegra in a day and Benadryl as needed. QNasl. Saw nurse practitioner who added Pepcid 2times a day. Did this for 3 weeks pills still feel stuck at back of throat on and off in a day.
59 2021-05-07 rash, itchy skin An awful rash described as "a wild wild rash on my chest, bright red itchy angry"/Rash on mostly upp... Read more
An awful rash described as "a wild wild rash on my chest, bright red itchy angry"/Rash on mostly upper left part of back and right hand; itchy hurting mess//Every rash is painful and itching/ Rash is very itchy/ rash is a scratchy, hurty mess; itchy hurting mess/ Every rash is painful and itching/very painful/hurty mess; Tired and sleepy; Tired and sleepy; This is spontaneous report from contactable consumer (patient herself) via a medical information team. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 15Apr2021 at 12:10 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included fibromyalgia from an unspecified date in 2012, lupus psoriasis from an unspecified date in 2010, allergies, compromised immune status, genetic /chromosomal abnormalities, respiratory illness, endocrine abnormalities, diabetes from an unspecified date in 2015, chronic fatigue (chronic fatigue syndrome) from an unspecified date in 2012, obesity, psoriasis from an unspecified date in 2010, migraine, anxiety, and depression from an unspecified date in 1965. Concomitant medications included atenolol (Strength: 50 mg) from an unspecified date in 1988 at 50 mg, daily for migraine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), in left arm on 25Mar2021 (at the age of 59-year-old, Lot number: ER2613) as a single dose for COVID-19 immunisation and experienced left arm soreness and slept for 3 days on 25Mar2021. It was reported that the patient received first dose in left arm up very high in the muscle. The family history included glaucoma, anxiety, and depression from an unspecified date in 1965, diabetes from an unspecified date in 2015, heart disease. Prior vaccinations (within 4 weeks) was none. The patient did not develop adverse events prior vaccinations. Additional vaccines administered on same date of the Pfizer suspect was none. Caller was a consumer, enquired asking what she was supposed to do with this rash. Caller reports that she received her second vaccine dose on 15Apr2021 and 4 hours after getting her vaccination she became an "itchy hurting mess" on 19Apr2021. Her first vaccine dose was reportedly 3 weeks prior to her second. She reports that she was experiencing an awful rash described as "a wild rash on my chest, bright red itchy angry" on 19Apr2021. Caller reports that she has seen her healthcare professional twice her Dermatologist three times and her Psychiatrist twice with no improvement or guidance. Caller states "Pfizer was the one who made it they should know what do to about the side effects". Caller reports that she has tried numerous over the counter products and medicines to help with her rash, but nothing has helped. Caller reports that she has asked her doctor to give her a cortisone shot and was refused because it may interfere with the vaccine. Caller became audibly upset asking loudly, "what am I supposed to do?!" and "what happens to me" reporting that people get the shot, and they are "thrown to the wind" and no one knows what to do for me. Caller asks, "How many people total have had adverse reactions after getting the vaccine." During this call, caller threatened to go to the News and then stated, "I don't know what to do I may have to kill myself". Caller made no additional statements of harm to herself and no need to direct to suicide hotline was necessary. Caller was a consumer, asking "how do I get help to pay for the medicines I have had to use after getting the vaccine." Caller was a consumer, asking "what would be a contraindication to getting the vaccine." Caller was a consumer, asking, "did you have anyone with autoimmune problems get the vaccine". Caller reports that she has fibromyalgia, lupus Psoriasis and says, I have an autoimmune disease, I am not immunosuppressed. Received call from consumer regarding the Pfizer COVID vaccine. She has reported adverse events. There was no prescriber. The doctor's on site need more training. She should have never been allowed to have the vaccine. She had a swollen left eye and a rash around left eye when she went in and the doctor said it was ok. She wanted to know if there was any directive on who should not get the vaccine. Small rash around left eye started to spread. The rash was there before. It was hard to comb out what happened when. Rash was very itchy and very painful. Nobody knows what it was. She has been to 6 doctors. This was the second dose that she started having the issues with the rash. She later stated she had arm pain and slept for 3 days after the first dose. She has a growth that was there previous on the upper left arm and during the second injection, she thinks it was given a little higher in the shoulder, closer to where that growth was. She was not sure that one was given in the muscle. The Effexor was increased at first due to titration up to full capacity or dose. Then titration down because of side effects and then titration down due to rash. She stated it was the same rash that we are talking about. It was in a pharmacy vial with no lot or expiration. If she ever had a regular vial it was thrown away. There were different bottles with different doses and different lots and expirations. She no longer has any of the bottles to provide a lot or expiration. She has the 150mg, count size was 90 tablets. This was the one she was taking when she was taking the shot. It was in a Pharmacy vial. Her current dose was 75 mg once daily. That was in a pharmacy vial with no lot or expiration. She has pictures of the rash and it is bright red and very angry. They did a biopsy of chest on 27Apr2021, and the results are not back yet. She went to dermatologist for the third time on 27Apr2021. For the first one, she only slept for 3 days and only had arm pain. She later stated she might have slept for 3,4 or 5 days, she does not remember. ER or physician's office required. Physician visits 16Apr2021, saw a dermatologist at withheld Dermatology, that she doesn't remember his name. He was a 50-year-old male doctor. Creams, ointments and later stated Hydrocortisone 1%. She has a bag full of creams and ointments. and was lucky she remembers what goes on what parts. Some do not go on face or near eye. This was the only one that went near her eye. Then on 20Apr2021, she saw Dr. at the same group with the same address and phone as last one. She does not remember what was given when. Maybe 2.5% cream was given then, but then said no, that was not during that visit. She does not remember when was given what. They just keep having her buy more lotion and buy more stuff. They have helped a little bit. Something inside of her body was causing it. The rash just keeps getting worse and they are a band aid, and nothing was getting rid of it. She does not wish to provide the names of those creams and ointments and did not wish to provide dose, lot, or expiration for any. She said they are not the issue. She then saw the same 50-year-old bald male, not Dr. the other guy, on 27Apr2021, she got a biopsy on her chest and does not have results. He prescribed a new cream. She also saw Dr., primary care physician, 27Apr2021. She said she believes it was because of the vaccine but she did not want to give cortisone or prednisone because it might negate the vaccine. She directly faults Pfizer with her doctor not knowing what they could and could not use. She saw Dr. Psychiatrist, on 27Apr2021. She had already lowered her Effexor by phone. No additional treatment during that visit. She lowered the dosage on 22Apr2021 from 150 mg to 75 mg now. That doctor said she does not know if it was from the Effexor or the shot. The dermatologist does not know if it was from Psoriasis or the vaccine because the rash got worse in sun. Usually psoriasis gets better in the sun. Caller states she has done three reports so far and no one can help her. Says every idea they give her was one she has already done or can't do. States nobody knows why she has this rash, nor do they know what to do. She has been sleeping all day, every day, since 15Apr2021. She has lost 2 weeks of her life. She also wanted to know if Pfizer recommends giving the vaccine with autoimmune problems. She has not read anything about that. She lastly stated that the rash started in her upper arm and was now spreading to her lower right arm. This started 2 days ago (25Apr2021). Was there any clearing house for people with problems. She read there are like 400 people who have problems after the four hours. They did not count her and there are a probably a million other people. There was no specific information on those 400 people, and it was just a report. She did not have any further details to provide. Call handler asks caller if she was wanting to do a follow up report from the one this morning and if she has any new symptoms. The caller states that her rash has gotten worse. She states it was better in the morning, worse at night, better in the morning, worse at night. States her rash was a scratchy, hurty mess. She wants to know what to do about her rash. Caller says that the doctor won't give her steroid medications for the rash because she had the vaccine recently. Caller goes on about how she needs to speak with the people who developed the vaccine. States how can Pfizer just be out there telling everyone to get the vaccine, get the vaccine, get the vaccine; but then could not help them when they have a reaction. Caller randomly says that she has read about shingles after the vaccine. States why do they put polyethylene glycol in things if they know some people are allergic? Caller did not specify that this was in the vaccine, she just stated it as things. Call handler asks caller if she was allergic to polyethylene glycol? Caller yells she doesn't know. States her rash itches and hurts and was driving her nuts. Again says better in the morning, worse at night, better in the morning, worse at night. The patient was tired and sleepy on 15Apr2021. No investigation assessment. The patient underwent lab test and procedure which included biopsy: Results are not back yet on 27Apr2021. The outcome of the events tired and sleepy was not recovered, recovering for the event rash, itchy and unknown for the other event. Description of Product Complaint: Description of complaint: Unspecified creams and ointments that were prescribed that are not helping her rash get any better. They just keep having her buy more lotion and buy more stuff. They have helped a little bit. Something inside of her body was causing it. The rash just keeps getting worse and they are a band aid, and nothing was getting rid of it. She has a bag full of them and did not wish to provide the names, manufacturer's, doses, lots, or expirations. She only stated name of Hydrocortisone 1%. She later stated one was changed to 2.5% but did not wish to provide details about which one. She did not wish to provide lot or expiration for any of them. Product strength and count size dispensed: Unknown. Additional lot numbers: None was a sample of the product available to be returned. Follow-up attempts are completed. No further information is expected.
59 2021-05-07 skin mass little heart palpitations; felt really warm; felt like she was on fire; Nauseous; she was white as a... Read more
little heart palpitations; felt really warm; felt like she was on fire; Nauseous; she was white as a ghost; felt cold; Dizzy; bruised her tailbone; Passed out; from when she fell she has a knot on the back of her head, and her back has a kink; from when she fell she has a knot on the back of her head, and her back has a kink; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in left arm on 22Apr2021 17:36 (Lot Number: EW0161) (at age 59 years old) as single dose for covid-19 immunisation. Medical history included diabetic from an unknown date and unknown if ongoing diagnosed in 2001-2002. The patient's concomitant medications were not reported. She did not get any other vaccinations yesterday or in the last four weeks. She says she has started no other new meds recently. The patient stated she got her first dose on 22Apr2021 and was perfectly fine, she didn't feel anything. She says when she went to bed a few hours later, she felt really really warm like she was sunburnt or something. She says she slept, then woke up around midnight and got up and thought maybe she had to go to the bathroom. She says she felt nauseous and thought she was going to be sick so she went back to the bathroom and she was white as a ghost, and felt cold and dizzy. She says she was feeling like she was gonna pass out, so she thought her sugar levels had dropped really low, so she went downstairs to check them then woke up on the floor, she had passed out. She says she came to, and checked her sugar and it was normal, 110, so she is assuming she passed out due to the shot. She says her first dose was injected around 17:36, and it was a few hours later when she went to bed around 09:00-9:30PM and got into bed when she kind of felt like she was on fire. She says she did no treatment; she went to sleep. She says from when she fell she has a knot on the back of her head, and her back has a kink in it. She says she is sure she has also bruised her tailbone. As of 23Apr2021, she doesn't feel warm or anything now, she just has little heart palpitations that is all, and those have stayed about the same. Outcome of the events was unknown.
59 2021-05-07 itchy skin, rash, rash macular, hives spots where she bleeds from scratching; red spots on her arms that weren't there before. She wouldn'... Read more
spots where she bleeds from scratching; red spots on her arms that weren't there before. She wouldn't call those spots a rash; itching kept her up all night/ She was up all night; rash and welts and the rash was moving up in her face; welts; hands started itching/itching moved up her arms and down her legs and then her whole body was itching; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 05Feb2021 13:30 (Lot Number: EN5318) as single dose for covid-19 immunisation. Medical history included high blood pressure and did have surgery in Jan2021, a week before she received the Covid 19 vaccine. She had screws placed in her foot. Her foot had been injured from being twisted too many times. It was an old injury. Concomitant medications included atenolol; omeprazole; venlafaxine; and hydrochlorothiazide, valsartan (VALSARTAN/HCTZ TEVA); all ongoing. Probably about 15 years ago, she received a flu vaccine where her husband worked. His place of employment offered flu vaccines to employees and their families every year. She went to get the flu vaccine and that was probably around 9:00AM and by the time she got off work that day she was so sick with the chills that she crawled into bed. It felt like she had the flu. The next day she felt better just worn out. She hasn't had a flu vaccine since then. She received her first Covid 19 vaccine on 05Feb2021 and about 20 minutes after (05Feb2021 13:50), she received the vaccine her hands started itching and she didn't think a lot about it. As time wore on, the itching moved up her arms and down her legs and then her whole body was itching. By Sunday, 07Feb2021 she had a rash and welts and the rash was moving up in her face. She went to the emergency room on Sunday, 07Feb2021 because the rash was on her face. She was getting scared. She was miserable. She was taking Benadryl and it wasn't doing anything for her. The emergency room gave her a Benadryl injection and liquid steroids and prescribed 2 epinephrine pens (Epi-pens) in case she started to have problems breathing. She did not have trouble breathing. She also received pills to help with her itching. She was still taking those pills because she was still itching. As of 23Apr2021, it was still persisting nothing has improved slightly. It keeps her up at night, making her miserable, and described it as severe. She had spots where she bleeds from scratching. She was up all night two days ago because the itching was so bad. The pills do help but she has to work so she can not take too many or she will be asleep at her desk. Patient hoped that Pfizer would have something to tell her healthcare provider about what to do for her. She was advised by her doctor to not get the second Covid 19 vaccine. She went to her family doctor about a week later and explained what had happened with the Covid 19 vaccine and her doctor was able to review her emergency room visit paperwork. Her primary care doctor prescribed more of the pills for itching because she had gone through the pills that the emergency department prescribed. She reported that the rash has improved but at times, all of a sudden, she'll start itching and it's the type of itching that she can't stop scratching. With scratching it will grow into welts and a rash and then it goes away. She doesn't like to take the pills prescribed for itching because she doesn't like to take medicine. The itching kept her up all night in different parts of her body. The itching will ease down and then the itching will stop and then probably a good hour will pass and the rash will go away. The only thing that was left to see was where she scratched on her body. She still has red spots on her arms that weren't there before. She wouldn't call those spots a rash. The pill she was prescribed for itching is Hydroxyzine 25mg take one by mouth every 6 hours as needed for itching. This one helps but she doesn't want to take it because it can make her tired and she has to work. Outcome of the event "hands started itching/itching moved up her arms and down her legs and then her whole body was itching" was not recovered while unknown for other events.
59 2021-05-10 redness Mouth broke out; zit that broke out on the top of her eyebrow. There are hard little bumps; they wer... Read more
Mouth broke out; zit that broke out on the top of her eyebrow. There are hard little bumps; they were red and hard; Arm was sore; puffy/swollen; She had a breakout on her face, a couple of lesions, and her mouth broke out.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included allergic to Penicillin, crustaceans, shellfish, and mushrooms. Those were what she usually had a breakout for. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced drug allergy and second degree burns. Her reaction to amoxicillin was probably 15 years before. The patient had a reaction to her first Covid-19 shot. She took the first shot last Tuesday. She had a breakout on her face, a couple of lesions, and her mouth broke out. It looked like a reaction. She took a couple of diphenhydramine hydrochloride (BENADRYL), and it was going away. Her second shot was scheduled for next Tuesday 11May2021. She needed to know if there was anything in the shot that would cause this. She was leery of taking it. She was okay with it, and the diphenhydramine hydrochloride was fine. She did contact her doctor. That was it, she had nothing else just the breakout. She thought it was maybe Thursday 22Apr2021 or Friday 23Apr2021 that she noticed the breakout on her face. She started trying to take some diphenhydramine hydrochloride. It was rapid when it happened, not slow. She saw these as almost like a reaction. She had welting on the skin similar to a reaction to dust mites. There was this thing she thought was just a zit that broke out on the top of her eyebrow. There were hard little bumps. One had gone away, and the other was still there. It was almost like when she had a breakout of zits was kind of what she would say. It was dissipating. She started taking rounds of diphenhydramine hydrochloride to stop the reaction, and it was working. She was concerned about the second shot. She didn't know if it was an allergic reaction to amoxicillin or any other type of medicine if it was in there. That was what she was concerned about. Before she got the second shot she needed an idea of what might have happened. The lesions came a day or so after the breakout on her face. She would say Sunday 25Apr2021 was when she saw the lesions above her eyebrows. It was right at the beginning of her eyebrow. It was really hard at first. It was not itching, just like zits. Similarly, they were red and hard. Once again she started the diphenhydramine hydrochloride and saw a little bit of difference, but had to keep putting on topical Aquaphor and cocoa butter. She had to keep putting it on there, it was just swollen. The lesions were puffy and red. There was just one left, it was going down. Her mouth was the number one thing. She thought it was from wearing a mask. She had never had a breakout with a mask before. She took the shot on Tuesday, and her arm was sore just for 24 hours. She noticed her mouth broke out Thursday or Friday for sure when she woke up. At first she just kind of forgot about the shot and didn't put two and two together. She took diphenhydramine hydrochloride. It was the same type of reaction she would have if it was amoxicillin. She really needed to know if she should anticipate something with the second shot. Outcome of event a breakout on her face, a couple of lesions, and her mouth broke out was resolving, and of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.